Study Details

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.

Participation Requirements

Age

18 Years +

Sex

All

Healthy Volunteers

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

Mayo Clinic Florida

Jacksonville, Florida, United States, 32224

University of Chicago Medical Center

Chicago, Illinois, United States, 60637

Loyola University Medical Center

Maywood, Illinois, United States, 60153

Mayo Clinic

Rochester, Minnesota, United States, 55905

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

Swedish Cancer Institute

Seattle, Washington, United States, 98104

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

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