title: A Randomized, Open Label Multi-Center Study of XRP6258 at 25 mg/m^2 in Combination With Prednisone Every 3 Weeks Compared to Mitoxantrone in Combination With Prednisone For The Treatment of Hormone Refractory Metastatic Prostate Cancer Previously Treated With A Taxotere®-Containing Regimen

acronym: TROPIC

summary: This is a randomized, open-label, multi-center study comparing the safety and efficacy of XRP6258 plus prednisone to mitoxantrone plus prednisone in the treatment of hormone refractory metastatic prostate cancer previously treated with a Taxotere®-containing regimen. The primary objective is overall survival. Secondary objectives include progression free survival, overall response rate, prostate-specific antigen (PSA) response/progression, pain response/progression, overall safety, and pharmacokinetics. Patients will be treated until disease progression, death, unacceptable toxicity, or for a maximum of 10 cycles. Patients will have long-term follow-up for a maximum of up to 2 years.

ReferenceCitation: Lorente D, Mateo J, Templeton AJ, Zafeiriou Z, Bianchini D, Ferraldeschi R, Bahl A, Shen L, Su Z, Sartor O, de Bono JS. Baseline neutrophil-lymphocyte ratio (NLR) is associated with survival and response to treatment with second-line chemotherapy for advanced prostate cancer independent of baseline steroid use. Ann Oncol. 2015 Apr;26(4):750-755. doi: 10.1093/annonc/mdu587. Epub 2014 Dec 23.

ReferenceCitation: Bahl A, Oudard S, Tombal B, Ozgüroglu M, Hansen S, Kocak I, Gravis G, Devin J, Shen L, de Bono JS, Sartor AO; TROPIC Investigators. Impact of cabazitaxel on 2-year survival and palliation of tumour-related pain in men with metastatic castration-resistant prostate cancer treated in the TROPIC trial. Ann Oncol. 2013 Sep;24(9):2402-8. doi: 10.1093/annonc/mdt194. Epub 2013 May 30.

ReferenceCitation: Pouessel D, Oudard S, Gravis G, Priou F, Shen L, Culine S. [Cabazitaxel for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: the TROPIC study in France]. Bull Cancer. 2012 Jul-Aug;99(7-8):731-41. doi: 10.1684/bdc.2012.1608. French.

ReferenceCitation: de Bono JS, Oudard S, Ozguroglu M, Hansen S, Machiels JP, Kocak I, Gravis G, Bodrogi I, Mackenzie MJ, Shen L, Roessner M, Gupta S, Sartor AO; TROPIC Investigators. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. Lancet. 2010 Oct 2;376(9747):1147-54. doi: 10.1016/S0140-6736(10)61389-X.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
South Africa
Russian Federation
Argentina
India
Turkey
Mexico
Singapore
Sweden
Slovakia
Brazil
Canada
Hungary
Germany
Denmark
Taiwan
Finland
Czech Republic
Korea, Republic of
France
Chile
Netherlands

location_facility:
Sanofi-Aventis Hungaria
sanofi-aventis South Africa
sanofi-aventis Brazil
sanofi-aventis Canada
sanofi-aventis Russia
sanofi-aventis South Korea
sanofi-aventis Singapore
sanofi-aventis Mexico
sanofi-aventis India
sanofi-aventis Argentina
sanofi-aventis Slovakia
sanofi-aventis Belgium
sanofi-aventis US
sanofi-aventis Italy
sanofi-aventis Chile
sanofi-aventis Netherlands
sanofi-aventis Finland
sanofi-aventis Denmark
sanofi-aventis Czech Republic
sanofi-aventis Sweden
sanofi-aventis UK
sanofi-aventis Turkey
sanofi-aventis Taiwan
sanofi-aventis Spain
sanofi-aventis France
sanofi-aventis Germany


type: EudraCT Number

title: International, Multicenter, Randomized, Parallel Group, Double-blind Study, in Patients With Acute Symptomatic Deep Vein Thrombosis of the Lower Limbs, Demonstrating the Bioequipotency at Steady State of Equimolar Doses of SSR126517E (3.0 mg) Once a Week and SR34006 (2.5 mg) Once a Week, Documenting the Safety and Efficacy of Both Compounds During a 6-month Treatment, and Demonstrating the Neutralizing Effect of SSR29261 on the SSR126517E-induced Anti-Xa Activity

acronym: EQUINOX

summary:
The three purposes of this study are the following:

To compare during a 6-month treatment the safety and effectiveness of idrabiotaparinux (SSR126517) with that of idraparinux (SR34006), taking into account new events of deep venous thrombosis (DVT) and pulmonary embolism (PE), and bleeding risk;
To compare the activities of idrabiotaparinux and idraparinux directly in blood during and after a 6-month treatment;
To check the ability of avidin (SSR29261) to reverse the blood thinning activity of idrabiotaparinux at the end of a 6-month treatment period.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: Equinox Investigators. Efficacy and safety of once weekly subcutaneous idrabiotaparinux in the treatment of patients with symptomatic deep venous thrombosis. J Thromb Haemost. 2011 Jan;9(1):92-9. doi: 10.1111/j.1538-7836.2010.04100.x.

ReferenceType: derived

ReferenceCitation: Trellu M, Fau JB, Cortez P, Cheng S, Paty I, Boëlle E, Donat F, Sanderink GJ. Bioequipotency of idraparinux and idrabiotaparinux after once weekly dosing in healthy volunteers and patients treated for acute deep vein thrombosis. Br J Clin Pharmacol. 2013 May;75(5):1255-64. doi: 10.1111/bcp.12009.

ReferenceCitation: Paty I, Trellu M, Destors JM, Cortez P, Boëlle E, Sanderink G. Reversibility of the anti-FXa activity of idrabiotaparinux (biotinylated idraparinux) by intravenous avidin infusion. J Thromb Haemost. 2010 Apr;8(4):722-9. doi: 10.1111/j.1538-7836.2010.03746.x. Epub 2010 Jan 17.

lead_sponsor: Sanofi

location_country:
Denmark
Poland
Brazil
Spain
Italy
Austria
Australia
Mexico
Argentina
Canada
Czech Republic
New Zealand
Russian Federation
United States
France
Israel
South Africa
Belgium
Turkey
Netherlands

location_facility:
sanofi-aventis Israel
Sanofi-Aventis
sanofi-aventis Mexico
sanofi-aventis, Netherlands
Sanofi-aventis
sanofi-aventis France
sanofi-aventis Turkey

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


type: Other Identifier

title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Design Study to Evaluate the Efficacy and Safety of Teriflunomide in Reducing the Frequency of Relapses and Delaying the Accumulation of Physical Disability in Subjects With Multiple Sclerosis With Relapses

acronym: TEMSO

summary:
The primary objective was to determine the effect of teriflunomide on the frequency of relapses in patients with relapsing multiple sclerosis (MS).

Secondary objectives were:

to evaluate the effect of teriflunomide on the accumulation of disability as measured by Expanded Disability Status Scale [EDSS], the burden of disease as measured by Magnetic Resonance Imaging [MRI] and patient-reported fatigue;
to evaluate the safety and tolerability of teriflunomide.

ReferenceCitation: O'Connor P, Wolinsky JS, Confavreux C, Comi G, Kappos L, Olsson TP, Benzerdjeb H, Truffinet P, Wang L, Miller A, Freedman MS; TEMSO Trial Group. Randomized trial of oral teriflunomide for relapsing multiple sclerosis. N Engl J Med. 2011 Oct 6;365(14):1293-303. doi: 10.1056/NEJMoa1014656.

ReferenceCitation: Sprenger T, Kappos L, Sormani MP, Miller AE, Poole EM, Cavalier S, Wuerfel J. Effects of teriflunomide treatment on cognitive performance and brain volume in patients with relapsing multiple sclerosis: Post hoc analysis of the TEMSO core and extension studies. Mult Scler. 2022 Oct;28(11):1719-1728. doi: 10.1177/13524585221089534. Epub 2022 Apr 29.

ReferenceCitation: Comi G, Freedman MS, Meca-Lallana JE, Vermersch P, Kim BJ, Parajeles A, Edwards KR, Gold R, Korideck H, Chavin J, Poole EM, Coyle PK. Prior treatment status: impact on the efficacy and safety of teriflunomide in multiple sclerosis. BMC Neurol. 2020 Oct 6;20(1):364. doi: 10.1186/s12883-020-01937-4.

ReferenceCitation: Radue EW, Sprenger T, Gaetano L, Mueller-Lenke N, Cavalier S, Thangavelu K, Panzara MA, Donaldson JE, Woodward FM, Wuerfel J, Wolinsky JS, Kappos L. Teriflunomide slows BVL in relapsing MS: A reanalysis of the TEMSO MRI data set using SIENA. Neurol Neuroimmunol Neuroinflamm. 2017 Aug 9;4(5):e390. doi: 10.1212/NXI.0000000000000390. eCollection 2017 Sep.

ReferenceCitation: Sormani MP, Truffinet P, Thangavelu K, Rufi P, Simonson C, De Stefano N. Predicting long-term disability outcomes in patients with MS treated with teriflunomide in TEMSO. Neurol Neuroimmunol Neuroinflamm. 2017 Jun 28;4(5):e379. doi: 10.1212/NXI.0000000000000379. eCollection 2017 Sep.

ReferenceCitation: Freedman MS, Wolinsky JS, Comi G, Kappos L, Olsson TP, Miller AE, Thangavelu K, Benamor M, Truffinet P, O'Connor PW; TEMSO and TOWER Study Groups. The efficacy of teriflunomide in patients who received prior disease-modifying treatments: Subgroup analyses of the teriflunomide phase 3 TEMSO and TOWER studies. Mult Scler. 2018 Apr;24(4):535-539. doi: 10.1177/1352458517695468. Epub 2017 Mar 17.

ReferenceCitation: Miller AE, O'Connor P, Wolinsky JS, Confavreux C, Kappos L, Olsson TP, Truffinet P, Wang L, D'Castro L, Comi G, Freedman MS; Teriflunomide Multiple Sclerosis Trial Group. Pre-specified subgroup analyses of a placebo-controlled phase III trial (TEMSO) of oral teriflunomide in relapsing multiple sclerosis. Mult Scler. 2012 Nov;18(11):1625-32. doi: 10.1177/1352458512450354. Epub 2012 Jun 21.

location_country:
United Kingdom
Italy
Ukraine
United States
Poland
Portugal
Austria
Russian Federation
Turkey
Norway
Sweden
Canada
Switzerland
Germany
Denmark
Estonia
Finland
Czech Republic
France
Chile
Netherlands

location_facility:
Sanofi-Aventis Switzerland
sanofi-aventis Finland
sanofi-aventis, Canada
Sanofi-Aventis
Sanofi-Aventis Austria
sanofi-aventis Denmark
sanofi-aventis Poland
Sanofi-Aventis Administrative Office
sanofi-aventis UK
sanofi-aventis France
sanofi-aventis Turkey
Sanofi-Aventis Deutschland GmbH


title: A Randomized Dose Ranging Study of Hexadecasaccharide Including Active Control, in Patients With Unstable Angina or Non-ST-Segment Elevation Myocardial Infarction Scheduled to Undergo Percutaneous Coronary Intervention (SHINE)

acronym: SHINE

summary: The purpose of this study is to test whether SR123781A is a possible treatment for patients with acute coronary syndromes (heart attack) who are scheduled to undergo a percutaneous coronary intervention (PCI) within 48 hours after inclusion in the study. Two doses of SR123781A are currently tested, each in a group of about 180 patients per group to find which is the most adequate, versus heparin and glycoprotein IIbIIIa (GPIIBIIIA) antagonist.

location_country:
Poland
Brazil
Portugal
Spain
Russian Federation
Australia
Mexico
Argentina
Canada
Czech Republic
Korea, Republic of
United States
Chile
France
India
Belgium
Turkey
Netherlands

location_facility:
Sanofi-aventis
Sanofi-Aventis France
Sanofi-Aventis


title: LIVACOR Trial: Minimally Invasive LIVer And Simultaneous COlorectal Resection

acronym: LIVACOR

summary: The LIVACOR - Trial is a European wide, randomized controlled, open-label, multicenter trial. Patients with synchronous colorectal liver metastases (CRLMs) and primary colorectal tumor are considered eligible and will be randomized between minimally invasive (MI) combined or staged colorectal resection (all colectomies, including high anterior resection) and liver resection of up to three segments.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: van der Poel MJ, Tanis PJ, Marsman HA, Rijken AM, Gertsen EC, Ovaere S, Gerhards MF, Besselink MG, D'Hondt M, Gobardhan PD. Laparoscopic combined resection of liver metastases and colorectal cancer: a multicenter, case-matched study using propensity scores. Surg Endosc. 2019 Apr;33(4):1124-1130. doi: 10.1007/s00464-018-6371-1. Epub 2018 Aug 1.

