A Study to Evaluate the Efficacy and Safety of Liso-cel Compared to Standard of Care in Adults With Relapsed or Refractory Follicular Lymphoma

NCT06313996 | Withdrawn Phase 3 FDA Drug

• 2 other identifiers: CA082-0112023-507477-18
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Liso-cel compared to standard of care in adults with Relapsed or Refractory Follicular Lymphoma.

Conditions

Relapsed or Refractory Follicular Lymphoma

Keywords

Lisocabtagene Maraleucel; Liso-cel; Follicular Lymphoma

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  Defined as the time from randomization to death due to any cause or progressive disease (PD) per independent review committee (IRC) assessment using the Lugano 2014 Criteria, whichever occurs first

  Up to 5 years from the last participant randomized

Secondary Outcomes (19)

• Complete response (CR)

  Up to 5 years from the last participant randomized

• Overall survival (OS)

  Up to approximately 7 years

• Overall response (OR)

  Up to 5 years from the last participant randomized

• Duration of response (DOR)

  Up to 5 years from the last participant randomized

• Event-free survival (EFS)

  Up to 5 years from the last participant randomized

Study Arms (2)

Arm A

ACTIVE COMPARATOR

Active Comparators: R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) B-R (bendamustine and rituximab) R2 (rituximab and lenalidomide)

Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Rituximab; Drug: Prednisone; Drug: Bendamustine; Drug: Lenalidomide

Arm B

EXPERIMENTAL

Lisocabtagene Maraleucel

Drug: Fludarabine; Drug: Liso-cel

Interventions

Cyclophosphamide DRUG

Specified dose on specified days

Arm A

Doxorubicin DRUG

Specified dose on specified days

Arm A

Vincristine DRUG

Specified dose on specified days

Arm A

Rituximab DRUG

Specified dose on specified days

Arm A

Prednisone DRUG

Specified dose on specified days

Arm A

Bendamustine DRUG

Specified dose on specified days

Arm A

Lenalidomide DRUG

Specified dose on specified days

Arm A

Fludarabine DRUG

Specified dose on specified days

Arm B

Liso-cel DRUG

Specified dose on specified days

Also known as: Lisocabtagene Maraleucel, BREYANZI

Arm B

Eligibility Criteria

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

You may qualify if:

• Participants must have measurable disease.
• Participants must have previously been treated with certain defined anti-cancer therapies and their disease must have come back or must have not responded to the previous or last treatment.
• Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Participants that have histologically confirmed Follicular Lymphoma (FL) (Grade 1, 2, or 3a) corresponding to the most recent relapse prior to screening.
• Participants that have Relapsed or refractory FL, as assessed by the Investigator.
• Participants that have received at least one prior line and no more than three prior lines of systemic therapy including a combination of an anti-CD20 antibody and an alkylating agent.
• Participants that received one prior line of systemic therapy are eligible if they present with high risk features.

You may not qualify if:

• Participants must not have any history of heart problems.
• Participants must not have any bleeding disorders.
• Participants must not have any Central Nervous System involvement by Follicular Lymphoma or other brain conditions.

Sponsors & Collaborators

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

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Recurrence; Lymphoma, Follicular

Interventions

Cyclophosphamide; Doxorubicin; Vincristine; Rituximab; Prednisone; Bendamustine Hydrochloride; Lenalidomide; fludarabine

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Butyrates; Acids, Acyclic; Carboxylic Acids; Benzimidazoles; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Isoindoles

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 15, 2024
• Study Start: March 29, 2024
• Primary Completion (Estimated): October 16, 2031
• Study Completion (Estimated): October 16, 2031
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

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