NCT04002401
Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Rituximab in Participants With Refractory Large B-Cell Lymphoma
PHASE2
COMPLETED
NCT04002401
INTERVENTIONAL
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)
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.
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.
Refractory Large B-cell Lymphoma
- TREATMENT
-
- Type: BIOLOGICAL
- Name: Axicabtagene Ciloleucel
- Description: A single infusion of CAR-transduced autologous T cells administered intravenously
- Arm Group Labels: Axicabtagene Ciloleucel and Rituximab Combination
-
- Type: DRUG
- Name: Rituximab
- Description: Administered intravenously
- Arm Group Labels: Axicabtagene Ciloleucel and Rituximab Combination
-
- Type: DRUG
- Name: Fludarabine
- Description: Administered according to package insert
- Arm Group Labels: Axicabtagene Ciloleucel and Rituximab Combination
-
- Type: DRUG
- Name: Cyclophosphamide
- Description: Administered according to package insert
- Arm Group Labels: Axicabtagene Ciloleucel and Rituximab Combination
- Kite, A Gilead Company