title: A Phase 1/2 Multi-Center Study Evaluating the Safety and Efficacy of KTE-X19 in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (r/r ALL) (ZUMA-3)

publications_result: Oluwole OO, Shah BD, Baer MR, Bishop MR, Holmes H, Schiller GJ, et al. Outcomes of Patients with Relapsed/Refractory Acute Lymphoblastic Leukemia Treated with Prior Blinatumomab in ZUMA-3, a Study of KTE-C19, an Anti-CD19 Chimeric Antigen Receptor (CAR) T Cell Therapy [Abstract S1569]. The 23rd European Hematology Association (EHA) Congress 2018 14-17 June; Stockholm, Sweden.

ReferenceCitation: Sabatino M, Choi K, Chiruvolu V, Better M. Production of Anti-CD19 CAR T Cells for ZUMA-3 and -4: Phase 1/2 Multicenter Studies Evaluating KTE-C19 in Patients With Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia (R/R ALL) [Abstract 711]. Blood 2016;128 (22):1227.

ReferenceCitation: Shah B, Castro J, Gokbuget N, Kersten MJ, Hagenbeek T, Wierda W, et al. ZUMA-3: A Phase 1/2 Multi-center Study Evaluating the Safety and Efficacy of KTE-C19 Anti-CD19 CAR T Cells in Adult Subjects with Relapsed/Refractory B Precursor Acute Lymphoblastic Leukemia (r/r ALL). European Society for Medical Oncology (ESMO) Congress 2016;Abstract 3713.

ReferenceCitation: Shah B, Huynh V, Sender LS, Lee DW, Castro JE, Wierda WG, et al. High Rates of Minimal Residual Disease-Negative (MRD-) Complete Responses (CR) in Adult and Pediatric and Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia (R/R ALL) Treated With KTE-C19 (Anti-CD19 Chimeric Antigen Receptor [CAR] T Cells): Preliminary Results of the ZUMA-3 and ZUMA-4 Trials. Blood 2016;128 (22):2803.

ReferenceCitation: Shah B, Stock W, Wierda W, Topp M, Kersten MJ, Houot R, et al. KTE-C19, an Anti-CD19 Chimeric Antigen Receptor (CAR) T cell Therapy in Adult Patients (Pts) With Relapsed/ Refractory Acute Lymphoblastic Leukemia (R/R ALL) in the ZUMA-3 Trial: Preliminary Results of Novel Safety Interventions [Abstract ALL-025]. Clinical lymphoma, myeloma & leukemia 2017;17:S253.

ReferenceCitation: Shah B, Stock W, Wierda W, Topp MS, Kersten MJ, Houot R, et al. Preliminary Results of Novel Safety Interventions in Adult Patients (Pts) With Relapsed/Refractory Acute Lymphoblastic Leukemia (R/R ALL) in the ZUMA-3 Trial. European Society for Medical Oncology (ESMO) Congress 2017.

ReferenceCitation: Shah B, Wierda WG, Schiller GJ, Bishop MR, Castro JE, Sabatino M, et al. KTE-C19 Chimeric Antigen Receptor (CAR) T Cell Therapy in Adults with High-Burden Relapsed/Refractory Acute Lymphoblastic Leukemia (R/R ALL): Updated Results from Phase 1/2 of ZUMA-3 [Abstract P523]. The 22nd European Hematology Association (EHA) Congress 2017 22-25 June; Madrid, Spain.

ReferenceCitation: Shah BD, Bishop MR, Oluwole OO, Logan A, Baer MR, Donnellan WB, et al. End of Phase I Results of ZUMA-3, A Phase 1/2 Study of KTE-X19, Anti-CD19 Chimeric Antigen Receptor (CAR) T Cell Therapy, in Adult Patients (pts) with Relapsed/Refractory (R/R) Acute Lymphoblastic Leukemia (ALL) [Abstract]. J Clin Oncol 2019;37 (15):7006.

ReferenceCitation: Shah BD, Bishop MR, Oluwole OO, Logan AC, Baer MR, Donnellan WB, O'Dwyer KM, Holmes H, Arellano ML, Ghobadi A, Pagel JM, Lin Y, Cassaday RD, Park JH, Abedi M, Castro JE, DeAngelo DJ, Malone AK, Mawad R, Schiller GJ, Rossi JM, Bot A, Shen T, Goyal L, Jain RK, Vezan R, Wierda WG. KTE-X19 anti-CD19 CAR T-cell therapy in adult relapsed/refractory acute lymphoblastic leukemia: ZUMA-3 phase 1 results. Blood. 2021 Jul 8;138(1):11-22. doi: 10.1182/blood.2020009098.

ReferenceCitation: Shah BD, Oluwole OO, Baer MR, Bishop MR, Holmes H, Schiller GJ, et al. KTE-C19, an Anti-CD19 Chimeric Antigen Receptor (CAR) T Cell Therapy, in Adult Patients with Relapsed/ Refractory Acute Lymphoblastic Leukemia (R/R ALL): Outcomes in Patients Who Were Treated with Prior Blinatumomab in ZUMA-3 [Abstract ALL-128]. Clinical lymphoma, myeloma & leukemia 2018;18 (Supplement 1):S184.

ReferenceCitation: Shah BD, Oluwole OO, Baer MR, Bishop MR, Holmes H, Schiller GJ, et al. Outcomes of Patients Treated With Prior Blinatumomab in ZUMA-3, a Study of KTE-C19, an Anti-CD19 Chimeric Antigen Receptor T Cell Therapy, in Adult Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia. ASCO; 2018 01-05 June; Chicago, IL.

ReferenceCitation: Shah BD, Stock W, Wierda WG, Oluwole O, Holmes H, Schiller GJ, et al. Phase 1 Results of ZUMA-3: KTE-C19, an Anti-CD19 Chimeric Antigen Receptor (CAR) T Cell Therapy, in Adult Patients with Relapsed/Refractory Acute Lymphoblastic Leukemia (R/R ALL) [Abstract 612]. Blood 2017;130 (Supplement 1):888.

ReferenceCitation: Shah BD, Wierda WG, Schiller GJ, Bishop MR, Castro JE, Sabatino M, et al. Updated results from ZUMA- 3, a phase 1/2 study of KTE-C19 chimeric antigen receptor (CAR) T cell therapy, in adults with high-burden relapsed/refractory acute lymphoblastic leukemia (R/R ALL) [Abstract 3024]. American Society of Clinical Oncology (ASCO) Annual Meeting; 2017 02-06 June; Chicago, Illinois.

ReferenceCitation: Shah BD, Ghobadi A, Oluwole OO, Logan AC, Boissel N, Cassaday RD, Leguay T, Bishop MR, Topp MS, Tzachanis D, O'Dwyer KM, Arellano ML, Lin Y, Baer MR, Schiller GJ, Park JH, Subklewe M, Abedi M, Minnema MC, Wierda WG, DeAngelo DJ, Stiff P, Jeyakumar D, Feng C, Dong J, Shen T, Milletti F, Rossi JM, Vezan R, Masouleh BK, Houot R. KTE-X19 for relapsed or refractory adult B-cell acute lymphoblastic leukaemia: phase 2 results of the single-arm, open-label, multicentre ZUMA-3 study. Lancet. 2021 Aug 7;398(10299):491-502. doi: 10.1016/S0140-6736(21)01222-8. Epub 2021 Jun 4.

ReferenceCitation: Shah BD, Smith NJ, Feng C, Jeyakumar S, Castaigne JG, Faghmous I, Masouleh BK, Malone DC, Bishop MR. Cost-Effectiveness of KTE-X19 for Adults with Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia in the United States. Adv Ther. 2022 Aug;39(8):3678-3695. doi: 10.1007/s12325-022-02201-6. Epub 2022 Jun 21.

location_country:
Netherlands
Canada
United States
France
Germany

location_facility: Washington University School of Medicine

location_facility: University of California Irvine Medical Center

location_facility: University of Texas MD Anderson Cancer Center

location_facility: University of California Los Angeles (UCLA)

location_facility: University of MD Greenbaum Comprehensive Cancer Center

location_facility: University of California Davis Comprehensive Cancer Center

location_facility: Hopital Pontchaillou - CHU de Rennes - Service d'Hematologie

location_facility: University Health Network - Princess Margaret

summary: The primary objectives of this study are to determine the safety and efficacy of brexucabtagene autoleucel (KTE-X19) in adult participants with relapsed/refractory (r/r) B-precursor acute lymphoblastic leukemia (ALL).


ipd_sharing: No

status: Completed

primary_purpose: Treatment

acronym: COLUMBUS-AMD

intervention_type: Biological

title: Efficacy and Safety of the Biosimilar Ranibizumab FYB201 in Comparison to Lucentis in Patients With Neovascular Age-related Macular Degeneration

study_completion_date_type: Actual

lead_sponsor: Bioeq GmbH

source: euctr

design_allocation: Randomized

study_start_date_type: Actual

study_type: Interventional

enrollment_type: Actual

location_country:
Poland
Spain
Italy
Austria
Russian Federation
United Kingdom
Ukraine
Hungary
France
Israel
Germany
Czechia

location_facility: University of Bonn, Department of Ophthalmology

summary: The purpose of this study is to determine the efficacy and safety of the biosimilar ranibizumab FYB201 in comparison to Lucentis in patients with neovascular age-related macular degeneration.

lead_sponsor_type: industriel

status_simplified: Completed


ipd_sharing: Yes

intervention_type: Drug

title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9883/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

lead_sponsor: Gilead Sciences

type: EudraCT Number

ReferenceType: result

ReferenceCitation: Sax PE, Pozniak A, Montes ML, Koenig E, DeJesus E, Stellbrink HJ, Antinori A, Workowski K, Slim J, Reynes J, Garner W, Custodio J, White K, SenGupta D, Cheng A, Quirk E. Coformulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection (GS-US-380-1490): a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Lancet. 2017 Nov 4;390(10107):2073-2082. doi: 10.1016/S0140-6736(17)32340-1. Epub 2017 Aug 31.

ReferenceCitation: Gupta SK, Post FA, Arribas JR, Eron JJ Jr, Wohl DA, Clarke AE, Sax PE, Stellbrink HJ, Esser S, Pozniak AL, Podzamczer D, Waters L, Orkin C, Rockstroh JK, Mudrikova T, Negredo E, Elion RA, Guo S, Zhong L, Carter C, Martin H, Brainard D, SenGupta D, Das M. Renal safety of tenofovir alafenamide vs. tenofovir disoproxil fumarate: a pooled analysis of 26 clinical trials. AIDS. 2019 Jul 15;33(9):1455-1465. doi: 10.1097/QAD.0000000000002223.

ReferenceCitation: Stellbrink HJ, Arribas JR, Stephens JL, Albrecht H, Sax PE, Maggiolo F, Creticos C, Martorell CT, Wei X, Acosta R, Collins SE, Brainard D, Martin H. Co-formulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Lancet HIV. 2019 Jun;6(6):e364-e372. doi: 10.1016/S2352-3018(19)30080-3. Epub 2019 May 5.

