Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis
Dates
study started
completion around

Description

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.

Official Title

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)

Keywords

Leukemia, Lymphocytic, Chronic, B-Cell, Small Lymphocytic lymphoma, B cell malignancies, CD19+ B cell malignancies, Non-Hodgkin lymphoma, Lymphoma, Leukemia, Lymphoid Leukemia, Cyclophosphamide, Bendamustine Hydrochloride, Rituximab, Fludarabine, Idelalisib, Liso-cel, Bendamustine, Liso-cel Monotherapy

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • Heart problems
  • Bleeding disorders
  • Active cancer in their brain
  • Other reasons include:
    1. Having certain treatments in the past
    2. Having certain infections that are not under control
    3. Having certain brain conditions

      Other protocol-defined inclusion/exclusion criteria apply.

Locations

  • University of California Davis (UC Davis) Comprehensive Cancer Center
    Sacramento California 95817 United States
  • Banner MD Anderson Cancer Center
    Gilbert Arizona 85234 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Links
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting FDA Safety Alerts and Recalls
ID
NCT06205290
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 200 study participants
Last Updated