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

Summary

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.

Conditions

• Follicular Lymphoma

Interventions

DRUG

Vincristin

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

DRUG

Prednisone

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

DRUG

Rituximab

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

DRUG

Obinutuzumab

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

DRUG

Bendamustin

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

DRUG

Mosunetuzumab

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

DRUG

Lenalidomide

20 mg/day Day 1 to Day 21 from C2 to C12

DRUG

Rituximab

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

DRUG

Obinutuzumab

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

DRUG

Cyclophosphamide

750 mg/m2 Day 1 from C1 to C6

DRUG

Doxorubicin

50 mg/m2 Day 1 from C1 to C6

Sponsors & Collaborators

• Lymphoma Study Association

  collaborator OTHER

• Swiss Cancer Institute

  collaborator OTHER

• Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

  collaborator OTHER

• The Lymphoma Academic Research Organisation

  lead OTHER

Principal Investigators

• Franck MORSCHHAUSER · Lymphoma Study Association

• Christian BUSKE · GLA

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-06-07

Primary Completion

2028-11-30

Completion

2034-04-30

FDA Drug

Yes

Countries

• Belgium
• France
• Germany
• Portugal
• Spain

Study Locations