Spots Global Cancer Trial Database for A Study to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL)
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Trial Identification
Brief Title: A Study to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL)
Official Title: A Phase 2, Open-label, Single Arm, Multicohort, Multicenter Trial to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL)
Study ID: NCT04245839
Conditions
Study Description
Brief Summary: This is a global Phase 2, open-label, single-arm, multicohort, multicenter study to evaluate efficacy and safety of JCAR017 in adult subjects with r/r FL or MZL. The study will be conducted in compliance with the International Council on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements. This study is divided into three periods: * Pretreatment, which consists of screening assessments, leukapheresis and the Pretreatment evaluation; * Treatment, which starts with the administration of lymphodepleting (LD) chemotherapy and continues through JCAR017 administration at Day 1 with follow-up through Day 29; * Posttreatment, which includes follow-up assessments for disease status and safety for 5 years.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Local Institution - 111, Santa Monica, California, United States
Local Institution - 107, Aurora, Colorado, United States
Local Institution - 105, New Haven, Connecticut, United States
Local Institution - 103, Chicago, Illinois, United States
Local Institution - 109, Niles, Illinois, United States
Local Institution - 102, Baltimore, Maryland, United States
Local Institution - 100, Boston, Massachusetts, United States
Local Institution - 101, Boston, Massachusetts, United States
Local Institution - 116, New York, New York, United States
Local Institution - 110, Charlotte, North Carolina, United States
Local Institution - 112, Cleveland, Ohio, United States
Local Institution - 114, Portland, Oregon, United States
Local Institution - 117, Philadelphia, Pennsylvania, United States
Local Institution - 113, Sioux Falls, South Dakota, United States
Local Institution - 104, Houston, Texas, United States
Local Institution - 115, Charlottesville, Virginia, United States
Local Institution - 108, Seattle, Washington, United States
Local Institution - UNK-201, Salzburg, , Austria
Local Institution - 450, Wien, , Austria
Local Institution - 150, Toronto, Ontario, Canada
Local Institution - 151, Montreal, Quebec, Canada
Local Institution - 252, Lille, , France
Local Institution - 251, Montpellier CEDEX 5, , France
Local Institution - 250, Pierre-Benite CEDEX, , France
Local Institution - 501, Köln, , Germany
Local Institution - 502, Munich, , Germany
Local Institution - 500, Ulm, , Germany
Local Institution - 300, Bergamo, , Italy
Local Institution - 301, Naples, , Italy
Local Institution - 553, Sapporo-shi, Hokkaido, Japan
Local Institution - 550, Chuo-ku, Tokyo, Japan
Local Institution - 551, Minato-ku, Tokyo, Japan
Local Institution - 552, Fukuoka, , Japan
Local Institution - 350, Salamanca, , Spain
Local Institution - 351, Sevilla, , Spain
Local Institution - 600, Stockholm, , Sweden
Local Institution - 200, London, , United Kingdom
Local Institution - 201, Manchester, , United Kingdom
Contact Details
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR
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