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

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.

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.

family: Sax

full_name: Paul E Sax

given: Paul E

family: Pozniak

full_name: Anton Pozniak

given: Anton

family: Montes

full_name: M Luisa Montes

given: M Luisa

family: Koenig

full_name: Ellen Koenig

given: Ellen

family: DeJesus

full_name: Edwin DeJesus

given: Edwin

family: Stellbrink

full_name: Hans-Jürgen Stellbrink

given: Hans-Jürgen

family: Antinori

full_name: Andrea Antinori

given: Andrea

family: Workowski

full_name: Kimberly Workowski

given: Kimberly

family: Slim

full_name: Jihad Slim

given: Jihad

family: Reynes

full_name: Jacques Reynes

given: Jacques

family: Garner

full_name: Will Garner

given: Will

family: Custodio

full_name: Joseph Custodio

given: Joseph

family: White

full_name: Kirsten White

given: Kirsten

family: SenGupta

full_name: Devi SenGupta

given: Devi

family: Cheng

full_name: Andrew Cheng

given: Andrew

family: Quirk

full_name: Erin Quirk

given: Erin

journal_name: The Lancet

title: 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

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.

family: Gupta

full_name: Samir K. Gupta

given: Samir K.

family: Post

full_name: Frank A. Post

given: Frank A.

family: Arribas

full_name: José R. Arribas

given: José R.

family: Eron

full_name: Joseph J. Eron

given: Joseph J.

family: Wohl

repositories_institution:
Indiana University - IUScholarWorks
PubMed Central - Europe PMC

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.

name: Gilead Sciences, Foster City, California, USA

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: 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.

repository_institution: University of North Carolina at Chapel Hill - Carolina Digital Repository

repository_institution: Queen Mary University of London - Queen Mary Research Online

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

location_facility: North Texas Infectious Diseases Consultants PA

location_facility: Cone Health Regional Center for Infectious Disease


title: A Phase 1/2, Open-label Study to Evaluate the Safety and Antitumor Activity of MEDI0680 (AMP-514) in Combination With Durvalumab Versus Nivolumab Monotherapy in Subjects With Select Advanced Malignancies

summary: To evaluate the Safety and Antitumor Activity of MEDI0680 (AMP-514) in Combination with Durvalumab versus Nivolumab Monotherapy in Participants with Select Advanced Malignancies.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ipd_sharing: Yes

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

lead_sponsor: MedImmune LLC

location_country:
United States
Netherlands
France
Australia
Canada
United Kingdom

intervention_type: Biological

lead_sponsor_type: industriel

status_simplified: Completed


title: A Double-Blind, Randomized, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of CHS-0214 Versus Enbrel in Subjects With Rheumatoid Arthritis and Inadequate Response to Treatment With Methotrexate

summary:
This is a two part study comparing CHS-0214 to Enbrel in patients with active rheumatoid arthritis and an inadequate response with Methotrexate (MTX) who are naive to biologic therapies.

Pt.1 is a 24-week randomized, double-blind, active-control, parallel-group, multi-center global study. The primary end point is 20% improvement in American College of Rheumatology criteria (ACR-20) at week 24. Comparing CHS-0214 to Enbrel for efficacy and safety.

Pt. 2 is an open-label single arm study in which patients with at least an ACR-20 response receive CHS-0214. Continued response and safety will be evaluated.

lead_sponsor: Coherus Biosciences, Inc.

location_country:
United States
South Africa
Spain
France
Japan
Poland
Israel
Hungary
Russian Federation
Belarus
Germany
United Kingdom

location_facility: University of Szeged, Faculty of Medicine

location_facility: Rinku Hashimoto Rheumatology Orthopedics

location_facility: SMO.MD GmbH - Zentrum fuer klinische Studien

location_facility: The Center for Rheumatology and Bone Research

location_facility: Hokkaido Medical Center for Rheumatic Diseases

location_facility: Tokito Clinic Rheumatology and Orthopaedics, Surgery

location_facility: St. Petersburg State Healthcare Institution "Consultative diagnostic center #85

location_facility: Prywatna Praktyka Lekarska Prof UM dr hab. Med. Pawel Hrycaj

location_facility: Nagasaki Medical Hospital of Rheumatology

location_facility: Medical Corporation Kojyokai Hirose Clinic

location_facility: Municipal Healthcare Institution "Emergency Clinical Hospital n.a. N.V. Soloviev

location_facility: Smolensk State Medical University (SSMU)

location_facility: Synexus Polska Sp. z o.o. Oddzial w Warszawie

location_facility: Rheumatoid Arthritis Investigational Network

location_facility: Wirral University Teaching Hospital NHS Foundation Trust

location_facility: Sverdlovsk Regional Clinical Hospital #1

location_facility: Otsuka Clinica of Rheumatism and Medicine

location_facility: Yoshida Orthopaedic and Rheumatology Clinic

location_facility: Orszagos Reumatologiai es Fizioterapias Intezet

location_facility: Synexus Polska Sp. z o.o. Oddzial w Katowicach

location_facility: Kawasaki Rheumatism and Internal Medicine Clinic

location_facility: Synexus Polska Sp. z o.o. Oddzial w Gdyni

location_facility: Center of Innovative Diagnostics and Therapeutics Rheumatology/Immunology

location_facility: Hospital Regional Universitario de Málaga

location_facility: Kondo Clinic for Rheumatism and Orthopaedics

location_facility: State Healthcare Institution of Moscow City Clinical Hospital #15 n.a. O.M. Filatov

location_facility: Japanese Red Cross Nagoya Daiichi Hospital

location_facility: University of Occupational and Environmental Health Hospital

location_facility: Mazowieckie Centrum Badan Klinicznych (MCBK) SC

intervention_type: Drug


title: An Open Label Study of the Efficacy and Safety of Re-treatments With Rituximab (MabThera/Rituxan) in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNFa Therapies

summary: This study will assess the long-term safety and efficacy of repeating treatment with MabThera, in combination with methotrexate and steroids, in patients who were previously randomized into MabThera study WA17042. The anticipated time on study treatment is until Mabthera is available on the local market and the target sample size is 100-500 individuals.

ReferenceType: derived

ReferenceCitation: Keystone E, Fleischmann R, Emery P, Furst DE, van Vollenhoven R, Bathon J, Dougados M, Baldassare A, Ferraccioli G, Chubick A, Udell J, Cravets MW, Agarwal S, Cooper S, Magrini F. Safety and efficacy of additional courses of rituximab in patients with active rheumatoid arthritis: an open-label extension analysis. Arthritis Rheum. 2007 Dec;56(12):3896-908.

lead_sponsor: Hoffmann-La Roche

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


lead_sponsor: Debiopharm International SA

location_country:
United States
France

type: EudraCT Number

source: euctr

title: A Multicenter, Open-label, Randomized, 2-arm, Phase II Trial of Pharmacodynamics, Pharmacokinetics and Safety of Two Dose Regimens of DEB025/Alisporivir in Combination With Ribavirin Therapy in Chronic Hepatitis C Genotype 2 and 3 Patients Who Have Previously Failed Interferon Therapy or Are Intolerant or Unable to Take Interferon.

summary: The primary purpose of this study is to evaluate the pharmacodynamic (i.e. hepatitis C virus (HCV) viral load), pharmacokinetic and safety profiles between two treatment groups receiving different doses of DEB025 in combination with ribavirin (RBV) during the first 12 weeks treatment in chronic hepatitis C genotype (GT)-2 and GT-3 patients who had previously failed interferon therapy or were intolerant or unable to take interferon.


title: A Randomized, Open Label, Phase 2 Study of the Selective Inhibitor of Nuclear Export (SINE) Selinexor (KPT-330) Versus Specified Physician's Choice in Patients ≥ 60 Years Old With Relapsed or Refractory Acute Myeloid Leukemia (AML) Who Are Ineligible for Intensive Chemotherapy and/or Transplantation

acronym: SOPRA

summary: This is a randomized, multicenter, open-label, phase 2 study of the SINE compound, selinexor given orally versus specified investigator choices (one of three potential salvage therapies). Participants age ≥ 60 years with relapsed or refractory AML of any type except for AML M3, after one prior therapy only, who have never undergone and who are not currently eligible for stem cell transplantation and are currently deemed unfit for intensive chemotherapy.

ReferenceCitation: Sweet K, Bhatnagar B, Döhner H, Donnellan W, Frankfurt O, Heuser M, Kota V, Liu H, Raffoux E, Roboz GJ, Röllig C, Showel MM, Strickland SA Jr, Vives S, Tang S, Unger TJ, Joshi A, Shen Y, Alvarez MJ, Califano A, Crochiere M, Landesman Y, Kauffman M, Shah J, Shacham S, Savona MR, Montesinos P. A 2:1 randomized, open-label, phase II study of selinexor vs. physician's choice in older patients with relapsed or refractory acute myeloid leukemia. Leuk Lymphoma. 2021 Dec;62(13):3192-3203. doi: 10.1080/10428194.2021.1950706. Epub 2021 Jul 29.

family: Sweet

full_name: Kendra Sweet

given: Kendra

sequence: first

name: Ohio State University, Columbus, OH, USA

family: Bhatnagar

full_name: Bhavana Bhatnagar

given: Bhavana

sequence: additional

family: Döhner

full_name: Hartmut Döhner

given: Hartmut

name: Sarah Cannon Cancer Center, Nashville, TN, USA

family: Donnellan

full_name: Will Donnellan

name: Northwestern University, Chicago, IL, USA

family: Frankfurt

full_name: Olga Frankfurt

given: Olga

name: Hannover Medical School, Hannover, Germany

family: Heuser

full_name: Michael Heuser

given: Michael

family: Kota

full_name: Vamsi Kota

given: Vamsi

family: Liu

full_name: Hongtao Liu

given: Hongtao

family: Raffoux

full_name: Emmanuel Raffoux

given: Emmanuel

name: Weill Cornell Medicine, New York, NY, USA

family: Roboz

full_name: Gail J. Roboz

given: Gail J.

name: Dresden University of Technology, Dresden, Germany

family: Röllig

full_name: Christoph Röllig

given: Christoph

name: Johns Hopkins University, Baltimore, MD, USA

family: Showel

full_name: Margaret M. Showel

given: Margaret M.

name: Vanderbilt-Ingram Cancer Center, Nashville, TN, USA

family: Strickland

full_name: Stephen A. Strickland

given: Stephen A.

suffix: Jr.

name: ICO Badalona-Hospital Germans Trias i Pujol, Badalona, Spain

family: Vives

full_name: Susana Vives

given: Susana

name: Karyopharm Therapeutics, Newton, MA, USA

family: Tang

full_name: Shijie Tang

given: Shijie

family: Unger

full_name: Thaddeus J. Unger

given: Thaddeus J.

family: Joshi

full_name: Anita Joshi

given: Anita

family: Shen

full_name: Yao Shen

given: Yao

family: Alvarez

full_name: Mariano J. Alvarez

given: Mariano J.

family: Califano

full_name: Andrea Califano

family: Crochiere

full_name: Marsha Crochiere

given: Marsha

family: Landesman

full_name: Yosef Landesman

given: Yosef

family: Kauffman

full_name: Michael Kauffman

name: Vanderbilt University, Nashville, TN, USA

name: Departamento de Hematologia, Hospital Universitario y Politécnico La Fe, Valencia, Spain

name: CIBERONC, Instituto de Salud Carlos III, Madrid, Spain

title: A 2:1 randomized, open-label, phase II study of selinexor vs. physician’s choice in older patients with relapsed or refractory acute myeloid leukemia

location_country:
Italy
Netherlands
Germany
France
Poland
Israel
Spain
Denmark
United States
United Kingdom
Canada

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocławiu

location_facility: AMC, Academisch Medisch Centrum Afdeling Klinische Hematologie

location_facility: Royal Liverpool University Hospital, Dept of Cellular and Molecular Physiology, Molecular and Clinical Cancer Medicine

location_facility: University of Massachusetts Medical School

location_facility: Ninewells Hospital and Medical School NHS Tayside

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Department of Haematology, National University Hospital, Rigshospitalet

location_facility: Texas Transplant Institute/Sarah Cannon Research Institute

location_facility: Jonsson Comprehensive Cancer Center / University of California, Los Angeles

location_facility: Stanford Cancer Institute / Stanford University

location_facility: Westchester Medical Center / New York Medical College

location_facility: UNIVERSITY HOSPITAL OF MÜNSTER Medizinische Klinik und Poliklinik A, Universitätsklinikum Münster

location_facility: Radboud University Medical Center Department of Haematology (476)

location_facility: H. Lee Moffitt Cancer Center and Research Institute

location_facility: Institut Universitaire du Cancer Toulouse

location_facility: Universitair Medisch Centrum Groningen Department of Haematology

location_facility: Sir Mortimer B. Davis Jewish General Hospital / McGill University

location_facility: Vanderbilt-Ingram Cancer Center / Vanderbilt University

location_facility: Colorado Blood Cancer Institute/Sarah Cannon Research Institute

location_facility: Tennessee Oncology/Sarah Cannon Research Institute

location_facility: AORN Cardarelli / UOSC di Ematologia con TMO

location_facility: Plymouth Hospitals NHS Trust/Derriford Hospital

location_facility: New York Presbyterian Hospital / Weill Cornell Medical College

location_facility: Samodzielny Publiczny Zakład Opieki Zdrowotnej Ministerstwa Spraw Wewnętrznych

location_facility: MD Anderson Cancer Center / University of Texas

location_facility: Wojewódzki Szpital Specjalistyczny im. M. Kopernika, Klinika Hematologii

location_facility: Medizinische Hochschule Hannover (Hannover Medical School) Dept. of Hematology, Hemostasis, Oncology, and Stem Cell Transplantation

location_facility: Milton S. Hershey Medical Center / Penn State

location_facility: Stellvertretende Klinikleiterin Charité, Campus Benjamin Franklin

location_facility: Ev. Diakonie-Krankenhaus Gemeinnutzige GMBH Medizinische Klinik 2

location_facility: Abteilung Hämatologie, internistische Onkologie und Hämostaseologie

location_facility: UNIVERSITÄTSKLINIKUM TU DRESDEN Medizinische Klinik und Poliklinik I,

location_facility: Hull and East Yorkshire Hospitals NHS Trust Queens Centre for Oncology and Haematology

location_facility: Winship Cancer Institute / Emory University

location_facility: Ohio State University Comprehensive Cancer Center

location_facility: Sidney Kimmel Comprehensive Cancer Center / John Hopkins University

location_facility: Odense University Hospital, Department of Hematology

location_facility: Hospital Universitario de Salamanca Servicio de Hematologia


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.

name: Gilead Sciences, Inc., 333 Lakeside Drive, Foster City, CA 94404, USA

family: Andreatta

full_name: Kristen Andreatta

given: Kristen

family: Willkom

full_name: Madeleine Willkom

given: Madeleine

family: Martin

full_name: Ross Martin

given: Ross

family: Chang

full_name: Silvia Chang

given: Silvia

family: Wei

full_name: Lilian Wei

given: Lilian

full_name: Hui Liu

given: Hui

full_name: Ya-Pei Liu

given: Ya-Pei

family: Graham

full_name: Hiba Graham

given: Hiba

family: Quirk

full_name: Erin Quirk

given: Erin

full_name: Hal Martin

given: Hal

family: White

full_name: Kirsten L White

given: Kirsten L

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Antimicrobial Chemotherapy

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

evidence: oa repository (via OAI-PMH doi match)

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

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;:.

family: Molina

full_name: Jean-Michel Molina

given: Jean-Michel

family: Ward

full_name: Douglas Ward

given: Douglas

family: Brar

full_name: Indira Brar

given: Indira

family: Mills

full_name: Anthony Mills

given: Anthony

family: Stellbrink

full_name: Hans-Jürgen Stellbrink

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.

journal_name: The Patient - Patient-Centered Outcomes Research

evidence: oa repository (via OAI-PMH title and first author match)

repository_institution: RePEc: Research Papers in Economics - RePEc

repositories_institution: University of North Carolina at Chapel Hill - Carolina Digital Repository

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


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

ipd_sharing: No

lead_sponsor: Axovant Sciences Ltd.

