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

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Study ID
NCT06205290
Phase
PHASE3
Status
Withdrawn

Conditions

  • Leukemia, Lymphocytic, Chronic, B-Cell

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Liso-cel — BIOLOGICAL
    Specified dose on specified days
  • Idelalisib — DRUG
    Specified dose on specified days
  • Rituximab — DRUG
    Specified dose on specified days
  • Bendamustine — DRUG
    Specified dose on specified days
  • Fludarabine — DRUG
    Specified dose on specified days
  • Cyclophosphamide — DRUG
    Specified dose on specified days

Study Details

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.

Key Dates

Start date
Jan 16, 2024
Status verified
Mar 2024
Primary completion
Oct 13, 2031
Completion
Oct 13, 2031

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Liso-cel Monotherapy
  • Active Comparator: Arm B: Investigator's Choice

Primary Outcome Measure

Progression Free Survival (PFS) per independent review committee (IRC) assessment [ Time Frame: Up to 5 years from the last participant randomized ]

Locations (16)

FacilityCityStateZIPSite coordinators
Banner MD Anderson Cancer CenterGilbertArizona85234-
Local Institution - 0023DuarteCalifornia91010-
University of California Davis (UC Davis) Comprehensive Cancer CenterSacramentoCalifornia95817-
Local Institution - 0120AtlantaGeorgia30322-
St. Luke's Mountain States Tumor Institute : BoiseBoiseIdaho83712-
Local Institution - 0058Iowa CityIowa52242-
Local Institution - 0048Saint MatthewsKentucky40207-
Local Institution - 0101MinneapolisMinnesota55455-
Local Institution - 0121New YorkNew York10029-
Stony Brook UniversityStony BrookNew York11794-
Oncology Hematology CareCincinnatiOhio45242-
University Hospitals Cleveland Medical CenterClevelandOhio44106-
St. David's South Austin Medical CenterAustinTexas78704-
Virginia Oncology AssociatesNorfolkVirginia23502-
Local Institution - 0068MorgantownWest Virginia26506-
University Hospital and UW Health ClinicsMadisonWisconsin53792-

Find similar trials in Gilbert, AZ

By research site
Banner MD Anderson Cancer Center· Gilbert, AZLocal Institution - 0023· Duarte, CAUniversity of California Davis (UC Davis) Comprehensive Cancer Center· Sacramento, CALocal Institution - 0120· Atlanta, GASt. Luke's Mountain States Tumor Institute : Boise· Boise, IDLocal Institution - 0058· Iowa City, IA

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