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

Withdrawn before enrolling · Phase 3

Conditions studied: Leukemia, Lymphocytic, Chronic, B-Cell

In brief

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 facts

Study ID

NCT06205290

Run by

Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

People needed

0

Starts

2024-01-16

Expected to finish

2031-10-13

Last updated by the study team

2024-04-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify if…

• 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.

Where it is running

• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
• Local Institution - 0023 — Duarte, California, United States
• University of California Davis (UC Davis) Comprehensive Cancer Center — Sacramento, California, United States
• Local Institution - 0120 — Atlanta, Georgia, United States
• St. Luke's Mountain States Tumor Institute : Boise — Boise, Idaho, United States
• Local Institution - 0058 — Iowa City, Iowa, United States
• Local Institution - 0048 — Saint Matthews, Kentucky, United States
• Local Institution - 0101 — Minneapolis, Minnesota, United States
• Local Institution - 0121 — New York, New York, United States
• Stony Brook University — Stony Brook, New York, United States
• Oncology Hematology Care — Cincinnati, Ohio, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• St. David's South Austin Medical Center — Austin, Texas, United States
• Virginia Oncology Associates — Norfolk, Virginia, United States
• Local Institution - 0068 — Morgantown, West Virginia, United States
• University Hospital and UW Health Clinics — Madison, Wisconsin, United States
• Local Institution - 0094 — Salzburg, Austria
• Local Institution - 0093 — Vienna, Austria
• Local Institution - 0113 — Yvoir, Namur, Belgium
• Local Institution - 0112 — Leuven, Vlaams-Brabant, Belgium
• Local Institution - 0038 — Lyon, Auvergne-Rhône-Alpes, France
• Local Institution - 0122 — Rennes, Brittany Region, France
• Local Institution - 0036 — Montpellier, Languedoc-Roussillon, France
• Local Institution - 0035 — Clermont-Ferrand, France
• Local Institution - 0037 — Paris, France

Full record on ClinicalTrials.gov

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