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

• Status: Active, not recruiting
• Trial end date: 2036-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Cyclophosphamide; Fludarabine; Fludarabine phosphate; Lenalidomide; Rituximab

Criteria

Key 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

Key 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.