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

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

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

Collaborators

Celgene Corporation

Investigators

  • 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)

January 16, 2024

Primary Completion (Estimated)

October 13, 2031

Study Completion (Estimated)

October 13, 2031

Study Registration Dates

First Submitted

December 19, 2023

First Submitted That Met QC Criteria

January 9, 2024

First Posted (Actual)

January 16, 2024

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

March 31, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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