ReferenceCitation: Pan L, Tong C, Fu S, Fang J, Gu Q, Wang S, Jiang Z, Juengpanich S, Cai X. Laparoscopic procedure is associated with lower morbidity for simultaneous resection of colorectal cancer and liver metastases: an updated meta-analysis. World J Surg Oncol. 2020 Sep 21;18(1):251. doi: 10.1186/s12957-020-02018-z.

ReferenceCitation: Boudjema K, Locher C, Sabbagh C, Ortega-Deballon P, Heyd B, Bachellier P, Métairie S, Paye F, Bourlier P, Adam R, Merdrignac A, Tual C, Le Pabic E, Sulpice L, Meunier B, Regimbeau JM, Bellissant E; METASYNC Study group. Simultaneous Versus Delayed Resection for Initially Resectable Synchronous Colorectal Cancer Liver Metastases: A Prospective, Open-label, Randomized, Controlled Trial. Ann Surg. 2021 Jan 1;273(1):49-56. doi: 10.1097/SLA.0000000000003848.

ReferenceCitation: Gavriilidis P, Sutcliffe RP, Hodson J, Marudanayagam R, Isaac J, Azoulay D, Roberts KJ. Simultaneous versus delayed hepatectomy for synchronous colorectal liver metastases: a systematic review and meta-analysis. HPB (Oxford). 2018 Jan;20(1):11-19. doi: 10.1016/j.hpb.2017.08.008. Epub 2017 Sep 7.

ipd_sharing: Undecided

lead_sponsor: Fondazione Poliambulanza Istituto Ospedaliero

location_country:
Luxembourg
Spain
Italy
Russian Federation
Netherlands
United Kingdom
France
Belgium
Norway
Germany

location_facility: Manchester University NHS Foundation Trust

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: University Hospital Birmingham NHS Foundation Trust

location_facility: Klinikum Saarbrücken, Klinik für Allgemein-, Viszeral- und Thoraxchirurgie, Chirurgische Onkologie

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: University of Navarrra Hospital (Clinica Universitaria)

location_facility: Liverpool University Hospitals NHS Foundation Trust

location_facility: Azienda Ospedaliero-Universitaria di Modena

intervention_type: Procedure

status_simplified: Ongoing


title: A Multicenter, Double-blind, Randomized, Parallel-group Study to Evaluate the Safety, Tolerability, and Efficacy of Once Daily Amlodipine/Valsartan 5/80 mg as Compared to Amlodipine/Valsartan 5/40 mg or to Amlodipine 5 mg Once Daily in Elderly Patients With Essential Hypertension Not Adequately Controlled After Four Weeks on Amlodipine 5 mg Once Daily

summary: To characterize the safety, tolerability, and efficacy profile of amlodipine/valsartan 5/80 mg as compared to amlodipine/valsartan 5/40 mg (with optional titration to 5/80 mg) and amlodipine 5 mg monotherapy in elderly patients (≥ 65 years of age) with essential hypertension. All three regimens are expected to be well tolerated.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Poland
Spain
Italy
Finland
Czech Republic
Sweden
Hungary
France
Germany
Slovakia

location_facility:
Investigative site Sweden
Novartis Investigative site
Investigative site Slovakia
Investigative site Spain
Sites in Czech Republic
Investigative site Finland
Investigative site Hungary
Investigative site Poland
Investigative sites Czech Repbulic
Investigative sites Czech Republic
Investigative site Czech Republic
Investigative site France
Investigative site Italy
Investigative site Germany
Investigative site Czech Repbulic


title: Third Prospective, Observational, International, Multicenter Study on Mechanical Ventilation

acronym: ISMV

summary:
The objective of this study is to obtain a better understanding of the spectrum of use of mechanical ventilation in intensive care units:

Main analysis: To know the all-cause mortality rate in mechanically ventilated patients

Secondary analyses:

To know the current status of mechanical ventilation in the intensive care unit and determine the number and percentage of patients who are admitted to an intensive care unit and require mechanical ventilation.
To compare the results with prior data collected in previous observational studies (1998 and 2004)
Non-invasive positive pressure ventilation
Weaning
Use of adjuvant therapies as steroids or selective digestive decontamination
Sedation including prevalence of delirium in mechanically ventilated patients
Prediction of the duration of mechanical ventilation
Other

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Esteban A, Anzueto A, Frutos F, Alía I, Brochard L, Stewart TE, Benito S, Epstein SK, Apezteguía C, Nightingale P, Arroliga AC, Tobin MJ; Mechanical Ventilation International Study Group. Characteristics and outcomes in adult patients receiving mechanical ventilation: a 28-day international study. JAMA. 2002 Jan 16;287(3):345-55.

ReferenceCitation: Esteban A, Ferguson ND, Meade MO, Frutos-Vivar F, Apezteguia C, Brochard L, Raymondos K, Nin N, Hurtado J, Tomicic V, González M, Elizalde J, Nightingale P, Abroug F, Pelosi P, Arabi Y, Moreno R, Jibaja M, D'Empaire G, Sandi F, Matamis D, Montañez AM, Anzueto A; VENTILA Group. Evolution of mechanical ventilation in response to clinical research. Am J Respir Crit Care Med. 2008 Jan 15;177(2):170-7. Epub 2007 Oct 25. Review.

ReferenceCitation: Nin N, Muriel A, Peñuelas O, Brochard L, Lorente JA, Ferguson ND, Raymondos K, Ríos F, Violi DA, Thille AW, González M, Villagomez AJ, Hurtado J, Davies AR, Du B, Maggiore SM, Soto L, D'Empaire G, Matamis D, Abroug F, Moreno RP, Soares MA, Arabi Y, Sandi F, Jibaja M, Amin P, Koh Y, Kuiper MA, Bülow HH, Zeggwagh AA, Anzueto A, Sznajder JI, Esteban A; VENTILA Group. Severe hypercapnia and outcome of mechanically ventilated patients with moderate or severe acute respiratory distress syndrome. Intensive Care Med. 2017 Feb;43(2):200-208. doi: 10.1007/s00134-016-4611-1. Epub 2017 Jan 20.

ReferenceCitation: Esteban A, Frutos-Vivar F, Muriel A, Ferguson ND, Peñuelas O, Abraira V, Raymondos K, Rios F, Nin N, Apezteguía C, Violi DA, Thille AW, Brochard L, González M, Villagomez AJ, Hurtado J, Davies AR, Du B, Maggiore SM, Pelosi P, Soto L, Tomicic V, D'Empaire G, Matamis D, Abroug F, Moreno RP, Soares MA, Arabi Y, Sandi F, Jibaja M, Amin P, Koh Y, Kuiper MA, Bülow HH, Zeggwagh AA, Anzueto A. Evolution of mortality over time in patients receiving mechanical ventilation. Am J Respir Crit Care Med. 2013 Jul 15;188(2):220-30. doi: 10.1164/rccm.201212-2169OC.

lead_sponsor: Hospital Universitario Getafe

location_country:
Saudi Arabia
Italy
Spain
Venezuela
United States
Peru
Japan
Poland
Portugal
Russian Federation
Australia
Argentina
Tunisia
Uruguay
Puerto Rico
India
Panama
Turkey
Mexico
Egypt
Brazil
Netherlands
Canada
Hungary
China
Germany
Denmark
Taiwan
Greece
New Zealand
Ecuador
Vietnam
Korea, Republic of
France
Chile
Colombia
Bolivia
Morocco

location_facility: Policlinico "P. Giaccone", Università Di Palermo

location_facility: Chongqing Medical University 1st Hospital

location_facility: Hospital Clinic-IDIBAPS (ICU medical & ICU respiratory)

location_facility: Staedtisches Krankenhaus Martha-Maria Halle-Doelau gGmbH

location_facility: Hospital Universitario, Universidad Abierta Interamericana

location_facility: Fondazione IRCCS "Cà Grande" Ospedale Maggiore Policlinico, Università Di Milano

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: Fundación Hospital Universitario de Alcorcón

location_facility: Hospital General de Agudos Juan A. Fernandez

location_facility: Katholische Stiftung Marienhospital Aachen

location_facility: Hospital General de Agudos donación Francisco Santojanni

location_facility: University of Louisville School of Medicine

location_facility: Hospital Chuncheon Sacred Heart Hospital, Hallym University Medical Center

location_facility: Charité Universitaetsklinikum (ICU medical-surgical & ICU other)

location_facility: National Institute Of Surgery Named After A.V. Vishnevskij

location_facility: Hospital Universitario Doctor Josep Trueta

location_facility: Hospital General de Agudos Dalmacio Vélez Sársfield

location_facility: Complejo Hospitalario de Santiago de Compostela

location_facility: Hospital de Pronto Socorro Risoleta Tolentino Neves

location_facility: Oklahoma University Health Science Center & VA medical Center

location_facility: Bombay Hospital Institute of Medical Sciences

location_facility: Santa Casa de Misericórdia de Ouro Preto

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Hospital General de Agudos Bernardino Rivadavia

location_facility: Hospital Universitario de Nuevo León 'Dr. Eleuterio González'

location_facility: Universitaetsklinikum Bonn (ICU medical-surgical & ICU surgical)

location_facility: Ermstalklinik Staedtisches Krankenhaus Sindelfingen

location_facility: Calcutta medical research institute (CMRI)

location_facility: Ospedale "San Giovanni Battista - Molinette", Università Di Torino

location_facility: Universitaetsklinikum der Martin-Luther-Universitaet Halle-Wittenberg

location_facility: Hospital Universitário da Universidade Federal de Juiz de Fora

location_facility: Ospedale "San Gerardo", Università Di Milano Bicocca

location_facility: Asan Medical Center, University of Ulsan

location_facility: Hôpital Militaire D'Instruction Mohamed V

location_facility: Vanderbilt University School Of Medicine

location_facility: Medical Faculty of Yuzuncu Yil University

location_facility: Hospital Regional de Alta Especialidad de la Mujer

location_facility: Hospital General de Jerez de la Frontera

location_facility: University Hospital San Antonio and South Texas Veterans Health Care System

location_facility: Grupo Cimca Hospital de San José (medical ICU)

location_facility: Ospedale Maggiore Della Carità, Università Del Piemonte Orientale "Amedeo Avogadro"

location_facility: Policlinico "Umberto I", Università La Sapienza

location_facility: Hospital Yonsei University Wonju Christian

location_facility: Evangelisches Waldkrankenhaus Bad Godesberg gGmbH

location_facility: Instituto Nacional De Ciencias Médicas y Nutrición Salvador Zubirán

location_facility: King Saud Bin Abdulaziz University for Health Sciences

location_facility: Samsung Medical Center, Sungkyunkwan University

location_facility: University Of Texas Medical Branch at Galveston

location_facility: Hospital Fattouma Bourguina (ICU medical & ICU surgical)

location_facility: Centro Hospitalar Trás-Os-Montes E Alto Douro

location_facility: Policlinico Universitario "S. Orsola-Malpighi"

location_facility: University of Iowa Hospitals and Clinics

location_facility: Ospedale Policlinico "Federico II", Università Di Napoli

location_facility: Umae Hospital De Especialidades Dr. Antonio Fraga Mouret

location_facility: Hospital Severance, Yonsei University Health System

location_facility: Centro Hospitalar Do Porto - Hospital Geral De Santo António

location_facility: Pamela Youde Nethersole Eastern Hospital

location_facility: Clínica Medellín & Universidad Pontificia Bolivariana

location_facility: Hospital de SOLCA (ICU medical surgical & ICU medical)

location_facility: Hospital Interzonal de Agudos San Martin

location_facility: Clínica Privada de Especialidades de Villa María

location_facility: Hospital Interzonal General de Agudo Profesor Dr .Luis Guemes

location_facility: Instituto Português de Oncología Francisco Gentil

location_facility: Vrije Universiteit Medisch Centrum (VUMC) (Three units)

location_facility: Evangelisches Krankenhaus Elisabethenstift gGmbH

location_facility: Fondazione IRCCS Policlinico "S. Matteo", Università Di Pavia (ICU 1 & ICU 2)

location_facility: Hospital Pusan National University of Yangsan

location_facility: Centre Hospitalier de Châlons en Champagne

location_facility: Ospedale Policlinico, Università Di Bari

location_facility: Hospital de Santo Antonio dos Capuchos, Centro Hospitalar de Lisboa Central, E.P.E.

location_facility: Policlinico "Agostino Gemelli", Università Cattolica Del Sacro Cuore

location_facility: Ospedale "Arnas Civico, Di Cristina, Benfratelli"

location_facility: Karol Marcinkowski University Of Medical Sciences

lead_sponsor_type: academique


title: A Randomised,Double Blind, Placebo Controlled, Multicentre Trial of Abagovomab Maintenance Therapy in Patients With Epithelial Ovarian Cancer After Complete Response to First Line Chemotherapy

acronym: MIMOSA

summary: The purpose of this study is to evaluate the benefit of vaccination with Abagovomab, an experimental immunotherapy in ovarian cancer patients. The benefit will be evaluated in terms of time the remission status is kept as well as prolongation of life expectancy.

status: Terminated

ReferenceCitation: Reinartz S, Köhler S, Schlebusch H, Krista K, Giffels P, Renke K, Huober J, Möbus V, Kreienberg R, DuBois A, Sabbatini P, Wagner U. Vaccination of patients with advanced ovarian carcinoma with the anti-idiotype ACA125: immunological response and survival (phase Ib/II). Clin Cancer Res. 2004 Mar 1;10(5):1580-7.

