Spots Global Cancer Trial Database for A Phase 2 Multicenter Study of Axicabtagene Ciloleucel in Subjects With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma
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Trial Identification
Brief Title: A Phase 2 Multicenter Study of Axicabtagene Ciloleucel in Subjects With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma
Official Title: A Phase 2 Multicenter Study of Axicabtagene Ciloleucel in Subjects With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma (iNHL)
Study ID: NCT03105336
Study Description
Brief Summary: This study will enroll approximately 160 adult participants who have relapsed or refractory (r/r) iNHL to be infused with the study treatment, axicabtagene ciloleucel, to see if their disease responds to this experimental product and if this product is safe. Axicabtagene ciloleucel is made from the participants own white blood cells which are genetically modified and grown to fight cancer. An objective response rate of 70% is targeted.
Detailed Description: All enrolled participants will be screened for eligibility then will undergo leukapheresis to collect white blood cells for manufacturing. In preparation for the infusion with axicabtagene ciloleucel, participants will undergo conditioning chemotherapy with cyclophosphamide and fludarabine for 3 days to help the study treatment be effective. After the product is manufactured and conditioning chemotherapy period is complete, participants will be infused with axicabtagene ciloleucel and then monitored in a hospital for a minimum of 7 days. After completing at least 60 months (FL participants) or at least 24 months (MZL participants) of assessments in this study since the initial axicabtagene ciloleucel infusion and after agreement by the Sponsor, participants will transition to a long-term follow-up (LTFU) study, KT-US-982-5968 where they will complete the remainder of the 15 year follow-up assessments.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
USC Norris Comprehensive Cancer Center, Los Angeles, California, United States
University of California Los Angeles, Los Angeles, California, United States
Georgetown Lombardi Comprehensive Cancer Center, Washington, District of Columbia, United States
University of Miami Hospital and Clinics, Miami, Florida, United States
H Lee Moffitt Cancer Center, Tampa, Florida, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Hackensack University Medical Center - John Theurer Cancer Center, Hackensack, New Jersey, United States
Columbia University Medical Center, New York, New York, United States
University of Rochester Medical Center (URMC), Rochester, New York, United States
Ohio State University Medical Center, Cleveland, Ohio, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
MD Anderson Cancer Center, Houston, Texas, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
Centre Hospitalier Régional Universitaire de Lille, Lille, , France
Centre Hospitalier Lyon Sud, Pierre Benite, , France
Contact Details
Name: Kite Study Director
Affiliation: Kite, A Gilead Company
Role: STUDY_DIRECTOR
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