A Study to Compare the Efficacy and Safety of Lisocabtagene Maraleucel vs Investigator's Choice Options in Adult Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, Whose Disease Has Failed Treatment With Both BTKi and BCL2i Therapies
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| ClinicalTrials.gov Identifier: NCT06205290 |
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Recruitment Status :
Withdrawn
(Business objectives have changed.)
First Posted : January 16, 2024
Last Update Posted : April 2, 2024
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Sponsor:
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
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Brief Summary:
The purpose of this study is to compare the efficacy and safety of liso-cel vs Investigator's Choice options (idelalisib + rituximab or bendamustine + rituximab) in adult participants with R/R CLL or SLL, whose disease has failed treatment with both BTKi and BCL2i targeted therapies.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Leukemia, Lymphocytic, Chronic, B-Cell | Biological: Liso-cel Drug: Idelalisib Drug: Rituximab Drug: Bendamustine Drug: Fludarabine Drug: Cyclophosphamide | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 0 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Global Phase 3, Randomized, Open-label, Multi-center Trial Designed to Compare the Efficacy and Safety of Lisocabtagene Maraleucel vs Investigator's Choice Options (Idelalisib + Rituximab or Bendamustine + Rituximab) in Adult Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL), Whose Disease Has Failed Treatment With Both BTKi and BCL2i Targeted Therapies (A Double Class Exposed Population) |
| Estimated Study Start Date : | January 16, 2024 |
| Estimated Primary Completion Date : | October 13, 2031 |
| Estimated Study Completion Date : | October 13, 2031 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
| Experimental: Arm A: Liso-cel Monotherapy |
Biological: Liso-cel
Specified dose on specified days
Other Names:
Drug: Fludarabine Specified dose on specified days
Other Names:
Drug: Cyclophosphamide Specified dose on specified days
Other Names:
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| Active Comparator: Arm B: Investigator's Choice |
Drug: Idelalisib
Specified dose on specified days
Other Name: Zydelig® Drug: Rituximab Specified dose on specified days
Other Names:
Drug: Bendamustine Specified dose on specified days
Other Names:
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Primary Outcome Measures :
- Progression Free Survival (PFS) per independent review committee (IRC) assessment [ Time Frame: Up to 5 years from the last participant randomized ]
Secondary Outcome Measures :
- Overall Survival (OS) [ Time Frame: Up to 5 years from the last participant randomized ]
- Complete Response Rate (CRR) per IRC assessment [ Time Frame: Up to 5 years from the last participant randomized ]
- CRR per investigators' assessment [ Time Frame: Up to 5 years from the last participant randomized ]
- Complete response with incomplete bone marrow recovery (CRi) [ Time Frame: Up to 5 years from the last participant randomized ]
- Minimal residual disease (MRD)-negativity rate [ Time Frame: Up to 5 years from the last participant randomized ]
- Overall Response Rate (ORR) per IRC assessment [ Time Frame: Up to 5 years from the last participant randomized ]
- ORR per investigators' assessment [ Time Frame: Up to 5 years from the last participant randomized ]
- Duration of Response (DOR) per IRC assessment [ Time Frame: Up to 5 years from the last participant randomized ]
- Duration of Complete Response (DOCR) per IRC assessment [ Time Frame: Up to 5 years from the last participant randomized ]
- PFS per investigators' assessment [ Time Frame: Up to 5 years from the last participant randomized ]
- Progression post next line of treatment (PFS-2) [ Time Frame: Up to 5 years from the last participant randomized ]
- Number of participants with Adverse Events (AEs) [ Time Frame: Up to 5 years from the last participant randomized ]
- Number of participants with Adverse Events of Special Interest (AESIs) [ Time Frame: Up to 5 years from the last participant randomized ]
- Number of participants with laboratory abnormalities [ Time Frame: Up to 5 years from the last participant randomized ]
- Time from randomization to first confirmed clinically meaningful improvement from baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 questionnaire (EORTC QLQ-C30) [ Time Frame: Up to 5 years from the last participant randomized ]
The following domains on the EORTC QLQ-C30 will be assessed:
- Fatigue
- Physical functioning
- Role functioning
- Cognitive functioning
- Global health status/quality of life (GHS/QoL)
- Time from randomization to first confirmed clinically meaningful improvement from baseline in the European Quality of Life Module Chronic Lymphocytic Leukemia 17 (EORTC QLQ-CLL17) [ Time Frame: Up to 5 years from the last participant randomized ]
The following domains on the EORTC QLQ-CLL17 will be assessed:
- Symptom burden
- Physical condition/fatigue
- Mean changes from baseline in the following key health-related quality of life (HRQoL) domains: GHS/QoL [ Time Frame: Up to 5 years from the last participant randomized ]As assessed by EORTC QLQ-C30
- Mean changes from baseline in the following key HRQoL domains: Fatigue [ Time Frame: Up to 5 years from the last participant randomized ]As assessed by EORTC QLQ-C30
- Mean changes from baseline in the following key HRQoL domains: Physical functioning [ Time Frame: Up to 5 years from the last participant randomized ]As assessed by EORTC QLQ-C30
- Mean changes from baseline in the following key HRQoL domains: Role functioning [ Time Frame: Up to 5 years from the last participant randomized ]As assessed by EORTC QLQ-C30
- Mean changes from baseline in the following key HRQoL domains: Cognitive functioning [ Time Frame: Up to 5 years from the last participant randomized ]As assessed by EORTC QLQ-C30
- Mean changes from baseline in the following key HRQoL domains: Symptom burden [ Time Frame: Up to 5 years from the last participant randomized ]As assessed by EORTC QLQ-CLL17
- Mean changes from baseline in the following key HRQoL domains: Physical condition/fatigue [ Time Frame: Up to 5 years from the last participant randomized ]As assessed by EORTC QLQ-CLL17
Information from the National Library of Medicine
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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
Inclusion Criteria
- Must have what doctors call measurable disease, which will be evaluated before each participant take part of the study.
- Must have received both a BTKi and a BCL2i treatment, and their disease must have come back or not responded to treatment, or they must not have been able to tolerate the side-effects of the BTKi and/or BCL2i treatment(s).
- Must also have an ECOG performance score of 0 or 1, which means they are able to carry out their normal daily activities without any problems.
Exclusion Criteria
- Heart problems.
- Bleeding disorders.
- Active cancer in their brain.
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Other reasons include:.
i) Having certain treatments in the past.
ii) Having certain infections that are not under control.
iii) Having certain brain conditions.
- Other protocol-defined Inclusion/Exclusion criteria 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): NCT06205290
Locations
Show 48 study locations
Sponsors and Collaborators
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Celgene Corporation
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
| Responsible Party: | Juno Therapeutics, Inc., a Bristol-Myers Squibb Company |
| ClinicalTrials.gov Identifier: | NCT06205290 |
| Other Study ID Numbers: |
CA082-1170 |
| First Posted: | January 16, 2024 Key Record Dates |
| Last Update Posted: | April 2, 2024 |
| Last Verified: | March 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) |
| Time Frame: | See plan description |
| Access Criteria: | See plan description |
| URL: | https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company:
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Small Lymphocytic lymphoma B cell malignancies CD19+ B cell malignancies Non-Hodgkin lymphoma |
Additional relevant MeSH terms:
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Lymphoma Leukemia Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Hematologic Diseases Leukemia, B-Cell Chronic Disease Disease Attributes Pathologic Processes |
Cyclophosphamide Bendamustine Hydrochloride Rituximab Fludarabine Idelalisib 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 |