A Phase 2 Multicenter Study of Axicabtagene Ciloleucel in Subjects With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma (ZUMA-5)
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|ClinicalTrials.gov Identifier: NCT03105336|
Recruitment Status : Active, not recruiting
First Posted : April 7, 2017
Last Update Posted : April 20, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Follicular Lymphoma Marginal Zone Lymphoma Indolent Non-Hodgkin Lymphoma||Biological: axicabtagene ciloleucel Drug: Cyclophosphamide Drug: Fludarabine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||159 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Multicenter Study of Axicabtagene Ciloleucel in Subjects With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma (iNHL)|
|Actual Study Start Date :||June 20, 2017|
|Estimated Primary Completion Date :||September 2036|
|Estimated Study Completion Date :||September 2036|
Experimental: axicabtagene ciloleucel
Participants will receive a conditioning chemotherapy regimen of fludarabine and cyclophosphamide, followed by a single infusion of CAR transduced autologous T cells.
Biological: axicabtagene ciloleucel
A single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered intravenously.
- Objective response rate per central read [ Time Frame: Up to 15 years ]Complete response (CR) + partial response (PR) per the Lugano Classiciation (Cheson et al, 2014).
- CR Rate per central read [ Time Frame: Up to 15 years ]CRR is defined as the incidence of CR as best response to treatment by the Lugano Classification (Cheson et al, 2014)
- DOR [ Time Frame: Up to 15 years ]DOR is defined only for subjects who experience an objective response and is the time from the first objective response to disease progression per (Cheson et al, 2014) or disease-related death, whichever comes first.
- PFS [ Time Frame: Up to 15 years ]PFS is defined as the time from the axicabtagene ciloleucel infusion date to the date of disease progression per (Cheson et al, 2014) or death from any cause.
- Percentage of Participants Experiencing Treatment-Emergent Adverse Events [ Time Frame: Up to 15 years ]
- Overall Survival (OS) [ Time Frame: Up to 15 years ]OS is defined as the time from KTE-C19 infusion to the date of death.
- Levels of anti-CD19 CAR T cells in blood [ Time Frame: At enrollment, Day 7, Week 2, Week 4, Month 3, Month 6, Month 12, Month 18, Month 24, annually up to year 5. ]
- Levels of cytokines in serum [ Time Frame: At enrollment, prior to axicabtagene ciloleucel infusion on Day 0, Day 3, Day 7, Week 2, Week 4 ]
- Percentage of Participants experiencing anti-axicabtagene ciloleucel antibodies [ Time Frame: At enrollment, Week 4, Month 3, every 3 months up to Month 12 ]
- Percentage of Participants Experiencing clinically significant changes in lab values [ Time Frame: Up to 5 years ]
- Time to next Therapy [ Time Frame: Up to 15 years ]Time from axi-cel infusion date to the start of the subsequent new lymphoma therapy or death from any cause.
- Objective response rate among participants with 3 or more lines of prior therapy [ Time Frame: Up to 15 years ]Complete response (CR) + partial response (PR) per the Lugano Classiciation (Cheson et al, 2014) for participants with 3 or more lines of prior therapy.
- Complete response rate among those participants with 3 or more lines of prior therapy [ Time Frame: Up to 15 years ]Complete response rate is defined as the incidence of CR as best response to treatment by the Lugano Classification (Cheson et al, 2014) for participants with 3 or more lines of prior therapy.
- Objective Response Rate as Determined by the Investigator Read [ Time Frame: Up to 15 years ]ORR per investigator read is defined as the incidence of a CR or a PR by the Lugano Classification.
- Best Objective Response per Central Read or Investigator Read [ Time Frame: Up to 15 years ]Best objective response is defined as the incidence of CR, PR, stable disease (SD), PD, or non-evaluable (NE) as best response to treatment by the Lugano Classification
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Key Inclusion Criteria:
- Individual has [follicular lymphoma or marginal zone lymphoma that has progressed after at least 2 lines of treatment with combination chemoimmunotherapy] (e.g. R-bendamustine, R-CHOP).
- Individual has [measurable disease].
- Individual has no known presence or history of central nervous system (CNS) involvement by lymphoma.
- If individual is on conventional systemic therapy or systemic inhibitory/stimulatory immune checkpoint therapy, individual is able to stop conventional therapy 2 weeks or 5 half-lives, whichever is shorter, or immune checkpoint therapy 3 half-lives prior to planned leukapheresis.
- Individual has Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 and adequate renal, hepatic, pulmonary, and cardiac function
- Individual is not pregnant or breastfeeding (female individuals only) and is willing to use birth control from the time of consent through 12 months following chimeric antigen receptor (CAR) T cell infusion (both male and female individuals).
Key Exclusion Criteria:
- Transformed follicular lymphoma (FL) or marginal zone lymphoma (MZL)
- Small lymphocytic lymphoma
- Histological Grade 3b FL
- Individual will have undergone autologous transplant within 6 weeks of planned leukapheresis or has undergone allogeneic transplant.
- Individual has evidence of involvement of the heart by lymphoma or requirement for urgent therapy due to ongoing or impending oncologic emergency (e.g. mass effect, tumor lysis syndrome, etc.)
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03105336
|Study Director:||Kite Study Director||Kite, A Gilead Company|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Kite, A Gilead Company|
|Other Study ID Numbers:||
2017-001912-13 ( EudraCT Number )
|First Posted:||April 7, 2017 Key Record Dates|
|Last Update Posted:||April 20, 2023|
|Last Verified:||April 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Lymphoma, B-Cell, Marginal Zone
Neoplasms by Histologic Type
Immune System Diseases
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological