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Brief Title: A Study to Determine Safety, Feasibility and Efficacy of JCAR015 in Adult Subjects With B-Cell Acute Lymphoblastic Leukemia
Official Title: A Phase 2, Open-label, Multiple Cohort, Single-arm, Multi-center Trial to Determine the Safety, Feasibility and Efficacy of JCAR015 in Adult Subjects With B-cell Acute Lymphoblastic Leukemia.
Study ID: NCT02973191
Brief Summary: This is a single-arm, multi-center, open-label, Phase 2 study to determine the efficacy and safety of JCAR015 in adult subjects with B-cell ALL. The study is divided into two sequential parts, Part A and Part B; subjects will be screened and will provide informed consent before initiating any study procedures in Part A of the study.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Universitair Ziekenhuis Gent, Gent, , Belgium
University de Lille, Lille, , France
Hopital Saint Louis, Paris, , France
Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden, Dresden, , Germany
Universitatsklinikum Frankfurt, Frankfurt, , Germany
University of Munich Grosshadern, Grosshadern Campus, , Germany
University of Cologne, Köln, , Germany
University of Leipzig, Leipzig, , Germany
Universitaetsklinikum Ulm, Ulm, , Germany
USC Ematologia, Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, , Italy
Istituto Clinico Humanitas - Istituti di Ricovero E Cura A Carattere Scientifico (IRCSS), Milan, , Italy
Universita La Sapienza, Roma, , Italy
Azienda Ospedaliera Citta della Salute e della Scienza di Torino, Torino, , Italy
ICO-Hospital Germans Trias i Pujol, Barcelona, , Spain
Hospital Universitario de Salamanca, Salamanca, , Spain
Chuv Bh-04, Lausanne, , Switzerland
Bristol Royal Infirmary, University of Bristol Foundation Trust, Bristol, , United Kingdom
UCL Cancer Institute, London, , United Kingdom
Name: Jens Hasskarl, MD
Affiliation: Celgene Corporation
Role: STUDY_DIRECTOR