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A Phase 2 Multicenter Study of Axicabtagene Ciloleucel in Subjects With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma (ZUMA-5)

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ClinicalTrials.gov Identifier: NCT03105336
Recruitment Status : Recruiting
First Posted : April 7, 2017
Last Update Posted : June 29, 2018
Sponsor:
Information provided by (Responsible Party):
Kite, A Gilead Company

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Follicular Lymphoma Marginal Zone Lymphoma Indolent Non-Hodgkin Lymphoma Biological: axicabtagene ciloleucel Phase 2

Detailed Description:

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)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Experimental: axicabtagene ciloleucel Biological: axicabtagene ciloleucel
A conditioning chemotherapy regiment of fludarabine and cyclophosphamide will be administered followed by a single infusion of CAR transduced autologous T cells administered intravenously.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Overall Survival [ Time Frame: 12 months ]
    Defined as the time from axicabtagene ciloleucel infusion to the date of death.

  3. Incidences of AEs [ Time Frame: 12 months ]
    The frequency of any AEs that occurred during study participation.

  4. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1) Subject has [follicular lymphoma that has progressed within 24 months of first diagnosis and treatment with combination chemoimmunotherapy] (e.g. R-bendamustine, R-CHOP) OR Progression of iNHL within 6 months of completion of second or later line therapy containing both an anti-CD20 antibody and alkylating agent OR Progression of iNHL at any point following autologous transplantation.

    2) Subject has [measurable disease].

    3) Subject has no known presence or history of CNS involvement by lymphoma.

    4) If subject is on conventional systemic therapy or systemic inhibitory/stimulatory immune checkpoint therapy, subject is able to stop conventional therapy 2 weeks or 5 half-lives, whichever is shorter, or immune checkpoint therapy 3 half-lives prior to planned leukapheresis.

    5) Subject has ECOG performance status of 0-1 and adequate renal, hepatic, pulmonary, and cardiac function

    6) Subject is not pregnant or breastfeeding (female subjects only) and is willing to use birth control from the time of consent through 6 months following CAR T cell infusion (both male and female subjects).B24

Exclusion Criteria:

  • 1) Transformed FL

    2) Small lymphocytic lymphoma

    3) Histological Grade 3b FL

    4) Subject will have undergone autologous transplant within 6 weeks of planned leukapheresis or has undergone allogeneic transplant.

    5) Subject has evidence of involvement of the heart by lymphoma or requirement for urgent therapy due to ongoing or impending oncologic emergency (e.g. mass effect, tumor lysis syndrome, etc.)


Information from the National Library of Medicine

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


Contacts
Contact: Medical Information 844-454-KITE medinfo@kitepharma.com

Locations
United States, Arizona
Banner MD Anderson Cancer Center Recruiting
Gilbert, Arizona, United States, 85234
Contact: Andrea Winkle    480-256-3421    andrea.winkle@bannerhealth.com   
Principal Investigator: Javier Munos, MD         
United States, California
USC Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Kevin Kelly, MD       kevin.kelly@med.usc.edu   
University of California Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Sven de Vos, MD, PhD       devos@mednet.ucla.edu   
United States, District of Columbia
Georgetown Lombardi Comprehensive Cancer Center Recruiting
Washington, District of Columbia, United States, 20057
Contact: Pashna Munshi, MD       pashna.n.munshi@gunet.georgetown.edu   
United States, Florida
University of Miami Hospital and Clinics Recruiting
Miami, Florida, United States, 33136
Contact: Nathalie Luis    305-243-7648    nluis@med.miami.edu   
H Lee Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Matthew Scott       matthew.scott@moffitt.org   
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    frances_batarse@urmc.rochester.edu   
Contact: Carla Casulo, MD         
United States, Ohio
Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Nicole Szuminski    614-688-9796    nicole.szuminski@osumc.edu   
United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111-2497
Contact: Richard Matthew    215-214-3125    richard.mathew@fccc.edu   
Principal Investigator: Henry Fung, MD         
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Linda Fukas       fukaslj@upmc.edu   
Contact: Bridget Sweterlistch       sweterlitschbm@upmc.edu   
Principal Investigator: Kathleen Dorritie, MD         
UPMC Hillman Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Linda Fukas       fukaslj@upmc.edu   
Principal Investigator: Allison Sehgal, MD         
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Brittany Howell    615-341-7859    brittany.howell@scresearch.net   
Principal Investigator: Ian Flinn, MD, PhD         
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Liliana Vallejo       lnvallejo@mdanderson.org   
Contact: Sherry Adkins       sadkins@mdanderson.org   
Principal Investigator: Sattva Neelapu, MD         
United States, Washington
Fred Hutchinson Cancer Research Center Recruiting
Seattle, Washington, United States, 98109
Contact: Immunotherapy Trials Intake    206-606-4668    immunotherapy@seattlecca.org   
Sponsors and Collaborators
Kite, A Gilead Company
Investigators
Study Director: Wayne Godfrey, MD, MS Kite, A Gilead Company

Responsible Party: Kite, A Gilead Company
ClinicalTrials.gov Identifier: NCT03105336     History of Changes
Other Study ID Numbers: KTE-C19-105
First Posted: April 7, 2017    Key Record Dates
Last Update Posted: June 29, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell, Marginal Zone
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell