LAST UPDATED
February 20, 2024
Clinicaltrials.gov ID
EudraCT ID
OVERVIEW
A Phase 2 Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Rituximab in Participants With Refractory Large B-Cell Lymphoma (ZUMA-14) (ZUMA-14)
PROTOCOL SUMMARY
The primary objective of this study is to estimate the efficacy of axicabtagene ciloleucel in combination with rituximab, as measured by assessment of response rates in adult participants with relapsed/refractory large B-cell lymphoma.
View moreParticipation requirements
Age
18 years +
Sex
All
Healthy Volunteers
No
Age
18 years +
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
Refractory Large B-cell Lymphoma
Gender
N/A
Date
November 2019 - January 2023
Study Type
Interventional
Study Phase
Phase 2
Product
Axicabtagene Ciloleucel, Rituximab, Fludarabine, Cyclophosphamide
Eligibility information
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 renal, hepatic, pulmonary, and cardiac function
Exclusion criteria
- Known CD19 negative or CD20 negative tumor
- History of Richter's transformation of Chronic Lymphocytic Leukemia (CLL)
- 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 6 months
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Locations
Locations (14)
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
City of Hope National Medical Center
Duarte, California, United States, 91010-3012
Stanford Cancer Institute
Palo Alto, California, United States, 94305
UCLA Hematology/Oncology
Santa Monica, California, United States, 90404
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Loyola University Medical Center
Maywood, Illinois, United States, 60153
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Columbia University Medical Center, New York Presbyterian Hospital
New York, New York, United States, 10032
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
St. David's South Austin Medical Center
Austin, Texas, United States, 78704
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
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