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

March 31, 2024 updated by: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: First line of the email MUST contain the NCT# and Site #.

Study Contact Backup

  • Name: BMS Study Connect Contact Cener www.BMSStudyConnect.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Locations

  • Austria
      • Salzburg, Austria, 5020
        • Local Institution - 0094
      • Wien, Austria, 1090
        • Local Institution - 0093
  • Belgium
    • Namur
      • Yvoir, Namur, Belgium, 5530
        • Local Institution - 0113
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Local Institution - 0112
  • France
      • Clermont-Ferrand, France, 63100
        • Local Institution - 0035
      • Paris, France, 75013
        • Local Institution - 0037
      • Toulouse, France, 31100
        • Local Institution - 0034
    • Bretagne
      • Rennes, Bretagne, France, 35033
        • Local Institution - 0122
    • Languedoc-Roussillon
      • Montpellier, Languedoc-Roussillon, France, 34295
        • Local Institution - 0036
    • Rhône-Alpes
      • Lyon, Rhône-Alpes, France, 69008
        • Local Institution - 0038
  • Germany
      • Heidelberg, Germany, D-69120
        • Local Institution - 0079
      • Köln, Germany, 50937
        • Local Institution - 0082
      • Ulm, Germany, 89081
        • Local Institution - 0080
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
        • Local Institution - 0084
      • Leipzig, Sachsen, Germany, 04103
        • Local Institution - 0081
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Local Institution - 0083
  • Italy
      • Bologna, Italy, 40138
        • Local Institution - 0088
    • Milano
      • Milan, Milano, Italy, 20162
        • Local Institution - 0091
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • Local Institution - 0117
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1105 AZ
        • Local Institution - 0114
  • Norway
      • Oslo, Norway, 0372
        • Local Institution - 0073
  • Spain
      • Salamanca, Spain, 37007
        • Local Institution - 0103
    • Barcelona [Barcelona]
      • Barcelona, Barcelona [Barcelona], Spain, 08035
        • Local Institution - 0104
      • L'Hospitalet Del Llobregat, Barcelona [Barcelona], Spain, 08908
        • Local Institution - 0105
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Local Institution - 0107
    • Madrid, Comunidad De
      • Madrid, Madrid, Comunidad De, Spain, 28034
        • Local Institution - 0108
    • Valenciana, Comunitat
      • Valencia, Valenciana, Comunitat, Spain, 46010
        • Local Institution - 0106
  • Sweden
      • Huddinge, Sweden, 141 86
        • Local Institution - 0071
  • United Kingdom
      • Leeds, United Kingdom, LS9 7TF
        • Local Institution - 0111
      • Oxford, United Kingdom, 0X3 7LE
        • Local Institution - 0110
    • London, City Of
      • London, London, City Of, United Kingdom, NW1 2PG
        • Local Institution - 0115
      • London, London, City Of, United Kingdom, SE5 9RS
        • Local Institution - 0109
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Banner MD Anderson Cancer Center
    • California
      • Duarte, California, United States, 91010
        • Local Institution - 0023
      • Sacramento, California, United States, 95817
        • University of California Davis (UC Davis) Comprehensive Cancer Center
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Local Institution - 0120
    • Idaho
      • Boise, Idaho, United States, 83712
        • St. Luke's Mountain States Tumor Institute : Boise
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Local Institution - 0058
    • Kentucky
      • Saint Matthews, Kentucky, United States, 40207
        • Local Institution - 0048
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Local Institution - 0101
    • New York
      • New York, New York, United States, 10029
        • Local Institution - 0121
      • Stony Brook, New York, United States, 11794
        • Stony Brook University
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Oncology Hematology Care
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center
    • Texas
      • Austin, Texas, United States, 78704
        • St. David's South Austin Medical Center
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Virginia Oncology Associates
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Local Institution - 0068
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University Hospital and UW Health Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

- Other protocol-defined Inclusion/Exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm A: Liso-cel Monotherapy
Drug: Cyclophosphamide
Specified dose on specified days
Other Names:
  • Cytoxan®
  • Endoxan®
Drug: Fludarabine
Specified dose on specified days
Other Names:
  • Fludara®
  • Bendarabin®
Biological: Liso-cel
Specified dose on specified days
Other Names:
  • JCAR017
  • Breyanzi®
  • BMS-986387
  • lisocabtagene maraleucel
Active Comparator: Arm B: Investigator's Choice
Drug: Rituximab
Specified dose on specified days
Other Names:
  • Rituxan®
  • Truxima®
  • Mabthera®
  • Riximyo®
Drug: Bendamustine
Specified dose on specified days
Other Names:
  • Bendeka®
  • Treanda®
  • Belrapzo®
Drug: Idelalisib
Specified dose on specified days
Other Names:
  • Zydelig®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Progression Free Survival (PFS) per independent review committee (IRC) assessment
Time Frame: Up to 5 years from the last participant randomized
Up to 5 years from the last participant randomized

