Description:
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.
Title
- Brief Title: Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Rituximab in Participants With Refractory Large B-Cell Lymphoma
- Official Title: 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)
Clinical Trial IDs
- ORG STUDY ID:
KT-US-471-0114
- SECONDARY ID:
2019-004803-11
- NCT ID:
NCT04002401
Conditions
- Refractory Large B-cell Lymphoma
Interventions
Drug | Synonyms | Arms |
---|
Axicabtagene Ciloleucel | Yescarta® | Axicabtagene Ciloleucel and Rituximab Combination |
Rituximab | RITUXAN® | Axicabtagene Ciloleucel and Rituximab Combination |
Fludarabine | | Axicabtagene Ciloleucel and Rituximab Combination |
Cyclophosphamide | | Axicabtagene Ciloleucel and Rituximab Combination |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Axicabtagene Ciloleucel and Rituximab Combination | Experimental | Participants will receive rituximab, and fludarabine and cyclophosphamide conditioning chemotherapy, followed by axicabtagene ciloleucel and additional rituximab. | - Axicabtagene Ciloleucel
- Rituximab
- Fludarabine
- Cyclophosphamide
|
Eligibility 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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Complete Response (CR) Rate |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | CR rate is defined as the incidence of a CR per the Lugano Classification as determined by study investigators. |
Secondary Outcome Measures
Measure: | Percentage of Participants Experiencing Adverse Events and Clinically Significant Changes in Safety Lab Values |
Time Frame: | Up to 15 years |
Safety Issue: | |
Description: | |
Measure: | Objective Response Rate (ORR) |
Time Frame: | Time Frame: Up to 2 years |
Safety Issue: | |
Description: | ORR is defined as the incidence of either a CR or a partial response (PR) per the Lugano Classification as determined by study investigators. |
Measure: | Duration of Response (DOR) |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | DOR is defined only for participants who experience an objective response and is the time from the first objective response to disease progression per the Lugano Classification as determined by study investigators or death from any cause. |
Measure: | Progression-Free Survival (PFS) |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | PFS is defined as the time from the axicabtagene ciloleucel infusion date to the date of disease progression per Lugano Classification as determined by study investigators or death from any cause. |
Measure: | Overall Survival (OS) |
Time Frame: | Up to 15 years |
Safety Issue: | |
Description: | OS is defined as the time from axicabtagene ciloleucel infusion to the date of death. |
Measure: | Levels of Axicabtagene Ciloleucel in Blood |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Gilead Sciences |
Last Updated
August 23, 2021