ReferenceCitation: Acosta RK, Willkom M, Martin R, Chang S, Wei X, Garner W, Lutz J, Majeed S, SenGupta D, Martin H, Quirk E, White KL. Resistance Analysis of Bictegravir-Emtricitabine-Tenofovir Alafenamide in HIV-1 Treatment-Naive Patients through 48 Weeks. Antimicrob Agents Chemother. 2019 Apr 25;63(5). pii: e02533-18. doi: 10.1128/AAC.02533-18. Print 2019 May.

ReferenceCitation: Acosta R, Willkom M, Martin R, Chang S, Liu X, Hedskog C, et al. Low-frequency resistance variants in ART-naive participants do not affect bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) triple therapy outcome. [Poster MOPEB242]. 10th IAS Conference on HIV Science (IAS 2019); 2019 July 21-24; Mexico City, Mexico.

ReferenceCitation: Johnson M, Taylor S, Wei X, Collins SE, Martin H. Hepatic Safety of Bictegravir/Emtricitabine/Tenofovir Alafenamide [Poster P061]. 25th Annual Conference of the British HIV Association; 2019 02-05 April; Bournemouth, United Kingdom.

ReferenceCitation: Gupta S, Mills A, Brinson C, Workowski K, Clarke A, Antinori A, et al. 96 Week Efficacy and Safety of B/F/TAF in Treatment-Naïve Adults and Adults ≥50 Years [Poster 502]. CROI 2019; 2019 04-07 March; Seattle, WA.

ReferenceCitation: Acosta R, White K, Garner W, Wei X, Andreatta K, Willkom M, et al. HIV-1 subtype (B or non-B) had no impact on the efficacy of B/F/TAF or resistance development in five phase 3 treatment-naïve or switch studies. [Poster THPEB077]. 22nd International AIDS Conference; 2018 July 23-27; Amsterdam, Netherlands.

ReferenceCitation: White K, Kulkarni R, Willkom M, Martin R, Chang S, Wei X, et al. Pooled week 48 efficacy and baseline resistance: B/F/TAF in treatment-naive patients. [Poster 532]. Conference on Retroviruses and Opportunistic Infections; 2018 March 4-7; Boston, USA.

ReferenceCitation: Wohl D, Clarke A, Maggiolo F, Garner W, Laouri M, Martin H, Quirk E. Patient-Reported Symptoms Over 48 Weeks Among Participants in Randomized, Double-Blind, Phase III Non-inferiority Trials of Adults with HIV on Co-formulated Bictegravir, Emtricitabine, and Tenofovir Alafenamide versus Co-formulated Abacavir, Dolutegravir, and Lamivudine. Patient. 2018 Oct;11(5):561-573. doi: 10.1007/s40271-018-0322-8.

ReferenceCitation: Wohl DA, Yazdanpanah Y, Baumgarten A, Clarke A, Thompson MA, Brinson C, Hagins D, Ramgopal MN, Antinori A, Wei X, Acosta R, Collins SE, Brainard D, Martin H. Bictegravir combined with emtricitabine and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Lancet HIV. 2019 Jun;6(6):e355-e363. doi: 10.1016/S2352-3018(19)30077-3. Epub 2019 May 5.

ReferenceCitation: Acosta R, Andreatta K, D'Antoni M, Collins S, Martin H, White K. HIV Viral Blips in Adults Treated with INSTI-Based Regimens Through 144 Weeks. [Poster 540]. Conference on Retroviruses and Opportunistic Infections 2020 (CROI 2020); 2020 March 8-11; Boston, Massachusetts.

ReferenceCitation: Mills A, Gupta SK, Brinson C, Workowski K, Clarke A, Antinori A, Stephens JL, et al. 144-Week Efficacy and Safety of B/F/TAF in Treatment-Naive Adults Age ≥50 Years. [Poster 477]. Conference on Retroviruses and Opportunistic Infections 2020 (CROI 2020); 2020 March 8-11; Boston, Massachusetts.

ReferenceCitation: Orkin C, DeJesus E, Sax PE, Arribas JR, Gupta SK, Martorell C, Stephens JL, Stellbrink HJ, Wohl D, Maggiolo F, Thompson MA, Podzamczer D, Hagins D, Flamm JA, Brinson C, Clarke A, Huang H, Acosta R, Brainard DM, Collins SE, Martin H; GS-US-380-1489; GS-US-380-1490 study investigators. Fixed-dose combination bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir-containing regimens for initial treatment of HIV-1 infection: week 144 results from two randomised, double-blind, multicentre, phase 3, non-inferiority trials. Lancet HIV. 2020 Jun;7(6):e389-e400. doi: 10.1016/S2352-3018(20)30099-0.

ReferenceCitation: Ramgopal M, Maggiolo F, Ward D, Leboucche B, Rizzardini G, Molina JM, et al. Pooled Analysis of 4 International Trials of Bictegravir/Emtrictabine/Tenofovir Alafenamide (B/F/TAF) in Adults Aged ≥ 65 Years Demonstrating Safety and Efficacy: Week 48 Results. [Oral OAB0403].AIDS 2020; 2020 July 6-10; Virtual.

ReferenceCitation: Acosta R, Andreatta K, D'Antoni M, Collins S, Martin H, White K. Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) shows high efficacy in clinical study participants infected with HIV-1 subtype F. [Poster P124]. HIV Drug Therapy 2020 (HIV Glasgow 2020); 2020 October 5-8; Glasgow, United Kingdom.

ReferenceCitation: Acosta R, Chen G, Chang S, Martin R, Wang X, Huang H, et al. HIV with Transmitted Drug Resistance Is Durably Suppressed by B/F/TAF at Week 144. [Poster 430]. Conference on Retroviruses and Opportunistic Infections 2021 (CROI 2021); 2021 June 3-November 3; Virtual.

ReferenceCitation: Acosta RK, Chen GQ, Chang S, Martin R, Wang X, Huang H, Brainard D, Collins SE, Martin H, White KL. Three-year study of pre-existing drug resistance substitutions and efficacy of bictegravir/emtricitabine/tenofovir alafenamide in HIV-1 treatment-naive participants. J Antimicrob Chemother. 2021 Jul 15;76(8):2153-2157. doi: 10.1093/jac/dkab115.

ReferenceCitation: Workowski K, Orkin C, Sax P, Hagins D, Koenig E, Stephens JL, et al. Four-Year Outcomes of B/F/TAF in Treatment-Naïve Adults [Poster 415]. Conference on Retroviruses and Opportunistic Infections 2021 (CROI 2021); 2021 June 3-November 3; Virtual.

ReferenceCitation: Acosta R, Chen G, Qin L, Wang X, Huang H, Hindman J, et al. Achievement of Undetectable HIV-1 RNA in the B/F/TAF Treatment-Naive Clinical Trials. [Poster PEB150]. 11th IAS Conference on HIV Science (IAS 2021); 2021 July 18-21; Virtual.

ReferenceCitation: Acosta R, Chen G, Huang H, Liu H, White K. Unreturned Pill Bottles in the 1489 and 1490 Clinical Trials: An Important Measure of Poor Adherence That Is Often Ignored in Pill Count Calculations. [Poster 902]. IDWeek 2021; 2021 September 29-October 3; Virtual.

ReferenceCitation: Arribas J, Orkin C, Maggiolo F, Antinori A, Lazzarin A, Yasdanpanah, et al. Long-term Analysis of B/F/TAF in Treatment-Naïve Adults Living With HIV Through Four Years of Follow-up. [PEB151]. 11th IAS Conference on HIV Science (IAS 2021); 2021 July 18-21; Virtual.

ReferenceCitation: Daar E, Orkin C, Sax P, Stephens J, Koenig E, Clarke A, et al. Incidence of Metabolic Complications Among Treatment-naïve Adults Living With HIV-1 Randomized to B/F/TAF, DTG/ABC/3TC or DTG+F/TAF After 3 Years. [Oral 69]. IDWeek 2021; 2021 September 29- October 3; Virtual.

ReferenceCitation: Pozniak A, et al. Outcomes 48 Weeks After Switching From DTG/ABC/3TC or DTG+F/TAF to B/F/TAF. [PE2/68]. 18th European AIDS Conference (EAC 2021), 2021 October 27-30; London, United Kingdom.

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy

location_country:
Spain
Dominican Republic
Italy
Australia
United Kingdom
Canada
Puerto Rico
United States
France
Belgium
Germany

location_facility: North Texas Infectious Diseases Consultants PA

location_facility: Cone Health Regional Center for Infectious Disease

summary: This primary objective of this study is to evaluate the efficacy of a fixed dose combination (FDC) containing bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus dolutegravir (DTG) + a FDC containing emtricitabine/tenofovir alafenamide (F/TAF) in HIV-1 infected, antiretroviral treatment-naive adults.


title: A Phase 3, Double-Blind, Placebo Controlled Multicenter Study to Determine the Efficacy and Safety of Luspatercept (ACE-536) in Adults With Transfusion Dependent Beta (B)-Thalassemia

acronym: BELIEVE

summary:
This is a Phase 3, double-blind, randomized, placebo-controlled, multicenter study to determine the efficacy and safety of luspatercept (ACE-536) plus Best supportive care (BSC) versus placebo plus BSC in adults who require regular red blood cell transfusion due to (β)-thalassemia.

The study is divided into the following periods:

Historical Period,
Screening/Run-in Period,
Double-blind Treatment Period (48 weeks),
Double-blind Long-term Treatment Period, (at the investigator's discretion an additional 48 weeks),
Open-Label Phase post unblinding and upon Data Monitoring Committee positive recommendation
Post-treatment Follow-up Period

ReferenceCitation: Porter J. Beyond transfusion therapy: new therapies in thalassemia including drugs, alternate donor transplant, and gene therapy. Hematology Am Soc Hematol Educ Program. 2018 Nov 30;2018(1):361-370. doi: 10.1182/asheducation-2018.1.361. Review.

ReferenceCitation: Piga A, Perrotta S, Gamberini MR, Voskaridou E, Melpignano A, Filosa A, Caruso V, Pietrangelo A, Longo F, Tartaglione I, Borgna-Pignatti C, Zhang X, Laadem A, Sherman ML, Attie KM. Luspatercept improves hemoglobin levels and blood transfusion requirements in a study of patients with β-thalassemia. Blood. 2019 Mar 21;133(12):1279-1289. doi: 10.1182/blood-2018-10-879247. Epub 2019 Jan 7.

ReferenceType: derived

ReferenceCitation: Cappellini MD, Taher AT. The use of luspatercept for thalassemia in adults. Blood Adv. 2021 Jan 12;5(1):326-333. doi: 10.1182/bloodadvances.2020002725.

