drugset / Trial / NCT06205290
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
Phase 3
Withdrawn
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Celgene Corporation · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2024-01-16
- Primary completion
- 2031-10-13
- Completion
- 2031-10-13
Outcome
Outcome not reported
Stopped (Business): “Business objectives have changed.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bendamustine | Small molecule | — | — |
| Comparator | Idelalisib | Small molecule | — | — |
| Subject | Liso-cel | Cell therapy | — | — |
| Comparator | Rituximab | Monoclonal antibody | — | — |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Fludarabine | Small molecule | — | — |