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

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

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.

status: Active, not recruiting

study_completion_date_type: Anticipated

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

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

location_facility: Dokuz Eylul University Faculty of Medicine

location_facility: Azienda Ospedaliera Universitaria Policlinico G. Martino

location_facility: Instituto de Neurologia de Curitiba - Hospital Ecoville

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata

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

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

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

location_facility: Azienda Ospedaliero Universitaria San Martino

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

location_facility: Groupe Hospitalier Pellegrin - Hôpital Pellegrin

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

location_facility: The Methodist Hospital Research Institute

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

location_facility: Selcuk Universitesi Selcuklu Tip Fakultesi Hastanesi

location_facility: Fondazione Istituto Neurologico Casimiro Mondino

location_facility: Azienda Ospedaliero-Universitaria Santa Maria della Misericordia

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

location_facility: Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Hospital das Clínicas da Faculdade de Medicina da UNICAMP

location_facility: Complejo Medico de la Policia Federal Argentina Churruca Visca

location_facility: University Hospital Centre "Sestre Milosrdnice"

location_facility: Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego

location_facility: IRCCS Ospedale Casa Sollievo della Sofferenza

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

location_facility: Instituto de Investigaciones Neurologicas Raul Carrea, FLENI

status_simplified: Ongoing


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.

lead_sponsor: Celgene

location_country:
Italy
United States
France
Greece
Spain
Germany

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

location_facility: Hospital General Universitario de Valencia

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele

location_facility: North Shore Hematology Oncology Associates

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

location_facility: Policlinico Universitario Campus Biomedico Di Roma


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.

family: Chilvers

full_name: Mark A Chilvers

given: Mark A

family: Davies

full_name: Jane C Davies

given: Jane C

family: Milla

full_name: Carlos Milla

given: Carlos

family: Tian

full_name: Simon Tian

given: Simon

family: Han

full_name: Zifei Han

given: Zifei

family: Cornell

full_name: Alexandra G Cornell

given: Alexandra G

family: Owen

full_name: Caroline A Owen

given: Caroline A

family: Ratjen

full_name: Felix Ratjen

given: Felix

journal_name: The Lancet Respiratory Medicine

oa_host_type: repository

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: Imperial College London - Spiral

version: submittedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: 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

lead_sponsor: Vertex Pharmaceuticals Incorporated

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

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

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.

name: Ramsay Générale de Santé, Institut Cardiovasculaire Paris Sud, Massy, France (B.C., M.A.).

family: Chevalier

full_name: Bernard Chevalier

given: Bernard

name: Instituto Dante Pazzanese de Cardiologia (A.A.).

name: Hospital Albert Einstein Sao Paulo, Brazil (A.A.).

family: Abizaid

full_name: Alexandre Abizaid

given: Alexandre

name: CHU Toulouse Rangueil, Toulouse, France (D.C.).

family: Carrié

full_name: Didier Carrié

given: Didier

name: Universitätsklinikum Schleswig-Holstein, Kiel, Germany (N.F., M.L.).

family: Frey

full_name: Norbert Frey

given: Norbert

family: Lutz

full_name: Matthias Lutz

given: Matthias

name: St.- Johannes-Hospital, Dortmund, Germany (J.W.-A.).

family: Weber-Albers

full_name: Joachim Weber-Albers

given: Joachim

name: Szpital Uniwersytecki w Krakowie, Poland (D.D.).

family: Dudek

full_name: Darius Dudek

given: Darius

name: Reva Medical, San Diego, CA (S.-C.W., J.A.).

family: Weng

full_name: Shu-Chuan Weng

given: Shu-Chuan

family: Akodad

full_name: Mariama Akodad

given: Mariama

family: Anderson

full_name: Jeffrey Anderson

given: Jeffrey

name: Columbia University Medical Center / New York-Presbyterian Hospital (G.W.S.).

name: The Cardiovascular Research Foundation, New York, NY (G.W.S.).

family: Stone

full_name: Gregg W. Stone

given: Gregg W.

name: on behalf of the FANTOM II Clinical Investigators

oa_host_type: publisher

evidence: open (via free pdf)

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: REVA Medical, Inc.

location_country: Brazil Netherlands France Poland Belgium Australia Denmark Germany

location_facility: Krakowskie Centrum Kardiologii Inwazyjnej

location_facility: Oddział Kardiologii Inwazyjnej I Katedra

location_facility: Szpital Kliniczny Przemienienia Panskiego UM w Poznaniu

location_facility: Prince of Wales Hospital (Eastern Heart)

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. 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.

family: Giustina

full_name: Andrea Giustina

given: Andrea

family: Bronstein

full_name: Marcello D. Bronstein

given: Marcello D.

family: Chanson

full_name: Philippe Chanson

given: Philippe

family: Petersenn

full_name: Stephan Petersenn

given: Stephan

family: Casanueva

full_name: Felipe F. Casanueva

given: Felipe F.

family: Sert

full_name: Caroline Sert

given: Caroline

family: Houchard

full_name: Aude Houchard

given: Aude

family: Melmed

full_name: Shlomo Melmed

given: Shlomo

journal_name: Pituitary

license: cc-by

license_normalized: cc-by

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Ipsen

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

location_facility: University Hospital, Dept of Endocrinology

location_facility: Endocrinology and Metabolism Churchill Hospital

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

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

location_facility: Azienda Ospedaliero Universitaria Pisana-Endcrinologia 2

location_facility: Endocrinology, University Hospital, Policlinica Gemelu

location_facility: Azienda Ospedaliero Universitar a Fedderico II


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.

family: Schmidt

full_name: Wolfgang A. Schmidt

given: Wolfgang A.

family: Dasgupta

full_name: Bhaskar Dasgupta

given: Bhaskar

family: Luqmani

full_name: Raashid Luqmani

given: Raashid

family: Unizony

full_name: Sebastian H. Unizony

given: Sebastian H.

family: Blockmans

full_name: Daniel Blockmans

given: Daniel

family: Lai

full_name: Zhihong Lai

given: Zhihong

family: Kurrasch

full_name: Regina H. Kurrasch

given: Regina H.

family: Lazic

full_name: Ivana Lazic

given: Ivana

family: Brown

full_name: Kurt Brown

given: Kurt

family: Rao

full_name: Ravi Rao

given: Ravi

journal_name: Rheumatology and Therapy

oa_colors: green gold

evidence: oa journal (via doaj)

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories:
LIRIAS (KU Leuven)
PubMed Central

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

lead_sponsor: GlaxoSmithKline

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


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

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


lead_sponsor: Janssen Research & Development, LLC

location_country:
Brazil
Sweden
United Kingdom
Spain
Germany
France
Japan
Poland
Israel
Belgium
Argentina
Australia
China
Puerto Rico
Russian Federation
United States
Turkey
Korea, Republic of
Ukraine

title: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor, PCI-32765 (Ibrutinib), in Combination With Either Bendamustine and Rituximab (BR) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects With Previously Treated Indolent Non-Hodgkin Lymphoma (iNHL)

summary: The purpose of this study is to evaluate the efficacy and safety of PCI-32765 (ibrutinib) administered in combination with either bendamustine and rituximab (BR) or rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in adult participants with previously treated indolent Non-Hodgkin lymphoma.


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.

name: Department of Women's and Children's Health; University of Liverpool; Liverpool UK

family: Southern

full_name: Kevin W Southern

given: Kevin W

family: Murphy

full_name: Jared Murphy

given: Jared

family: Sinha

full_name: Ian P Sinha

given: Ian P

name: Department of Biostatistics; University of Liverpool; Liverpool UK

family: Nevitt

full_name: Sarah J Nevitt

given: Sarah J

journal_name: Cochrane Database of Systematic Reviews

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

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.

family: Ratjen

full_name: Felix Ratjen

given: Felix

family: Hug

full_name: Christopher Hug

given: Christopher

family: Marigowda

full_name: Gautham Marigowda

given: Gautham

family: Tian

full_name: Simon Tian

given: Simon

family: Huang

full_name: Xiaohong Huang

given: Xiaohong

family: Stanojevic

full_name: Sanja Stanojevic

given: Sanja

family: Milla

full_name: Carlos E Milla

given: Carlos E

family: Robinson

full_name: Paul D Robinson

given: Paul D

family: Waltz

full_name: David Waltz

given: David

family: Davies

full_name: Jane C Davies

given: Jane C

family: Rosenfeld

full_name: Margaret Rosenfeld

given: Margaret

family: Starner

full_name: Timothy Starner

given: Timothy

family: Retsch-Bogart

full_name: George Retsch-Bogart

given: George

family: Chmiel

full_name: James Chmiel

given: James

family: Orenstein

full_name: David Orenstein

full_name: Carlos Milla

given: Carlos

family: Rubenstein

full_name: Ronald Rubenstein

given: Ronald

family: Walker

full_name: Seth Walker

given: Seth

family: Cornell

title: 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

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

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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ReferenceCitation: Homasson JP, Thiery JP, Angebault M, Ovtracht L, Maiwand O. The operation and efficacy of cryosurgical, nitrous oxide-driven cryoprobe. I. Cryoprobe physical characteristics: their effects on cell cryodestruction. Cryobiology. 1994 Jun;31(3):290-304.