ReferenceCitation: Wagner U, Köhler S, Reinartz S, Giffels P, Huober J, Renke K, Schlebusch H, Biersack HJ, Möbus V, Kreienberg R, Bauknecht T, Krebs D, Wallwiener D. Immunological consolidation of ovarian carcinoma recurrences with monoclonal anti-idiotype antibody ACA125: immune responses and survival in palliative treatment. See The biology behind: K. A. Foon and M. Bhattacharya-Chatterjee, Are solid tumor anti-idiotype vaccines ready for prime time? Clin. Cancer Res., 7:1112-1115, 2001. Clin Cancer Res. 2001 May;7(5):1154-62.

ReferenceCitation: Pfisterer J, du Bois A, Sehouli J, Loibl S, Reinartz S, Reuss A, Canzler U, Belau A, Jackisch C, Kimmig R, Wollschlaeger K, Heilmann V, Hilpert F. The anti-idiotypic antibody abagovomab in patients with recurrent ovarian cancer. A phase I trial of the AGO-OVAR. Ann Oncol. 2006 Oct;17(10):1568-77.

ReferenceCitation: Sabbatini P, Dupont J, Aghajanian C, Derosa F, Poynor E, Anderson S, Hensley M, Livingston P, Iasonos A, Spriggs D, McGuire W, Reinartz S, Schneider S, Grande C, Lele S, Rodabaugh K, Kepner J, Ferrone S, Odunsi K. Phase I study of abagovomab in patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer. Clin Cancer Res. 2006 Sep 15;12(18):5503-10.

ReferenceCitation: Buzzonetti A, Fossati M, Catzola V, Scambia G, Fattorossi A, Battaglia A. Immunological response induced by abagovomab as a maintenance therapy in patients with epithelial ovarian cancer: relationship with survival-a substudy of the MIMOSA trial. Cancer Immunol Immunother. 2014 Oct;63(10):1037-45. doi: 10.1007/s00262-014-1569-0. Epub 2014 Jun 21.

ReferenceCitation: Sabbatini P, Harter P, Scambia G, Sehouli J, Meier W, Wimberger P, Baumann KH, Kurzeder C, Schmalfeldt B, Cibula D, Bidzinski M, Casado A, Martoni A, Colombo N, Holloway RW, Selvaggi L, Li A, del Campo J, Cwiertka K, Pinter T, Vermorken JB, Pujade-Lauraine E, Scartoni S, Bertolotti M, Simonelli C, Capriati A, Maggi CA, Berek JS, Pfisterer J. Abagovomab as maintenance therapy in patients with epithelial ovarian cancer: a phase III trial of the AGO OVAR, COGI, GINECO, and GEICO--the MIMOSA study. J Clin Oncol. 2013 Apr 20;31(12):1554-61. doi: 10.1200/JCO.2012.46.4057. Epub 2013 Mar 11.

lead_sponsor: Menarini Group

location_country:
Poland
Spain
Italy
Czech Republic
Hungary
France
United States
Belgium
Germany

location_facility: University of California, Los Angeles (UCLA)

location_facility: Women and Infants Hospital of Rhode Island

location_facility: Policlinico di Modena, Dipartimento di Oncologia ed Ematologia

location_facility: SPZOZ Wojewodzki Szpital Specjalistyczny Nr 3, Oddzial Onkologii

location_facility: Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie, Klinika Nowotworów Narządów Płciowych Kobiecych

location_facility: Universtita' Cattolica del Sacro Cuore Dipartimento di Oncologia

location_facility: DH Oncologico U.O. Medicina Oncologica Ospedale Ramazzini

location_facility: Hospital Clínico Universitario de Santiago de Compostela

location_facility: Hospital Clinic i Provincial de Barcelona, Servicio de Oncologia

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: Azienda Ospedaliera - Universitaria Careggi

location_facility: Policlinico Umberto I D.H. Oncologico Oncologia Medica

location_facility: Hospital Clinico de Malaga. Servicio de Oncologia

location_facility: Dipartimento di Ginecologia ed Ostetricia Policlinico Universitario Gemelli

location_facility: Krajska nemocnice Liberec, oddeleni gynekologicko porodnicke

location_facility: Harry and Jeanette Weinberg Cancer Institute at Franklin Square

location_facility: Klinikum der Stadt Wolfsburg-FrauenklinikWolfsburg

location_facility: Universitair Ziekenhuis Gent Medische Oncologie 4B-Z

location_facility: Klinikum der Universität München-Innenstadt

location_facility: AZ Sint Augustinus, Oncologisch Centrum GVA

location_facility: Hospital General Universitario de Valencia

location_facility: Klinikum der Stadt Villingen-Schwenningen GmbH

location_facility: Instituto Catalán de Oncología - Hospital Universitari de Girona "Dr. Josep Trueta". Oncologia Medica

location_facility: Fővárosi Önkormányzat Szent Margit Kórháza, Onkológia

location_facility: Hackensack University Medical Center, Obstetrics and Gynecology Oncology

location_facility: Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András Kórháza, Szülészet-Nőgyógyászati Osztály

location_facility: Klinika Onkologii, Oddzial Chemioterapii Akademii Medycznej w Poznaniu

location_facility: Semmelweis Egyetem, I sz. Szülészeti és Nőgyógyászati Klinika

location_facility: Debreceni Egyetem Orvos és Egészségtudományi Centrum, Szülészetl es Nőgyógyászatl Klinika

location_facility: Gynekologicko-porodnicka klinika FN Plzen

location_facility: Oddzial Onkologii Wojewódzki Szpital Specjalistyczny

location_facility: Hospital Son Dureta, Servicio de Oncología

location_facility: Komárom-Esztergom Megyei Onkormanyzat Szent Borbála Kórház, Szülészet-Nőgyógyászati Osztály

location_facility: Wojewodzkie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej

location_facility: Unità Operativa Ginecologia e Ostetricia 2^, Università degli studi di Bari, Policlinico

location_facility: Petz Aladar Megyei Oktató Kórház, Onkoradiológia

location_facility: Martin-Luther-Universität Halle-Wittenberg, Klinikum der Medizinischen Fakultät

location_facility: Istituto Nazionale per lo studio e la cura dei tumori "Fondazione Pascale" Oncologia Medica

location_facility: Wojskowy Instytut Medyczny; Klinika Onkologii Centralnego Szpitala Klinicznego MON

location_facility: "Centrum Onkologii, Instytut im. M. Skłodowskiej-Curie, Oddział w Krakowie,

location_facility: Centro Oncológico Regional de Galicia, Servicio de Oncologia Medica

location_facility: Oncologia Medica Ospedale di Faenza - AUSL di Ravenna

location_facility: Klinikum Südstadt der Hansestadt Rostock

location_facility: Curtis and Elizabeth Anderson Cancer Institute

location_facility: Azienda Ospedaliera San Martino - Padiglione Malattie Complesse, Dipartimento di Oncologia Medica

location_facility: Semmelweis Egyetem II. sz. Szülészeti és Nőgyógyászati Klinika

location_facility: Ospedale Casa Sollievo della Sofferenza - Unita' Operativa di Ostetricia e Ginecologia

location_facility: Pécsi Tudományegyetem, ÁOK Szülészeti és Nőgyógyászati Klinika

location_facility: Azienda Ospedaliera San Carlo - Oncologia Medica

location_facility: Istituto Europeo di Oncologia - Divisione di Ginecologia

location_facility: Centralny Szpital Kliniczny MSWiA, Klinika Onkologii, Hematologii i Chorob Wewnetrznych

location_facility: Ospedali Riuniti Bianchi-Melacrino-Morelli - Oncologia Medica

location_facility: Hospital Universitario Arnau de Vilanova, Servicio de Oncologia

location_facility: Universitätsklinikum Schleswig-Holstein Campus Kiel

location_facility: Hospital Clinico San Carlos, Servicio de Oncología Medica

location_facility: Ospedale S. Orsola Malpighi, Oncologia Medica

location_facility: Hospital Vall d'Hebrón, Servicio de Oncologia

location_facility: Oddzial Chemioterapii ZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie

location_facility: Arcispedale Santa Maria Nuova, Oncologia Medica

location_facility: Klinika Chemioterapii Nowotworów Akademii Medycznej w Łodzi, Regionalny Osrodek Onkologiczny

location_facility: Dipartimento di Discipline Ginecologiche e Ostetriche - Universita degli Studi di Torino - Azienda ospedaliera O.I.R.M.-S'Anna

location_facility: Wojewodzki Szpital Zespolony, Oddzial Onkologii Klinicznej

intervention_type: Biological

status_simplified: Unknown


title: Open-Label Study to Determine How Prior Therapy With Alendronate or Risedronate in Postmenopausal Women With Osteoporosis Influences the Clinical Effectiveness of Teriparatide

summary: To determine how prior therapy with alendronate or risedronate in postmenopausal women with osteoporosis influences the clinical effectiveness of teriparatide; The primary objective of the study is to compare the teriparatide (human, recombinant PTH[1-34])-associated change from baseline in a marker of bone formation, N-terminal propeptide of type I collagen (P1NP), between subjects previously treated with risedronate and those previously treated with alendronate.

design_allocation: Non-Randomized

ReferenceCitation: Miller PD, Delmas PD, Lindsay R, Watts NB, Luckey M, Adachi J, Saag K, Greenspan SL, Seeman E, Boonen S, Meeves S, Lang TF, Bilezikian JP; Open-label Study to Determine How Prior Therapy with Alendronate or Risedronate in Postmenopausal Women with Osteoporosis Influences the Clinical Effectiveness of Teriparatide Investigators. Early responsiveness of women with osteoporosis to teriparatide after therapy with alendronate or risedronate. J Clin Endocrinol Metab. 2008 Oct;93(10):3785-93. doi: 10.1210/jc.2008-0353. Epub 2008 Aug 5.

location_country:
United Kingdom
Australia
Canada
United States
France
Belgium
Netherlands

location_facility:
sanofi-aventis, France
sanofi-aventis, Canada
sanofi-aventi, UK
sanofi-aventis, Netherlands
sanofi-aventis, Belgium
sanofi-aventis, Australia
sanofi-aventis, US


title: Randomized, Multicenter, Double-Blind, Placebo-Controlled, Two-Arm Parallel Group Trial of Rimonabant 20-mg od, for Inhibition of Atherosclerosis Progression Assessed by IVUS (IntraVascular UltraSounds), in Overweight Patients With Clustering Risk Factors

summary: The purpose of this study is to determine if rimonabant 20 mg once daily (od) administered during 18-20 months will reduce progression of coronary atherosclerosis as assessed by intravascular ultrasound (IVUS) when administered on top of standard behavioral and pharmacological therapy given as needed, in patients with abdominal obesity associated with current smoking and/or metabolic syndrome.

ReferenceCitation: Nissen SE, Nicholls SJ, Wolski K, Rodés-Cabau J, Cannon CP, Deanfield JE, Després JP, Kastelein JJ, Steinhubl SR, Kapadia S, Yasin M, Ruzyllo W, Gaudin C, Job B, Hu B, Bhatt DL, Lincoff AM, Tuzcu EM; STRADIVARIUS Investigators. Effect of rimonabant on progression of atherosclerosis in patients with abdominal obesity and coronary artery disease: the STRADIVARIUS randomized controlled trial. JAMA. 2008 Apr 2;299(13):1547-60. doi: 10.1001/jama.299.13.1547. Epub 2008 Apr 1.

location_country:
Poland
Spain
Italy
Australia
Canada
United States
France
Belgium
Netherlands

location_facility:
sanofi-aventis, France
The Cleveland Clinic Foundation
sanofi-aventis Italy
sanofi-aventis Spain
sanofi-aventis, Netherlands
sanofi-aventis Poland
Sanofi-Aventis Administrative Office
sanofi-aventis, Belgium
sanofi-aventis, Australia


title: Safety and Efficacy of Orally Administered Fx-1006A in Patients With Familial Amyloid Polyneuropathy (FAP): A Randomized, Double-blind, Placebo-controlled Study

summary:
This study will examine whether Fx-1006A is effective in halting the progression of Familial Amyloid Polyneuropathy (FAP).

Deposition of TTR amyloid is associated with a variety of human diseases. Deposition of amyloid fibrils of variant TTR (primarily V30M) in peripheral nerve tissue produces the condition called FAP.

The prevention of the formation of amyloid by stabilization of the TTR native state should constitute an effective therapy for amyloid diseases. Therapeutic intervention with a TTR stabilizer drug, such as Fx-1006A, is hypothesized to stop progression of the disease in FAP patients. FAP is a uniformly fatal disease and Fx-1006A is intended to halt the relentless neurological deterioration FAP patients experience.

This Phase 2/3 study will enroll early to mid-stage FAP patients in order to interrupt and stabilize the disease at a point in time where progression of motor and autonomic dysfunction can be maximally effected. Male and female patients with FAP with documented V30M TTR mutation will receive Fx-1006A or placebo once daily for a period of eighteen (18) months.

ReferenceCitation: Merlini G, Coelho T, Waddington Cruz M, Li H, Stewart M, Ebede B. Evaluation of Mortality During Long-Term Treatment with Tafamidis for Transthyretin Amyloidosis with Polyneuropathy: Clinical Trial Results up to 8.5 Years. Neurol Ther. 2020 Jun;9(1):105-115. doi: 10.1007/s40120-020-00180-w. Epub 2020 Feb 27.

ReferenceCitation: Huber P, Flynn A, Sultan MB, Li H, Rill D, Ebede B, Gundapaneni B, Schwartz JH. A comprehensive safety profile of tafamidis in patients with transthyretin amyloid polyneuropathy. Amyloid. 2019 Dec;26(4):203-209. doi: 10.1080/13506129.2019.1643714. Epub 2019 Jul 27.

ReferenceCitation: Amass L, Li H, Gundapaneni BK, Schwartz JH, Keohane DJ. Influence of baseline neurologic severity on disease progression and the associated disease-modifying effects of tafamidis in patients with transthyretin amyloid polyneuropathy. Orphanet J Rare Dis. 2018 Dec 17;13(1):225. doi: 10.1186/s13023-018-0947-7.

ReferenceCitation: Gundapaneni BK, Sultan MB, Keohane DJ, Schwartz JH. Tafamidis delays neurological progression comparably across Val30Met and non-Val30Met genotypes in transthyretin familial amyloid polyneuropathy. Eur J Neurol. 2018 Mar;25(3):464-468. doi: 10.1111/ene.13510. Epub 2017 Dec 26.

ReferenceCitation: Keohane D, Schwartz J, Gundapaneni B, Stewart M, Amass L. Tafamidis delays disease progression in patients with early stage transthyretin familial amyloid polyneuropathy: additional supportive analyses from the pivotal trial. Amyloid. 2017 Mar;24(1):30-36. doi: 10.1080/13506129.2017.1301419. Epub 2017 Apr 10.

ReferenceCitation: Waddington Cruz M, Amass L, Keohane D, Schwartz J, Li H, Gundapaneni B. Early intervention with tafamidis provides long-term (5.5-year) delay of neurologic progression in transthyretin hereditary amyloid polyneuropathy. Amyloid. 2016 Sep;23(3):178-183. Epub 2016 Aug 5.

lead_sponsor: Pfizer

location_country:
Brazil
Portugal
Spain
United Kingdom
Argentina
Sweden
United States
France
Germany

location_facility: Unidade Clinica de Paramiloidose-Hospital Santo Antonio

location_facility: Serviço de Neurologia-Hospital de Santa Maria

location_facility: Universitatsklinikum Munster, Transplant Hepatology

location_facility: FLENI-Hepatology and Organ Transplant Dept.

location_facility: Hospital Universitário Prof. Clementino Fraga Filho-UFRJ


title: A Confirmatory, Prospective, Open-label, Multi-centre Phase 3 Study to Evaluate Diagnostic Performance of Zirconium-labelled Girentuximab to Non-invasively Detect ccRCC by PET/CT Imaging in Patients With Indeterminate Renal Masses

summary: 89Zr-TLX250 is under clinical development as a diagnostic agent targeting clear cell renal cell carcinoma.

status: Active, not recruiting

primary_purpose: Diagnostic

ipd_sharing: No

lead_sponsor: Telix International Pty Ltd

location_country:
Australia
Canada
United States
France
Turkey
Belgium
Netherlands

location_facility: CHU de Québec - Université Laval - L'Hôtel-Dieu de Québec

location_facility: CHU de Bordeaux, Groupe hospitalier Pellegrin

location_facility: City of Hope Comprehensive Cancer Center

location_facility: Advanced Molecular Imaging & Therapy, LLC

location_facility: University of California, Los Angeles Campus,

location_facility: Centre De Recherche Centre hospitalier de l/Universite de Montreal (CrCHUM )

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Hacettepe University Faculty of Medicine

location_facility: SEATTLE CANCER CARE ALLIANCE, University of Washington

location_facility: Ankara University Medical Faculty Hospital

intervention_type: Diagnostic Test


title: Quality of Life in Patients With Congenital Afibrinogenemia

acronym: QualyAFIB

summary: The aim of this observational study is to evaluate the quality of life in patients with congenital afibrinogenemia using the Haemo-QoL SF for kids and the Haem-A-QoL for adult patients.

time_perspective: Cross-Sectional

ReferenceCitation: Casini A, von Mackensen S, Santoro C, Djambas Khayat C, Belhani M, Ross C, Dorgalaleh A, Naz A, Ünal E, Abdelwahab M, Lozeron ED, Trillot N, Susen S, Peyvandi F, de Moerloose P; QualyAfib Study Group. Clinical phenotype, fibrinogen supplementation, and health-related quality of life in patients with afibrinogenemia. Blood. 2021 Jun 3;137(22):3127-3136. doi: 10.1182/blood.2020009472.

lead_sponsor: University Hospital, Geneva

location_country:
Serbia
Spain
Italy
United States
Japan
Poland
Tunisia
India
Turkey
Slovakia
Egypt
Kuwait
Lebanon
Canada
Switzerland
Germany
Algeria
France
Netherlands
Morocco
Pakistan

location_facility: National Centre of Hemostasis and Thrombosis

location_facility: Institute of Hematology and Transfusion Medicine

location_facility: National Institute Of Blood Disease and Bone Marrow Transplantation

location_facility: Hospital Universitari i Politecnic La Fe

intervention_type: Other


title: A Randomized Phase II-III Multicenter Trial of Docetaxel Plus Cisplatin and Docetaxel Plus 5-FU Versus Cisplatin Plus 5-FU in 1st Line Treatment of Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck.

summary: The purpose of the study is to compare time to progression and overall survival after treatment with Taxotere plus cisplatin versus cisplatin plus 5-FU (PF treatment group) in the first line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck.

location_country:
Réunion
Brazil
Spain
Greece
Austria
Australia
Italy
Argentina
Canada
Guadeloupe
Russian Federation
Switzerland
Hungary
Uruguay
United States
France
Israel
South Africa
Belgium
Germany

location_facility:
sanofi-aventis Greece
sanofi-aventis Israel
Sanofi-Aventis Hungaria
sanofi-aventis South Africa
sanofi-aventis, France
Sanofi-Aventis
sanofi-aventis Italy
sanofi-aventis Canada
sanofi-aventis Switzerland
sanofi-aventis US
sanofi-aventis, Belgium
sanofi-aventis, Australia
sanofi-aventis Germany


title: A Phase 1, Multinational Study of MCLA-117 in Acute Myelogenous Leukemia

summary: This is a First-in-Human, single arm, open-label, multi-national study designed to determine the safety, tolerability and preliminary efficacy of MCLA 117.

lead_sponsor: Merus N.V.

location_country:
Italy
United States
France
Belgium
Netherlands

location_facility: Ziekenhuis Netwerk Antwerpen Campus Stuivenberg

location_facility: Georgia Cancer Center, Augusta University

location_facility: The University of Texas, MD Anderson Cancer Center


title: Double-blind, Randomised, Placebo-controlled, Phase III Study Comparing the Efficacy and Safety of Bilastine 20 mg Once Daily and Levocetirizine 5 mg for the Treatment of Chronic Idiopathic Urticaria

summary: The objective of the study is to evaluate the efficacy and tolerability of Bilastine 20 mg Q.D., compared to Levocetirizine 5 mg Q.D. and placebo for the treatment of Chronic Idiopathic Urticaria.

ReferenceCitation: Church MK. Safety and efficacy of bilastine: a new H(1)-antihistamine for the treatment of allergic rhinoconjunctivitis and urticaria. Expert Opin Drug Saf. 2011 Sep;10(5):779-93. doi: 10.1517/14740338.2011.604029. Epub 2011 Aug 11. Review. Erratum in: Expert Opin Drug Saf. 2012 Jan;11(1):175.

ReferenceCitation: Zuberbier T, Oanta A, Bogacka E, Medina I, Wesel F, Uhl P, Antépara I, Jáuregui I, Valiente R; Bilastine International Working Group. Comparison of the efficacy and safety of bilastine 20 mg vs levocetirizine 5 mg for the treatment of chronic idiopathic urticaria: a multi-centre, double-blind, randomized, placebo-controlled study. Allergy. 2010 Apr;65(4):516-28. doi: 10.1111/j.1398-9995.2009.02217.x. Epub 2009 Oct 23.

lead_sponsor: Faes Farma, S.A.

location_country: Poland Romania Spain Argentina France Belgium Germany

location_facility:
Centre nº 806
Centre nº 501
Centre nº 301
Centre nº 507
Centre nº 400
Centre nº 707
Centre nº 504
Centre nº 703
Centre nº 704
Centre nº 800
Centre nº 406
Centre nº 506
Centre nº 503
Centre nº 108
Centre nº 106
Centre nº 802
Centre nº 706
Centre nº 103
Centre nº 700
Centre nº 702
Centre nº 200
Centre nº 805
Centre nº 100
Centre nº 105
Centre nº 201
Centre nº 404
Centre nº 107
Centre nº 307
Centre nº 308
Centre nº 302
Centre nº 203
Centre nº 202
Centre nº 101
Centre nº 701
Centre nº 204
Centre nº 505
Centre nº 803
Centre nº 410
Centre nº 411
Centre nº 407
Centre nº 303
Centre nº 305
Centre nº 109
Centre nº 804
Centre nº 801
Centre nº 705
Centre nº 102
Centre nº 104
Centre nº 500
Centre nº 502


title: A 2-Part, Randomized, Double-Blind, Placebo-Controlled, Dose-Titration, Safety, Tolerability, and Pharmacokinetics Study (Part 1) Followed by an Open-Label Efficacy and Safety Evaluation (Part 2) of SRP-4053 in Patients With Duchenne Muscular Dystrophy Amenable to Exon 53 Skipping

lead_sponsor: Sarepta Therapeutics, Inc.

source: euctr

ReferenceCitation: Frank DE, Schnell FJ, Akana C, El-Husayni SH, Desjardins CA, Morgan J, Charleston JS, Sardone V, Domingos J, Dickson G, Straub V, Guglieri M, Mercuri E, Servais L, Muntoni F; SKIP-NMD Study Group. Increased dystrophin production with golodirsen in patients with Duchenne muscular dystrophy. Neurology. 2020 May 26;94(21):e2270-e2282. doi: 10.1212/WNL.0000000000009233. Epub 2020 Mar 5.

