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

Juno Therapeutics

Status and phase: Not yet enrolling; Phase 3

Conditions: Relapsed or Refractory Follicular Lymphoma

Treatments: Drug: Vincristine; Drug: Rituximab; Drug: Liso-cel; Drug: Lenalidomide; Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Prednisone; Drug: Fludarabine; Drug: Bendamustine

Study type: Interventional

Funder types: Industry

Identifiers

NCT06313996

CA082-011

2023-507477-18 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups

Arm A

Active Comparator group

Description:

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

Treatment:

Drug: Bendamustine

Drug: Prednisone

Drug: Cyclophosphamide

Drug: Doxorubicin

Drug: Lenalidomide

Drug: Rituximab

Drug: Vincristine

Arm B

Experimental group

Description:

Lisocabtagene Maraleucel

Treatment:

Drug: Fludarabine

Drug: Liso-cel