Spots Global Cancer Trial Database for Study Evaluating Safety and Efficacy of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
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Trial Identification
Brief Title: Study Evaluating Safety and Efficacy of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
Official Title: An Open-Label, Phase 1/2 Study of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (017004)
Study ID: NCT03331198
Study Description
Brief Summary: This is a Phase 1/2, open-label, multicenter study to determine the efficacy and safety of JCAR017 in adult subjects with relapsed or refractory CLL or SLL. The study will include a Phase 1 part to determine the recommended dose of JCAR017 monotherapy in subjects with relapsed or refractory CLL or SLL, followed by a Phase 2 part to further assess the efficacy and safety of JCAR017 monotherapy treatment at the recommended dose. A separate Phase 1 cohort will assess the combination of JCAR017 and concurrent ibrutinib. Another separate Phase 1 cohort will assess the combination of JCAR017 and concurrent venetoclax. In all subjects, the safety, efficacy, and pharmacokinetics (PK) of JCAR017 will be evaluated.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Local Institution - 0006, Birmingham, Alabama, United States
University of Alabama at Birmingham, Birmingham, Alabama, United States
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
Local Institution - 0043, Gilbert, Arizona, United States
Local Institution - 0007, Duarte, California, United States
City of Hope, Duarte, California, United States
Local Institution - 0025, La Jolla, California, United States
UC San Diego Moores Cancer Center, La Jolla, California, United States
Local Institution - 0059, Los Angeles, California, United States
University of California, Los Angeles, Los Angeles, California, United States
Local Institution - 0010, San Francisco, California, United States
University of California, San Francisco, San Francisco, California, United States
Georgetown University Medical Center, Washington, District of Columbia, United States
Local Institution - 0085, Washington, District of Columbia, United States
Local Institution - 0080, Jacksonville, Florida, United States
Mayo Clinic, Jacksonville, Florida, United States
Local Institution - 0019, Atlanta, Georgia, United States
The Blood and Marrow Transplant Group of Georgia (BMTGA), Atlanta, Georgia, United States
Local Institution - 0003, Chicago, Illinois, United States
Northwestern University, Chicago, Illinois, United States
Local Institution - 0016, Chicago, Illinois, United States
University of Chicago Medical Center, Chicago, Illinois, United States
Local Institution - 0005, Boston, Massachusetts, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Local Institution - 0015, Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Local Institution - 0084, Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
Local Institution - 0062, Detroit, Michigan, United States
Local Institution - 0054, Rochester, Minnesota, United States
Mayo Clinic, Rochester, Minnesota, United States
Local Institution - 0008, Omaha, Nebraska, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
Local Institution - 0038, Hackensack, New Jersey, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Local Institution - 0077, New Brunswick, New Jersey, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Local Institution - 0035, New York, New York, United States
Columbia University Medical Center, New York, New York, United States
Local Institution - 0026, New York, New York, United States
Weill Cornell Medical College, New York, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
University Hospitals Seidman Cancer Center (Case Western), Cleveland, Ohio, United States
Local Institution - 0078, Cleveland, Ohio, United States
Local Institution - 0031, Columbus, Ohio, United States
Local Institution - 0082, Oklahoma City, Oklahoma, United States
University of Oklahoma Health Sciences Center (Stephenson Cancer Center), Oklahoma City, Oklahoma, United States
Local Institution - 0098, Eugene, Oregon, United States
Local Institution - 0088, Philadelphia, Pennsylvania, United States
University of Pennsylvania Perelman Center for Advanced Medicine, Philadelphia, Pennsylvania, United States
Local Institution - 0032, Philadelphia, Pennsylvania, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
Local Institution - 0029, Pittsburgh, Pennsylvania, United States
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
Baylor University Medical Center, Dallas, Texas, United States
Local Institution - 0083, Dallas, Texas, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
Local Institution - 0079, Dallas, Texas, United States
Local Institution - 0002, Houston, Texas, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
Local Institution - 0028, Salt Lake City, Utah, United States
Local Institution - 0087, Richmond, Virginia, United States
Virginia Commonwealth University, Richmond, Virginia, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
Local Institution - 0018, Seattle, Washington, United States
Local Institution - 0055, Milwaukee, Wisconsin, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Contact Details
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR
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