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

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)

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
BIOLOGICAL	Liso-cel	Specified dose on specified days
DRUG	Idelalisib	Specified dose on specified days
DRUG	Rituximab	Specified dose on specified days
DRUG	Bendamustine	Specified dose on specified days
DRUG	Fludarabine	Specified dose on specified days
DRUG	Cyclophosphamide	Specified dose on specified days

Timeline

• Start date: 2024-01-16
• Primary completion: 2031-10-13
• Completion: 2031-10-13
• First posted: 2024-01-16
• Last updated: 2024-04-02

Locations

48 sites across 11 countries: United States, Austria, Belgium, France, Germany, Italy, Netherlands, Norway, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study