Study of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Follicular Lymphoma (ZUMA-22)
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| ClinicalTrials.gov Identifier: NCT05371093 |
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Recruitment Status :
Recruiting
First Posted : May 12, 2022
Last Update Posted : April 30, 2024
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Sponsor:
Kite, A Gilead Company
Information provided by (Responsible Party):
Gilead Sciences ( Kite, A Gilead Company )
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Brief Summary:
The goal of this clinical study is test how well the study drug, axicabtagene ciloleucel, works in participants with relapsed/refractory follicular lymphoma
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Relapsed/Refractory Follicular Lymphoma | Biological: Axicabtagene Ciloleucel Drug: Cyclophosphamide Drug: Fludarabine Drug: Lenalidomide Drug: Rituximab Drug: Doxorubicin Drug: Vincristine Drug: Prednisone Drug: Bendamustine | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 230 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 3 Randomized, Open-Label, Multicenter Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Follicular Lymphoma |
| Actual Study Start Date : | September 12, 2022 |
| Estimated Primary Completion Date : | October 2030 |
| Estimated Study Completion Date : | October 2030 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Lymphoma
Drug Information
available for:
Axicabtagene ciloleucel
| Arm | Intervention/treatment |
|---|---|
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Experimental: Axicabtagene Ciloleucel
Participants will receive cyclophosphamide 500 mg/m^2/day intravenously (IV) and fludarabine 30 mg/m^2/day IV lymphodepleting chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10^6 anti-cluster of differentiation (CD)19 chimeric antigen receptor (CAR) transduced autologous T cells/kg on Day 0. For participants weighing ≥ 100 kg, a maximum flat dose of axicabtagene ciloleucel at 2 x 10^8 anti-CD19 CAR T cells will be administered.
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Biological: Axicabtagene Ciloleucel
A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells
Other Names:
Drug: Cyclophosphamide Administered intravenously Drug: Fludarabine Administered intravenously |
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Active Comparator: Standard of Care Therapy
Participants will receive the investigator's choice of one of the following therapies/dosing schedules:
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Drug: Cyclophosphamide
Administered intravenously Drug: Lenalidomide Administered orally Drug: Rituximab Administered intravenously Drug: Doxorubicin Administered intravenously Drug: Vincristine Administered intravenously Drug: Prednisone Administered orally Drug: Bendamustine Administered intravenously |
Primary Outcome Measures :
- Progression-free Survival (PFS) as Assessed by Blinded Central Assessment per Lugano Classification [ Time Frame: Up to 5 years ]PFS is defined as the time from randomization to disease progression or death due to any cause.
Secondary Outcome Measures :
- Overall Survival (OS) [ Time Frame: Up to 5 years ]OS is defined as the time from randomization to death from any cause.
- Complete Response (CR) Rate as Assessed by Blinded Central Assessment per Lugano Classification [ Time Frame: Up to 5 years ]CR rate is defined as the proportion of participants with best overall response of CR during the study prior to any subsequent off-protocol anti-follicular lymphoma (FL) therapy.
- Objective Response Rate (ORR) as Assessed by Blinded Central Assessment per Lugano Classification [ Time Frame: Up to 5 years ]Objective response rate is defined as the proportion of participants with best overall response of either a complete response or a partial response during the study prior to any subsequent off-protocol anti-FL therapy.
- Duration of Response (DOR) as Assessed by Blinded Central Assessment per Lugano Classification [ Time Frame: Up to 5 years ]DOR is defined as the time from first objective response to disease progression or death from any cause.
- Duration of CR as Assessed by Blinded Central Assessment per Lugano Classification [ Time Frame: Up to 5 years ]Duration of CR is defined as the time from first CR to disease progression or death from any cause.
- Event Free Survival (EFS) as Assessed by Blinded Central Assessment per Lugano Classification [ Time Frame: Up to 5 years ]EFS is defined as the time from randomization to the earliest date of disease progression, the initiation of subsequent off-protocol anti-FL therapy, or death from any cause.
- Time to Next Treatment (TTNT) [ Time Frame: Up to 5 years ]TTNT is defined as the time from randomization to the start of subsequent off-protocol anti-lymphoma therapy or death from any cause.
- Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Randomization up to 5 years plus 30 days ]
- Percentage of Participants Experiencing Clinically Significant Changes in Safety Laboratory Values [ Time Frame: Randomization up to 5 years plus 30 days ]
- Percentage of Participants with Replication-competent Retrovirus in Blood Over time [ Time Frame: Up to 5 years ]
- Change From Baseline in the Global Health Status Quality of Life Scale of the European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire-30 (EORTC QLQ-C30) [ Time Frame: Baseline, up to 5 years ]The EORTC-QLQ-C30 is a multi-item questionnaire measuring the following content five (5) multi-item functional scales, three (3) multi-item symptom scales, one (1) global health status scale, and one (1) global health-related quality of life (HRQoL) each scale is measured from 0 to 100 after a linear transformation. Higher scores for functioning scales and for the Global Health Status or Global HRQoL scales indicate a higher level of functioning and a better HRQoL respectively, whereas higher scores in symptom scales represent a higher level of symptoms.
- Change From Baseline in the Physical Functioning Domain of the EORTC QLQ-C30 [ Time Frame: Baseline, up to 5 years ]The EORTC-QLQ-C30) is a multi-item questionnaire measuring the following content five (5) multi-item functional scales, three (3) multi-item symptom scales, one (1) global health status scale, and one (1) global health-related quality of life (HRQoL) each scale is measured from 0 to 100 after a linear transformation. Higher scores for functioning scales and for the Global Health Status or Global HRQoL scales indicate a higher level of functioning and a better HRQoL respectively, whereas higher scores in symptom scales represent a higher level of symptoms.
