Status:
WITHDRAWN
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
Lead Sponsor:
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Collaborating Sponsors:
Celgene Corporation
Conditions:
Leukemia, Lymphocytic, Chronic, B-Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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.
- 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.
Exclusion
Key Trial Info
Start Date :
January 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 13 2031
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06205290
Start Date
January 16 2024
End Date
October 13 2031
Last Update
April 2 2024
Active Locations (48)
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1
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
2
Local Institution - 0023
Duarte, California, United States, 91010
3
University of California Davis (UC Davis) Comprehensive Cancer Center
Sacramento, California, United States, 95817
4
Local Institution - 0120
Atlanta, Georgia, United States, 30322