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WITHDRAWNPHASE3

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

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)

NCT06205290•Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (48)

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

Key Dates

Start Date

January 16, 2024

Primary Completion Date

October 13, 2031

Completion Date

October 13, 2031

Last Updated

April 2, 2024

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Liso-cel

BIOLOGICAL

Idelalisib

DRUG

Rituximab

DRUG

Bendamustine

DRUG

Fludarabine

DRUG

Cyclophosphamide

DRUG

Long-Term Safety of Pirtobrutinib in Participants With Previously Treated Types of Blood Cancers

NCT07162181

Lymphoma, Non-HodgkinLeukemia, Lymphocytic, Chronic, B-Cell+1 more

View study

COMPLETEDPHASE1

A Study of JNJ-64264681 in Participants With Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia

NCT04210219

Lymphoma, Non-HodgkinLeukemia, Lymphocytic, Chronic, B-Cell

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 2, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Long-Term Safety of Pirtobrutinib in Participants With Previously Treated Types of Blood Cancers

A Study of JNJ-64264681 in Participants With Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia

A Study to Assess Safety of ImbruvicaTM in Indian Participants With Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma Who Have Received at Least One Prior Therapy or Chronic Lymphocytic Leukemia With 17p Deletion

A Study of Ibrutinib in the Treatment of Chronic Lymphocytic Leukemia and Mantle-cell Lymphoma in Routine Clinical Practice

A Phase 1/2, Open-label, Dose Finding Study to Evaluate CC-122 in Combination With Ibrutinib and Obinutuzumab in Subjects With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

A Study to Assess the Efficacy of Rituximab (MabThera) in First Line Treatment of Chronic Lymphocytic Leukemia (CLL)