ReferenceCitation: Cappellini MD, Viprakasit V, Taher AT, Georgiev P, Kuo KHM, Coates T, Voskaridou E, Liew HK, Pazgal-Kobrowski I, Forni GL, Perrotta S, Khelif A, Lal A, Kattamis A, Vlachaki E, Origa R, Aydinok Y, Bejaoui M, Ho PJ, Chew LP, Bee PC, Lim SM, Lu MY, Tantiworawit A, Ganeva P, Gercheva L, Shah F, Neufeld EJ, Thompson A, Laadem A, Shetty JK, Zou J, Zhang J, Miteva D, Zinger T, Linde PG, Sherman ML, Hermine O, Porter J, Piga A; BELIEVE Investigators. A Phase 3 Trial of Luspatercept in Patients with Transfusion-Dependent β-Thalassemia. N Engl J Med. 2020 Mar 26;382(13):1219-1231. doi: 10.1056/NEJMoa1910182.

lead_sponsor: Celgene

location_country:
Taiwan
United Kingdom
Greece
Italy
Australia
Lebanon
Canada
Thailand
Tunisia
United States
France
Israel
Turkey
Malaysia
Bulgaria

location_facility: Ente Ospedaliero Ospedali Galliera - Centro della Microcitemia e delle Anemie Congenite

location_facility: Seconda Universita Degli Studi Di Napoli

location_facility: General Children's Hospital "Agia Sophia"

location_facility: Chiang Mai University - Maharaj Nakorn Chiang Mai Hospital

location_facility: Children's Hospital and Research Center at Oakland

location_facility: Ann and Robert H Lurie Childrens Hospital of Chicago

location_facility: Hospital of the University of Pennsylvania

location_facility: Ege Universitesi Tip Fakultesi Hastanesi

location_facility: Fondazione Ca Granda IRCCS Ospedale Maggiore

location_facility: Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna

location_facility: University Mulitiprofile Hospital for Active Treatment Sveti Georgi EAD

location_facility: GH de Institut Catholique St. VincentHématologie

location_facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello

location_facility: Multiprofile Hospital for Active Treatment Sveta Marina EAD

location_facility: Royal Adelaide Hospital Institute of Medical and Veterinary Science

location_facility: Specialized Hospital for Active Treatment of Haematological Diseases - Sofia

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi

location_facility: Universita degli Studi di Cagliari - ASL8

location_facility: Chulalongkorn University Faculty of Medicine - King Chulalongkorn Memorial Hospital

location_facility: Azienda Ospedaliero Universitaria S. Luigi Gonzaga

location_facility: Hospital Pulau Pinang c/o Penang Medical College

location_facility: Cukurova University Medical Faculty Balcali Hospital

location_facility: Azienda Ospedaliera Universitaria Integrata Di Verona

location_facility: Barts Health NHS Trust - The Royal London Hospital

location_facility: General Hospital Georgios Gennimatas of Athens

intervention_type: Other


title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching From a Regimen of Dolutegravir and ABC/3TC, or a Fixed Dose Combination (FDC) of ABC/DTG/3TC to a FDC of GS-9883/F/TAF in HIV-1 Infected Subjects Who Are Virologically Suppressed

summary: The primary objective of this study is to evaluate the efficacy of switching from a regimen of dolutegravir (DTG) and abacavir/lamivudine (ABC/3TC) or a fixed dose combination (FDC) of abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) to a FDC of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing DTG and ABC/3TC as the FDC ABC/DTG/3TC in virologically suppressed Human Immunodeficiency Virus- 1 (HIV-1) infected adults.

ReferenceCitation: Andreatta K, Willkom M, Martin R, Chang S, Wei L, Liu H, Liu YP, Graham H, Quirk E, Martin H, White KL. Switching to bictegravir/emtricitabine/tenofovir alafenamide maintained HIV-1 RNA suppression in participants with archived antiretroviral resistance including M184V/I. J Antimicrob Chemother. 2019 Dec 1;74(12):3555-3564. doi: 10.1093/jac/dkz347. Erratum in: J Antimicrob Chemother. 2019 Dec 1;74(12):3646-3647.

ReferenceCitation: Molina JM, Ward D, Brar I, Mills A, Stellbrink HJ, López-Cortés L, Ruane P, Podzamczer D, Brinson C, Custodio J, Liu H, Andreatta K, Martin H, Cheng A, Quirk E. Switching to fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide from dolutegravir plus abacavir and lamivudine in virologically suppressed adults with HIV-1: 48 week results of a randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial. Lancet HIV. 2018 Jul;5(7):e357-e365. doi: 10.1016/S2352-3018(18)30092-4. Epub 2018 Jun 18. Erratum in: Lancet HIV. 2018 Jun 22;:.

ReferenceCitation: Wohl D, Clarke A, Maggiolo F, Garner W, Laouri M, Martin H, Quirk E. Patient-Reported Symptoms Over 48 Weeks Among Participants in Randomized, Double-Blind, Phase III Non-inferiority Trials of Adults with HIV on Co-formulated Bictegravir, Emtricitabine, and Tenofovir Alafenamide versus Co-formulated Abacavir, Dolutegravir, and Lamivudine. Patient. 2018 Oct;11(5):561-573. doi: 10.1007/s40271-018-0322-8.

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.

location_country:
Spain
Italy
United Kingdom
Australia
Canada
Puerto Rico
United States
France
Belgium
Germany


title: A Long-Term, Open-Label Extension Study of the Safety and Tolerability of RVT-101 in Subjects With Alzheimer's Disease

summary: This 12-month open-label study will provide further information regarding the long-term safety and tolerability of intepirdine (RVT-101) for subjects with Alzheimer's disease who have completed the double-blind, placebo-controlled, lead-in study RVT-101-3001 (double-blind study).

status: Terminated

lead_sponsor: Axovant Sciences Ltd.

location_country:
Croatia
Poland
Taiwan
Serbia
Spain
Italy
United Kingdom
Australia
Argentina
Canada
Korea, Republic of
United States
Chile
France
Singapore
Germany
Bulgaria
Slovakia
Czechia

status_simplified: Unknown


title: A Phase 3, Double-blind, Randomized Study of RVT-101 Versus Placebo When Added to Existing Stable Donepezil Treatment in Subjects With Mild to Moderate Alzheimer's Disease

summary: This study seeks to confirm a demonstrated treatment effect of intepirdine (RVT-101) as an adjunctive therapy to donepezil for the treatment of subjects with Alzheimer's disease.


type: Other Identifier

title: An Open-Label, Multicenter, Phase 1 Study of Ramucirumab Plus MEDI4736 in Patients With Locally Advanced and Unresectable or Metastatic Gastrointestinal or Thoracic Malignancies

summary: The main purpose of this study is to evaluate the safety of ramucirumab plus MEDI4736 in participants with locally advanced and unresectable or metastatic gastrointestinal or thoracic malignancies including gastric or gastroesophageal junction (GEJ) adenocarcinoma, non-small cell lung cancer (NSCLC), or hepatocellular carcinoma (HCC).

design_allocation: Non-Randomized

lead_sponsor: Eli Lilly and Company

location_country:
Taiwan
Spain
Italy
Korea, Republic of
United States
Israel
France
Germany

location_facility: University of Texas MD Anderson Cancer Center

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.


title: A Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Immune Globulin Infusion 10% (Human) With Recombinant Human Hyaluronidase (HYQVIA/HyQvia) and Immune Globulin Infusion (Human), 10% (GAMMAGARD LIQUID/KIOVIG) for the Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

summary:
The aim of this study is to learn more about the following treatment options in adults with CIDP:

Subcutaneous self-infusion with HyQvia.
Intravenous infusion with Gammagard/Kiovig. Gammagard and Kiovig are the brand names for the same immunoglobulin compound.

The study is in two parts. In Part 1, participants receive either HyQvia or a placebo subcutaneously. In Part 2 (only for participants who have a CIPD relapse during Part 1), participants will receive Gammagard Liquid/Kiovig intravenously. US participants will receive Gamunex-C.

The first SC infusion will be given in the study clinic. The remaining SC infusions may be given in the study clinic or the participant's home. This will be decided by the study doctor and whether the participant or their caregiver can do the self-infusion.

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.

lead_sponsor: Baxalta now part of Shire

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
United States
Czechia
Poland
Argentina
Israel
Turkey
Mexico
Norway
Sweden
Slovakia
Brazil
Canada
Germany
Denmark
Greece
France
Colombia

location_facility: Instituto de Neurologia de Curitiba - Hospital Ecoville

location_facility: Instituto Nacional de Ciencias Médicas y Nutricion Dr. Salvador Zubiran

location_facility: Univerzitna nemocnica Bratislava Nemocnica ak. L. Derera, II. Neurologicka klinika

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Institucion Prestadora de Servicios de Salud de la Universidad de Antioquia "IPS UNIVERSITARIA"

location_facility: Complejo Medico de la Policia Federal Argentina Churruca Visca

location_facility: Selcuk Universitesi Selcuklu Tip Fakultesi Hastanesi

location_facility: IRCCS Ospedale Casa Sollievo della Sofferenza

location_facility: Dokuz Eylul University Faculty of Medicine

location_facility: Azienda Ospedaliero Universitaria San Martino

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata

location_facility: Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty

location_facility: University Hospital Centre "Sestre Milosrdnice"

location_facility: Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino

location_facility: The Methodist Hospital Research Institute

location_facility: Groupe Hospitalier Pellegrin - Hôpital Pellegrin

location_facility: Hospital das Clínicas da Faculdade de Medicina da UNICAMP

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

location_facility: Azienda Ospedaliero-Universitaria Santa Maria della Misericordia

location_facility: University of Kansas Medical Center Research Institute, Inc.

location_facility: HUAP - UFF - Hospital Universitario Antonio Pedro - Universidade Federal Fluminense

location_facility: Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza

location_facility: Fondazione Istituto Neurologico Casimiro Mondino

location_facility: Azienda Ospedaliera Universitaria Policlinico G. Martino

location_facility: COPERNICUS Podmiot Leczniczy Sp. z o. o.,

location_facility: Instituto de Investigaciones Neurologicas Raul Carrea, FLENI


title: A Phase 2 Multicenter, Randomized, Placebo Controlled, Double Blind Study to Assess the Safety and Efficacy of CC-486 (Oral Azacitidine) in Combination With Pembrolizumab (MK-3475) Versus Pembrolizumab Plus Placebo in Subjects With Previously Treated Locally Advanced or Metastatic Non-small Cell Lung Cancer

summary: The purpose of this study is to determine whether the combination therapy of CC-486 (oral azacitidine) and pembrolizumab provides improved patient outcomes compared to pembrolizumab alone in patients with previously treated locally advanced or metastatic non-small cell lung cancer.