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Up to 5 years from the last participant randomized
Up to 5 years from the last participant randomized
Complete Response Rate (CRR) per IRC assessment
Time Frame: Up to 5 years from the last participant randomized
Up to 5 years from the last participant randomized
CRR per investigators' assessment
Time Frame: Up to 5 years from the last participant randomized
Up to 5 years from the last participant randomized
Complete response with incomplete bone marrow recovery (CRi)
Time Frame: Up to 5 years from the last participant randomized
Up to 5 years from the last participant randomized
Minimal residual disease (MRD)-negativity rate
Time Frame: Up to 5 years from the last participant randomized
Up to 5 years from the last participant randomized
Overall Response Rate (ORR) per IRC assessment
Time Frame: Up to 5 years from the last participant randomized
Up to 5 years from the last participant randomized
ORR per investigators' assessment
Time Frame: Up to 5 years from the last participant randomized
Up to 5 years from the last participant randomized
Duration of Response (DOR) per IRC assessment
Time Frame: Up to 5 years from the last participant randomized
Up to 5 years from the last participant randomized
Duration of Complete Response (DOCR) per IRC assessment
Time Frame: Up to 5 years from the last participant randomized
Up to 5 years from the last participant randomized
PFS per investigators' assessment
Time Frame: Up to 5 years from the last participant randomized
Up to 5 years from the last participant randomized
Progression post next line of treatment (PFS-2)
Time Frame: Up to 5 years from the last participant randomized
Up to 5 years from the last participant randomized
Number of participants with Adverse Events (AEs)
Time Frame: Up to 5 years from the last participant randomized
Up to 5 years from the last participant randomized
Number of participants with Adverse Events of Special Interest (AESIs)
Time Frame: Up to 5 years from the last participant randomized
Up to 5 years from the last participant randomized
Number of participants with laboratory abnormalities
Time Frame: Up to 5 years from the last participant randomized
Up to 5 years from the last participant randomized
Time from randomization to first confirmed clinically meaningful improvement from baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 questionnaire (EORTC QLQ-C30)
Time Frame: Up to 5 years from the last participant randomized

The following domains on the EORTC QLQ-C30 will be assessed:

  • Fatigue
  • Physical functioning
  • Role functioning
  • Cognitive functioning
  • Global health status/quality of life (GHS/QoL)
Up to 5 years from the last participant randomized
Time from randomization to first confirmed clinically meaningful improvement from baseline in the European Quality of Life Module Chronic Lymphocytic Leukemia 17 (EORTC QLQ-CLL17)
Time Frame: Up to 5 years from the last participant randomized

The following domains on the EORTC QLQ-CLL17 will be assessed:

  • Symptom burden
  • Physical condition/fatigue
Up to 5 years from the last participant randomized
Mean changes from baseline in the following key health-related quality of life (HRQoL) domains: GHS/QoL
Time Frame: Up to 5 years from the last participant randomized
As assessed by EORTC QLQ-C30
Up to 5 years from the last participant randomized
Mean changes from baseline in the following key HRQoL domains: Fatigue
Time Frame: Up to 5 years from the last participant randomized
As assessed by EORTC QLQ-C30
Up to 5 years from the last participant randomized
Mean changes from baseline in the following key HRQoL domains: Physical functioning
Time Frame: Up to 5 years from the last participant randomized
As assessed by EORTC QLQ-C30
Up to 5 years from the last participant randomized
Mean changes from baseline in the following key HRQoL domains: Role functioning
Time Frame: Up to 5 years from the last participant randomized
As assessed by EORTC QLQ-C30
Up to 5 years from the last participant randomized
Mean changes from baseline in the following key HRQoL domains: Cognitive functioning
Time Frame: Up to 5 years from the last participant randomized
As assessed by EORTC QLQ-C30
Up to 5 years from the last participant randomized
Mean changes from baseline in the following key HRQoL domains: Symptom burden
Time Frame: Up to 5 years from the last participant randomized
As assessed by EORTC QLQ-CLL17
Up to 5 years from the last participant randomized
Mean changes from baseline in the following key HRQoL domains: Physical condition/fatigue
Time Frame: Up to 5 years from the last participant randomized
As assessed by EORTC QLQ-CLL17
Up to 5 years from the last participant randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Celgene Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 16, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 13, 2031

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 13, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 16, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 2, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CA082-1170

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html

IPD Sharing Time Frame

See plan description

IPD Sharing Access Criteria

See plan description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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