ReferenceCitation: Hamilton A, Hu J. An electronic cryoprobe for cryosurgery using heat pipes and thermoelectric coolers: a preliminary report. J Med Eng Technol. 1993 May-Jun;17(3):104-9.

ReferenceCitation: Rabin Y, Julian TB, Wolmark N. A compact cryosurgical apparatus for minimally invasive procedures. Biomed Instrum Technol. 1997 May-Jun;31(3):251-8.

ReferenceCitation: Rabin Y, Coleman R, Mordohovich D, Ber R, Shitzer A. A new cryosurgical device for controlled freezing. Cryobiology. 1996 Feb;33(1):93-105.

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ReferenceCitation: Gage AA, Baust JM, Baust JG. Experimental cryosurgery investigations in vivo. Cryobiology. 2009 Dec;59(3):229-43. doi: 10.1016/j.cryobiol.2009.10.001. Epub 2009 Oct 13. Review.

ReferenceCitation: McTaggart RA, Dupuy DE. Thermal ablation of lung tumors. Tech Vasc Interv Radiol. 2007 Jun;10(2):102-13. Review.

ReferenceCitation: Callstrom MR, Charboneau JW. Image-guided palliation of painful metastases using percutaneous ablation. Tech Vasc Interv Radiol. 2007 Jun;10(2):120-31. Review.

ReferenceCitation: McQuay HJ, Collins SL, Carroll D, Moore RA. Radiotherapy for the palliation of painful bone metastases. Cochrane Database Syst Rev. 2000;(2):CD001793. Review. Update in: Cochrane Database Syst Rev. 2013;11:CD001793.

ReferenceCitation: Callstrom MR, Atwell TD, Charboneau JW, Farrell MA, Goetz MP, Rubin J, Sloan JA, Novotny PJ, Welch TJ, Maus TP, Wong GY, Brown KJ. Painful metastases involving bone: percutaneous image-guided cryoablation--prospective trial interim analysis. Radiology. 2006 Nov;241(2):572-80.

ReferenceCitation: Coleman RE. Management of bone metastases. Oncologist. 2000;5(6):463-70. Review.

ReferenceCitation: Goetz MP, Callstrom MR, Charboneau JW, Farrell MA, Maus TP, Welch TJ, Wong GY, Sloan JA, Novotny PJ, Petersen IA, Beres RA, Regge D, Capanna R, Saker MB, Grönemeyer DH, Gevargez A, Ahrar K, Choti MA, de Baere TJ, Rubin J. Percutaneous image-guided radiofrequency ablation of painful metastases involving bone: a multicenter study. J Clin Oncol. 2004 Jan 15;22(2):300-6.

ReferenceCitation: Callstrom MR, Charboneau JW, Goetz MP, Rubin J, Wong GY, Sloan JA, Novotny PJ, Lewis BD, Welch TJ, Farrell MA, Maus TP, Lee RA, Reading CC, Petersen IA, Pickett DD. Painful metastases involving bone: feasibility of percutaneous CT- and US-guided radio-frequency ablation. Radiology. 2002 Jul;224(1):87-97.

ReferenceCitation: Belfiore G, Tedeschi E, Ronza FM, Belfiore MP, Della Volpe T, Zeppetella G, Rotondo A. Radiofrequency ablation of bone metastases induces long-lasting palliation in patients with untreatable cancer. Singapore Med J. 2008 Jul;49(7):565-70.

ReferenceCitation: Hurwitz MD, Ghanouni P, Kanaev SV, Iozeffi D, Gianfelice D, Fennessy FM, Kuten A, Meyer JE, LeBlang SD, Roberts A, Choi J, Larner JM, Napoli A, Turkevich VG, Inbar Y, Tempany CM, Pfeffer RM. Magnetic resonance-guided focused ultrasound for patients with painful bone metastases: phase III trial results. J Natl Cancer Inst. 2014 Apr 23;106(5). pii: dju082. doi: 10.1093/jnci/dju082.

ReferenceCitation: Simon CJ, Dupuy DE. Percutaneous minimally invasive therapies in the treatment of bone tumors: thermal ablation. Semin Musculoskelet Radiol. 2006 Jun;10(2):137-44. Epub 2006 Apr 5. Review.

ReferenceCitation: Ullrick SR, Hebert JJ, Davis KW. Cryoablation in the musculoskeletal system. Curr Probl Diagn Radiol. 2008 Jan-Feb;37(1):39-48. Review.

ReferenceCitation: Maiwand MO. The role of cryosurgery in palliation of tracheo-bronchial carcinoma. Eur J Cardiothorac Surg. 1999 Jun;15(6):764-8.

ReferenceCitation: Maiwand MO, Homasson JP. Cryotherapy for tracheobronchial disorders. Clin Chest Med. 1995 Sep;16(3):427-43. Review. Erratum in: Clin Chest Med 1995 Dec;16(4):ix.

ReferenceCitation: Sanderson DR, Neel HB 3rd, Fontana RS. Bronchoscopic cryotherapy. Ann Otol Rhinol Laryngol. 1981 Jul-Aug;90(4 Pt 1):354-8.

ReferenceCitation: Cozzi PJ, Lynch WJ, Collins S, Vonthethoff L, Morris DL. Renal cryotherapy in a sheep model; a feasibility study. J Urol. 1997 Feb;157(2):710-2.

ReferenceCitation: Gage AA, Fazekas G, Riley EE Jr. Freezing injury to large blood vessels in dogs. With comments on the effect of experimental freezing of bile ducts. Surgery. 1967 May;61(5):748-54.

ReferenceCitation: Gage AM, Montes M, Gage AA. Freezing the canine thoracic aorta in situ. J Surg Res. 1979 Nov;27(5):331-40.

ReferenceCitation: Ladd AP, Rescorla FJ, Baust JG, Callahan M, Davis M, Grosfeld JL. Cryosurgical effects on growing vessels. Am Surg. 1999 Jul;65(7):677-82.

ReferenceCitation: Mandeville AF, McCabe BF. Some observations on the cryobiology of blood vessels. Laryngoscope. 1967 Aug;77(8):1328-50.

ReferenceCitation: Callstrom MR, Dupuy DE, Solomon SB, Beres RA, Littrup PJ, Davis KW, Paz-Fumagalli R, Hoffman C, Atwell TD, Charboneau JW, Schmit GD, Goetz MP, Rubin J, Brown KJ, Novotny PJ, Sloan JA. Percutaneous image-guided cryoablation of painful metastases involving bone: multicenter trial. Cancer. 2013 Mar 1;119(5):1033-41. doi: 10.1002/cncr.27793. Epub 2012 Oct 12.

ReferenceCitation: Cleeland CS. The measurement of pain from metastatic bone disease: capturing the patient's experience. Clin Cancer Res. 2006 Oct 15;12(20 Pt 2):6236s-6242s. Review.

ReferenceCitation: Jennings JW, Prologo JD, Garnon J, Gangi A, Buy X, Palussière J, Kurup AN, Callstrom M, Genshaft S, Abtin F, Huang AJ, Iannuccilli J, Pilleul F, Mastier C, Littrup PJ, de Baère T, Deschamps F. Cryoablation for Palliation of Painful Bone Metastases: The MOTION Multicenter Study. Radiol Imaging Cancer. 2021 Feb 12;3(2):e200101. doi: 10.1148/rycan.2021200101. eCollection 2021 Mar.

family: Jennings

full_name: Jack W. Jennings

given: Jack W.

family: Prologo

full_name: J. David Prologo

given: J. David

family: Garnon

full_name: Julien Garnon

given: Julien

family: Gangi

full_name: Afshin Gangi

given: Afshin

family: Buy

full_name: Xavier Buy

given: Xavier

family: Palussière

full_name: Jean Palussière

given: Jean

family: Kurup

full_name: A. Nicholas Kurup

given: A. Nicholas

family: Callstrom

full_name: Matthew Callstrom

given: Matthew

family: Genshaft

full_name: Scott Genshaft

given: Scott

family: Abtin

full_name: Fereidoun Abtin

given: Fereidoun

full_name: Ambrose J. Huang

given: Ambrose J.

family: Iannuccilli

full_name: Jason Iannuccilli

given: Jason

family: Pilleul

full_name: Frank Pilleul

given: Frank

family: Mastier

full_name: Charles Mastier

publisher: Radiological Society of North America (RSNA)

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


title: APOLLO: A Phase 3 Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Patisiran (ALN-TTR02) in Transthyretin (TTR)-Mediated Polyneuropathy (Familial Amyloidotic Polyneuropathy-FAP)

summary: The purpose of this study is to evaluate the safety and efficacy of patisiran (ALN-TTR02) in patients with transthyretin (TTR) mediated amyloidosis. An open-label, single-arm, long-term follow-up extension study NCT02510261 (ALN-TTR02-006) was initiated to provide participants who completed this study with continued patisiran-LNP (lipid nanoparticle) treatment.