status: Active, not recruiting

study_completion_date_type: Anticipated

location_country:
Spain
Italy
Greece
United States
France
Germany

location_facility: Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale

location_facility: Hospital General Universitario de Valencia

location_facility: Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele

location_facility: North Shore Hematology Oncology Associates

location_facility: Institut Gustave Roussy IGR Centre de Lutte Contre le Canc

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: Policlinico Universitario Campus Biomedico Di Roma

status_simplified: Ongoing


title: A Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation

lead_sponsor: Vertex Pharmaceuticals Incorporated

ReferenceCitation: Chilvers MA, Davies JC, Milla C, Tian S, Han Z, Cornell AG, Owen CA, Ratjen F. Long-term safety and efficacy of lumacaftor-ivacaftor therapy in children aged 6-11 years with cystic fibrosis homozygous for the F508del-CFTR mutation: a phase 3, open-label, extension study. Lancet Respir Med. 2021 Jul;9(7):721-732. doi: 10.1016/S2213-2600(20)30517-8. Epub 2021 Jan 28. Erratum in: Lancet Respir Med. 2021 Apr;9(4):e38.

location_country:
Denmark
United Kingdom
Australia
Canada
Sweden
United States
France
Belgium
Germany

summary: Study 110 is a Phase 3, multicenter study in subjects aged 6 years and older with cystic fibrosis (CF) who are homozygous for the F508del-CF transmembrane conductance regulator (CFTR) mutation and who participated in Study 109 (NCT02514473) or Study 011B (NCT01897233). Study 110 is designed to evaluate the safety and efficacy of long term treatment of lumacaftor in combination with ivacaftor.


title: Safety & Performance Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold

acronym: FANTOM II

summary: The FANTOM II trial is intended to assess safety and performance of the Fantom Bioresorbable Coronary Scaffold in native coronary arteries.

status: Recruiting

enrollment_type: Anticipated

ReferenceCitation: Chevalier B, Abizaid A, Carrié D, Frey N, Lutz M, Weber-Albers J, Dudek D, Weng SC, Akodad M, Anderson J, Stone GW. Clinical and Angiographic Outcomes With a Novel Radiopaque Sirolimus-Eluting Bioresorbable Vascular Scaffold. Circ Cardiovasc Interv. 2019 Jun;12(6):e007283. doi: 10.1161/CIRCINTERVENTIONS.118.007283. Epub 2019 Jun 10.

lead_sponsor: REVA Medical, Inc.

location_country: Denmark Poland Brazil Australia Netherlands France Belgium Germany

location_facility: Oddział Kardiologii Inwazyjnej I Katedra

location_facility: Prince of Wales Hospital (Eastern Heart)

location_facility: Instituto Dante Pazzanese de Cardiologia

location_facility: Szpital Kliniczny Przemienienia Panskiego UM w Poznaniu

location_facility: Krakowskie Centrum Kardiologii Inwazyjnej

intervention_type: Device


title: International Multicentre Validation Study of SAGIT® Instrument in Acromegaly

acronym: SAGIT

summary:
Patients will be treated in accordance with the standard medical practice of the hospital where they have been recruited during their participation in this study. No additional assessments or tests will be required.

SAGIT® is a new instrument developed by a group of acromegaly experts to help practicing endocrinologists to manage acromegalic patients and disease activity in their clinical practice and define acromegaly staging. It reports 5 elements: Signs and symptoms - S; Associated comorbidities - A; Growth hormone (GH) concentration - G; Insulin-like growth factor 1(IGF-1) concentration -I; Tumour size- T.

The instrument has been pre evaluated during a qualitative pilot study. The purpose of the validation study is to define and validate the scoring of the SAGIT® instrument.

study_type: Observational

time_perspective: Other

ReferenceCitation: Giustina A, Bronstein MD, Chanson P, Petersenn S, Casanueva FF, Sert C, Houchard A, Melmed S. International Multicenter Validation Study of the SAGIT® Instrument in Acromegaly. J Clin Endocrinol Metab. 2021 Nov 19;106(12):3555-3568. doi: 10.1210/clinem/dgab536.

ReferenceCitation: Giustina A, Bronstein MD, Chanson P, Petersenn S, Casanueva FF, Sert C, Houchard A, Melmed S. Staging and managing patients with acromegaly in clinical practice: baseline data from the SAGIT® validation study. Pituitary. 2019 Oct;22(5):476-487. doi: 10.1007/s11102-019-00977-5.

lead_sponsor: Ipsen

location_country:
Denmark
Brazil
Spain
Italy
United Kingdom
Netherlands
United States
France
Belgium
Germany

location_facility: Endocrinology, University Hospital, Policlinica Gemelu

location_facility: Hospital de Condia(CHUS) RVA Ramon Baltar S/N

location_facility: Azienda Ospedaliero Universitaria Pisana-Endcrinologia 2

location_facility: Azienda Ospedaliero Universitar a Fedderico II

location_facility: University Hospital, Dept of Endocrinology

location_facility: Endocrinology and Metabolism Churchill Hospital

location_facility: Department of Clinical Medicine - The Department of Endocrinology and Diabetes


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Sirukumab in the Treatment of Patients With Giant Cell Arteritis

summary:
Sirukumab is a fully human anti-interleukin-6 (IL-6) immunoglobulin G1-kappa with a high affinity and specificity for binding to the human IL-6 molecule that may have therapeutic benefit in the treatment of giant cell arteritis (GCA) by interruption of multiple pathogenic pathways. Sirukumab inhibits IL-6-mediated signal transducer and activator of transcription 3 (STAT3) phosphorylation, resulting in the inhibition of the biological effect of IL-6. This study will evaluate the efficacy and safety of sirukumab to characterize the benefit-to-risk profile of sirukumab in the treatment of active GCA. The study will be conducted in 2 distinct parts (Part A and Part B) and consists of the following phases: Screening phase, Part A: 52-week double-blind treatment phase, Part B: 104-week extension phase with the option to receive open-label sirukumab based on disease status and a 16-week follow-up phase if applicable.

Approximately 204 subjects with a diagnosis of GCA and active disease within 6 weeks of baseline will be randomized into Part A, the 52-week double-blind treatment phase, to receive one of two doses of sirukumab or placebo, each in addition to a pre-specified prednisone taper. The efficacy and safety of sirukumab in sustaining remission will be assessed at Week 52. Subjects completing Part A of the study will be eligible to enter Part B, the 104-week extension phase, designed to investigate the long-term maintenance of remission and safety following cessation of sirukumab treatment and to assess long-term corticosteroid use. Subjects with active GCA at the end of Part A or those with new onset of GCA flare during the first 52 weeks of Part B will be eligible to receive open-label sirukumab. Subjects will need to have follow-up safety evaluations for at least 16 weeks after receiving the last dose of study drug, applicable only for those who are withdrawn prematurely from the study or whose open-label sirukumab treatment in Part B completes after Week 88.

ReferenceCitation: Schmidt WA, Dasgupta B, Luqmani R, Unizony SH, Blockmans D, Lai Z, Kurrasch RH, Lazic I, Brown K, Rao R. A Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Sirukumab in the Treatment of Giant Cell Arteritis. Rheumatol Ther. 2020 Dec;7(4):793-810. doi: 10.1007/s40744-020-00227-2. Epub 2020 Aug 25.

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

lead_sponsor: GlaxoSmithKline

location_country:
Poland
Spain
Italy
United Kingdom
Australia
Netherlands
New Zealand
Hungary
United States
France
Belgium
Germany
Bulgaria


title: A Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of Topical Alicaforsen Enema in Subjects With Active, Chronic, Antibiotic Refractory Primary Idiopathic Pouchitis

summary:
A Phase III, multi-centre, double-blind randomised controlled trial in subjects with chronic antibiotic refractory pouchitis.

Subjects will undertake a <2 week screening period to provide baseline data and be assessed for eligibility. At the Baseline visit (Day 1) eligible subjects will be randomised on a 1:1 basis to either a) 240 mg alicaforsen enema or b) matching placebo.

Study drug will be administered once nightly (on going to bed) up to and including week 6. Following the Day 1 Visit, subjects will return to the clinic for safety and efficacy assessments at Week 3, 6, 10, 18 and 26.

Subjects may receive certain permitted medications as per Entry Criteria, which must remain at stable doses throughout the trial. Introduction of any new medication for pouchitis, or a dose change to an existing concomitant medication for pouchitis, other than those detailed in the protocol, will not be permitted.

Clinical symptoms associated with pouchitis will be recorded daily by the patient in a diary card.

Subjects will undergo endoscopic examination of their pouch (during Screening, and at Weeks 6 and 10). Where technically feasible, each endoscopy will provide at least one biopsy sample for histopathology.

In addition to endoscopic, histopathologic and symptomatic assessments, Quality of Life will be assessed.

Bloods for routine assessment, including haematology and biochemistry will be taken. Bloods and stool samples will be collected to evaluate relevant biomarkers.

lead_sponsor: Atlantic Pharmaceuticals Ltd

location_country:
United Kingdom
Ireland
Italy
Canada
Switzerland
United States
France
Israel
Belgium
Netherlands

location_facility:
Site Reference ID/Investigator# 0103
Site Reference ID/Investigator# 0602
Site Reference ID/Investigator# 1003
Site Reference ID/Investigator# 1001
Site Reference ID/Investigator# 0506
Site Reference ID/Investigator# 1010
Site Reference ID/Investigator# 1006
Site Reference ID/Investigator# 0802
Site Reference ID/Investigator# 0701
Site Reference ID/Investigator# 0504
Site Reference ID/Investigator# 0803
Site Reference ID/Investigator# 0502
Site Reference ID/Investigator# 0403
Site Reference ID/Investigator# 0204
Site Reference ID/Investigator# 0201
Site Reference ID/Investigator# 0801
Site Reference ID/Investigator# 0902
Site Reference ID/Investigator# 0401
Site Reference ID/Investigator# 0102
Site Reference ID/Investigator# 1009
Site Reference ID/Investigator# 0503
Site Reference ID/Investigator# 0601
Site Reference ID/Investigator# 0202
Site Reference ID/Investigator # 1005
Site Reference ID/Investigator# 0501
Site Reference ID/Investigator# 0402
Site Reference ID/Investigator#1011
Site Reference ID/Investigator# 0101
Site Reference ID/Investigator# 1008
Site Reference ID/Investigator# 0302
Site Reference ID/Investigator# 0804
Site Reference ID/Investigator# 0203
Site Reference ID/Investigator# 1002
Site Reference ID/Investigator# 1007
Site Reference ID/Investigator#1012
Site Reference ID/Investigator# 1004
Site Reference ID/Investigator# 0301
Site Reference ID/Investigator# 0505
Site Reference ID/Investigator# 0404
Site Reference ID/Investigator# 0205
Site Reference ID/Investigator# 0901


title: An Open Label, Phase Ia/Ib Dose Finding Study With BI 894999 Orally Administered Once a Day in Patients With Advanced Malignancies, With Repeated Administration in Patients With Clinical Benefit

summary:
This study is open to adults with different types of advanced cancer (solid tumours). The study is also open to patients with diffuse large B-cell lymphoma in whom previous treatment was not successful. In some countries, adolescents who are at least 15 years old and who are diagnosed with NUT carcinoma can also participate. No standard treatment exists for this rare and aggressive form of cancer.

The purpose of this study is to find out the highest dose of BI 894999 that people can tolerate.

BI 894999 is tested for the first time in humans. Participants take tablets once daily. The study also tests whether participants can tolerate BI 894999 better when taken continuously or with breaks in between.

