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
Reason given: Business objectives have changed.
Key facts
- Where
- Atlanta, Austin, Boise, Cincinnati, Cleveland, Duarte, Gilbert, Iowa City, Madison, Minneapolis, Morgantown, New York, Norfolk, Sacramento, Saint Matthews, and Stony Brook, United StatesSee the 16 sites
- Phase
- Phase 3
Where in United States
- AtlantaAtlanta, United StatesNo longer taking part
- St. David's South Austin Medical CenterAustin, United StatesNo longer taking part
- St. Luke's Mountain States Tumor Institute : BoiseBoise, United StatesNo longer taking part
- Oncology Hematology CareCincinnati, United StatesNo longer taking part
- University Hospitals Cleveland Medical Center*Cleveland, United StatesNo longer taking part
- DuarteDuarte, United StatesNo longer taking part
- Banner MD Anderson Cancer CenterGilbert, United StatesNo longer taking part
- Iowa CityIowa City, United StatesNo longer taking part
- University Hospital and UW Health ClinicsMadison, United StatesNo longer taking part
- MinneapolisMinneapolis, United StatesNo longer taking part
- MorgantownMorgantown, United StatesNo longer taking part
- New YorkNew York, United StatesNo longer taking part
- Virginia Oncology AssociatesNorfolk, United StatesNo longer taking part
- University of California Davis (UC Davis) Comprehensive Cancer CenterSacramento, United StatesNo longer taking part
- Saint MatthewsSaint Matthews, United StatesNo longer taking part
- Stony Brook UniversityStony Brook, United StatesNo longer taking part
Trial details
- Who runs it
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
- Trial code
- NCT06205290
- Record updated
- 2 April 2024
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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: Heart problems; Bleeding disorders; Active cancer in their brain; Having certain infections that are not under control; Having certain brain conditions; Other reasons include:; Having certain treatments in the past; Other protocol-defined Inclusion/Exclusion criteria apply.