ReferenceCitation: Zhang X, Goel V, Attarwala H, Sweetser MT, Clausen VA, Robbie GJ. Patisiran Pharmacokinetics, Pharmacodynamics, and Exposure-Response Analyses in the Phase 3 APOLLO Trial in Patients With Hereditary Transthyretin-Mediated (hATTR) Amyloidosis. J Clin Pharmacol. 2020 Jan;60(1):37-49. doi: 10.1002/jcph.1480. Epub 2019 Jul 19.

name: Alnylam Pharmaceuticals Cambridge MA USA

family: Zhang

full_name: Xiaoping Zhang

given: Xiaoping

family: Goel

full_name: Varun Goel

given: Varun

family: Attarwala

full_name: Husain Attarwala

given: Husain

family: Sweetser

full_name: Marianne T. Sweetser

given: Marianne T.

family: Clausen

full_name: Valerie A. Clausen

given: Valerie A.

family: Robbie

full_name: Gabriel J. Robbie

given: Gabriel J.

journal_name: The Journal of Clinical Pharmacology

title: Patisiran Pharmacokinetics, Pharmacodynamics, and Exposure‐Response Analyses in the Phase 3 APOLLO Trial in Patients With Hereditary Transthyretin‐Mediated (hATTR) Amyloidosis

ReferenceCitation: Minamisawa M, Claggett B, Adams D, Kristen AV, Merlini G, Slama MS, Dispenzieri A, Shah AM, Falk RH, Karsten V, Sweetser MT, Chen J, Riese R, Vest J, Solomon SD. Association of Patisiran, an RNA Interference Therapeutic, With Regional Left Ventricular Myocardial Strain in Hereditary Transthyretin Amyloidosis: The APOLLO Study. JAMA Cardiol. 2019 May 1;4(5):466-472. doi: 10.1001/jamacardio.2019.0849.

name: Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts

name: Shinshu University Hospital, Matsumoto, Nagano, Japan

family: Minamisawa

full_name: Masatoshi Minamisawa

given: Masatoshi

family: Claggett

full_name: Brian Claggett

given: Brian

name: National Reference Center for FAP/Assitance Publique–Hôpitaux de Paris/ Inserm U 1195/ CHU Bicêtre, Le Kremlin- Bicêtre, France

family: Adams

full_name: David Adams

given: David

name: Heidelberg University Hospital, Heidelberg, Germany

family: Kristen

full_name: Arnt V. Kristen

given: Arnt V.

name: Scientific Institute for Research and Healthcare, Policlinico San Matteo Hospital, University of Pavia, Pavia, Italy

family: Merlini

full_name: Giampaolo Merlini

given: Giampaolo

name: Service de cardiologie-Bichat University Hospital Assitance Publique–Hôpitaux de Paris, Paris Sud University, France

family: Slama

full_name: Michel S. Slama

given: Michel S.

family: Dispenzieri

full_name: Angela Dispenzieri

given: Angela

family: Shah

full_name: Amil M. Shah

given: Amil M.

family: Falk

full_name: Rodney H. Falk

given: Rodney H.

name: Alnylam Pharmaceuticals, Cambridge, Massachusetts

family: Karsten

full_name: Verena Karsten

given: Verena

ReferenceCitation: Solomon SD, Adams D, Kristen A, Grogan M, González-Duarte A, Maurer MS, Merlini G, Damy T, Slama MS, Brannagan TH 3rd, Dispenzieri A, Berk JL, Shah AM, Garg P, Vaishnaw A, Karsten V, Chen J, Gollob J, Vest J, Suhr O. Effects of Patisiran, an RNA Interference Therapeutic, on Cardiac Parameters in Patients With Hereditary Transthyretin-Mediated Amyloidosis. Circulation. 2019 Jan 22;139(4):431-443. doi: 10.1161/CIRCULATIONAHA.118.035831.

name: Brigham and Women’s Hospital, Harvard Medical School, Boston, MA (S.D.S., A.M.S.).

name: Assistance Publique – Hôpitaux de Paris, National Reference Center for FAP, CHU Bicêtre, INSERM U1195, Université Paris Sud, Le Kremlin-Bicêtre, France (D.A.).

name: Department of Cardiology, University of Heidelberg, Germany (A.K.).

name: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, México City, Mexico (A.G.-D.).

name: Department of Medicine/Cardiology, Columbia University Medical Center, New York, NY (M.S.M.).

name: Amyloidosis Research and Treatment Center, Foundation IRCCS Policlinico San Matteo and University of Pavia, Italy (G.M.).

name: French Referral Center for Cardiac Amyloidosis, Amyloidosis Mondor Network, GRC Amyloid Research Institute, Department of Cardiology, Assistance Publique – Hôpitaux de Paris, CHU Henri Mondor, and INSERM U955, Clinical Investigation Center, and DHU ATVB, Creteil, France (T.D.).

name: Hôpital Bichat, Cardiology Department, Université Paris Sud, Paris, France (M.S.S.).

name: Neurology Department, Columbia University, College of Physicians and Surgeons, New York, NY (T.H.B.).

name: Division of Hematology, Mayo Clinic, Rochester, MN (A.D.).

name: Amyloidosis Center, Boston Medical Center, MA (J.L.B.).

name: Alnylam Pharmaceuticals, Cambridge, MA (P.G., A.V., V.K., J.C., J.G., J.V.).

name: Department of Public Health and Clinical Medicine, Umeå University, Sweden (O.S.).

ReferenceCitation: Adams D, Gonzalez-Duarte A, O'Riordan WD, Yang CC, Ueda M, Kristen AV, Tournev I, Schmidt HH, Coelho T, Berk JL, Lin KP, Vita G, Attarian S, Planté-Bordeneuve V, Mezei MM, Campistol JM, Buades J, Brannagan TH 3rd, Kim BJ, Oh J, Parman Y, Sekijima Y, Hawkins PN, Solomon SD, Polydefkis M, Dyck PJ, Gandhi PJ, Goyal S, Chen J, Strahs AL, Nochur SV, Sweetser MT, Garg PP, Vaishnaw AK, Gollob JA, Suhr OB. Patisiran, an RNAi Therapeutic, for Hereditary Transthyretin Amyloidosis. N Engl J Med. 2018 Jul 5;379(1):11-21. doi: 10.1056/NEJMoa1716153.

name: From Assistance Publique–Hôpitaux de Paris (APHP), National Reference Center for Familial Amyloidotic Polyneuropathy, Centre Hospitalier Universitaire (CHU) Bicêtre, INSERM Unité 1195, Université Paris-Sud, Le Kremlin-Bicêtre (D.A.), the Department of Neuromuscular Disorders and ALS, Hôpital de la Timone, Marseille (S.A.), and the Department of Neurology, Amyloid Network, CHU Henri Mondor–APHP, Créteil (V.P.-B.) — all in France; the National Institute of Medical Sciences and Nutrition–Salvador Zubiran,...

