Spots Global Cancer Trial Database for A Study to Compare the Efficacy and Safety of JCAR017 to Standard of Care in Adult Subjects With High-risk, Transplant-eligible Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphomas
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Trial Identification
Brief Title: A Study to Compare the Efficacy and Safety of JCAR017 to Standard of Care in Adult Subjects With High-risk, Transplant-eligible Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphomas
Official Title: A Global Randomized Multicenter Phase 3 Trial of JCAR017 Compared to Standard of Care in Adult Subjects With High-risk, Second-line, Transplant-eligible Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphomas (TRANSFORM).
Study ID: NCT03575351
Conditions
Study Description
Brief Summary: The study will be conducted in compliance with the International Council for Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements. This is a randomized, open-label, parallel-group, multi-center trial in adult subjects with Relapsed or refractory (R/R) aggressive Non-Hodgkin lymphoma (NHL) to compare safety and efficacy between the standard of care (SOC) strategy versus JCAR017 (also known as lisocabtagene maraleucel or liso-cel). Subjects will be randomized to either receive SOC (Arm A) or to receive JCAR017 (Arm B). All subjects randomized to Arm A will receive Standard of care (SOC) salvage therapy (R-DHAP, RICE or R-GDP) as per physician's choice before proceeding to High dose chemotherapy (HDCT) and Hematopoietic stem cell transplant (HSCT). Subjects from Arm A may be allowed to cross over and receive JCAR017 upon confirmation of an EFS event. Subjects randomized to Arm B will receive Lymphodepleting (LD) chemotherapy followed by JCAR017 infusion.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Local Institution - 129, Scottsdale, Arizona, United States
Local Institution - 116, Scottsdale, Arizona, United States
Local Institution - 115, San Francisco, California, United States
Local Institution - 106, Aurora, Colorado, United States
Mayo Clinic - Jacksonville, Jacksonville, Florida, United States
Local Institution - 126, Tampa, Florida, United States
Local Institution - 108, Atlanta, Georgia, United States
Local Institution - 107, Atlanta, Georgia, United States
Local Institution - 122, Chicago, Illinois, United States
Loyola University Medical Center Cardinal Bernardin Cancer Center, Maywood, Illinois, United States
Local Institution - 102, Boston, Massachusetts, United States
Local Institution - 104, Boston, Massachusetts, United States
Local Institution - 120, Ann Arbor, Michigan, United States
Local Institution - 119, Detroit, Michigan, United States
Local Institution - 112, Minneapolis, Minnesota, United States
Local Institution - 103, Rochester, Minnesota, United States
Local Institution - 100, Omaha, Nebraska, United States
Local Institution - 121, Hackensack, New Jersey, United States
Local Institution - 111, Buffalo, New York, United States
Local Institution - 117, New York, New York, United States
Local Institution - 125, Charlotte, North Carolina, United States
Local Institution - 127, Oklahoma City, Oklahoma, United States
Local Institution - 101, Portland, Oregon, United States
Local Institution - 123, Pittsburgh, Pennsylvania, United States
Local Institution - 109, Dallas, Texas, United States
Local Institution - 124, Houston, Texas, United States
Local Institution - 114, Richmond, Virginia, United States
Local Institution - 110, Seattle, Washington, United States
Local Institution - 350, Gent, , Belgium
Local Institution - UNK 25, Helsinki, , Finland
Local Institution - 401, Lille, , France
Local Institution - 400, Marseille cedex, , France
Local Institution - 403, Pierre Benite, , France
Local Institution - 402, Villejuif CEDEX, , France
Local Institution - 455, Dresden, Saxony, Germany
Local Institution - 451, Berlin, , Germany
Local Institution - 452, Hamburg, , Germany
Local Institution - 450, Köln, , Germany
Local Institution - 454, Muenster, , Germany
Local Institution - 453, München, , Germany
Local Institution - 500, Rome, , Italy
Local Institution - 501, Rozzano (MI), , Italy
Local Institution - 502, Torino, , Italy
Local Institution - 203, Osaka, Osaka-shi, Japan
Local Institution - 200, Chuo-ku, Tokyo, Japan
Local Institution - 201, Minato-ku, Tokyo, Japan
Local Institution - 202, Bunkyo-ku, , Japan
Local Institution - 550, Rotterdam, , Netherlands
Local Institution - 600, Barcelona, , Spain
Local Institution - 601, Madrid, , Spain
Local Institution - 650, Stockholm, , Sweden
Local Institution - 700, Bern, , Switzerland
Local Institution - 751, Southampton, Hampshire, United Kingdom
Local Institution - 750, London, , United Kingdom
Contact Details
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR
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