Study Details

PROTOCOL 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.

Participation Requirements

Age

18 Years +

Sex

ALL

Healthy Volunteers

Medical Condition

Follicular Lymphoma, Marginal Zone Lymphoma, Indolent Non-Hodgkin Lymphoma

Gender

N/A

Date

June 2017 - December 2024

Study Type

INTERVENTIONAL

Study Phase

PHASE2

Product

axicabtagene ciloleucel, Cyclophosphamide, Fludarabine

Eligibility Information

Inclusion Criteria

1. Individual has [follicular lymphoma or marginal zone lymphoma that has progressed after at least 2 lines of treatment with combination chemoimmunotherapy] (e.g. R-bendamustine, R-CHOP).
2. Individual has [measurable disease].
3. Individual has no known presence or history of central nervous system (CNS) involvement by lymphoma.
4. If individual is on conventional systemic therapy or systemic inhibitory/stimulatory immune checkpoint therapy, individual 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. Individual has Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 and adequate renal, hepatic, pulmonary, and cardiac function
6. Individual is not pregnant or breastfeeding (female individuals only) and is willing to use birth control from the time of consent through 12 months following chimeric antigen receptor (CAR) T cell infusion (both male and female individuals).

Exclusion Criteria

1. Transformed follicular lymphoma (FL) or marginal zone lymphoma (MZL)
2. Small lymphocytic lymphoma
3. Histological Grade 3b FL
4. Individual will have undergone autologous transplant within 6 weeks of planned leukapheresis or has undergone allogeneic transplant.
5. Individual 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.)
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations

Locations (19)

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States, 85234

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States, 90033

University of California Los Angeles

Los Angeles, California, United States, 90095

Georgetown Lombardi Comprehensive Cancer Center

Washington, District of Columbia, United States, 20007

University of Miami Hospital and Clinics

Miami, Florida, United States, 33136

H Lee Moffitt Cancer Center

Tampa, Florida, United States, 33612

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Hackensack University Medical Center - John Theurer Cancer Center

Hackensack, New Jersey, United States, 07601

Columbia University Medical Center

New York, New York, United States, 10032

University of Rochester Medical Center (URMC)

Rochester, New York, United States, 14642

Ohio State University Medical Center

Cleveland, Ohio, United States, 44106

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States, 19111

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States, 15232

Sarah Cannon Research Institute

Nashville, Tennessee, United States, 37203

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States, 98109

Centre Hospitalier Régional Universitaire de Lille

Lille, France, 59037

Centre Hospitalier Lyon Sud

Pierre Benite, France, 69495

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

OVERVIEW