ReferenceCitation: Servais L, Mercuri E, Straub V, Guglieri M, Seferian AM, Scoto M, Leone D, Koenig E, Khan N, Dugar A, Wang X, Han B, Wang D, Muntoni F; SKIP-NMD Study Group. Long-Term Safety and Efficacy Data of Golodirsen in Ambulatory Patients with Duchenne Muscular Dystrophy Amenable to Exon 53 Skipping: A First-in-human, Multicenter, Two-Part, Open-Label, Phase 1/2 Trial. Nucleic Acid Ther. 2022 Feb;32(1):29-39. doi: 10.1089/nat.2021.0043. Epub 2021 Nov 17.

location_country:
United States
Italy
United Kingdom
France

location_facility: Great Ormond Street Hospital for Children NHS Foundation Trust

summary: This is a first-in-human, multiple-dose 2-part study to assess the safety, tolerability, efficacy, and pharmacokinetics of SRP-4053 in Duchenne muscular dystrophy (DMD) patients with deletions amenable to exon 53 skipping.


title: Asymptomatic Sexually Transmitted Infections (STI) : Comparison of Two Screening Strategies Routine Screening Versus Screening as Reported by the Risks Taken by the Patient, in a Cohort of HIV Outpatients Men Who Have Sex With Men

acronym: DRIVER

summary: Comparison of two screening strategies of asymptomatic sexually transmitted infections : routine screening versus screening as reported by the risks taken by the patient, in a cohort of HIV outpatients men who have sex with men. The aim of this study will be create and validate a simple tool for clinicians. A digital tool will be developed will allowed empowerment of HIV-positive men who have sex with men.

primary_purpose: Screening

lead_sponsor: Hopital Foch

location_facility: Hôpital Mignot-centre hospitalier de versailles


title: Two Part (Double-blind Inclisiran Versus Placebo [Year 1] Followed by Open-label Inclisiran [Year 2]) Randomized Multicenter Study to Evaluate Safety, Tolerability, and Efficacy of Inclisiran in Adolescents (12 to Less Than 18 Years) With Homozygous Familial Hypercholesterolemia and Elevated LDL-cholesterol (ORION-13)

summary: This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in adolescents with homozygous familial hypercholesterolemia (HoFH) and elevated low density lipoprotein cholesterol (LDL-C).

ReferenceCitation: Reijman MD, Schweizer A, Peterson ALH, Bruckert E, Stratz C, Defesche JC, Hegele RA, Wiegman A. Rationale and design of two trials assessing the efficacy, safety, and tolerability of inclisiran in adolescents with homozygous and heterozygous familial hypercholesterolaemia. Eur J Prev Cardiol. 2022 Jul 20;29(9):1361-1368. doi: 10.1093/eurjpc/zwac025.

ReferenceCitation: Warden BA, Duell PB. Inclisiran: A Novel Agent for Lowering Apolipoprotein B-containing Lipoproteins. J Cardiovasc Pharmacol. 2021 Aug 1;78(2):e157-e174. doi: 10.1097/FJC.0000000000001053.

ipd_sharing: Yes

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

location_country:
Slovenia
Greece
Lebanon
Netherlands
Canada
Switzerland
United States
France
Turkey
Malaysia

location_facility: University Medical Centre Ljubljana, Div. of Pediatric Dept. of Endocrinology, Diabetes and Metabolic Diseases

location_facility: American University of Beirut Medical Center


title: SafeHeal Colovac Colorectal Anastomosis Protection Device Evaluation (SAFE-2) Pivotal Study: A Study to Evaluate the Safety and Effectiveness of the Colovac Colorectal Anastomosis Protection Device

summary: A randomized trial to assess the safety and effectiveness of the Colovac in providing temporary protection of the anastomosis in subjects undergoing lower anterior resection for colorectal cancer.

status: Suspended

lead_sponsor: SafeHeal Inc

location_country:
United States
France
Belgium

location_facility:
Cedars-Sinai Medical Center
Tampa General Hospital
Dartmouth-Hitchcock
Maimonides Medical Center
Lankenau Medical Center
UMass Memorial Medical Center
Hôpital Saint Antoine Paris
Kaiser Permanente - Los Angeles
Universitair Ziekenhuis Antwerpen
Mount Sinai Hospital
Lenox Hill Hospital
USC Keck Hospital


primary_purpose: Prevention

title: A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of Oral Islatravir Once-Monthly as Preexposure Prophylaxis in Cisgender Men and Transgender Women Who Have Sex With Men, and Are at High Risk for HIV-1 Infection

lead_sponsor: Merck Sharp & Dohme LLC

type: Registry Identifier

location_country:
Brazil
Thailand
Peru
United States
France
South Africa
Japan

location_facility: Perinatal HIV Research Unit (PHRU)-HIV Prevention CRS ( Site 0203)

location_facility: Centro de Referência e Treinamento DST/AIDS ( Site 0351)

location_facility: HIV Netherlands Australia Thailand Research Collaboration ( Site 0056)

location_facility: The GW Medical Faculty Associates-Medicine ( Site 0033)

location_facility: Rutgers New Jersey Medical School-Clinical Research Center ( Site 0017)

location_facility: Ponce De Leon Center Grady Health ( Site 0032)

location_facility: Bridge HIV - San Francisco Department of Public Health ( Site 0003)

location_facility: The University of Mississippi Medical Center ( Site 0012)

location_facility: UCLA Center for Clinical AIDS Research and Education ( Site 0011)

location_facility: Central Texas Clinical Research ( Site 0002)

location_facility: Wits Reproductive Health and HIV Institute (WRHI)-Research Center ( Site 0201)

location_facility: Desmond Tutu HIV Foundation ( Site 0202)

location_facility: Center Hospital of the National Center for Global Health and Medicine ( Site 0101)

location_facility: The University of North Carolina at Chapel Hill ( Site 0019)

location_facility: Research Institute for Health Sciences-Research Institute for Health Sciences Building 1 ( Site 0052

location_facility: University of Alabama at Birmingham-UAB 1917 Research Clinic ( Site 0007)

location_facility: University of Miami Miller School of Medicine-Infectious Disease ( Site 0029)

location_facility: The Crofoot Research Center ( Site 0025)

location_facility: Midway Immunology and Research Center ( Site 0014)

location_facility: Chulalongkorn University-Pediatrics ( Site 0051)

location_facility: Hôpital Saint-Louis-Infectious Diseases and tropical diseases ( Site 0151)

summary: The main purpose of the study is to evaluate the safety and tolerability of oral Islatravir (ISL) once monthly (QM) as Preexposure Prophylaxis (PrEP) in cisgender men who have sex with men (MSM) and transgender women (TGW) who have sex with men and who are at high risk of HIV-1 infection with 48 or 96 weeks of treatment and a minimum follow-up of 42 days.


acronym: STOP PIV - Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects

title: A Phase III Randomized Placebo-Controlled Study to Examine the Efficacy and Safety of DAS181 for the Treatment of Lower Respiratory Tract Parainfluenza Infection in Immunocompromised Subjects

lead_sponsor: Ansun Biopharma, Inc.

location_country:
Denmark
Taiwan
Hong Kong
Australia
Korea, Republic of
United States
France
China

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital

location_facility: University of California Davis Health System

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: University of California San Diego Medical Center

location_facility: University of Pittsburgh Medical Center Health System

location_facility: Froedtert Medical College Pulmonary Clinic

location_facility: The First Affiliated Hospital, Zhejiang University School of Medicine

location_facility: Ann & Robert H. Lurie Children's Hospital of Chicago

location_facility: Seoul National University Bundang Hospital

summary:
This study will seek to enroll immunocompromised patients with Lower Tract parainfluenza infection.

It also contains a sub-study to enroll patients with severe COVID-19.


acronym: Hubble Zoom

title: A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease

lead_sponsor: Takeda

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

location_country:
Poland
United Kingdom
Ukraine
Hungary
United States
France
Israel
Belgium

location_facility: Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski

location_facility: Kharkiv Regional Clinical Children's Hospital

location_facility: Uniwersytecki Szpital Dzieciecy w Krakowie

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

location_facility: Universitair Ziekenhuis Leuven - Campus Gasthuisberg

location_facility: Tel Aviv Sourasky Medical Center - Dept. of Gastroenterology and Hepatology

location_facility: Hopital Necker-Enfants Malades - Service de Gastroenterologie-Hepatologie-Nutrition Pediatriques

location_facility: Children's Center for Digestive Healthcare

location_facility: Hopital Universitaire des Enfants Reine Fabiola

location_facility: Nemours Childrens Specialty Care - Jacksonville

location_facility: Barts and The London NHS Trust - Children's Clinical Research Facility

location_facility: Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi Osrodek Pediatryczny im Marii Konopnicki

location_facility: The Edmond and Lily Safra Children's Hospital - Sheba Medical Center

location_facility: BAZ Megyei Korhaz es Egyetemi Oktatokorhaz

location_facility: Schneider Children's Medical Center of Israel

summary: The purpose of this study is to determine the safety profile of long-term vedolizumab IV treatment in pediatric participants with UC or CD.


title: A Multicenter, Phase 1, Open-Label, Dose-Escalation Study of ABBV-085, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors

summary: This is an open-label dose escalation study designed to evaluate the safety and pharmacokinetics of ABBV-085 and determine the recommended Phase 2 dose (as monotherapy or in combination with standard therapies) in subjects with advanced solid tumors.

ReferenceCitation: Ray U, Pathoulas CL, Thirusangu P, Purcell JW, Kannan N, Shridhar V. Exploiting LRRC15 as a Novel Therapeutic Target in Cancer. Cancer Res. 2022 May 3;82(9):1675-1681. doi: 10.1158/0008-5472.CAN-21-3734. Review.

lead_sponsor: AbbVie

location_country:
United States
Spain
France

location_facility: Mary Crowley Cancer Research /ID# 148580

location_facility: Dana-Farber Cancer Institute /ID# 143782

location_facility: South Texas Accelerated Research Therapeutics /ID# 141715

location_facility: Washington University-School of Medicine /ID# 151348

location_facility: University of California, Los Angeles /ID# 148586

location_facility: Univ of Colorado Cancer Center /ID# 148581

location_facility: Hosp Univ Madrid Sanchinarro /ID# 146039

location_facility: Carolina BioOncology Institute /ID# 148583


title: A Multicenter, Prospective, Randomized, Open-label, Intra-subject Controlled Study of the Efficacy and Safety of ABH001 for the Treatment of Stalled Chronic Cutaneous Wounds Associated With Generalized Epidermolysis Bullosa

summary:
The purpose of this study is to evaluate the efficacy and safety of ABH001 in the treatment of patients with epidermolysis bullosa who have wounds that are not healing.

It is hypothesized that ABH001 may initiate and continue wound healing in patients with epidermolysis bullosa.

lead_sponsor: Shire Regenerative Medicine, Inc.

location_country:
Poland
Portugal
Spain
Austria
Canada
United States
France
Germany

location_facility: Landeskrankenhaus Salzburg-Universitätsklinikum der Paracelsus Medizinischen Privatuniversität

location_facility: Warszawki Uniwersytet Medyczny Katedra I Klinika Dermatologiczna

location_facility: Lucile Packard Children's Hospital at Stanford University

location_facility: University of Freiburg (Studiensekretariat Hautklinik Universitätsklinikum Freiburg - Hautklinik)

location_facility: Ann & Robert H. Lurie Children's Hospital of Chicago

location_facility: Rady Children's Hospital - San Diego/UCSD, Pediatric and Adolescent Dermatology


title: A Phase I/II, Multicenter, Open-label Study of MAK683 in Adult Patients With Advanced Malignancies

location_country:
Hong Kong
Spain
Italy
Canada
United States
France
China
Singapore
Japan
Germany

location_facility: University of Texas MD Anderson Cancer Center Dept of Onc

summary: The purpose of this Phase I/II study is to establish the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) and to evaluate the safety, antitumor activity and pharmacokinetic (PK) profile of MAK683 in patients with advanced malignancies such as Diffuse Large B cell Lymphoma (DLBCL), nasopharyngeal carcinoma (NPC) or other advanced solid tumors for whom no further effective standard treatment is available.


title: A Phase 3 Multi-Center Parallel Design Clinical Trial to Compare the Efficacy and Safety of 5 % Minoxidil Foam vs. 2 % Minoxidil Solution in Females for the Treatment of Female Pattern Hair Loss - Androgenetic Alopecia (MINALO3004, NCT01145625)

lead_sponsor: Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.

ReferenceCitation: Blume-Peytavi U, Shapiro J, Messenger AG, Hordinsky MK, Zhang P, Quiza C, Doshi U, Olsen EA. Efficacy and Safety of Once-Daily Minoxidil Foam 5% Versus Twice-Daily Minoxidil Solution 2% in Female Pattern Hair Loss: A Phase III, Randomized, Investigator-Blinded Study. J Drugs Dermatol. 2016 Jul 1;15(7):883-9.

location_country:
United Kingdom
Canada
United States
France
Germany

location_facility: Klinik für Dermatologie, Venerologie und Allergologie, Clinical Research Center for Hair and Skin Science

summary:
This is a year-long clinical trial to evaluate the effectiveness and safety in women with Female Pattern Hair Loss (FPHL), comparing a new 5% minoxidil topical foam (MTF) formulation applied once a day versus the 2% minoxidil topical solution (MTS) applied twice a day.