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

repository_institution: University College London - UCL Discovery

ReferenceCitation: Adams D, Suhr OB, Dyck PJ, Litchy WJ, Leahy RG, Chen J, Gollob J, Coelho T. Trial design and rationale for APOLLO, a Phase 3, placebo-controlled study of patisiran in patients with hereditary ATTR amyloidosis with polyneuropathy. BMC Neurol. 2017 Sep 11;17(1):181. doi: 10.1186/s12883-017-0948-5.

repository_institution: RCAAP Project by FCT - Portuguese National Funding Agency for Science, Research and Technology - RCAAP Search Portal

location_country:
Malaysia
Australia
Taiwan
France
Japan
Argentina
Canada
Korea, Republic of
Sweden
Netherlands
Bulgaria
Portugal
Germany
United States
United Kingdom
Italy
Brazil
Mexico
Cyprus
Spain
Turkey


title: A 12-month, Phase IV, Randomized, Open Label, Multicenter Study to Compare Efficacy of 0.5 mg Ranibizumab Pro re Nata (PRN) Versus 2 mg Aflibercept Bimonthly Intravitreal Injections on Retinal Thickness Stability Till Month 6 of Treatment and Explore Functional Outcomes up to Month 12 in Patients With Neovascular (Wet) Age-related Macular Degeneration (AMD)

acronym: SALT

summary: The purpose of this study was to compare the efficacy of 0.5 mg ranibizumab versus 2 mg aflibercept bimonthly intravitreal injections on retinal thickness stability.

lead_sponsor: Novartis Pharmaceuticals

location_country: Austria Sweden Switzerland Netherlands France Norway Belgium Portugal Denmark Germany


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: 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.

family: Wajs

full_name: Ewa Wajs

given: Ewa

family: Aluisio

full_name: Leah Aluisio

given: Leah

family: Holder

full_name: Richard Holder

given: Richard

family: Daly

full_name: Ella J. Daly

given: Ella J.

family: Lane

full_name: Rosanne Lane

given: Rosanne

family: Lim

full_name: Pilar Lim

given: Pilar

family: George

full_name: Joyce E. George

given: Joyce E.

family: Morrison

full_name: Randall L. Morrison

given: Randall L.

family: Sanacora

full_name: Gerard Sanacora

given: Gerard

family: Young

full_name: Allan H. Young

given: Allan H.

family: Kasper

full_name: Siegfried Kasper

given: Siegfried

family: Sulaiman

full_name: Ahmad Hatim Sulaiman

given: Ahmad Hatim

family: Li

full_name: Cheng-Ta Li

given: Cheng-Ta

family: Paik

full_name: Jong-Woo Paik

given: Jong-Woo

family: Manji

full_name: Husseini Manji

given: Husseini

family: Hough

full_name: David Hough

family: Grunfeld

full_name: Jennifer Grunfeld

given: Jennifer

family: Jeon

full_name: Hong Jin Jeon

given: Hong Jin

family: Wilkinson

full_name: Samuel T. Wilkinson

given: Samuel T.

family: Drevets

full_name: Wayne C. Drevets

given: Wayne C.

family: Singh

full_name: Jaskaran B. Singh

given: Jaskaran B.

journal_name: The Journal of Clinical Psychiatry

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.

name: Janssen Research and Development, LLC, Department of Global Analytics – Neuroscience, Titusville

name: Janssen Research and Development, Belgium, Department of Neuroscience, Beerse, Belgium

name: Janssen Research and Development, LLC, Department of Neuroscience, San Diego, CA

name: Janssen Research and Development, LLC, Department of Statistics & Decision Sciences, Titusville, NJ

name: Janssen Research and Development, LLC, Department of Clinical Medical Affairs, Titusville, NJ

name: Janssen Research and Development, France, Department of Clinical Medical Affairs, Issy-les-Moulineaux, France

journal_name: International Journal of Neuropsychopharmacology

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


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.

family: Sharman

full_name: Jeff P Sharman

given: Jeff P

family: Egyed

full_name: Miklos Egyed

given: Miklos

family: Jurczak

full_name: Wojciech Jurczak

given: Wojciech

family: Skarbnik

full_name: Alan Skarbnik

given: Alan

family: Pagel

full_name: John M Pagel

given: John M

family: Flinn

full_name: Ian W Flinn

given: Ian W

family: Kamdar

full_name: Manali Kamdar

given: Manali

family: Munir

full_name: Talha Munir

given: Talha

family: Walewska

full_name: Renata Walewska

given: Renata

family: Corbett

full_name: Gillian Corbett

given: Gillian

family: Fogliatto

full_name: Laura Maria Fogliatto

given: Laura Maria

family: Herishanu

full_name: Yair Herishanu

given: Yair

family: Banerji

full_name: Versha Banerji

given: Versha

family: Coutre

full_name: Steven Coutre

given: Steven

family: Follows

full_name: George Follows

given: George

family: Walker

full_name: Patricia Walker

given: Patricia

family: Karlsson

full_name: Karin Karlsson

given: Karin

family: Ghia

full_name: Paolo Ghia

given: Paolo

family: Janssens

full_name: Ann Janssens

given: Ann

family: Cymbalista

full_name: Florence Cymbalista

given: Florence

family: Woyach

full_name: Jennifer A Woyach

given: Jennifer A

family: Salles

full_name: Gilles Salles

given: Gilles

family: Wierda

full_name: William G Wierda

given: William G

title: Acalabrutinib with or without obinutuzumab versus chlorambucil and obinutuzumab for treatment-naive chronic lymphocytic leukaemia (ELEVATE-TN): a randomised, controlled, phase 3 trial

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


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.

lead_sponsor: Grifols Therapeutics LLC

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

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

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

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

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

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

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

location_facility: Uniwersyteckie Centrum Kliniczne, Dept of Neurology

location_facility: Fakultni nemocnice Brno, Dept of Neurologicka klinika

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden

location_facility: Houston Methodist Neurological Institute

location_facility: Ohio State University Wexner Medical Center

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

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

location_facility: Universitaetsklinikum Jena, Klinik fuer Neurologie

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny, Dept of Neurology

location_facility: CHU Strasbourg - Nouvel Hôpital Civil, Clinique Neurologique

location_facility: Universitaetsklinikum Koeln, Neurologie und Psychiatrie

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

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics

location_facility: London Health Sciences Centre - University Hospital

location_facility: University of Florida Health Science Center

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

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

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


title: A RANDOMIZED, OPEN-LABEL, ACTIVE CONTROLLED, SAFETY AND DESCRIPTIVE EFFICACY STUDY IN PEDIATRIC SUBJECTS REQUIRING ANTICOAGULATION FOR THE TREATMENT OF A VENOUS THROMBOEMBOLIC EVENT

summary: To assess the safety and descriptive efficacy of apixaban in pediatric subjects requiring anticoagulation for the treatment of a VTE.

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:
Austria
United States
Germany
France
Israel
Australia
Russian Federation
Spain
Canada
United Kingdom
Ukraine

location_facility: Riley Hospital for Children at IU Health

location_facility: Dnipropetrovsk Regional Children's Hospital

location_facility: Investigational Drug Service, Duke University Hospital

location_facility: St. Christopher's Healthcare d/b/a St. Christopher's Hospital for Children

location_facility: Levine Children's Hospital, Pediatric Research

location_facility: Hamilton Health Science Corporation/McMaster Children's Hospital

location_facility: Soroka University Medical Center -Pharmacy

location_facility: Birmingham Children's Hospital NHS Foundation Trust

location_facility: University of Mississippi Medical Center

location_facility: Communal Institution "Zaporizhzhia Regional Clinical Children's Hospital"

location_facility: University of Iowa Hospitals and Clinics

location_facility: Children's Hospital and Research Center Oakland

location_facility: Children's Healthcare of Atlanta Center for Advanced Pediatrics - Pediatric Research Unit

location_facility: University of California Davis Comprehensive Cancer Center

location_facility: University of Oklahoma Health Sciences Center

location_facility: Children's Hospital of Michigan - Hematology Clinic

location_facility: Nemours/ Alfred I. duPont Hospital for Children

location_facility: Medical University of South Carolina: Shawn Jenkins Women's and Children's Hospital

location_facility: Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK)

location_facility: Children's Hospital Colorado - Investigational Drug Services

location_facility: Children's Hospital of Wisconsin Logistics Warehouse

location_facility: Kaiser Permanente Roseville Medical Center

location_facility: Texas Children's Hospital- Main Hospital

location_facility: Soroka University Medical Center -Imaging Unit

location_facility: State Autonomous Healthcare Institution "Children's Republican Clinical Hospital of Ministry of

location_facility: Bleeding and Clotting Disorders Institute

location_facility: Medical University of South Carolina: Investigational Drug Services

location_facility: Connecticut Children's Medical Center Pharmacy

location_facility: Noah's Ark Children's Hospital for Wales

location_facility: Loma Linda University Children's Hospital

location_facility: Service d'Imagerie Medicale du Pr F. Laurent

location_facility: Children's Hematology and Oncology a division of Kidz medical Service

