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
NCT06205290 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL
Last updated 2024-04-02
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.
Conditions
- Leukemia, Lymphocytic, Chronic, B-Cell
Interventions
- BIOLOGICAL
-
Specified dose on specified days
- DRUG
-
Idelalisib
Specified dose on specified days
- DRUG
-
Specified dose on specified days
- DRUG
-
Specified dose on specified days
- DRUG
-
Specified dose on specified days
- DRUG
-
Specified dose on specified days
Sponsors & Collaborators
-
Celgene Corporation
collaborator INDUSTRY -
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
lead INDUSTRY
Principal Investigators
-
Bristol-Myers Squibb · Bristol-Myers Squibb
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-01-16
- Primary Completion
- 2031-10-13
- Completion
- 2031-10-13
- FDA Drug
- Yes
Countries
- United States
- Austria
- Belgium
- France
- Germany
- Italy
- Netherlands
- Norway
- Spain
- Sweden
- United Kingdom
Study Locations
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