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

NCT06205290 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: CA082-1170
• Study Type: interventional
• Target: N/A
• Locations: 11 countries
• Sites: 48

Brief 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.

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Keywords

Small Lymphocytic lymphoma; B cell malignancies; CD19+ B cell malignancies; Non-Hodgkin lymphoma

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS) per independent review committee (IRC) assessment

  Up to 5 years from the last participant randomized

Secondary Outcomes (23)

• Overall Survival (OS)

  Up to 5 years from the last participant randomized

• Complete Response Rate (CRR) per IRC assessment

  Up to 5 years from the last participant randomized

• CRR per investigators' assessment

  Up to 5 years from the last participant randomized

• Complete response with incomplete bone marrow recovery (CRi)

  Up to 5 years from the last participant randomized

• Minimal residual disease (MRD)-negativity rate

  Up to 5 years from the last participant randomized

Study Arms (2)

Arm A: Liso-cel Monotherapy

EXPERIMENTAL

Biological: Liso-cel; Drug: Fludarabine; Drug: Cyclophosphamide

Arm B: Investigator's Choice

ACTIVE COMPARATOR

Drug: Idelalisib; Drug: Rituximab; Drug: Bendamustine

Interventions

Liso-cel BIOLOGICAL

Specified dose on specified days

Also known as: JCAR017, Breyanzi®, BMS-986387, lisocabtagene maraleucel

Arm A: Liso-cel Monotherapy

Idelalisib DRUG

Specified dose on specified days

Also known as: Zydelig®

Arm B: Investigator's Choice

Rituximab DRUG

Specified dose on specified days

Also known as: Rituxan®, Mabthera®, Riximyo®, Truxima®

Arm B: Investigator's Choice

Bendamustine DRUG

Specified dose on specified days

Also known as: Bendeka®, Treanda®, Belrapzo®

Arm B: Investigator's Choice

Fludarabine DRUG

Specified dose on specified days

Also known as: Fludara®, Bendarabin®

Arm A: Liso-cel Monotherapy

Cyclophosphamide DRUG

Specified dose on specified days

Also known as: Endoxan®, Cytoxan®

Arm A: Liso-cel Monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Juno Therapeutics, Inc., a Bristol-Myers Squibb Company: lead
• Celgene Corporation: collaborator

Study Sites (48)

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

Location

Local Institution - 0023

Duarte, California, 91010, United States

Location

University of California Davis (UC Davis) Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

Local Institution - 0120

Atlanta, Georgia, 30322, United States

Location

St. Luke's Mountain States Tumor Institute : Boise

Boise, Idaho, 83712, United States

Location

Local Institution - 0058

Iowa City, Iowa, 52242, United States

Location

Local Institution - 0048

Saint Matthews, Kentucky, 40207, United States

Location

Local Institution - 0101

Minneapolis, Minnesota, 55455, United States

Location

Local Institution - 0121

New York, New York, 10029, United States

Location

Stony Brook University

Stony Brook, New York, 11794, United States

Location

Oncology Hematology Care

Cincinnati, Ohio, 45242, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

St. David's South Austin Medical Center

Austin, Texas, 78704, United States

Location

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

Location

Local Institution - 0068

Morgantown, West Virginia, 26506, United States

Location

University Hospital and UW Health Clinics

Madison, Wisconsin, 53792, United States

Location

Local Institution - 0094

Salzburg, 5020, Austria

Location

Local Institution - 0093

Vienna, 1090, Austria

Location

Local Institution - 0113

Yvoir, Namur, 5530, Belgium

Location

Local Institution - 0112

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Local Institution - 0038

Lyon, Auvergne-Rhône-Alpes, 69008, France

Location

Local Institution - 0122

Rennes, Brittany Region, 35033, France

Location

Local Institution - 0036

Montpellier, Languedoc-Roussillon, 34295, France

Location

Local Institution - 0035

Clermont-Ferrand, 63100, France

Location

Local Institution - 0037

Paris, 75013, France

Location

Local Institution - 0034

Toulouse, 31100, France

Location

Local Institution - 0084

Dresden, Saxony, 01307, Germany

Location

Local Institution - 0081

Leipzig, Saxony, 04103, Germany

Location

Local Institution - 0083

Kiel, Schleswig-Holstein, 24105, Germany

Location

Local Institution - 0082

Cologne, 50937, Germany

Location

Local Institution - 0079

Heidelberg, D-69120, Germany

Location

Local Institution - 0080

Ulm, 89081, Germany

Location

Local Institution - 0091

Milan, Milano, 20162, Italy

Location

Local Institution - 0088

Bologna, 40138, Italy

Location

Local Institution - 0114

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

Local Institution - 0117

Groningen, 9713 GZ, Netherlands

Location

Local Institution - 0073

Oslo, 0372, Norway

Location

Local Institution - 0104

Barcelona, Barcelona [Barcelona], 08035, Spain

Location

Local Institution - 0105

L'Hospitalet Del Llobregat, Barcelona [Barcelona], 08908, Spain

Location

Local Institution - 0107

Santander, Cantabria, 39008, Spain

Location

Local Institution - 0108

Madrid, Madrid, Comunidad de, 28034, Spain

Location

Local Institution - 0106

Valencia, Valenciana, Comunitat, 46010, Spain

Location

Local Institution - 0103

Salamanca, 37007, Spain

Location

Local Institution - 0071

Huddinge, 141 86, Sweden

Location

Local Institution - 0115

London, London, City of, NW1 2PG, United Kingdom

Location

Local Institution - 0109

London, London, City of, SE5 9RS, United Kingdom

Location

Local Institution - 0111

Leeds, LS9 7TF, United Kingdom

Location

Local Institution - 0110

Oxford, 0X3 7LE, United Kingdom

Location

Related Links

• BMS Clinical Trial Information

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Non-Hodgkin

Interventions

idelalisib; Rituximab; Bendamustine Hydrochloride; fludarabine; fludarabine phosphate; Cyclophosphamide

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phosphoramide Mustards; Phosphoramides; Organophosphorus Compounds

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 16, 2024
• Study Start: January 16, 2024
• Primary Completion (Estimated): October 13, 2031
• Study Completion (Estimated): October 13, 2031
• Last Updated: April 2, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See plan description
• Access Criteria: See plan description

Locations

BE (2); GB (4); FR (6); AU (2); NO (1); ES (6); US (16); DE (6); IT (2); NL (2); SE (1)