Participants can stay in the study as long as they benefit from the treatment and can tolerate it.

The doctors also regularly check the general health of the participants.

ipd_sharing_description:
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

The data shared are the raw clinical study data sets.

lead_sponsor: Boehringer Ingelheim

location_country:
Spain
Korea, Republic of
United States
France
Belgium
Germany

location_facility: The University of Texas MD Anderson Cancer Center


title: A Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation

ReferenceCitation: Southern KW, Murphy J, Sinha IP, Nevitt SJ. Corrector therapies (with or without potentiators) for people with cystic fibrosis with class II CFTR gene variants (most commonly F508del). Cochrane Database Syst Rev. 2020 Dec 17;12:CD010966. doi: 10.1002/14651858.CD010966.pub3.

ReferenceCitation: Ratjen F, Hug C, Marigowda G, Tian S, Huang X, Stanojevic S, Milla CE, Robinson PD, Waltz D, Davies JC; VX14-809-109 investigator group. Efficacy and safety of lumacaftor and ivacaftor in patients aged 6-11 years with cystic fibrosis homozygous for F508del-CFTR: a randomised, placebo-controlled phase 3 trial. Lancet Respir Med. 2017 Jul;5(7):557-567. doi: 10.1016/S2213-2600(17)30215-1. Epub 2017 Jun 9. Erratum in: Lancet Respir Med. 2017 Aug;5(8):e28.

summary: To evaluate the efficacy and safety of lumacaftor in combination with ivacaftor in subjects aged 6 Through 11 years with cystic fibrosis (CF), homozygous for the F508del CF transmembrane conductance regulator (CFTR) mutation


title: Multicenter Study of Cryoablation for Palliation of Painful Bone Metastases

acronym: MOTION

summary: This study will evaluate the efficacy of cryoablation for palliation of painful metastases in participants with metastatic lesions involving bone who have failed, are not candidates for, or are not experiencing adequate pain relief from current pain therapies (for example, radiation, analgesics).

ReferenceType: background

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lead_sponsor: Boston Scientific Corporation

location_country:
United States
France

location_facility:
Rhode Island Hospital
Institut Bergonié
Crittenton Hospital
Emory University Hospital
Mayo Clinic Rochester
Washington University in St. Louis
Centre Léon Bérard
UCLA Ronald Reagan Medical Center
Institut Gustave Roussy
University Hospital of Strasbourg
Massachusetts General Hospital


acronym: C-OPTIMISE

title: A Multicenter, Open-label (Part A) Followed by a Randomized, Double-blind, Parallel-group, Placebo Controlled Study (Part B) to Evaluate Maintenance of Remission in Subjects With Active Axial Spondyloarthritis (axSpA) Receiving Either Certolizumab Pegol 200 mg Q2W or 200 mg Q4W as Compared to Placebo

lead_sponsor: UCB BIOSCIENCES GmbH

ReferenceCitation: Landewé RB, van der Heijde D, Dougados M, Baraliakos X, Van den Bosch FE, Gaffney K, Bauer L, Hoepken B, Davies OR, de Peyrecave N, Thomas K, Gensler LS. Maintenance of clinical remission in early axial spondyloarthritis following certolizumab pegol dose reduction. Ann Rheum Dis. 2020 Jul;79(7):920-928. doi: 10.1136/annrheumdis-2019-216839. Epub 2020 May 7. Erratum in: Ann Rheum Dis. 2020 Sep;79(9):e120.

ReferenceCitation: Landewé R, van der Heijde D, Dougados M, Baraliakos X, Van den Bosch F, Gaffney K, Bauer L, Hoepken B, de Peyrecave N, Thomas K, Gensler LS. Induction of Sustained Clinical Remission in Early Axial Spondyloarthritis Following Certolizumab Pegol Treatment: 48-Week Outcomes from C-OPTIMISE. Rheumatol Ther. 2020 Sep;7(3):581-599. doi: 10.1007/s40744-020-00214-7. Epub 2020 Jun 11.

location_country:
Poland
Taiwan
Romania
Spain
United Kingdom
Netherlands
Hungary
France
United States
Turkey
Belgium
Germany
Bulgaria
Czechia

summary: Patients receive study drug for one year (Part A). If, after the initial run-in phase, a sustained remission is reached they will be randomly split into one of three dose groups for another year (Part B). The maintenance of the sustained remission will be analyzed.


title: A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination With Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults With Early Rheumatoid Arthritis Who Are Methotrexate Naive

lead_sponsor: Bristol-Myers Squibb

location_country:
Spain
Italy
United Kingdom
United States
Peru
Romania
Japan
South Africa
Czechia
Poland
Austria
Australia
Russian Federation
Argentina
Monaco
Israel
Mexico
Singapore
Sweden
Brazil
Canada
Hungary
Germany
Taiwan
Qatar
Finland
Korea, Republic of
France
Chile
Colombia
Netherlands

location_facility: Instituto De Ginecologia Y Reproduccion Inv. Clinical Sac

location_facility: Fundacion Instituto de Reumatologia Fernando Chalem

location_facility: Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S

location_facility: Inland Rheumatology Clinical Trials Inc.

location_facility: Clinical Research Center Of Reading, Llp

location_facility: Schwerpunktpraxis fuer Rheumatologie an den Kreiskliniken

location_facility: Slaski Szpital Reumatologiczno - Rehabilitacyjny

location_facility: Instituto de Asistencia Reumatologica Integral

location_facility: CHI St. Vincent Medical Group Hot Springs

location_facility: Arthritis Clinic Of Northern Virginia, P.C.

location_facility: Organizacion Medica De Investigacion S.A. (Omi)

location_facility: Rheumatologische Schwerpunktpraxis Dr. Zinke

location_facility: Hospital General De Agudos J.M. Ramos Mejia

location_facility: Centre De Recherche Musculo-Squelettique

location_facility: Rheumatology Associates Of North Alabama, P.C.

location_facility: Oklahoma Ctr For Arthritis Therapy And Research, Inc.

location_facility: Valerius Medical Group and Research Center

location_facility: SANUS Szpital Specjalistyczny Sp. z o.o.

location_facility: Immanuel Krankenhaus Berlin/Rheumaklinik Berlin Buch

location_facility: Instytut Reumatologii, I Klinika Reumatologii

location_facility: Centro De Investigaciones Reumatologicas

location_facility: Arthritis And Osteoporosis Associates, Pa

location_facility: Hospital Privado-Centro Medico De Cordoba S.A.

location_facility: Arizona Arthritis & Rheumatology Research PLLC

location_facility: Rheumatology Associates Of Central Florida, P.A.

location_facility: Gemeinschaftspraxis Drs. von Hinueber u Demary

summary: The purpose of this study is to determine if abatacept is effective in the treatment of early rheumatoid arthritis.


title: A Phase 3, 24-Week Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study of Reslizumab Subcutaneous Dosing (110 mg Every 4 Weeks) in Patients With Oral Corticosteroid Dependent Asthma and Elevated Blood Eosinophils

summary: The primary objective of the study is to determine the ability of reslizumab administered by subcutaneous injection to produce a corticosteroid-sparing effect in patients with oral corticosteroid (OCS)-dependent asthma and elevated blood eosinophils, without loss of asthma control.

ReferenceCitation: Bernstein JA, Virchow JC, Murphy K, Maspero JF, Jacobs J, Adir Y, Humbert M, Castro M, Marsteller DA, McElhattan J, Hickey L, Garin M, Vanlandingham R, Brusselle G. Effect of fixed-dose subcutaneous reslizumab on asthma exacerbations in patients with severe uncontrolled asthma and corticosteroid sparing in patients with oral corticosteroid-dependent asthma: results from two phase 3, randomised, double-blind, placebo-controlled trials. Lancet Respir Med. 2020 May;8(5):461-474. doi: 10.1016/S2213-2600(19)30372-8. Epub 2020 Feb 14.

lead_sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

location_country:
Poland
Spain
Italy
Russian Federation
Australia
Mexico
Argentina
Netherlands
Ukraine
Hungary
Korea, Republic of
United States
France
Israel
Belgium
Germany
Czechia

location_facility:
Teva Investigational Site 53317
Teva Investigational Site 53316
Teva Investigational Site 20051
Teva Investigational Site 80082
Teva Investigational Site 87021
Teva Investigational Site 58241
Teva Investigational Site 53322
Teva Investigational Site 31158
Teva Investigational Site 32574
Teva Investigational Site 20057
Teva Investigational Site 54133
Teva Investigational Site 32573
Teva Investigational Site 13356
Teva Investigational Site 58249
Teva Investigational Site 50356
Teva Investigational Site 35189
Teva Investigational Site 13365
Teva Investigational Site 50383
Teva Investigational Site 53320
Teva Investigational Site 53318
Teva Investigational Site 13358
Teva Investigational Site 21106
Teva Investigational Site 21091
Teva Investigational Site 21105
Teva Investigational Site 50384
Teva Investigational Site 50419
Teva Investigational Site 20050
Teva Investigational Site 13343
Teva Investigational Site 87024
Teva Investigational Site 53321
Teva Investigational Site 50386
Teva Investigational Site 13344
Teva Investigational Site 21101
Teva Investigational Site 20059
Teva Investigational Site 58235
Teva Investigational Site 80085
Teva Investigational Site 13346
Teva Investigational Site 58245
Teva Investigational Site 58248
Teva Investigational Site 58239
Teva Investigational Site 58243
Teva Investigational Site 21104
Teva Investigational Site 50358
Teva Investigational Site 80084
Teva Investigational Site 51233
Teva Investigational Site 50357
Teva Investigational Site 50385
Teva Investigational Site 87022
Teva Investigational Site 20066
Teva Investigational Site 13347
Teva Investigational Site 87020
Teva Investigational Site 87023
Teva Investigational Site 21100
Teva Investigational Site 35185
Teva Investigational Site 21094
Teva Investigational Site 13345
Teva Investigational Site 13372
Teva Investigational Site 51253
Teva Investigational Site 58250
Teva Investigational Site 35186
Teva Investigational Site 58244
Teva Investigational Site 13354
Teva Investigational Site 30154
Teva Investigational Site 13348
Teva Investigational Site 58237
Teva Investigational Site 21090
Teva Investigational Site 13363
Teva Investigational Site 13367
Teva Investigational Site 78090
Teva Investigational Site 50417
Teva Investigational Site 32576
Teva Investigational Site 38084
Teva Investigational Site 37058
Teva Investigational Site 78089
Teva Investigational Site 51232
Teva Investigational Site 78093
Teva Investigational Site 32622
Teva Investigational Site 35187
Teva Investigational Site 30152
Teva Investigational Site 13370
Teva Investigational Site 80091
Teva Investigational Site 13349
Teva Investigational Site 50418
Teva Investigational Site 58251
Teva Investigational Site 58238
Teva Investigational Site 31159
Teva Investigational Site 13351
Teva Investigational Site 13377
Teva Investigational Site 78092
Teva Investigational Site 20058
Teva Investigational Site 13368
Teva Investigational Site 31160
Teva Investigational Site 78091
Teva Investigational Site 31161
Teva Investigational Site 58242
Teva Investigational Site 13369
Teva Investigational Site 13362
Teva Investigational Site 32580
Teva Investigational Site 38085
Teva Investigational Site 21102
Teva Investigational Site 13357
Teva Investigational Site 13342
Teva Investigational Site 20052
Teva Investigational Site 87025
Teva Investigational Site 32578
Teva Investigational Site 78097
Teva Investigational Site 13352
Teva Investigational Site 20056
Teva Investigational Site 20087
Teva Investigational Site 13371
Teva Investigational Site 58246
Teva Investigational Site 21093
Teva Investigational Site 37059
Teva Investigational Site 32621
Teva Investigational Site 58240
Teva Investigational Site 21103
Teva Investigational Site 20055
Teva Investigational Site 13366
Teva Investigational Site 32579
Teva Investigational Site 53323
Teva Investigational Site 50382
Teva Investigational Site 53319
Teva Investigational Site 54132
Teva Investigational Site 51254
Teva Investigational Site 53358
Teva Investigational Site 13350
Teva Investigational Site 80083


title: An Open-label, Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression

summary: The purpose of this open-label, multicenter study is to assess the long term safety and efficacy of intranasal esketamine plus an oral antidepressant in participants with treatment-resistant depression (TRD).

