Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Follicular

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Follicular Lymphoma

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Anti-Infective Agents

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Doxorubicin

Liposomal doxorubicin

Prednisone

Bendamustine Hydrochloride

Rituximab

Vincristine

Lenalidomide

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antineoplastic Agents, Immunological

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Tubulin Modulators

Antimitotic Agents

Angiogenesis Inhibitors

Growth Inhibitors

Active Comparators:

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

B-R (bendamustine and rituximab)

R2 (rituximab and lenalidomide)

Bendamustine

Liso-cel

BMS Study Connect www.BMSStudyConnect.com

First line of the email MUST contain the NCT# and Site #

Bristol-Myers Squibb

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.

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.

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

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)

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

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

Defined as participants achieving a complete response per IRC assessment using the Lugano 2014 Criteria

Defined as the time from randomization to death due to any cause

Defined as participants achieving a response (CR or partial response (PR)) per IRC assessment using the Lugano 2014 Criteria

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

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

Defined as time from randomization to start of new anti-cancer therapy or death due to any cause, whichever occurs first

Defined as the time from randomization to death from any cause or tumor progression on next line treatment per Investigator assessment, whichever occurs first

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)

Celgene Corporation

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

Participants will receive mosunetuzumab for 12 cycles, plus lenalidomide from cycles 2-12 (Cycle length = 21 days for Cycle 1; cycle length = 28 days for Cycles 2-12)

Participants will receive weekly rituximab in Cycle 1, then on Day 1 of Cycles 3, 5, 7, 9, and 11. Participants will also receive lenalidomide in Cycles 1-12. (Cycle length = 28 days for Cycles 1-12)

Participants will receive intravenous (IV) mosunetuzumab in a step-up dosing schedule on Days 1, 8, and 15 of Cycle 1, and on Day 1 of Cycles 2-12

Mosunetuzumab

Participants will receive oral lenalidomide once daily on Days 1-21 of Cycles 2-12 (M + Len) or Cycles 1-12 (R + Len)

Participants will receive IV rituximab on Days 1, 8, 15, and 22 of Cycle 1, then on Day 1 of Cycles 3, 5, 7, 9, and 11

Tocilizumab will be administered as needed to manage cytokine release syndrome (CRS) events

Tociluzumab

Reference Study ID: GO42909 https://forpatients.roche.com/

Clinical Trials

This study will evaluate the efficacy and safety of mosunetuzumab in combination with lenalidomide (M + Len) compared to rituximab in combination with lenalidomide (R + Len) in participants with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least one line of prior systemic therapy.

A Study Evaluating the Efficacy and Safety of Mosunetuzumab in Combination With Lenalidomide in Comparison to Rituximab in Combination With Lenalidomide With a US Extension of Mosunetuzumab in Combination With Lenalidomide in Participants With Follicular Lymphoma

Phase III Randomized, Open-Label, Multicenter Study Evaluating Efficacy and Safety of Mosunetuzumab in Combination With Lenalidomide in Comparison to Rituximab in Combination With Lenalidomide With a Non-Randomized Single Arm US Extension of Mosunetuzumab in Combination With Lenalidomide in Patients With Follicular Lymphoma After at Least One Line of Systemic Therapy

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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	Relapsed or Ref...	Cyclophosphamid... Doxorubicin Vincristine Rituximab Prednisone Bendamustine Lenalidomide Fludarabine Liso-cel	18 Years -	Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
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	Relapsed or Ref...	Cyclophosphamid... Doxorubicin Vincristine Rituximab Prednisone Bendamustine Lenalidomide Fludarabine Liso-cel	18 Years -	Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
A Study Evaluating the Efficacy and Safety of Mosunetuzumab in Combination With Lenalidomide in Comparison to Rituximab in Combination With Lenalidomide With a US Extension of Mosunetuzumab in Combination With Lenalidomide in Participants With Follicular Lymphoma	NCT04712097	Relapsed or Ref...	Mosunetuzumab Lenalidomide Rituximab Tociluzumab	18 Years -	Hoffmann-La Roche

Spots Global Cancer Trial Database for relapsed or refractory follicular lymphoma