location_facility: UCSF Mission Bay Investigational Drug Pharmacy

location_facility: Birmingham Women's and Children's NHS Foundation Trust

location_facility: OU Medical Center Investigational Drug Pharmacy

location_facility: UCSF Mission Bay Pediatric Clinical Research Center

location_facility: Children's Healthcare of Atlanta-Egleston

location_facility: New York-Presbyterian Morgan Stanley Children's Hospital

location_facility: Municipal enterprise "Dnipropetrovsk Regional Children's Clinical Hospital"

location_facility: Technische Universitat, Deutsches Herzzentrum Munchen

location_facility: FSBI "NRMC PHOI n.a.Dmitry Rogachev" of Minzdrav Russia

location_facility: Children's Healthcare of Atlanta Center for Advanced Pediatrics-IDS Pharmacy

location_facility: Newcastle Upon Tyne Hospitals NHS Foundation Trust

location_facility: Texas Children's Hospital- Wallace Tower

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

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: JDCH Division of Pediatric Hematology and Oncology

location_facility: University Hospitals Cleveland Medical Center

location_facility: Monroe Carell Jr. Children's Hospital at Vanderbilt

location_facility: AdventHealth Orlando-Pharmacy Investigational Drug Services

location_facility: State Budgetary Healthcare Institution of Moscow city

location_facility: Communal Enterprise "Dnipropetrovsk Specialized Clinical Medical Center of Mother and Child

location_facility: AdventHealth Pediatric Oncology Hematology at Orlando

location_facility: Kaiser Permanente-Oakland c/o Kris Nishimura, Pharm. D

location_facility: Lucile Packard Children's Hosptial - Stanford University

location_facility: State Autonomous Healthcare Institution of Sverdlovsk Region

location_facility: The Children's Hospital of Philadelphia - Investigational Pharmacy


title: A Randomized, Double-blind, Parallel-arm, Phase I Study to Evaluate the Pharmacokinetics and Pharmacodynamics of BI 695500 vs. Rituximab (MabThera) Induction Immunotherapy as a First-line Treatment in Patients With Low Tumor Burden Follicular Lymphoma

summary:
The primary objective of the study is to assess the pharmacokinetic (PK) similarity of Boehringer Ingelheim (BI) 695500 vs. rituximab (MabThera®) in previously untreated patients with low tumor burden follicular lymphoma (LTBFL).

The secondary objective of the study is to evaluate the pharmacodynamics (PD), safety, and anti-tumor activity of BI 695500 vs. rituximab (MabThera®), as well as the presence of anti-drug antibodies (ADAs).

lead_sponsor: Boehringer Ingelheim

location_country:
Austria
Spain
Croatia
Czechia
France
Greece
Poland
Hungary
Australia
Belgium
New Zealand
Russian Federation
Germany

location_facility: General Hospital of Athens "G. Gennimatas"

location_facility: Centre Hospitalier Départemental Les Oudairies

location_facility: BHI of Omsk region - Clinical Oncology Dispensary

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: Oncol Centre M Sklodowska-Curie, Dept of Lung & Chest Cancer

location_facility: St. Petersburg GUZ City Clinical Oncology Dispensary

location_facility: Semmelweis University, 1st Dept. Internal Medicine


title: ASPIRE: Adult SPasticity International REgistry on BOTOX® Treatment

acronym: ASPIRE

summary: This is a registry study in adults with spasticity to determine onabotulinumtoxinA use in clinical practice. Treatment will be administered in accordance with physician standard practice. All treatment decisions lie with the physician.

time_perspective: Prospective

ReferenceCitation: Esquenazi A, Francisco GE, Feng W, Baricich A, Gallien P, Fanning K, Zuzek A, Bandari DS, Wittenberg GF. Real-World Adherence to OnabotulinumtoxinA Treatment for Spasticity: Insights From the ASPIRE Study. Arch Phys Med Rehabil. 2021 Nov;102(11):2172-2184.e6. doi: 10.1016/j.apmr.2021.06.008. Epub 2021 Jul 7.

family: Esquenazi

full_name: Alberto Esquenazi

given: Alberto

family: Francisco

full_name: Gerard E. Francisco

given: Gerard E.

family: Feng

full_name: Wuwei Feng

given: Wuwei

family: Baricich

full_name: Alessio Baricich

given: Alessio

family: Gallien

full_name: Philippe Gallien

given: Philippe

family: Fanning

full_name: Kristina Fanning

given: Kristina

family: Zuzek

full_name: Aleksej Zuzek

given: Aleksej

family: Bandari

full_name: Daniel S. Bandari

given: Daniel S.

family: Wittenberg

full_name: George F. Wittenberg

given: George F.

journal_name: Archives of Physical Medicine and Rehabilitation

ReferenceCitation: Esquenazi A, Bavikatte G, Bandari DS, Jost WH, Munin MC, Tang SFT, Largent J, Adams AM, Zuzek A, Francisco GE. Long-Term Observational Results from the ASPIRE Study: OnabotulinumtoxinA Treatment for Adult Lower Limb Spasticity. PM R. 2021 Oct;13(10):1079-1093. doi: 10.1002/pmrj.12517. Epub 2021 Jan 11.

name: MossRehab Gait and Motion Analysis Laboratory  Elkins Park PA USA

family: Bavikatte

full_name: Ganesh Bavikatte

given: Ganesh

name: Multiple Sclerosis Center of California  Laguna Hills CA USA

name: Department of Neurology University of Freiburg  Freiburg im Breisgau Germany

name: Parkinson‐Klinik Ortenau  Wolfach Germany

family: Jost

full_name: Wolfgang H. Jost

given: Wolfgang H.

name: Department of Physical Medicine and Rehabilitation University of Pittsburgh School of Medicine  Pittsburgh PA USA

family: Munin

full_name: Michael C. Munin

given: Michael C.

name: Department of Physical Medicine and Rehabilitation Lotung Poh‐Ai Hospital  Yilan Taiwan

family: Tang

full_name: Simon Fuk Tan Tang

given: Simon Fuk Tan

name: IQVIA Real‐World Evidence Solutions  Cambridge MA USA

family: Largent

full_name: Joan Largent

given: Joan

name: Allergan, An AbbVie company  Irvine CA USA

family: Adams

full_name: Aubrey Manack Adams

given: Aubrey Manack

name: University of Texas Health Science Center McGovern Medical School and TIRR Memorial Hermann  Houston TX USA

title: Long‐Term Observational Results from the ASPIRE Study: OnabotulinumtoxinA Treatment for Adult Lower Limb Spasticity

ReferenceCitation: Francisco GE, Jost WH, Bavikatte G, Bandari DS, Tang SFT, Munin MC, Largent J, Adams AM, Zuzek A, Esquenazi A. Individualized OnabotulinumtoxinA Treatment for Upper Limb Spasticity Resulted in High Clinician- and Patient-Reported Satisfaction: Long-Term Observational Results from the ASPIRE Study. PM R. 2020 Nov;12(11):1120-1133. doi: 10.1002/pmrj.12328. Epub 2020 Feb 27.

name: The University of Texas Health Science Center McGovern Medical School and TIRR Memorial Hermann  Houston TX

name: Multiple Sclerosis Center of California & Research Group  Newport Beach CA

title: Individualized OnabotulinumtoxinA Treatment for Upper Limb Spasticity Resulted in High Clinician‐ and Patient‐Reported Satisfaction: Long‐Term Observational Results from the ASPIRE Study

location_country:
Italy
United States
France
Spain
Germany
United Kingdom
Taiwan

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Hospital Universitario Mutua de Terrassa

location_facility: Hospital de Conxo (Santiago de Compostela) GALICIA

location_facility: Michigan Institute for Neurological Disorders

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Dayton Center for Neurological Disorders

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: The National Hospital for Neurology & Neurosurgery

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

location_facility: Nottingham University Hospitals City Campus

location_facility: Loma Linda University School Of Medicine

location_facility: Azienda Ospedaliero - Universitaria Maggiore delle Carità

location_facility: Emerald Coast Center for Neurological Disorders

location_facility: The Curators of the University of Missouri on behalf of University of Missouri Health Care

location_facility: University of Pittsburgh Medical Center Health System

location_facility: Albert Einstein Healthcare Network, Moss Rehabilitation Hospital


title: A Phase 1/2, Multicenter, Open-Label, Dose-Escalation and Expansion, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-221 in Subjects With Advanced Hematologic Malignancies With an IDH2 Mutation

summary:
The primary objectives of Phase 1 Dose Escalation/Part 1 Expansion are:

To assess the safety and tolerability of treatment with enasidenib administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle in participants with advanced hematologic malignancies.
To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and/or the recommended Phase 2 dose (RP2D) of enasidenib in participants with advanced hematologic malignancies.