This clinical trial uses an objective measurement called Target Area Hair Count (TAHC) to evaluate if there is a change in the number of hairs in the area being examined after using the product for 24 weeks (and also after using the product for 12 Weeks and for 52 weeks).

This trial will determine if the benefit of using either study product outweighs the risks.


title: Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features: the p53abn-RED Trial, the MMRd-GREEN Trial, the NSMP-ORANGE Trial and the POLEmut-BLUE Trial

acronym: RAINBO

summary:
The RAINBO umbrella program consists of four clinical trials investigating new adjuvant therapies in endometrial cancer patients. Eligible patients will be assigned to one of the four RAINBO trials based on the molecular profile of their cancer:

p53 abnormal endometrial cancer patients to the p53abn-RED trial
mismatch repair deficient endometrial cancer patients to the MMRd-GREEN trial
no specific molecular profile endometrial cancer patients to NSMP-ORANGE trial
POLE mutant endometrial cancer patients to the POLEmut-BLUE trial

ReferenceCitation: IMPLEMENTATION OF COLLABORATIVE TRANSLATIONAL RESEARCH (TRANSPORTEC) FINDINGS IN AN INTERNATIONAL ENDOMETRIAL CANCER CLINICAL TRIALS PROGRAM (RAINBO). T Bosse, M Powell, E Crosbie, A Leary, J Kroep, K Han, J Mcalpine, N Horeweg, S De Boer, M De Bruyn, R Nout, V Smit, HW Nijman, N Singh, H Mackay, R Edmondson, L Mileshkin, D Church, H Kitchener, CL Creutzberg. Int J Gynecol Cancer 2021;31(Suppl 3):A1-A395. DOI: 10.1136/ijgc-2021-ESGO.171

doi: implementation

ipd_sharing_description: Following the planned translational work in the RAINBO programme and publications, the translational research (TR) committee will open up the sample collection to external researchers. Access will be granted following completion of a research proposal form and approval by the TR committee chaired by Dr. Tjalling Bosse. All external researchers will be expected to demonstrate funding for their project and ethics approval. Data will be made available as required through data sharing agreements. The following will be reviewed when considering applications for data sharing and sample access: data and sample use is in-keeping with patient consent, the proposed project has scientific value, with defined objectives and study plan, trial data are appropriate for the intended purpose, acknowledgement of the RAINBO Programme in all publications that arise from the data sharing, compliance with legal and regulatory requirements as applicable and patient confidentiality maintained at all times.

lead_sponsor: Leiden University Medical Center

location_country:
Netherlands
Canada
United Kingdom
France

location_facility: The p53abn-RED trial: Institute Gustave Roussy

location_facility: The MMRd-GREEN trial: Leiden University Medical Center

location_facility: The NSMP-ORANGE trial: Barts Health NHS Trust

location_facility: The NSMP-ORANGE trial: Manchester Academic Health Science Centre, St Mary's Hospita

location_facility: The POLEmut-BLUE trial: University of British Columbia

location_facility: The POLEmut-BLUE trial: Princess Margaret Cancer Centre, University of Toronto

intervention_type: Radiation


title: Molecular Targeted Maintenance Therapy Versus Standard of Care in Advanced Biliary Cancer: an International, Randomised, Controlled, Open-label, Platform Phase 3 Trial

summary:
The object of this trial is to evaluate whether the introduction of a targeted therapy after 4 cycles of the current standard-of-care treatment for advanced biliary cancer is superior to continuing with the standard treatment.

The trial is composed of two phases: (i) An initial screening phase to identify a suitable patient population, during which a molecular profile of the patient's tumour will be obtained, and (ii) a randomised comparative trial in which patients with disease control after 4 cycles of standard treatment, and whose tumour harbours a targetable molecular alteration, will be randomised (2:1) to receive either a matched targeted therapy or to continue with the standard treatment.

study_start_date_type: Anticipated

status: Not yet recruiting

ipd_sharing_description: Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.

lead_sponsor: UNICANCER

location_country:
France
United Kingdom
Belgium

location_facility: Groupe Hospitalier Diaconesses Croix Saint-Simon


title: A Six-month Double-blind, Randomized, Placebo-controlled Study Investigating the Safety and Tolerability of Deferiprone in Patients With Friedreich's Ataxia

summary:
The primary objective of this study is to demonstrate the safety and tolerability of deferiprone in subjects with Friedreich's ataxia (FRDA).

The secondary objective is to evaluate the efficacy of deferiprone for the treatment of FRDA, as assessed by a 9-Hole Peg Test (9HPT), Timed 25-Foot Walk (T25FW), Low-Contrast Letter Acuity test (LCLA), International Cooperative Ataxia Rating Scale (ICARS), and Friedreich's Ataxia Rating Scale (FARS).

The tertiary objectives are to evaluate the effect of deferiprone on:

cardiac function as measured by changes in Left Ventricular Shortening Fraction (LVSF), Left Ventricular Ejection Fraction (LVEF) and Left Ventricular (LV) mass using echocardiogram (ECHO),
quality of life using quality-of-life surveys, and
functional status using Activities of Daily Living (ADL).

lead_sponsor: ApoPharma

location_country: Spain Italy Australia Canada France Belgium

location_facility: La Fundacion Para la Investigacion Biomedica

location_facility: Fondazione IRCCS Istituto Neurologico "C. Besta"


title: Randomized Clinical Trial to Evaluate the Interest of a Down-scaled Treatment Strategy Using Dual Therapy (Nucleoside Analogs) in HIV Infected Patients Already Being Treated Using Triple Therapy, Who Present With a Successful Virological Control and for Which the HIV Reservoir is Low to Moderate

acronym: TRULIGHT

summary:
In the early 2000s, the "TRILEGE©" study was realized to determine if the reductive anti retroviral strategy from an initial triple therapy (based on a protease inhibitor as the third agent) towards a dual therapy of nucleoside analogs (in particular the association of "zidovudine +lamivudine") for patients infected by HIV and stabilized for at least 3 months at a threshold value of 400 copies/ml, would allow to obtain a well-controlled plasmatic viral load, with an aim to reduce the long-term side effects of the treatment.

The afore mentioned study showed that the reductive anti retroviral strategy was a failure. No study has as yet to revaluate this strategy, in particular in the current context of antiretroviral treatments.

Indeed, modern nucleoside inhibitors (Kivexa®, Truvada®) have extended half-lives as well as a superior intrinsic power as compared to treatments proposed in the initial "TRILEGE©" study. Furthermore, the better quality of current triple therapy (as compared to that used 10 years ago) has lead to substantial viral reservoir reduction.

Currently, a small number of patients is being successfully treated in the long-term (viral load < 20 copies/ml) using nucleoside analog dual therapy. The particular characteristics of these patients have yet to be thoroughly investigated.

The patients concerned were all treated prematurely before ever passing below 200 lymphocytes T CD4/mm3. It occurred that all these patients presented a low viral reservoir as measured by HIV DNA quantification (< 2,7 log copies/106 PBMC).

Therefore, by targeting patients who have (1) a strong immune restoration, (2) a low HIV DNA value and (3) a very good observance, the investigators emit the hypothesis that, reductive anti retroviral strategy that would consist in changing from a conventional triple therapy towards a Nucleoside reverse-transcriptase inhibitors dual therapy, could allow for durable control of viral replication with the concomitant benefice of reduced antiretroviral side effects and cost.

ReferenceCitation: Prazuck T, Verdon R, Le Moal G, Ajana F, Bernard L, Sunder S, Roncato-Saberan M, Ponscarme D, Etienne M, Viard JP, Pasdeloup T, Darasteanu I, Pialoux G, de la Blanchardière A, Avettand-Fènoël V, Parienti JJ, Hocqueloux L; TRULIGHT Study Team. Tenofovir disoproxil fumarate and emtricitabine maintenance strategy in virologically controlled adults with low HIV-1 DNA: 48 week results from a randomized, open-label, non-inferiority trial. J Antimicrob Chemother. 2021 May 12;76(6):1564-1572. doi: 10.1093/jac/dkab038.

ReferenceCitation: Hocqueloux L, Gubavu C, Prazuck T, De Dieuleveult B, Guinard J, Sève A, Mille C, Gardiennet E, Lopez P, Rouzioux C, Lefeuvre S, Avettand-Fènoël V. Genital Human Immunodeficiency Virus-1 RNA and DNA Shedding in Virologically Suppressed Individuals Switching From Triple- to Dual- or Monotherapy: Pooled Results From 2 Randomized, Controlled Trials. Clin Infect Dis. 2020 Apr 15;70(9):1973-1979. doi: 10.1093/cid/ciz511.

lead_sponsor: University Hospital, Tours

location_facility: Service des maladies Infectieuses et tropicales, CH GEORGES RENON

location_facility: Service des Maladies Infectieuses et tropicales, APHP SAINT LOUIS

location_facility: Service de Medecine Interne et Maladies Infectieuses, CHRU BRETONNEAU, TOURS CEDEX9

location_facility: Service de Pneumologie, centre Hospitalier Fontenoy, CH de CHARTRES

location_facility: Centre de diagnostic et thérapeutique, Hopital Hotel Dieu

location_facility: Consultation Maladies Infectieuses, Chu de Poitiers, Cedex

location_facility: Service de Médecine Interne, CH de SAINTONGE- BP 326

location_facility: Service des Maladies Infectieuses, CHR Orléans La Source, ORLEANS CEDEX 2

location_facility: Service d'Immunologie Clinique centre de Vaccination anti- VIH ANRS Hopital Henri- Mondor

location_facility: Service de Médecine Interne et Maladies Infectieuses, Groupe Hospitalier La Rochelle, Cedex 01

location_facility: Unité des Maladies Infectieuses, CHU de CAEN

location_facility: Service Universitaire des Maladies Infectieuses et du Voyageur, CH DRON


title: Safety and Efficacy of Endovascular Treatment of Unruptured Intracranial Aneurysms in the Prevention of Aneurysmal Haemorrhages: A Randomized Comparison With Indefinite Deferral of Treatment in 2002 Patients Followed for 10 Years

acronym: TEAM

summary: The management of patients with unruptured aneurysms is controversial. Patients with unruptured aneurysms may suffer intracranial hemorrhage, but the incidence of this event is still debated. Endovascular treatment can prevent rupture, but involves immediate risks; furthermore, successful treatment does not eliminate all risks. A randomized trial may be the best way to demonstrate the potential benefits of endovascular over conservative management of unruptured aneurysms.

ReferenceCitation: Raymond J, Meder JF, Molyneux AJ, Fox AJ, Johnston SC, Collet JP, Rouleau I; Trial on Endovascular Aneurysm Management (TEAM) collaborative group. Trial on endovascular treatment of unruptured aneurysms (TEAM): study monitoring and rationale for trial interruption or continuation. J Neuroradiol. 2007 Mar;34(1):33-41. Review.

ReferenceCitation: Raymond J, Meder JF, Molyneux AJ, Fox AJ, Johnston SC, Collet JP, Rouleau I; Trial On Endovascular Aneurysm Management Team Collaborative Group. Unruptured intracranial aneurysms: the unreliability of clinical judgment, the necessity for evidence, and reasons to participate in a randomized trial. J Neuroradiol. 2006 Oct;33(4):211-9. Review.

ReferenceCitation: Raymond J, Guilbert F, Weill A, Roy D. Unruptured intracranial aneurysms: a call for a randomized clinical trial. AJNR Am J Neuroradiol. 2006 Feb;27(2):242-3.

ReferenceCitation: Raymond J, Guilbert F, Weill A, Georganos SA, Juravsky L, Lambert A, Lamoureux J, Chagnon M, Roy D. Long-term angiographic recurrences after selective endovascular treatment of aneurysms with detachable coils. Stroke. 2003 Jun;34(6):1398-403. Epub 2003 May 29.

ReferenceCitation: Raymond J, Chagnon M, Collet JP, Guilbert F, Weill A, Roy D. A randomized trial on the safety and efficacy of endovascular treatment of unruptured intracranial aneurysms is feasible. Interv Neuroradiol. 2004 Jun 29;10(2):103-12. Epub 2004 Oct 22.

ReferenceCitation: Raymond J, Molyneux AJ, Fox AJ, Johnston SC, Collet JP, Rouleau I; TEAM Collaborative Group. The TEAM trial: safety and efficacy of endovascular treatment of unruptured intracranial aneurysms in the prevention of aneurysmal hemorrhages: a randomized comparison with indefinite deferral of treatment in 2002 patients followed for 10 years. Trials. 2008 Jul 16;9:43. doi: 10.1186/1745-6215-9-43.

