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

March 13, 2024 updated by: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

A Global Randomized Multicenter Phase 3 Trial to Compare the Efficacy and Safety of Lisocabtagene Maraleucel (JCAR017/BMS-986387) to Standard of Care in Adults With Relapsed or Refractory Follicular Lymphoma (TRANSFORM FL)

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The purpose of this phase III study is to evaluate the clinical benefit of liso-cel for the treatment of r/r FL by comparing it to standard of care therapy in patients with r/r FL, with progression-free survival (PFS) as the primary endpoint.

The primary objective is to demonstrate superiority of the Liso-cel treatment strategy over standard of care (SOC) therapy with respect to progression-free survival (PFS) determined by independent review committee (IRC) based on the Lugano response criteria.

Participants randomized to Arm A (Standard of Care) will receive RCHOP, BR, or R2 based on investigator choice and this has to be determined prior to randomization.

Participants randomized to Arm B (Liso-cel treatment) will receive a single infusion CAR-positive viable T-cells.

Study Type

Interventional

Enrollment (Estimated)

300

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 Contact

  • Name: First line of the email MUST contain the NCT# and Site #

Study Contact Backup

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

  • 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.

Exclusion Criteria

  • 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.
  • 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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm A

Active Comparators:

R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone)

B-R (bendamustine and rituximab)

R2 (rituximab and lenalidomide)
Drug: Rituximab
Specified dose on specified days
Drug: Prednisone
Specified dose on specified days
Drug: Cyclophosphamide
Specified dose on specified days
Drug: Doxorubicin
Specified dose on specified days
Drug: Lenalidomide
Specified dose on specified days
Drug: Bendamustine
Specified dose on specified days
Drug: Vincristine
Specified dose on specified days
Experimental: Arm B
Lisocabtagene Maraleucel
Drug: Fludarabine
Specified dose on specified days
Drug: Liso-cel
Specified dose on specified days
Other Names:
  • Lisocabtagene Maraleucel
  • BREYANZI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: Up to 5 years from the last participant randomized
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Complete response (CR)
Time Frame: Up to 5 years from the last participant randomized
Defined as participants achieving a complete response per IRC assessment using the Lugano 2014 Criteria
Up to 5 years from the last participant randomized
Overall survival (OS)
Time Frame: Up to approximately 7 years
Defined as the time from randomization to death due to any cause
Up to approximately 7 years
Overall response (OR)
Time Frame: Up to 5 years from the last participant randomized
Defined as participants achieving a response (CR or partial response (PR)) per IRC assessment using the Lugano 2014 Criteria
Up to 5 years from the last participant randomized
Duration of response (DOR)
Time Frame: Up to 5 years from the last participant randomized
Defined as the time from first response (CR or PR) per IRC assessment using the Lugano 2014 Criteria to PD or death due to any cause, whichever occurs first
Up to 5 years from the last participant randomized
Event-free survival (EFS)
Time Frame: Up to 5 years from the last participant randomized
Defined as the time from randomization to the first documentation of progressive disease (PD) per IRC assessed using the Lugano 2014 Criteria start of new anti-cancer therapy, or death due to any cause, whichever occurs first
Up to 5 years from the last participant randomized
Time to next anti-cancer therapy (TTNLT)
Time Frame: Up to 5 years from the last participant randomized
Defined as time from randomization to start of new anti-cancer therapy or death due to any cause, whichever occurs first
Up to 5 years from the last participant randomized
PFS rate
Time Frame: Up to 5 years from the last participant randomized
Up to 5 years from the last participant randomized
EFS rate
Time Frame: Up to 5 years from the last participant randomized
Up to 5 years from the last participant randomized
OS rate
Time Frame: Up to approximately 7 years
Up to approximately 7 years
Progression-free survival on the next line of treatment (PFS-2)
Time Frame: Up to 5 years from the last participant randomized
Defined as the time from randomization to death from any cause or tumor progression on next line treatment per Investigator assessment, whichever occurs first
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 event 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 serious adverse events (SAEs)
Time Frame: Up to 5 years from the last participant randomized
Up to 5 years from the last participant randomized
Frequency and length of hospitalizations
Time Frame: Up to 5 years from the last participant randomized
Up to 5 years from the last participant randomized
Number of participants with intensive care unit (ICU) inpatient days
Time Frame: Up to 5 years from the last participant randomized
Up to 5 years from the last participant randomized
Number of participants with non-ICU inpatient days
Time Frame: Up to 5 years from the last participant randomized
Up to 5 years from the last participant randomized
Mean change from baseline in key health-related quality of life (HRQoL) domains.
Time Frame: Up to 5 years from the last participant randomized

Key HRQoL Domains:

Global health status/quality of life (GHS/QoL), fatigue, pain, physical functioning, role functioning, cognitive functioning from The European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ C30), and Symptom Burden and Physical Condition/Fatigue from the European Quality of Life Module Non-Hodgkin's Lymphoma Low-Grade 20 items (EORTC QLQ-NHL-LG20)
Up to 5 years from the last participant randomized
Time to meaningful improvement/deterioration in key HRQoL domains.
Time Frame: Up to 5 years from the last participant randomized

Key HRQoL Domains:

Global health status/quality of life (GHS/QoL), fatigue, pain, physical functioning, role functioning, cognitive functioning from The European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ C30), and Symptom Burden and Physical Condition/Fatigue from the European Quality of Life Module Non-Hodgkin's Lymphoma Low-Grade 20 items (EORTC QLQ-NHL-LG20)
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)

March 29, 2024

Primary Completion (Estimated)

October 16, 2031

Study Completion (Estimated)

October 16, 2031

Study Registration Dates

First Submitted

February 26, 2024

First Submitted That Met QC Criteria

March 13, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA082-011
  • 2023-507477-18 (EudraCT Number)

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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