A Phase 2 Multicenter Study of Axicabtagene Ciloleucel in Subjects With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma (ZUMA-5)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03105336|
Recruitment Status : Recruiting
First Posted : April 7, 2017
Last Update Posted : December 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Follicular Lymphoma Marginal Zone Lymphoma Indolent Non-Hodgkin Lymphoma||Biological: KTE-C19||Phase 2|
This study will enroll approximately 50 adult subjects 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 subjects own white blood cells which are genetically modified and grown to fight cancer. An objective response rate of 70% is targeted.
All enrolled subjects will be screened for eligibility then will undergo leukapheresis to collect white blood cells for manufacturing. In preparation for the infusion with axicabtagene ciloleucel, subjects 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, subjects will be infused with axicabtagene ciloleucel and then monitored in a hospital for a minimum of 7 days. Subjects will be followed by their study doctor for continued monitoring of the safety and effectiveness of the study treatment for approximately 3 months after receiving treatment and then will be followed for safety for up to an additional 3 ½ years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Multicenter Study of Axicabtagene Ciloleucel in Subjects With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma (iNHL)|
|Actual Study Start Date :||May 10, 2017|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||July 2023|
A conditioning chemotherapy regiment of fludarabine and cyclophosphamide will be administered followed by a single infusion of CAR transduced autologous T cells administered intravenously.
Other Name: axicabtagene ciloleucel
- Objective response rate [ Time Frame: 6 months ]Complete response (CR) + partial response (PR) per the revised International Working Group (IWG) Response Criteria for Malignant Lymphoma (Cheson 2007) as determined by the study investigators.
- Progression Free Survival [ Time Frame: 12 months ]The time from the axicabtagene ciloleucel infusion date to the date of disease progression per the revised IWG Response Criteria for Malignant Lymphoma (Cheson 2007) or death from any cause.
- Overall Survival [ Time Frame: 12 months ]Defined as the time from axicabtagene ciloleucel infusion to the date of death.
- Incidences of AEs [ Time Frame: 12 months ]The frequency of any AEs that occurred during study participation.
- Clinical significant changes in lab values. [ Time Frame: 12 months ]The occurrence of any changes in lab values deemed to be clinically significant during study participation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03105336
|Contact: Medical Information||844-454-KITEemail@example.com|
|United States, California|
|USC Norris Comprehensive Cancer Center||Recruiting|
|Los Angeles, California, United States, 90033|
|Contact: Kevin Kelly, MD firstname.lastname@example.org|
|United States, District of Columbia|
|Georgetown Lombardi Comprehensive Cancer Center||Recruiting|
|Washington, District of Columbia, United States, 20057|
|Contact: Chaitra Ujjani, MD email@example.com|
|United States, Florida|
|University of Miami Hospital and Clinics||Recruiting|
|Miami, Florida, United States, 33136|
|Contact: Nathalie Luis 305-243-7648 firstname.lastname@example.org|
|H Lee Moffitt Cancer Center||Recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Matthew Scott email@example.com|
|United States, Massachusetts|
|Dana Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Krystle Benedict 617-582-8713 Krystle_Benedict@dfci.harvard.edu|
|Principal Investigator: Caron Jacobson, MD|
|United States, New York|
|University of Rochester Medical Center (URMC)||Recruiting|
|Rochester, New York, United States, 14642|
|Contact: Frances Batarse 585-275-5825 firstname.lastname@example.org|
|Contact: Carla Casulo, MD|
|United States, Ohio|
|Ohio State University Medical Center||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Nicole Szuminski 614-688-9796 email@example.com|
|United States, Pennsylvania|
|UPMC Hillman Cancer Center||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15213|
|Contact: Linda Fukas firstname.lastname@example.org|
|Principal Investigator: Allison Sehgal, MD|
|United States, Texas|
|MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Liliana Vallejo email@example.com|
|Contact: Sherry Adkins firstname.lastname@example.org|
|Principal Investigator: Sattva Neelapu, MD|
|United States, Washington|
|Fred Hutchinson Cancer Research Center||Recruiting|
|Seattle, Washington, United States, 98109|
|Contact: David Maloney, Dr. 206-667-5616 email@example.com|
|Study Director:||Zachary Roberts, MD, PhD||Kite, A Gilead Company|