ReferenceCitation: Naggara O, Raymond J, Guilbert F, Roy D, Weill A, Altman DG. Analysis by categorizing or dichotomizing continuous variables is inadvisable: an example from the natural history of unruptured aneurysms. AJNR Am J Neuroradiol. 2011 Mar;32(3):437-40. doi: 10.3174/ajnr.A2425. Epub 2011 Feb 17.

ReferenceCitation: Raymond J. Incidental intracranial aneurysms: rationale for treatment. Curr Opin Neurol. 2009 Feb;22(1):96-102. Review.

lead_sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

location_country:
United Kingdom
United States
Canada
France

location_facility: CHUM Notre-Dame Hospital / TEAM clinical research unit (Head office)

location_facility: TEAM European Coordination Centre NVRU- Radcliffe Infirmary

location_facility: TEAM France Coordination Unit - CHU Reims CRICAM

intervention_type: Device


title: Personalized Spacing of Eculizumab Infusions Based on Therapeutic Pharmacological Monitoring: Prospective Health-economic Evaluation in Patients in Remission With Atypical Hemolytic Uraemic Syndrome Requiring Long-term Treatment.

acronym: EspacECU

summary: Eculizumab is an anti-C5 monoclonal antibody approved for rare diseases including atypical haemolytic-uraemic syndrome. The maintenance phase dosing regimen is identical for all adult patients but several studies have shown a high interindividual kinetics variability. A tailored administration of eculizumab based on therapeutic drug monitoring will be compared with real-life administration in adults suffering from an atypical haemolytic uraemic syndrome. The objective is to improve efficiency of eculizumab administration.

location_facility:
CHU Besançon
Hôpital de Bois-Guillaume
Hôpital de la Milétrie
CHU Amiens Picardie
Hôpital Gabriel Montpied
Hôpital de la Côte de Nacre
Hôpital Louis Pasteur
CHU d'Angers
Hôpital Pontchaillou
Hotel Dieu
Hôpital Tenon
Nouvel Hôpital Civil
Hopital de la conception
Hopital Necker
Hopital Pasteur 2
Hôpital Maison Blanche
Hospices Civils de Lyon
Hôpitaux de Brabois


title: Safety & Efficacy of Neoadjuvant Immunotherapy With Durvalumab (MEDI 4736) Combined With Neoadjuvant Chemotherapy (Gemcitabine/Cisplatin or Gemcitabine/Carboplatin) in Patients With Operable, High-risk, Localized Urothelial Carcinoma of the Upper Urinary Tract

acronym: iNDUCT

summary:
Following radical nephrectomy (RNU) for upper tract urothelial carcinoma (UTUC) most patients face a poor prognosis. Indeed, patients who have undergone RNU for UTUC have 5-year recurrence-free and cancer specific survival probabilities of 69% and 73% respectively.

The primary objective of this study is to assess the pathological complete response rate to combination therapy with neoadjuvant durvalumab and chemotherapy (Gemcitabine/Cisplatin) before surgery in patients with high-risk, localized, non-metastatic urothelial carcinomas of the upper tract.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility:
Centre hospitalier Lyon Sud
Hôpital Pitié Salpétrière
Hôpital Foch
Institut Paoli Calmette
Iuct Oncopole
Hôpital Saint Louis
Hôpital Européen Georges Pompidou
Hôpital Bichat-Claude Bernard


title: Clinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation

acronym: ZERO-AF

summary: The purpose of this study is to establish the safety and effectiveness of the Blazer Open-Irrigated radiofrequency ablation catheter for the treatment of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation.

lead_sponsor: Boston Scientific Corporation

location_country:
Portugal
Spain
United Kingdom
Australia
Sweden
United States
France
Germany
Czechia

location_facility: Hospital of the University of Pennsylvania

location_facility: University of North Carolina Medical Center

location_facility: Texas Cardiac Arrhythmia Research Foundation

location_facility: University of Texas Health Science Center

location_facility: Strong Memorial Hospital of the University of Rochester


title: RNA Disruption Assay (RDA)-Breast Cancer Response Evaluation for Individualized Therapy (BREVITY / BREVITY-02 in Germany)

acronym: BREVITY

summary: The current study aims to provide validation results of RNA Disruption Assay (RDA) as a tumour response assessment tool that uses tumour core biopsies taken starting from 35 +/- 4 days after the initiation of neoadjuvant chemotherapy.

ReferenceCitation: Parissenti AM, Guo B, Pritzker LB, Pritzker KP, Wang X, Zhu M, Shepherd LE, Trudeau ME. Tumor RNA disruption predicts survival benefit from breast cancer chemotherapy. Breast Cancer Res Treat. 2015 Aug;153(1):135-44. doi: 10.1007/s10549-015-3498-9. Epub 2015 Jul 25.

ReferenceCitation: Narendrula R, Mispel-Beyer K, Guo B, Parissenti AM, Pritzker LB, Pritzker K, Masilamani T, Wang X, Lannér C. RNA disruption is associated with response to multiple classes of chemotherapy drugs in tumor cell lines. BMC Cancer. 2016 Feb 24;16:146. doi: 10.1186/s12885-016-2197-1.

ReferenceCitation: Toomey S, Eustace AJ, Pritzker LB, Pritzker KP, Fay J, O'Grady A, Cummins R, Grogan L, Kennedy J, O'Connor D, Young L, Kay EW, O'Donovan N, Gallagher WM, Kalachand R, Crown J, Hennessy BT. RE: RNA Disruption Assay as a Biomarker of Pathological Complete Response in Neoadjuvant Trastuzumab-Treated Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer. J Natl Cancer Inst. 2016 Jul 4;108(8). pii: djw111. doi: 10.1093/jnci/djw111. Print 2016 Aug.

ReferenceCitation: Pritzker K, Pritzker L, Generali D, Bottini A, Cappelletti MR, Guo B, Parissenti A, Trudeau M. RNA Disruption and Drug Response in Breast Cancer Primary Systemic Therapy. J Natl Cancer Inst Monogr. 2015 May;2015(51):76-80. doi: 10.1093/jncimonographs/lgv015.

ReferenceCitation: von Minckwitz G, Blohmer JU, Costa SD, Denkert C, Eidtmann H, Eiermann W, Gerber B, Hanusch C, Hilfrich J, Huober J, Jackisch C, Kaufmann M, Kümmel S, Paepke S, Schneeweiss A, Untch M, Zahm DM, Mehta K, Loibl S. Response-guided neoadjuvant chemotherapy for breast cancer. J Clin Oncol. 2013 Oct 10;31(29):3623-30. doi: 10.1200/JCO.2012.45.0940. Epub 2013 Sep 3.

ReferenceCitation: Cortazar P, Zhang L, Untch M, Mehta K, Costantino JP, Wolmark N, Bonnefoi H, Cameron D, Gianni L, Valagussa P, Swain SM, Prowell T, Loibl S, Wickerham DL, Bogaerts J, Baselga J, Perou C, Blumenthal G, Blohmer J, Mamounas EP, Bergh J, Semiglazov V, Justice R, Eidtmann H, Paik S, Piccart M, Sridhara R, Fasching PA, Slaets L, Tang S, Gerber B, Geyer CE Jr, Pazdur R, Ditsch N, Rastogi P, Eiermann W, von Minckwitz G. Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis. Lancet. 2014 Jul 12;384(9938):164-72. doi: 10.1016/S0140-6736(13)62422-8. Epub 2014 Feb 14. Review. Erratum in: Lancet. 2019 Mar 9;393(10175):986.

lead_sponsor: Rna Diagnostics Inc.

location_country:
Spain
Italy
Canada
United States
France
Germany

location_facility: SST di Cremona Multidisciplinare di Patologia Mammaria, Italy


title: Clinical Trial Comparing Two Electroconvulsive Therapy (ECT) Application Schemas in Ultra-resistant Schizophrenia

acronym: SURECT

summary: The effects of the ECT in schizophrenia ultra-resistant were studied in short times (4-6 months in most studies with follow-up). The literature identified a high relapse rate of 32% in the weeks to months after ECT discontinuation. The use of the ECT in the prevention of the relapse is partially known. In an empirical way, experts recommend protocols of prevention of the relapse going from 6 to 12 months. Nevertheless, the profit of a long cure (12 months) compared with a short cure (6 months) was never determined. Therefore, the investigators decided to lead a prospective randomized controlled study in order to compare the response rates between the two strategies of clozapine and ECT combinations applied to URS patients. The treatment consisted either in a short therapy of six months or a longer course of therapy of twelve months. To the investigators' knowledge, it is the first study which compares two ECT strategies (both the short duration and the longer one) for the treatment of URS patients.

ReferenceCitation: Moulier V, Krir MW, Dalmont M; SURECT Group, Guillin O, Rothärmel M. A prospective multicenter assessor-blinded randomized controlled study to compare the efficacy of short versus long protocols of electroconvulsive therapy as an augmentation strategy to clozapine in patients with ultra-resistant schizophrenia (SURECT study). Trials. 2021 Apr 15;22(1):284. doi: 10.1186/s13063-021-05227-3.

lead_sponsor: Centre Hospitalier du Rouvray

location_facility:
Montpellier University Hospital
CHU de Caen
Centre Hospitalier Henri Laborit
Centre Hospitalier Charles Perrens
CHU de Nantes
EPS Ville Evrard
Clermont-Ferrand Hospital
CHU de Toulouse
Centre Hospitalier de Cadillac
Centre Hospitalier Saint Anne


title: Clinical Evaluation of the StablePoint Catheter and Force Sensing System for Paroxysmal Atrial Fibrillation

acronym: NEwTON AF

summary: The NEwTON AF study is a multi-center, global, prospective, single arm study to establish the safety and effectiveness of the IntellaNav StablePoint Catheter and Force-Sensing System in subjects with symptomatic, drug refractory, recurrent paroxysmal atrial fibrillation.

location_country:
Taiwan
Hong Kong
United Kingdom
Italy
Austria
Netherlands
Canada
Monaco
United States
France
Belgium
Japan
Germany

location_facility: Wake Forest University School of Medicine

location_facility: University of Iowa Hospitals and Clinics

location_facility: Christus Trinity Mother Frances Health System

location_facility: St. Mary's Duluth Clinic Regional Heart Center

location_facility: Institut universitaire de Cardiologie et de Pneumologie de Quebec

location_facility: Chippenham and Johnston-Willis Hospital (CJW)

location_facility: Immanuel Klinikum Bernau Herzzentrum Brandenburg


title: Safety and Effectiveness IDE Trial for Boston Scientific's Cryoballoon in the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation

acronym: FROZEN-AF

summary: To establish the safety and effectiveness of the Boston Scientific Cardiac Cryoablation System for treatment of symptomatic, drug refractory, recurrent, paroxysmal atrial fibrillation (AF).

ipd_sharing_description: No requests for study data have been made at this time, however Boston's Scientific's policy on data sharing can be found at http://www.bostonscientific.com/en-US/data-sharing-requests.html

location_country:
Taiwan
Hong Kong
Italy
Netherlands
Canada
United States
France
Belgium
Germany

location_facility: Virginia Commonwealth University Health System

location_facility: Erasmus MC- University Medical Center Rotterdam


title: Very High Definition Cohort: Assessment of New Prognostic Biomarkers of Disability Worsening in a Multicenter Cohort of MS Patients by Imaging, Optical Coherence Tomography and Biology

acronym: VHD cohort

summary:
Multiple sclerosis (MS) is the most common acquired neurological disease leading to disability in young adults. MS often leads to the development of a physical and/or cognitive impairment that disables patients in their daily lives. Early use of disease modifying treatments for patients at risk of developing disability is therefore essential.

However, disability progression is very heterogeneous between patients and currently impossible to predict at the individual level. Thus, numerous studies, particularly epidemiological and imaging studies, have identified prognostic factors for the development of disability such as age, gender, number of relapses during the first years of the disease, existence of a residual disability after a first relapse, number of gadolinium-enhancing lesions on initial MRI, early brainstem and spinal cord lesions. However, these different factors only explain incompletely the progression of the physical or cognitive disability in MS patients. In particular, some components of MS pathophysiology, more related to the progressive development of disability, such as axonal degeneration or the existence of chronic inflammation of the central nervous system (CNS) are usually not measured by these biomarkers.

In this research project, the investigators will test promising biomarkers, focused on these components of the disease, on a large cohort of patients in a multicenter setting, in order to evaluate their added value to predict disability progression, in comparison with more classical biomarkers such as clinical characteristics, and brain and spinal cord lesion load.

