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Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Either Rituximab or Lenalidomide in Participants With Refractory Large B-Cell Lymphoma (ZUMA-14)

Trial Status: Active

The primary objective of this study is to estimate the efficacy of axicabtagene ciloleucel in combination with either rituximab or lenalidomide, as measured by assessment of response rates in adult participants with relapsed / refractory large B-cell lymphoma.

Inclusion Criteria

  • Histologically confirmed large B-cell lymphoma
  • Chemotherapy-refractory disease, defined as one or more of the following:
  • No response to first-line therapy (primary refractory disease)
  • No response to second or greater lines of therapy OR
  • Refractory after autologous stem cell transplant (ASCT)
  • At least 1 measureable lesion according to the Lugano Classification (Cheson 2014).
  • Individuals must have received adequate prior therapy, including at a minimum:
  • Anti-CD20 monoclonal antibody
  • An anthracycline-containing chemotherapy regimen
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate bone marrow, renal, hepatic, pulmonary, and cardiac function
  • Individuals must be able to comply with the requirements of REVLIMID Risk Evaluation and Mitigation Strategy (REMS)®

Exclusion Criteria

  • Known CD19 negative or CD20 negative tumor
  • History of Richter's transformation of Chronic Lymphocytic Leukemia (CLL)
  • Prior lenalidomide or other immunomodulatory imide drug (IMiD) treatment
  • Prior CAR therapy or other genetically modified T-cell therapy
  • Prior organ transplantation including prior allogeneic stem cell transplant (SCT)
  • Prior CD19 targeted therapy
  • Clinically significant infection or cardiopulmonary disease
  • Presence of any in-dwelling lines or drains (dedicated central venous access catheters allowed)
  • History or presence of central nervous system (CNS) lymphoma or nonmalignant CNS disorder or cerebrospinal fluid (CSF) malignant cells or brain metastases
  • History of autoimmune disease
  • History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the last year

California

Duarte
City of Hope Comprehensive Cancer Center
Status: ACTIVE

New Jersey

Hackensack
Hackensack University Medical Center
Status: ACTIVE

New York

New York
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: ACTIVE

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL

Texas

Houston
M D Anderson Cancer Center
Status: ACTIVE
Contact: Sattva S. Neelapu
Phone: 713-563-2347

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: IN_REVIEW

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Gilead

  • Primary ID KT-US-471-0114
  • Secondary IDs NCI-2019-04827
  • Clinicaltrials.gov ID NCT04002401