ReferenceCitation: Williamson DJ, Gogate JP, Kern Sliwa JK, Manera LS, Preskorn SH, Winokur A, Starr HL, Daly EJ. Longitudinal Course of Adverse Events With Esketamine Nasal Spray: A Post Hoc Analysis of Pooled Data From Phase 3 Trials in Patients With Treatment-Resistant Depression. J Clin Psychiatry. 2022 Sep 19;83(6). pii: 21m14318. doi: 10.4088/JCP.21m14318.

ReferenceCitation: Ochs-Ross R, Wajs E, Daly EJ, Zhang Y, Lane R, Lim P, Drevets WC, Steffens DC, Sanacora G, Jamieson C, Hough D, Manji H, Singh JB. Comparison of Long-Term Efficacy and Safety of Esketamine Nasal Spray Plus Oral Antidepressant in Younger Versus Older Patients With Treatment-Resistant Depression: Post-Hoc Analysis of SUSTAIN-2, a Long-Term Open-Label Phase 3 Safety and Efficacy Study. Am J Geriatr Psychiatry. 2022 May;30(5):541-556. doi: 10.1016/j.jagp.2021.09.014. Epub 2021 Oct 6.

ReferenceCitation: Wajs E, Aluisio L, Holder R, Daly EJ, Lane R, Lim P, George JE, Morrison RL, Sanacora G, Young AH, Kasper S, Sulaiman AH, Li CT, Paik JW, Manji H, Hough D, Grunfeld J, Jeon HJ, Wilkinson ST, Drevets WC, Singh JB. Esketamine Nasal Spray Plus Oral Antidepressant in Patients With Treatment-Resistant Depression: Assessment of Long-Term Safety in a Phase 3, Open-Label Study (SUSTAIN-2). J Clin Psychiatry. 2020 Apr 28;81(3). pii: 19m12891. doi: 10.4088/JCP.19m12891.

ReferenceCitation: Nijs M, Wajs E, Aluisio L, Turkoz I, Daly E, Janik A, Borentain S, Singh JB, DiBernardo A, Wiegand F. Managing Esketamine Treatment Frequency Toward Successful Outcomes: Analysis of Phase 3 Data. Int J Neuropsychopharmacol. 2020 Jul 29;23(7):426-433. doi: 10.1093/ijnp/pyaa027.

lead_sponsor: Janssen Research & Development, LLC

location_country:
Spain
United Kingdom
Lithuania
United States
South Africa
Belgium
Poland
Austria
Australia
Argentina
Turkey
Mexico
Sweden
Malaysia
Brazil
Germany
Bulgaria
Taiwan
Finland
Korea, Republic of
France


title: A Randomized, Multicenter, Open-Label, 3 Arm Phase 3 Study of Obinutuzumab in Combination With Chlorambucil, Acalabrutinib (ACP-196) in Combination With Obinutuzumab, and Acalabrutinib Monotherapy in Subjects With Previously Untreated CLL

summary: This study is evaluating the efficacy of obinutuzumab in combination with chlorambucil (Arm A) compared with acalabrutinib in combination with obinutuzumab (Arm B) for the treatment of previously untreated chronic lymphocytic leukemia (CLL).

status: Unknown status

ReferenceCitation: Sharman JP, Egyed M, Jurczak W, Skarbnik A, Pagel JM, Flinn IW, Kamdar M, Munir T, Walewska R, Corbett G, Fogliatto LM, Herishanu Y, Banerji V, Coutre S, Follows G, Walker P, Karlsson K, Ghia P, Janssens A, Cymbalista F, Woyach JA, Salles G, Wierda WG, Izumi R, Munugalavadla V, Patel P, Wang MH, Wong S, Byrd JC. Acalabrutinib with or without obinutuzumab versus chlorambucil and obinutuzmab for treatment-naive chronic lymphocytic leukaemia (ELEVATE TN): a randomised, controlled, phase 3 trial. Lancet. 2020 Apr 18;395(10232):1278-1291. doi: 10.1016/S0140-6736(20)30262-2. Erratum in: Lancet. 2020 May 30;395(10238):1694.

lead_sponsor: Acerta Pharma BV

location_country:
Poland
Brazil
Spain
Colombia
Italy
Australia
New Zealand
Canada
Lithuania
United Kingdom
Sweden
Hungary
United States
Chile
France
Israel
Belgium
Germany


title: A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in Symptomatic Subjects With Generalized Myasthenia Gravis

summary: The primary objective is to evaluate whether IGIV-C improves MG symptoms as compared to placebo in subjects with MG.

ReferenceCitation: Dalakas MC, Meisel A. Immunomodulatory effects and clinical benefits of intravenous immunoglobulin in myasthenia gravis. Expert Rev Neurother. 2022 Apr;22(4):313-318. doi: 10.1080/14737175.2022.2057223. Epub 2022 Apr 5. Review.

lead_sponsor: Grifols Therapeutics LLC

location_country:
Poland
Estonia
Canada
Lithuania
Hungary
United States
France
Belgium
Germany
Czechia

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny, Dept of Neurology

location_facility: Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii Klinicznej

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden

location_facility: Universitaetsklinikum Hamburg-Eppendorf, Klinik und Poliklinik fuer Neurologie

location_facility: CHU Strasbourg - Nouvel Hôpital Civil, Clinique Neurologique

location_facility: III Szpital Miejski w Lodzi im. Dr K. Jonschera

location_facility: Jahn Ferenc Del-pesti Korhaz es Rendelointezet, Neurologiai Osztaly

location_facility: CHU Nice - Hôpital de l'Archet 1, Ctre de Réf Maladies Neuromusculaires et SLA

location_facility: University Health Network (UHN) - Toronto General Hospital

location_facility: CHU de Toulouse - Hôpital Purpan, Service de Neurologie Générale

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

location_facility: Uniwersyteckie Centrum Kliniczne, Dept of Neurology

location_facility: University of Florida Health Science Center

location_facility: Pest Megyei Flor Ferenc Korhaz, Neurologia es Stroke Osztaly

location_facility: Krankenhaus Martha-Maria Halle-Doelau, Klinik fuer Neurologie

location_facility: Fakultni nemocnice Brno, Dept of Neurologicka klinika

location_facility: Universitaetsklinikum Jena, Klinik fuer Neurologie

location_facility: Houston Methodist Neurological Institute

location_facility: London Health Sciences Centre - University Hospital

location_facility: University of Kansas Medical Center Research Institute, Inc.

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics

location_facility: Hopital Neurologique Pierre Wertheimer, Neuro-musculaire - Electromyographie

location_facility: Ohio State University Wexner Medical Center

location_facility: Universitaetsklinikum Koeln, Neurologie und Psychiatrie


acronym: Basket

title: An Open-Label, Multicohort, Phase II Study of Atezolizumab in Advanced Solid Tumors

lead_sponsor: Hoffmann-La Roche

ReferenceCitation: Tabernero J, Andre F, Blay JY, Bustillos A, Fear S, Ganta S, Jaeger D, Maio M, Mileshkin L, Melero I. Phase II multicohort study of atezolizumab monotherapy in multiple advanced solid cancers. ESMO Open. 2022 Apr;7(2):100419. doi: 10.1016/j.esmoop.2022.100419. Epub 2022 Mar 16.

location_country:
Denmark
Poland
Brazil
Spain
Ireland
Austria
Italy
Netherlands
Canada
Finland
Russian Federation
Switzerland
United Kingdom
United States
France
Turkey
Norway
Germany

location_facility: Russian Oncology Research Center n.a. N.N. Blokhin Dpt of Clinical Pharmacology and Chemotherapy

location_facility: Herlev Hospital; Afdeling for Kræftbehandling

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: Sarah Cannon Cancer Center and Research Institute

location_facility: Prof. Dr. Cemil Tascioglu City Hospital; Med Onc

location_facility: St Vincent'S Uni Hospital; Medical Oncology

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: Kantonsspital St. Gallen; Onkologie/Hämatologie

location_facility: S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)

location_facility: University Health Network; Princess Margaret Hospital; Medical Oncology Dept

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii

location_facility: St James' Hospital; Cancer Clinical Trials Office

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

location_facility: Hopital Saint Louis, Service D Oncologie Medicale

location_facility: Oslo Universitetssykehus HF; Radiumhospitalet

location_facility: Universitatsklinik Heidelberg; Universitätshautklinik und Nationales Centrum für Tumorerkrankungen

location_facility: Helsinki University Central Hospital; Dept of Oncology

location_facility: Uniklinik-Eppendorf; Zentren F. Innere Medizin-Klinik U. Poliklinik

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Southampton General Hospital; Medical Oncology

location_facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Chemotherapie & Infektionskrankhei

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie; Klinika Now. Tkanek Miekkich,Kosci i Czer.

location_facility: Odense Universitetshospital, Onkologisk Afdeling, Klinisk Forsknings Enhed

location_facility: Haukeland Universitetssjukehus; Klinisk forskningspost

location_facility: Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP

location_facility: LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie

location_facility: Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie

summary: The primary efficacy objective for this study is to evaluate non-progression rate (NPR) at 18 weeks in participants with advanced solid tumors treated with atezolizumab, defined as the percentage of participants with complete response (CR), partial response (PR), or stable disease (SD) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1, or according to disease-specific criteria for prostate cancer and malignant pleural mesothelioma.