The primary objective of Phase 2 is:

• To assess the efficacy of enasidenib as treatment for participants with relapsed or refractory (R/R) acute myelogenous leukemia (AML) with an IDH2 mutation.

ReferenceCitation: Stein EM, DiNardo CD, Pollyea DA, Fathi AT, Roboz GJ, Altman JK, Stone RM, DeAngelo DJ, Levine RL, Flinn IW, Kantarjian HM, Collins R, Patel MR, Frankel AE, Stein A, Sekeres MA, Swords RT, Medeiros BC, Willekens C, Vyas P, Tosolini A, Xu Q, Knight RD, Yen KE, Agresta S, de Botton S, Tallman MS. Enasidenib in mutant IDH2 relapsed or refractory acute myeloid leukemia. Blood. 2017 Aug 10;130(6):722-731. doi: 10.1182/blood-2017-04-779405. Epub 2017 Jun 6.

ReferenceCitation: Fathi AT, DiNardo CD, Kline I, Kenvin L, Gupta I, Attar EC, Stein EM, de Botton S; AG221-C-001 Study Investigators. Differentiation Syndrome Associated With Enasidenib, a Selective Inhibitor of Mutant Isocitrate Dehydrogenase 2: Analysis of a Phase 1/2 Study. JAMA Oncol. 2018 Aug 1;4(8):1106-1110. doi: 10.1001/jamaoncol.2017.4695.

ReferenceCitation: Stein EM, DiNardo CD, Fathi AT, Pollyea DA, Stone RM, Altman JK, Roboz GJ, Patel MR, Collins R, Flinn IW, Sekeres MA, Stein AS, Kantarjian HM, Levine RL, Vyas P, MacBeth KJ, Tosolini A, VanOostendorp J, Xu Q, Gupta I, Lila T, Risueno A, Yen KE, Wu B, Attar EC, Tallman MS, de Botton S. Molecular remission and response patterns in patients with mutant-IDH2 acute myeloid leukemia treated with enasidenib. Blood. 2019 Feb 14;133(7):676-687. doi: 10.1182/blood-2018-08-869008. Epub 2018 Dec 3.

ReferenceCitation: Pollyea DA, Tallman MS, de Botton S, Kantarjian HM, Collins R, Stein AS, Frattini MG, Xu Q, Tosolini A, See WL, MacBeth KJ, Agresta SV, Attar EC, DiNardo CD, Stein EM. Enasidenib, an inhibitor of mutant IDH2 proteins, induces durable remissions in older patients with newly diagnosed acute myeloid leukemia. Leukemia. 2019 Nov;33(11):2575-2584. doi: 10.1038/s41375-019-0472-2. Epub 2019 Apr 9.

ReferenceCitation: Quek L, David MD, Kennedy A, Metzner M, Amatangelo M, Shih A, Stoilova B, Quivoron C, Heiblig M, Willekens C, Saada V, Alsafadi S, Vijayabaskar MS, Peniket A, Bernard OA, Agresta S, Yen K, MacBeth K, Stein E, Vassiliou GS, Levine R, De Botton S, Thakurta A, Penard-Lacronique V, Vyas P. Clonal heterogeneity of acute myeloid leukemia treated with the IDH2 inhibitor enasidenib. Nat Med. 2018 Aug;24(8):1167-1177. doi: 10.1038/s41591-018-0115-6. Epub 2018 Jul 16.

ReferenceCitation: Amatangelo MD, Quek L, Shih A, Stein EM, Roshal M, David MD, Marteyn B, Farnoud NR, de Botton S, Bernard OA, Wu B, Yen KE, Tallman MS, Papaemmanuil E, Penard-Lacronique V, Thakurta A, Vyas P, Levine RL. Enasidenib induces acute myeloid leukemia cell differentiation to promote clinical response. Blood. 2017 Aug 10;130(6):732-741. doi: 10.1182/blood-2017-04-779447. Epub 2017 Jun 6.

ReferenceCitation: Shih AH, Meydan C, Shank K, Garrett-Bakelman FE, Ward PS, Intlekofer AM, Nazir A, Stein EM, Knapp K, Glass J, Travins J, Straley K, Gliser C, Mason CE, Yen K, Thompson CB, Melnick A, Levine RL. Combination Targeted Therapy to Disrupt Aberrant Oncogenic Signaling and Reverse Epigenetic Dysfunction in IDH2- and TET2-Mutant Acute Myeloid Leukemia. Cancer Discov. 2017 May;7(5):494-505. doi: 10.1158/2159-8290.CD-16-1049. Epub 2017 Feb 13.

ReferenceCitation: Stein EM, Fathi AT, DiNardo CD, Pollyea DA, Roboz GJ, Collins R, Sekeres MA, Stone RM, Attar EC, Frattini MG, Tosolini A, Xu Q, See WL, MacBeth KJ, de Botton S, Tallman MS, Kantarjian HM. Enasidenib in patients with mutant IDH2 myelodysplastic syndromes: a phase 1 subgroup analysis of the multicentre, AG221-C-001 trial. Lancet Haematol. 2020 Apr;7(4):e309-e319. doi: 10.1016/S2352-3026(19)30284-4. Epub 2020 Mar 5.

family: Stein

full_name: Eytan M Stein

given: Eytan M

family: Fathi

full_name: Amir T Fathi

given: Amir T

family: DiNardo

full_name: Courtney D DiNardo

given: Courtney D

family: Pollyea

full_name: Daniel A Pollyea

given: Daniel A

family: Roboz

full_name: Gail J Roboz

given: Gail J

family: Collins

full_name: Robert Collins

given: Robert

family: Sekeres

full_name: Mikkael A Sekeres

given: Mikkael A

family: Stone

full_name: Richard M Stone

given: Richard M

family: Attar

full_name: Eyal C Attar

given: Eyal C

family: Frattini

full_name: Mark G Frattini

given: Mark G

family: Tosolini

full_name: Alessandra Tosolini

given: Alessandra

family: Xu

full_name: Qiang Xu

given: Qiang

family: See

full_name: Wendy L See

given: Wendy L

family: MacBeth

full_name: Kyle J MacBeth

given: Kyle J

family: de Botton

full_name: Stéphane de Botton

given: Stéphane

family: Tallman

full_name: Martin S Tallman

given: Martin S

family: Kantarjian

full_name: Hagop M Kantarjian

given: Hagop M

journal_name: The Lancet Haematology

ReferenceCitation: Intlekofer AM, Shih AH, Wang B, Nazir A, Rustenburg AS, Albanese SK, Patel M, Famulare C, Correa FM, Takemoto N, Durani V, Liu H, Taylor J, Farnoud N, Papaemmanuil E, Cross JR, Tallman MS, Arcila ME, Roshal M, Petsko GA, Wu B, Choe S, Konteatis ZD, Biller SA, Chodera JD, Thompson CB, Levine RL, Stein EM. Acquired resistance to IDH inhibition through trans or cis dimer-interface mutations. Nature. 2018 Jul;559(7712):125-129. doi: 10.1038/s41586-018-0251-7. Epub 2018 Jun 27.

family: Intlekofer

full_name: Andrew M. Intlekofer

given: Andrew M.

family: Shih

full_name: Alan H. Shih

given: Alan H.

bso_classification:
Earth, Ecology,
Energy and applied biology

ReferenceCitation: Stein EM. Enasidenib, a targeted inhibitor of mutant IDH2 proteins for treatment of relapsed or refractory acute myeloid leukemia. Future Oncol. 2018 Jan;14(1):23-40. doi: 10.2217/fon-2017-0392. Epub 2017 Sep 18.

name: Leukemia Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, 1275 York Ave, NY 10065, USA

location_facility: Memorial Sloan-Kettering Cancer Center - NYC

location_facility: Cornell University Weill Medical College

location_facility: Oregon Health and Science University OHSU

location_facility: UT Southwestern Medical Center at Dallas

location_facility: Sarah Cannon Research Institute Drug Development Unit

location_facility: University of Miami Sylvester Cancer Center