In particular, the investigators will test:

Imaging biomarkers extracted from brain and spinal cord MP2RAGE, brain and spinal cord QSM, brain and spinal cord relaxometry, brain diffusion and spinal cord magnetization transfer sequences
Biomarkers extracted from optical coherence tomography (OCT)
Biological biomarkers (serum neurofilament-light chain (NFL) and Glial Fibrillary Acidic Protein (GFAP))

lead_sponsor: EDMUS Foundation

location_facility:
CHU de Lyon
CHU de Strasbourg
CHU de Nîmes
CHU de Nancy
CHU de Rennes


title: Comparison of Scores for Early Brain Damage Assessment at Intensive Care Unit Admission After Cardiac Arrest

summary: Even in patients with successful return of spontaneous circulation (ROSC), outcome after cardiac arrest remains poor. The overall in-hospital survival rate widely varies both worldwide and across communities, from 1 to 4 folds according to circumstances of arrest and post-resuscitation interventions. Several studies have already shown that early interventions performed after ROSC, such as treatment of the cause, targeted temperature management, optimal hemodynamic management and extra-corporeal life support in selected patients, could improve the outcome in post-cardiac arrest patients. However, the decision process regarding the allocation of these resources, in parallel with the management of patients' proxies, remains a complex challenge for physicians facing these situations. Consequently, several prediction models and scores have been developed in order to stratify the risk of unfavorable outcome and to discriminate the best candidates for post-resuscitation interventions. Overall, several scores exist, but external validation are lacking and direct comparisons are needed to assess relative interest of scoring systems. Indeed, establishing the optimal scoring system is crucial, for optimal treatment allocation and appropriate information to relatives.

ipd_sharing_description: Sharing of IPD will be possible upon request to steering committee of the AfterROSC Network after approval of the project by ethics committee.

lead_sponsor: AfterROSC

location_facility:
CHU Nantes
Hopital Jacques Cartier
CH Versailles
Clinique Ambroise Paré
APHP, Cochin


title: Ability of a Virtual-reality Based Solution Aiming to Reduce Patient Burden Related to Repetitive Intravenous Perfusions. A Proof-of-concept Study in Hemophilia Patients Receiving Prophylactic Factor VIII Infusions

summary:
The main aim is to describe how the treatment burden and challenges of participants, relatives, and doctors during regular Factor VIII infusions to treat hemophilia evolve using a virtual-reality (VR) based solution. The study also aims to find out how well the VR based solution is tolerated and how satisfied the participants, relatives, and doctors are with it.

The VR based solution includes a mobile phone app and a 3D mask.

Participants will use the VR based solution while receiving prophylactic Factor VIII infusions for 4 weeks at home. Participants will visit the clinic for the last infusion; at this time data will be collected from participants, relatives, and doctors

primary_purpose: Supportive Care

location_facility:
CHU Purpan
HCL
CHU Pellegrin
CHU Saint Eloi
CHU Estaing


title: Cross-cultural Validation of a Screening Scale for the Misuse of Opioid Analgesics in Primary Care

acronym: VAMOS

summary:
Objective: Analgesic Opioids misuse among patients with chronic pain ranges from 0% to 50%. The general practitioner is the first prescriber of opioid analgesics Our objective was to validate in primary care the POMI (Prescription Opioid Misuse Index) to identify the misuse of AOs.

Study Setting: Patients with chronic pain, taking AOs for at least 3 months, and followed in general practice.

Study design: Psychometric study

Data Collection/Extraction methods: Eligible patients followed in general practice responded to the POMI: Test phase. They then responded after 2 weeks: the retest. The gold standard used was the DSM-V.

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility: Département de médecine Générale, Facultés de Médecine de Clermont-Ferrand

location_facility: CHU Clermont-Ferrand, UMR INSERM 1107, NEURO-DOL

location_facility: Département de médecine générale, Faculté de médecine, Toulouse

location_facility: Département de médecine générale, Faculté de médecine, Montpellier


title: Impact of Anti-inflammatory and Antibiotic Therapy on the Emergence of Peri-tonsillar Abscess

acronym: APA

summary:
Analyze in children and adults, risk factors in the onset of the APA. The main hypothesis focuses on the use of anti-inflammatory in the context of pharyngitis or sore throat before the symptoms of ABS. Secondary objectives:

- Analyze the implementation of a rapid diagnostic test and its result on the occurrence of an ABS
- Measure the frequency of prescription and describe the reasons for not prescribing an antibiotic for patients who consulted for a sore throat and having developed a PLA
- Describe the microbial flora could puncture of patients hospitalized for APA

lead_sponsor: Nantes University Hospital

location_facility:
Lille University Hospital
Angers university Hospital
Paris-Cochin Hospital
Poitiers University Hospital
Nantes University Hospital
Paris-Lariboisière Hospital
Toulouse University Hospital
Paris-Bichat-Hospital
Clermont Ferrand University Hospital
Paris-Tenon-Hospital
Rennes University hospital
Tours University Hosipital
Ambroise Paré Hospital
Grenoble University Hospital
Caen universty Hospital


title: Real-life Data From Diabetic Patients on Closed-loop Pumps

acronym: BLOOM

summary: To evaluate, in real life, the effect of closed-loop devices on the improvement of glycemic control in diabetic patients managed in the endocrinology departments of secondary care hospitals.

time_perspective: Retrospective

ipd_sharing_description: The database will be made available on a general-purpose open repository. Medical Subject Headings (MESH) terms will be used to describe clinical data. International standard unit will be used. Keyword are type I diabetes, Insulin Infusion Systems, Patient Outcome Assessment

lead_sponsor: Groupe Hospitalier de la Rochelle Ré Aunis

location_facility: CHI Mont de Marsan et du Pays des Sources


title: Evaluation of a Web Application on Event Reporting for Patients With B Lymphoma on First Line Treatment

acronym: EMILY

summary: Diffuse large B cell lymphoma is the most common malignant lymphoid hemopathy. More than half of the patients will be cured with an RCHOP-type immunochemotherapy protocol (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone). Monitoring of adverse effects, risk of relapse and quality of life are essential in overall management. Patients are the best candidates to report them. Managing these events should improve quality of life and reduce costs. The aim of this study is to assess the feasibility of monitoring these events by a web application (Oncolaxy©) and to compare it with a control population in the context of a randomized pilot study including 80 patients per arm with diffuse large cell B lymphoma in first-line treatment with R-CHOP.

lead_sponsor: Weprom

location_facility: Clinique Victor Hugo/Centre Jean Bernard/ILC


title: Prospective, Randomized, Double-blind Study Assessing the Effects of Levetiracetam Compared to Placebo in the Prevention of Early Epileptic Seizures and Late Epilepsy in Patients With Severe Traumatic Brain Injury

acronym: TRACK

summary: Post-traumatic seizures can appear frequently after a severe traumatic brain injury. Two types of seizures are usually identified: early seizures during the week following the trauma and late epilepsy afterward. Several antiepileptic drugs are usually used to prevent early seizures but no treatment has demonstrated any preventive effect against late epilepsy. Levetiracetam is an antiepileptic drug usually used for the treatment of epileptic patients and has pharmacologic properties that could also be interesting for the prevention of post-traumatic epilepsy.

lead_sponsor: Rennes University Hospital

location_facility: Explorations Fonctionnelles Neurologiques - CHU Nantes

location_facility: Neurophysiologie clinique - CHU Lyon (Hôpital neurologique)

location_facility: Beurophysiologie clinique - CHU Marseille

location_facility: Neurologie - CHU Tours Hopital Trousseau


title: An Open-label, Multicentre, Nonrandomized, Dose-escalating Phase I/II Study, With a Randomized Phase II Part, to Investigate the Safety and Tolerability of RO5072759 Given as Monotherapy in Patients With CD20+ Malignant Disease.

summary:
The primary objective for the phase I part of the study is to investigate the safety and tolerability of escalating intravenous (IV) doses of obinutuzumab given as monotherapy in participants with CD20+ (tumor-infiltrating lymphocytic) Malignant Disease, including B-cell chronic lymphocytic leukemia (CLL) and Non-Hodgkin's Lymphoma (NHL). The primary objective for the phase II part of the study is to investigate the efficacy and safety of one dose of obinutuzumab in participants with relapsed/refractory CLL and NHL that is, in turn, either indolent (iNHL) or aggressive (aNHL).

It is an open label dose escalating study in phase I and open label in phase II, but the two doses in iNHL & aNHL are randomized (to high or low dose of the same open label treatment). CLL was not randomized as only one dose level was used.

Participants with a response who might gain additional benefit from being treated again in the opinion of the investigator may be enrolled in a Retreatment Period.

ReferenceCitation: Gibiansky E, Gibiansky L, Buchheit V, Frey N, Brewster M, Fingerle-Rowson G, Jamois C. Pharmacokinetics, exposure, efficacy and safety of obinutuzumab in rituximab-refractory follicular lymphoma patients in the GADOLIN phase III study. Br J Clin Pharmacol. 2019 Sep;85(9):1935-1945. doi: 10.1111/bcp.13974. Epub 2019 Jul 12.

ReferenceCitation: Cartron G, Hourcade-Potelleret F, Morschhauser F, Salles G, Wenger M, Truppel-Hartmann A, Carlile DJ. Rationale for optimal obinutuzumab/GA101 dosing regimen in B-cell non-Hodgkin lymphoma. Haematologica. 2016 Feb;101(2):226-34. doi: 10.3324/haematol.2015.133421. Epub 2015 Dec 11.

ReferenceCitation: Cartron G, de Guibert S, Dilhuydy MS, Morschhauser F, Leblond V, Dupuis J, Mahe B, Bouabdallah R, Lei G, Wenger M, Wassner-Fritsch E, Hallek M. Obinutuzumab (GA101) in relapsed/refractory chronic lymphocytic leukemia: final data from the phase 1/2 GAUGUIN study. Blood. 2014 Oct 2;124(14):2196-202. doi: 10.1182/blood-2014-07-586610. Epub 2014 Aug 20.

ReferenceCitation: Morschhauser FA, Cartron G, Thieblemont C, Solal-Céligny P, Haioun C, Bouabdallah R, Feugier P, Bouabdallah K, Asikanius E, Lei G, Wenger M, Wassner-Fritsch E, Salles GA. Obinutuzumab (GA101) monotherapy in relapsed/refractory diffuse large b-cell lymphoma or mantle-cell lymphoma: results from the phase II GAUGUIN study. J Clin Oncol. 2013 Aug 10;31(23):2912-9. doi: 10.1200/JCO.2012.46.9585. Epub 2013 Jul 8.

ReferenceCitation: Salles GA, Morschhauser F, Solal-Céligny P, Thieblemont C, Lamy T, Tilly H, Gyan E, Lei G, Wenger M, Wassner-Fritsch E, Cartron G. Obinutuzumab (GA101) in patients with relapsed/refractory indolent non-Hodgkin lymphoma: results from the phase II GAUGUIN study. J Clin Oncol. 2013 Aug 10;31(23):2920-6. doi: 10.1200/JCO.2012.46.9718. Epub 2013 Jul 8.

ReferenceCitation: Salles G, Morschhauser F, Lamy T, Milpied N, Thieblemont C, Tilly H, Bieska G, Asikanius E, Carlile D, Birkett J, Pisa P, Cartron G. Phase 1 study results of the type II glycoengineered humanized anti-CD20 monoclonal antibody obinutuzumab (GA101) in B-cell lymphoma patients. Blood. 2012 May 31;119(22):5126-32. doi: 10.1182/blood-2012-01-404368. Epub 2012 Mar 19.

lead_sponsor: Hoffmann-La Roche

location_country: Germany France


title: Local Ablative Stereotactic Radiotherapy for Residual Hypermetabolic Lesion in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Long-term Responders to Immunotherapy : a Randomized, Multicenter, Open-label Phase III Study

summary:
At present, it is recommended to continue immunotherapy until progression or unacceptable toxicity.

However, only a minority of patients benefits from a durable response and most see the disease progress despite several months of control under immunotherapy. Multimodal approaches have been developed to improve their prognosis.

This study, randomized, open-label study aims to evaluate the impact of addition of ablative radiotherapy on OS of patients with NSCLC and oligometastatic lesions and treated by immunotherapy in first line (potentially associated with chemotherapy) or beyond. Stereotactic radiotherapy will be performed on a maximum of 5 residual hypermetabolic lesions seen on 18F-FDG PET / CT, in patients responding to immunotherapy (or with a stable disease) for at least 6 months.

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility:
ICO - Site Paul Papin
Centre François BACLESSE
Chu de Brest
Institut de cancérologie de l'ouest
Chu de Tours