- Change From Baseline in the Global Health Status Quality of Life Scale of the Low Grade Non-Hodgkin Lymphoma-20 (NHL-LG20) [ Time Frame: Baseline, up to 5 years ]The NHL-LG20 is is a 20-item supplement questionnaire that was specifically developed to assess HRQoL in participants with low-grade non-Hodgkin lymphomas (such as follicular lymphoma). The NHL-LG20 includes multi-item scales of symptom burden, physical condition/fatigue, worries/fears on health and functioning, and emotional impact; and is administered in conjunction with the EORTC QLQ-C30. Each scale is measured from 0 to 100 after a linear transformation. Higher scores for functional scales and for the global health status or global HRQoL scales indicate a higher level of functioning and a better HRQoL, whereas higher scores in symptom scales represent a higher level of symptoms.
- Change From Baseline in the Physical Functioning Domain of the NHL-LG20 [ Time Frame: Baseline, up to 5 years ]The NHL-LG20 is is a 20-item supplement questionnaire that was specifically developed to assess HRQoL in participants with low-grade non-Hodgkin lymphomas (such as follicular lymphoma). The NHL-LG20 includes multi-item scales of symptom burden, physical condition/fatigue, worries/fears on health and functioning, and emotional impact; and is administered in conjunction with the EORTC QLQ-C30. Each scale is measured from 0 to 100 after a linear transformation. Higher scores for functional scales and for the global health status or global HRQoL scales indicate a higher level of functioning and a better HRQoL, whereas higher scores in symptom scales represent a higher level of symptoms.
- Changes From Baseline in the European Quality of Life Five Dimensions Five Levels Scale (EQ-5D-5L) [ Time Frame: Baseline, up to 5 years ]The EQ-5D-5L questionnaire is a generic measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D-5L comprises 2 components: a questionnaire covering 5 dimensions and a tariff of values based upon direct valuations of health states using a visual analog scale (VAS). Rating gets recorded on a vertical VAS in which the endpoints are labeled best imaginable health state is 100 (on the top) and worst imaginable health state is 0 (on the bottom). Higher scores of EQ VAS indicate better health.
- Changes From Baseline in the Visual Analog Scale (VAS) Scores [ Time Frame: Baseline, up to 5 years ]The EQ-5D-5L VAS is a 20-cm VAS for recording self-rated current HRQoL state and is used to describe the participants health status on the day of the assessment. The EQ-5D-5L VAS score is recorded by each participant for his or her current HRQoL state and scored 0 ("the worst health you can imagine") to 100 ("the best health you can imagine"). Higher scores indicate better health.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria:
- Histologically-confirmed follicular lymphoma (FL) (Grade 1, 2, or 3a)
- Relapsed/refractory (R/r) disease after first-line chemoimmunotherapy and high-risk disease with relapse or progression within 24 months of the initial course of chemoimmunotherapy (ie, POD24), Or r/r disease after ≥ 2 prior systemic lines of therapy
- Clinical indication for treatment.
- At least 1 measurable lesion per the Lugano Classification {Cheson 2014}
- Adequate renal, hepatic, pulmonary, and cardiac function
Key Exclusion Criteria:
- Presence of large B cell lymphoma or transformed FL
- Small lymphocytic lymphoma
- Lymphoplasmacytic lymphoma
- Full-thickness involvement of the gastric wall by lymphoma
- FL Grade 3b
- Prior CD19-targeted therapy
- Prior CAR therapy or other genetically modified T-cell therapy
- Uncontrolled fungal, bacterial, viral, or other infection
- Active Infection with human immunodeficiency virus, hepatitis B virus or hepatitis C virus
- History or presence of a clincially significant central nervous system (CNS) disorder.
- History of autoimmune disease
- Known history or CNS lymphoma involvement
- Cardiac lymphoma involvement
- History of clinically significant cardiac disease 6 months before randomization
- Neuropathy greater than grade 2
- Females who are pregnant or breastfeeding
- Individuals of both genders who are not willing to practice birth control
- Presence of any indwelling line or drain (eg, percutaneous nephrostomy tube, indwelling Foley catheter, biliary drain, G/J-tube, pleural/peritoneal/pericardial catheter, or Ommaya reservoirs). Dedicated central venous access catheters such as Port-a-Cath or Hickman catheter are permitted.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Information from the National Library of Medicine
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): NCT05371093
Contacts
| Contact: Medical Information | 844-454-5483(1-844-454-KITE) | medinfo@kitepharma.com |
Locations
Show 69 study locations
Sponsors and Collaborators
Kite, A Gilead Company
Investigators
| Study Director: | Kite Study Director | Kite, A Gilead Company |
Additional Information:
| Responsible Party: | Kite, A Gilead Company |
| ClinicalTrials.gov Identifier: | NCT05371093 |
| Other Study ID Numbers: |
KT-US-473-0133 2021-003260-28 ( Other Identifier: European Medicines Agency ) |
| First Posted: | May 12, 2022 Key Record Dates |
| Last Update Posted: | April 30, 2024 |
| Last Verified: | April 2024 |
| 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 |
Additional relevant MeSH terms:
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Lymphoma Lymphoma, Follicular Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Prednisone Cyclophosphamide Bendamustine Hydrochloride Rituximab Doxorubicin Fludarabine |
Vincristine Lenalidomide Axicabtagene ciloleucel Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antineoplastic Agents, Immunological Antibiotics, Antineoplastic Topoisomerase II Inhibitors |