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Study of Mosunetuzumab Plus Lenalidomide Compared to Anti-CD20 Anti-body + Chemotherapy in Follicular Lymphoma FLIPI2-5

ConditionFollicular Lymphoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Lymphoma Academic Research Organisation

About this trial

This study is a phase III, randomized, open-label, international, multicenter, interventional trial, designed to compare the efficacy and safety of mosunetuzumab in combination with lenalidomide versus anti-CD20 monoclonal antibody (mAb) plus chemotherapy in patients with previously untreated FLIPI 2-5 follicular lymphoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Patient with histologically proven previously untreated CD20+ follicular lymphoma grade 1, 2, or 3a (including patient watched during up to 10 years after initial diagnosis) as assessed by the investigators according to the WHO 2016 classification12, or classical follicular lymphoma according to the WHO 2022 classification13. Diagnostic tissue must be available for central pathology review, exploratory endpoints and secondary data use.

FLIPI 2-5.

All Ann Arbor stages (including stage I if FLIPI ≥ 2).

At least one bi-dimensionally measurable nodal lesion, defined as > 15 mm in its longest dimension, or at least one bi-dimensionally measurable extra nodal lesion, defined as > 10 mm in its longest dimension (and FDG-avid lesion).

Disqualifiers

Grade 3b follicular lymphoma according to the WHO 2016 classification12, or follicular large B-cell lymphoma according to the WHO 2022 classification13

Suspicion or clinical evidence of transformed lymphoma at enrollment by investigator assessment.

Prior localized radiotherapy for the FL.

Prior history of another lymphoma.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mosunetuzumab

    Drug

    5 mg (step-up dosing) Day 1 of C1 45 mg Day 8 and Day 15 of C1, 45 mg Day 1 from C2 to C12, 45 mg Day 1 from C13 to C21

  • Lenalidomide

    Drug

    Lenalidomide starting dose is based on patient's creatinine clearance. Day 1 to Day 21 from C2 to C12

  • Rituximab

    Drug

    when associated to CHOP IV 375mg/m² SC 1400 mg allowed from C2 Day 1 of C1 Day 1 from C2 to C6 Day 1 from C7 to C20

  • Obinutuzumab

    Drug

    when associated to CHOP 1000 mg Day 1, Day 8, Day 15 of C1 Day 1 from C2 to C8 Day 1 from C9 to C18

  • Cyclophosphamide

    Drug

    750 mg/m2 Day 1 from C1 to C6

  • Doxorubicin

    Drug

    50 mg/m2 Day 1 from C1 to C6

  • Vincristin

    Drug

    1.4 mg/m2 (cap cf. below)$ Day 1 from C1 to C6

  • Prednisone

    Drug

    100 mg/day Day 1 to Day 5 from C1 to C6

  • Rituximab

    Drug

    when associated to bendamustin IV 375mg/m² SC 1400 mg allowed from C2 Day 1 of C1 Day 1 from C2 to C6 Day 1 from C7 to C18

  • Obinutuzumab

    Drug

    when associated to bendamustin 1000 mg Day 1, Day 8, Day 15 of C1 Day 1 from C2 to C8 Day 1 from C9 to C20

  • Bendamustin

    Drug

    90 mg/m2 Day 1 and Day 2 from C1 to C6

Treatment groups

790 Participants
are divided into 5 treatment groups
Group A: Mosun-LenExperimental treatment 2 interventions
Group B: R-CHOPActive comparator 5 interventions
Group C: G-CHOPActive comparator 5 interventions
Group D: R-BendaActive comparator 2 interventions
Group E: G-BendaActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Progression Free Survival (PFS)

time from randomization to the date of first documented disease progression/relapse or death from any cause, by Lugano 2014

Time frame
130 PFS events assessed by an Independent Review Committee (IRC) (4.6 years)
2

Progression Free Survival (PFS)

time from randomization to the date of first documented disease progression/relapse or death from any cause, by Lugano 2014

Time frame
173 PFS events assessed by IRC (5.8 y)

Secondary outcomes

1

Overall Response (OR)

by Lugano 2014 (PET-CT based response), assessed by investigator and IRC

Time frame
6 months
2

Complete Metabolic Rate (CMR)

by Lugano 2014 (PET-CT based response), assessed by investigator and IRC

Time frame
6 months
3

Overall Response (OR)

by Lugano 2014 (PET-CT based response), assessed by investigator and IRC

Time frame
12 months
4

Complete Metabolic Rate (CMR)

by Lugano 2014 (PET-CT based response), assessed by investigator and IRC

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Lymphoma Academic Research Organisation

Lead sponsor

Lymphoma Study Association

Collaborator

Swiss Cancer Institute

Collaborator

Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

Collaborator

Source ClinicalTrials.gov
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