Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Rituximab in Participants With Refractory Large B-Cell Lymphoma
- Interventional
- Not Recruiting
- NCT04002401
Contact Information
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.
Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers?
No
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.
- 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.