Mosunetuzumab-Lenalidomide Versus Investigator Choices in Patients With Relapsed or Refractory Marginal Zone Lymphoma

PHASE3RecruitingINTERVENTIONAL
Enrollment

260

Participants

Timeline

Start Date

September 5, 2023

Primary Completion Date

September 30, 2027

Study Completion Date

September 30, 2032

Conditions
Marginal Zone Lymphoma
Interventions
DRUG

Mosunetuzumab + Lenalidomide

"* Mosunetuzumab will be administered SC (21 days first cycle, then 28 days next cycles)~ * C1 (21-days cycle): step-up dosing schedule 5 mg Day 1, 45 mg on Day 8 and 45 mg Day 15~ * C2 to C12: 45 mg D1 28-days cycles~* Lenalidomide PO 20 mg/day from Day 1 to Day 21 from cycles C2 to C6 (cycles of 28 days)"

DRUG

- Rituximab + Lenalidomide (28-days cycles

"* Lenalidomide PO 20 mg/day, D1-21 from cycle 1 to cycle 6~* Rituximab\* 375 mg/m2 intravenously at Day 1 cycle 1, and then subcutaneous (1400 mg, flat dose) at D1 of cycles 2-12"

DRUG

- Rituximab + Bendamustine (28-days cycles)

"* Bendamustine IV 70 or 90 mg/m² (according to the investigator's judgment) D1 and D2/28 days x 6 cycles 28 days cycles). For patients in complete response (CR) at 3 cycles, Bendamustine and Rituximab could be stopped after 4 cycles at investigator discretion~* Rituximab\* 375 mg/m2 intravenously at cycle 1 Day 1, and then subcutaneous (1400 mg, flat dose) at D1 of cycles 2 to 6\*\* (28-days cycles) and then at D1 of three additional 56-days cycles (C7 to C9). \*\*For patients in complete response (CR) at 3 cycles, if Bendamustine is stopped, then Rituximab should also be omitted for C5 and C6."

DRUG

- Rituximab + CHOP (21-days cycles)

"* CHOP, IV standard dose from cycle 1 to 6~* Rituximab\* 375 mg/m2 intravenously at Day 1 cycle 1, and then subcutaneous (1400 mg, flat dose) at D1 of cycles 2 to 6 (21-days cycles), and then at D1 of three additional 56-days cycles (C7 to C9)"

Trial Locations (28)

1070

NOT_YET_RECRUITING

INSTITUT JULES BORDET - Service Hématologie, Anderlecht

1099

RECRUITING

INSTITUTO PORTUGUES DE ONCOLOGIA DE LISBOA FRANCISCO GENTIL - Departamento Hematologia, Lisbon

1200

NOT_YET_RECRUITING

UNIVERSITE CATHOLIQUE DE LOUVAIN SAINT-LUC - Service Hématologie, Brussels

5530

NOT_YET_RECRUITING

CHU UCL NAMUR - SITE GODINNE - Service Hématologie, Yvoir

9000

NOT_YET_RECRUITING

UNIVERSITAIR ZIEKENHUIS GENT - Service Hématologie, Ghent

Unknown

RECRUITING

CHU d'Amiens, Amiens

RECRUITING

CH d'Avignon - Hopital Henri Duffaut, Avignon

RECRUITING

CH de la Côte Basque - Hôpital de Bayonne, Bayonne

RECRUITING

CHRU Besançon - Hôpital Minjoz, Besançon

RECRUITING

Institut Bergonié, Bordeaux

RECRUITING

Chu Estaing, Clermont-Ferrand

RECRUITING

CHU Henri Mondor, Créteil

RECRUITING

CHU de Dijon, Dijon

RECRUITING

CHU de Grenoble - Hôpital Albert Michallon, La Tronche

RECRUITING

CHRU de LILLE - Claude Huriez, Lille

RECRUITING

Institut Paoli Calmette, Marseille

RECRUITING

CH Saint-Eloi, Montpellier

RECRUITING

CHU de Nancy - Brabois, Nancy

RECRUITING

Centre Catherine de Sienne, Nantes

RECRUITING

CHU de Nantes - Hôtel Dieu, Nantes

RECRUITING

Centre Antoine Lacassagne, Nice

RECRUITING

CHU de Nice, Nice

RECRUITING

CHR d'Orléans, Orléans

RECRUITING

APHP - Hôpital Saint Louis, Paris

RECRUITING

CHU Lyon Sud, Pierre-Bénite

RECRUITING

CHU de Rennes - Hôpital de Pontchaillou, Rennes

RECRUITING

Centre Henri Becquerel, Rouen

RECRUITING

Institut de Cancérologie de la Loire Lucien Neuwirth, Saint-Priest-en-Jarez

All Listed Sponsors
lead

The Lymphoma Academic Research Organisation

OTHER