title: Phase 3 Extension Study of Ataluren (PTC124) in Patients With Nonsense Mutation Cystic Fibrosis

lead_sponsor: PTC Therapeutics

location_country:
Poland
Brazil
Spain
Greece
Italy
Australia
Netherlands
Argentina
Canada
United Kingdom
United States
France
Israel
Belgium
Germany
Bulgaria

location_facility: University of Cologne Children's Hospital

location_facility: Hospital Regional Universitario de Malaga

location_facility: Children's Hospital and Research Center at Oakland

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

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: University of Toronto Hospital for Sick Children

location_facility: University Mulitiprofile Hospital for Active Treatment Sveti Georgi EAD

location_facility: New York University Langone Medical Center

location_facility: University Multiprofile Hospital for Active Treatment Aleksandrovska EAD

location_facility: Ippokratio General Hospital Of Thessaloniki

location_facility: Hopital Universitaire des Enfants Reine Fabiola

location_facility: Azienda Ospedaliero Universitaria Ospedall Riuniti di Acona-Umberto I G.M. Lancisi G. Salesi

location_facility: University of Texas Health Science Center

location_facility: Szpital Dzieciecy Polanki im Macieja Plazynskiego w Gdansku

location_facility: Hospital de Sabadell, Consorci Sanitari Parc Tauli

location_facility: Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul

summary: This is an open-label extension study for participants who completed a Phase 3, placebo-controlled study of ataluren in participants with nonsense mutation cystic fibrosis (nmCF) not receiving chronic inhaled aminoglycosides.


title: A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of Duvortuxizumab, A Humanized CD19 x CD3 Dual-Affinity Re-Targeting (DART®) Protein in Subjects With Relapsed or Refractory B-cell Malignancies

summary: The purpose of this study is to evaluate the safety, tolerability, dose-limiting toxicities (any harmful effect of a drug) (DLT), maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D) and preliminary clinical activity of duvortuxizumab when administered intravenously to participants with relapsed or refractory B-cell malignancies [diffuse-large B cell lymphoma (DLBCL), follicular lymphoma (FL), mantle-cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), and acute lymphoblastic leukemia (ALL)].

location_country:
Spain
United States
France
Israel
Belgium


title: Amplatzer™Amulet™ Observational Post-Market Study

acronym: Amulet™PMS

summary: This was a prospective, multicenter, observational, nonrandomized study to compile real world outcome data on the use of the Amulet™ device in non-valvular atrial fibrillation (NVAF) subjects. The study was designed to follow the Instructions For Use (IFU) to gather data on the implant procedure through two years of follow up with the Amulet™ device in a commercial clinical setting."

time_perspective: Prospective

ReferenceCitation: De Caterina AR, Nielsen-Kudsk JE, Schmidt B, Mazzone P, Fischer S, Lund J, Montorfano M, Gage R, Lam SCC, Berti S. Gender difference in left atrial appendage occlusion outcomes: Results from the Amplatzer™ Amulet™ Observational Study. Int J Cardiol Heart Vasc. 2021 Jul 26;35:100848. doi: 10.1016/j.ijcha.2021.100848. eCollection 2021 Aug.

ReferenceCitation: Piayda K, Hellhammer K, Nielsen-Kudsk JE, Schmidt B, Mazzone P, Berti S, Fischer S, Lund J, Montorfano M, Della Bella P, Gage R, Zeus T. Clinical outcomes of patients undergoing percutaneous left atrial appendage occlusion in general anaesthesia or conscious sedation: data from the prospective global Amplatzer Amulet Occluder Observational Study. BMJ Open. 2021 Mar 24;11(3):e040455. doi: 10.1136/bmjopen-2020-040455.

ReferenceCitation: Aminian A, De Backer O, Nielsen-Kudsk JE, Mazzone P, Berti S, Fischer S, Lund J, Montorfano M, Lam SCC, Freixa X, Gage R, Diener HC, Schmidt B. Incidence and clinical impact of major bleeding following left atrial appendage occlusion: insights from the Amplatzer Amulet Observational Post-Market Study. EuroIntervention. 2021 Oct 20;17(9):774-782. doi: 10.4244/EIJ-D-20-01309.

ReferenceCitation: Tarantini G, D'Amico G, Schmidt B, Mazzone P, Berti S, Fischer S, Lund J, Montorfano M, Della Bella P, Lam SCC, Cruz-Gonzalez I, Gage R, Zhao H, Omran H, Odenstedt J, Nielsen-Kudsk JE. The Impact of CHA(2)DS(2)-VASc and HAS-BLED Scores on Clinical Outcomes in the Amplatzer Amulet Study. JACC Cardiovasc Interv. 2020 Sep 28;13(18):2099-2108. doi: 10.1016/j.jcin.2020.06.003.

lead_sponsor: Abbott Medical Devices

location_country:
Denmark
Poland
Spain
Ireland
Italy
Australia
Netherlands
Finland
United Kingdom
Sweden
France
Chile
Israel
Belgium
Norway
Germany

location_facility: Azienda Ospedaliera S. Anna e S. Sebastiano

location_facility: Zentrum fur Herzgesundheit/Kardiologie am Alice Hospital Darmstadt

location_facility: Internistische Klinik Dr. Müller, München-Thalkirchen

location_facility: Charité - Universitätsmedizin Berlin (CBF)

location_facility: Ospedale del Cuoro Fondazione C. N. R. Regione Toscana G. Monasterio

location_facility: Nuovo Ospedale Civile Sant'Agostino Estense

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: The Cardinal Stefan Wyszynski Institute of Cardiology

location_facility: Harzklinikum Dorothea Christiane Erxleben GmbH

location_facility: Ospedale dell'Angelo and Ospedale SS Giovanni e Paolo Venezia

location_facility: Cardiac Arrhythmia Research Center, Centro Cardiologico Monzino, Unveristiy of Milan


title: An Open-Label, Multicenter, Phase 1 Study of Ramucirumab Plus Pembrolizumab in Patients With Locally Advanced and Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma, Non-Small Cell Lung Cancer, Transitional Cell Carcinoma of the Urothelium, or Biliary Tract Cancer

summary: The main purpose of this study is to evaluate the safety and preliminary efficacy of the combination of the study drug known as ramucirumab plus pembrolizumab in participants with locally advanced and unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma, non-small cell lung cancer (NSCLC), transitional cell carcinoma of the urothelium, or biliary tract cancer (BTC).

ReferenceCitation: Herbst RS, Arkenau HT, Bendell J, Arrowsmith E, Wermke M, Soriano A, Penel N, Santana-Davila R, Bischoff H, Chau I, Mi G, Wang H, Rasmussen E, Ferry D, Chao BH, Paz-Ares L. Phase 1 Expansion Cohort of Ramucirumab Plus Pembrolizumab in Advanced Treatment-Naive NSCLC. J Thorac Oncol. 2021 Feb;16(2):289-298. doi: 10.1016/j.jtho.2020.10.004. Epub 2020 Oct 15.

ReferenceCitation: Herbst RS, Arkenau HT, Santana-Davila R, Calvo E, Paz-Ares L, Cassier PA, Bendell J, Penel N, Krebs MG, Martin-Liberal J, Isambert N, Soriano A, Wermke M, Cultrera J, Gao L, Widau RC, Mi G, Jin J, Ferry D, Fuchs CS, Petrylak DP, Chau I. Ramucirumab plus pembrolizumab in patients with previously treated advanced non-small-cell lung cancer, gastro-oesophageal cancer, or urothelial carcinomas (JVDF): a multicohort, non-randomised, open-label, phase 1a/b trial. Lancet Oncol. 2019 Aug;20(8):1109-1123. doi: 10.1016/S1470-2045(19)30458-9. Epub 2019 Jul 10.

ReferenceCitation: Arkenau HT, Martin-Liberal J, Calvo E, Penel N, Krebs MG, Herbst RS, Walgren RA, Widau RC, Mi G, Jin J, Ferry D, Chau I. Ramucirumab Plus Pembrolizumab in Patients with Previously Treated Advanced or Metastatic Biliary Tract Cancer: Nonrandomized, Open-Label, Phase I Trial (JVDF). Oncologist. 2018 Dec;23(12):1407-e136. doi: 10.1634/theoncologist.2018-0044. Epub 2018 May 31.

lead_sponsor: Eli Lilly and Company

location_country:
Spain
United Kingdom
United States
France
Japan
Germany

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

location_facility: Florida Cancer Specialists and Research Institute


acronym: VALOR

title: A Double-blind, Randomized, Placebo-controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Lacosamide as Adjunctive Therapy for Uncontrolled Primary Generalized Tonic-Clonic Seizures in Subjects With Idiopathic Generalized Epilepsy

lead_sponsor: UCB BIOSCIENCES, Inc.

location_country:
Spain
Italy
United States
Romania
Belgium
Japan
Czechia
Poland
Portugal
Russian Federation
Australia
Israel
Mexico
Slovakia
Brazil
Hungary
China
Germany
Bulgaria
Taiwan
Korea, Republic of
France

summary: Evaluating efficacy & safety of lacosamide versus Placebo in a blinded fashion as add-on Therapy for Primary Generalized Tonic-clonic (PGTC) seizures in subject 4 years of age or greater with idiopathic generalized epilepsy currently taking 1 to 3 antiepileptic drugs. Maximum duration of study drug administration is 28 weeks. Eligible subjects may choose to enter the open-label extension study after completion.


title: A Phase 2, Double-blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of GS-5745 in Subjects With Moderately to Severely Active Crohn's Disease

summary: This study will primarily evaluate the safety and efficacy of andecaliximab in adults with active Crohn's disease. The study will consist of a Double-Blind Phase of 8 weeks followed by an Open-Label Extension. Participants who complete the Double-Blind Phase will be eligible to enroll in the optional Open-Label Extension for an additional 44 weeks. Participants who complete Week 52 assessments will be eligible to enter the Extended Treatment Phase to continue treatment with andecaliximab for an additional 156 weeks.

ReferenceCitation: Schreiber S, Siegel CA, Friedenberg KA, Younes ZH, Seidler U, Bhandari BR, Wang K, Wendt E, McKevitt M, Zhao S, Sundy JS, Lee SD, Loftus EV. A Phase 2, Randomized, Placebo-Controlled Study Evaluating Matrix Metalloproteinase-9 Inhibitor, Andecaliximab, in Patients With Moderately to Severely Active Crohn's Disease. J Crohns Colitis. 2018 Aug 29;12(9):1014-1020. doi: 10.1093/ecco-jcc/jjy070.

lead_sponsor: Gilead Sciences

location_country:
Poland
Spain
Italy
United Kingdom
Australia
New Zealand
Canada
Hungary
United States
France
South Africa
Germany
Czechia

location_facility: Washington University School of Medicine

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Cotton-O'Neil Clinical Research Center, Digestive Health

location_facility: Digestive Health Specialists of The Southeast

location_facility: Premier Medical Group Of The Hudson Valley

location_facility: Capital and Coast District Health board-Wellington hospital

location_facility: Gastroenterology Associates Of Central Georgia, LLC

location_facility: Gastroenterology Associates Of Tidewater

location_facility: Gastroenterology/Colorectal Medicine & Genetics

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Debreceni Egyeterm Orvos es Egeszsegtudomanyi Centrum

location_facility: Columbia University Medical Center/ New York Presbyterian

location_facility: Ertan Digestive Disease Center of Excellence, UTH/MH-TMC

location_facility: Ibd Clinical And Research Centre-Iscare Ivf

location_facility: Gastroenterology Research of San Antonio

location_facility: The Medical University of Bialystok Clinical

location_facility: Norfolk and Norwich University Hospital Nhs Foundation Trust

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: Medical Diagnostic Center (MDC)-Indiana University (IU) Health University Hospital


title: A Phase II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of Lenalidomide Combined With MOR00208 in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R-R DLBCL)

acronym: L-MIND

summary: This is an open-label, multicentre study to characterize the safety and efficacy of the human anti CD19 antibody MOR00208 in combination with Lenalidomide in adult subjects with relapsed/refractory Diffuse Large B-cell Lymphoma (DLBCL) who have had at least one, but no more than three prior systemic regimens and who are not eligible for high dose chemotherapy (HDC) with autologous stem-cell transplantation (ASCT) at the time of study entry.

ReferenceCitation: Duell J, Maddocks KJ, González-Barca E, Jurczak W, Liberati AM, De Vos S, Nagy Z, Obr A, Gaidano G, Abrisqueta P, Kalakonda N, André M, Dreyling M, Menne T, Tournilhac O, Augustin M, Rosenwald A, Dirnberger-Hertweck M, Weirather J, Ambarkhane S, Salles G. Long-term outcomes from the phase II L-MIND study of tafasitamab (MOR208) plus lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma. Haematologica. 2021 Aug 19. doi: 10.3324/haematol.2021.279802. [Epub ahead of print]

ReferenceCitation: Cherng HJ, Westin JR. Broadening the MIND: Tafasitamab and Lenalidomide versus Synthetic Controls. Clin Cancer Res. 2022 Sep 15;28(18):3908-3910. doi: 10.1158/1078-0432.CCR-22-1626.

ReferenceCitation: Nowakowski GS, Yoon DH, Peters A, Mondello P, Joffe E, Fleury I, Greil R, Ku M, Marks R, Kim K, Zinzani PL, Trotman J, Huang D, Waltl EE, Winderlich M, Kurukulasuriya NC, Ambarkhane S, Hess G, Salles G. Improved Efficacy of Tafasitamab plus Lenalidomide versus Systemic Therapies for Relapsed/Refractory DLBCL: RE-MIND2, an Observational Retrospective Matched Cohort Study. Clin Cancer Res. 2022 Sep 15;28(18):4003-4017. doi: 10.1158/1078-0432.CCR-21-3648.

ReferenceCitation: Zinzani PL, Rodgers T, Marino D, Frezzato M, Barbui AM, Castellino C, Meli E, Fowler NH, Salles G, Feinberg B, Kurukulasuriya NC, Tillmanns S, Parche S, Dey D, Fingerle-Rowson G, Ambarkhane S, Winderlich M, Nowakowski GS. RE-MIND: Comparing Tafasitamab + Lenalidomide (L-MIND) with a Real-world Lenalidomide Monotherapy Cohort in Relapsed or Refractory Diffuse Large B-cell Lymphoma. Clin Cancer Res. 2021 Nov 15;27(22):6124-6134. doi: 10.1158/1078-0432.CCR-21-1471. Epub 2021 Aug 25.

ReferenceCitation: Duell J, Maddocks KJ, González-Barca E, Jurczak W, Liberati AM, De Vos S, Nagy Z, Obr A, Gaidano G, Abrisqueta P, Kalakonda N, André M, Dreyling M, Menne T, Tournilhac O, Augustin M, Rosenwald A, Dirnberger-Hertweck M, Weirather J, Ambarkhane S, Salles G. Long-term outcomes from the Phase II L-MIND study of tafasitamab (MOR208) plus lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma. Haematologica. 2021 Sep 1;106(9):2417-2426. doi: 10.3324/haematol.2020.275958.

ReferenceCitation: Salles G, Duell J, González Barca E, Tournilhac O, Jurczak W, Liberati AM, Nagy Z, Obr A, Gaidano G, André M, Kalakonda N, Dreyling M, Weirather J, Dirnberger-Hertweck M, Ambarkhane S, Fingerle-Rowson G, Maddocks K. Tafasitamab plus lenalidomide in relapsed or refractory diffuse large B-cell lymphoma (L-MIND): a multicentre, prospective, single-arm, phase 2 study. Lancet Oncol. 2020 Jul;21(7):978-988. doi: 10.1016/S1470-2045(20)30225-4. Epub 2020 Jun 5.

lead_sponsor: MorphoSys AG

location_country:
Poland
Spain
Italy
United Kingdom
Hungary
France
United States
Belgium
Germany
Czechia


title: An Open Label Phase II Study of Tipifarnib in Advanced Non-Hematological Malignancies With HRAS Mutations

summary: Phase II study to investigate the antitumor activity in terms of objective response rate (ORR) of tipifarnib in subjects with advanced tumors that carry HRAS mutations and for whom there is no standard curative therapy available. Note; Only cohort 2 (Head & Neck SCC) and cohort 3 (Other SCC) are currently open

ReferenceCitation: Ho AL, Brana I, Haddad R, Bauman J, Bible K, Oosting S, Wong DJ, Ahn MJ, Boni V, Even C, Fayette J, Flor MJ, Harrington K, Kim SB, Licitra L, Nixon I, Saba NF, Hackenberg S, Specenier P, Worden F, Balsara B, Leoni M, Martell B, Scholz C, Gualberto A. Tipifarnib in Head and Neck Squamous Cell Carcinoma With HRAS Mutations. J Clin Oncol. 2021 Jun 10;39(17):1856-1864. doi: 10.1200/JCO.20.02903. Epub 2021 Mar 22. Erratum in: J Clin Oncol. 2021 Oct 1;39(28):3192.

ipd_sharing: Undecided

lead_sponsor: Kura Oncology, Inc.

location_country:
Spain
Greece
Italy
Netherlands
United Kingdom
Korea, Republic of
United States
France
Belgium
Germany

location_facility: Wihship Cancer Institute of Emory University

location_facility: Oklahoma University Health Sciences Center

location_facility: Hospital Universitario y Politécnico La Fe

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Hospital Universitario Virgen de la Rocio

location_facility: START, Centro Integral Oncologico Clara Campal

location_facility: Hospital Universitario Virgen de la Victoria


title: A Phase 2, Randomized, Open-label, Two-arm Study to Assess the Efficacy and Safety of the Epigenetic Modifying Effects of CC-486 (Oral Azacitidine) in Combination With Fulvestrant in Postmenopausal Women With ER+, HER2- Metastatic Breast Cancer Who Have Progressed on an Aromatase Inhibitor

lead_sponsor: Celgene

location_country:
Spain
Italy
United States
France
Belgium
Germany

location_facility: Hamatologisch Onkologische Praxis Eppendorf

location_facility: Universitatsklinikum Hamburg-Eppendorf / IVDP

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Hospital Clinico Universitario Virgen de La Victoria

location_facility: Clinique Sainte Elisabeth - Service d'Oncologie

location_facility: Centre Regional de lutte contre le cancer Paul Papin

location_facility: Azienda Ospedaliera Citta della Salute e della Scienza di Torino

location_facility: Centre Rene Gauducheau Centre de Lutte Contre Le Cancer Nantes Atlantique

summary: The purpose of this study to Assess the Efficacy and Safety of the Epigenetic Modifying Effects of CC-486 (Oral Azacitidine) in Combination With Fulvestrant in Postmenopausal Women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 (HER2-) Metastatic Breast Cancer Who Have Progressed on an Aromatase Inhibitor (AI).


title: An Open-label Phase 1b Study of PF-04449913 (Glasdegib) in Combination With Azacitidine in Patients With Previously Untreated Higher-Risk Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Chronic Myelomonocytic Leukemia

acronym: BRIGHT 1012

summary: This multi center open label Phase 1b study is designed to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of glasdegib (PF-04449913) when combined with azacitidine in patients with previously untreated Higher Risk Myelodysplastic Syndrome (MDS), Acute Myeloid Leukemia (AML), or Chronic Myelomonocytic Leukemia (CMML). This clinical study includes two components: (a) a safety lead in cohort (LIC) and (b) an expansion phase with an AML cohort and an MDS cohort.

ReferenceCitation: Sekeres MA, Schuster M, Joris M, Krauter J, Maertens J, Breems D, Gyan E, Kovacsovics T, Verma A, Vyas P, Wang ES, Ching K, O'Brien T, Gallo Stampino C, Ma WW, Kudla A, Chan G, Zeidan AM. A phase 1b study of glasdegib + azacitidine in patients with untreated acute myeloid leukemia and higher-risk myelodysplastic syndromes. Ann Hematol. 2022 Aug;101(8):1689-1701. doi: 10.1007/s00277-022-04853-4. Epub 2022 Apr 30.

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

location_country:
United Kingdom
Canada
United States
France
Belgium
Germany

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: Hospices Civils de Lyon - Hopital Lyon Sud- Hematologie

location_facility: The Newcastle Hospitals NHS Foundation Trust

location_facility: Ziekenhuis Netwerk Antwerpen - Campus Stuivenberg

location_facility: Duke University Health System: Adult Bone Marrow Transplant Clinic

location_facility: University of Washington Medical Center (UWMC)

location_facility: Staedtisches Klinikum Braunschweig gGmbH

location_facility: Hopital Saint-Louis (AP-HP) - Service Hematologie Senior

location_facility: Duke University Health System, Duke University Hospital

location_facility: Stony Brook University Hospital Cancer Center

location_facility: Smilow Cancer Center at Yale New Haven Hospital

location_facility: University of Alabama at Birmingham the Kirklin Clinic

location_facility: The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

location_facility: CHU de Tours-Hopital Bretonneau-Centre Regional de cancerologie Henry Kaplan


title: A Randomised Phase II Trial of Imatinib Alternating With Regorafenib Compared to Imatinib Alone for the First Line Treatment of Advanced Gastrointestinal Stromal Tumour (GIST)

acronym: ALT GIST

summary: An open label randomised trial for adults with histologically confirmed measurable metastatic GIST who have received no other treatment for metastatic disease. The study aims to determine if an alternating regimen of imatinib and regorafenib has sufficient activity and safety in comparison to imatinib alone to warrant further evaluation as a first line treatment for metastatic GIST.

lead_sponsor: Australasian Gastro-Intestinal Trials Group

location_country:
Spain
United Kingdom
Australia
Finland
Sweden
France
Singapore
Norway
Netherlands
Slovakia

location_facility: University Hospital Birmingham - Queen Elizabeth Hospital

location_facility: Nottingham University Hospitals NHS Trust - Nottingham City Hospital

location_facility: Peninsula & South Eastern Haematology and Oncology Group

location_facility: Netherlands Cancer Institute -Antoni Van Leeuwenhoek

location_facility: ICO L'Hospitalet - Hospital Duran i Reynals