Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

Summary

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.

Official Title

A Phase 2 Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Either Rituximab or Lenalidomide in Subjects With Refractory Large B-Cell Lymphoma (ZUMA-14)

Keywords

Refractory Large B-cell Lymphoma Lymphoma Lymphoma, B-Cell Cyclophosphamide Rituximab Fludarabine Lenalidomide Axicabtagene Ciloleucel

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 renal, hepatic, pulmonary, and cardiac function
  • Individuals must be able to comply with relevant, equivalent requirements adopted from the REVLIMID Risk Evaluation and Mitigation Strategy (REMS)® (United States) or additional Risk Minimization Measures (aRMMs) as part of the Risk Management Plan (RMP) (European Union)

You CAN'T join if...

  • 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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations

  • UCLA Hematology/Oncology accepting new patients
    Santa Monica California 90404 United States
  • City of Hope National Medical Center accepting new patients
    Duarte California 91010-3012 United States
  • Stanford Cancer Institute accepting new patients
    Palo Alto California 94305 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Gilead Sciences
ID
NCT04002401
Phase
Phase 2
Study Type
Interventional
Last Updated