Actively Recruiting
Mosunetuzumab-Lenalidomide Versus Investigator Choices in Patients With Relapsed or Refractory Marginal Zone Lymphoma
Led by The Lymphoma Academic Research Organisation · Updated on 2025-12-19
260
Participants Needed
48
Research Sites
469 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open label, multi-center, international, randomized phase III trial to compare the efficacy of Mosunetuzumab-Lenalidomide with investigator choices exclusively in R/R MZL patients. Patients with a proven diagnosis of EMZL, SMZL or NMZL subtypes and previously treated with at least one prior systemic treatment and not more than three prior lines are eligible. Previous treatment line must include at least one systemic line with a drug targeting CD20 (monoclonal antibody at least 2 cycles) with or without chemotherapy (R-CHOP, R-Bendamustine, R-CVP, R-Chlorambucil at least 2 cycles) or targeted treatment such as Ibrutinib. The patients will be Randomized as follows: Arm A - Experimental arm: • Mosunetuzumab-Lenalidomide Arm B - Comparator arms ( Investigator Choices): * Rituximab-Lenalidomide * Rituximab-Bendamustine * Rituximab-CHOP
CONDITIONS
Official Title
Mosunetuzumab-Lenalidomide Versus Investigator Choices in Patients With Relapsed or Refractory Marginal Zone Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of marginal zone lymphoma (extranodal, splenic, or nodal subtypes)
- Previously treated with at least one and no more than three systemic therapies, including at least one CD20-targeting drug
- Patients previously treated with lenalidomide are eligible if last dose was more than 12 months before study start
- Signed informed consent form
- Age 18 years or older at consent
- Ability to comply with study protocol and required hospitalizations
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Symptomatic disease requiring systemic treatment
- Not eligible for local therapy such as radiotherapy or surgery
- Stage I disease eligible only if not a candidate for local therapy
- Measurable disease on imaging with specified size criteria
- Adequate blood counts unless abnormalities are due to lymphoma or related causes
- Liver and kidney function within specified limits
- Negative hepatitis B virus PCR if hepatitis B core antibody positive
- For women of childbearing potential, negative pregnancy test and use of effective contraception
- For men, agreement to use contraception or abstinence during and after treatment
- Covered by social security (France)
- Able to understand and speak an official language of the study country
You will not qualify if you...
- Histologic transformation of MZL to high-grade lymphoma
- Prior treatment with mosunetuzumab or other CD20/CD3 bispecific antibodies
- Allogeneic stem cell transplant
- Radiotherapy within 2 weeks before study treatment
- Autologous stem cell transplant within 100 days before study treatment
- Monoclonal antibody treatment within 4 weeks before study treatment
- Systemic immunosuppressive medications within 2 weeks before treatment, except certain corticosteroids
- Use of other anticancer investigational therapies within 4 weeks before study treatment
- Pregnancy, breastfeeding, or intention to become pregnant during the study or within specified periods after treatment
- Live attenuated vaccine within 4 weeks before or during study treatment, except acute pandemic situations
- Active or history of central nervous system lymphoma
- Severe allergic reactions to monoclonal antibody therapies
- Known hypersensitivity to study drug components
- Inability to receive appropriate prophylaxis for blood clots
- Recent or active infections requiring intravenous antibiotics or hospitalization
- Significant cardiovascular, pulmonary, liver, or central nervous system diseases
- History of progressive multifocal leukoencephalopathy
- Positive HIV test
- Active hepatitis C virus infection
- History of hemophagocytic lymphohistiocytosis
- Recent autoimmune or inflammatory diseases requiring treatment
- Recent major surgery with bleeding risk
- Solid organ transplantation
- Serious medical conditions or abnormalities that preclude safe participation
- Legal or consent incapacity issues
- Inability to receive at least one comparator treatment regimen
- Suspicion or evidence of transformed lymphoma
- Uncontrolled symptomatic pleural or serous effusions
- Uncontrolled urinary obstruction causing kidney failure
- High tumor burden as defined by blood counts or organ size
AI-Screening
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Trial Site Locations
Total: 48 locations
1
INSTITUT JULES BORDET - Service Hématologie
Anderlecht, Belgium, 1070
Not Yet Recruiting
2
UNIVERSITE CATHOLIQUE DE LOUVAIN SAINT-LUC - Service Hématologie
Brussels, Belgium, 1200
Not Yet Recruiting
3
UNIVERSITAIR ZIEKENHUIS GENT - Service Hématologie
Ghent, Belgium, 9000
Actively Recruiting
4
CHU UCL NAMUR - SITE GODINNE - Service Hématologie
Yvoir, Belgium, 5530
Not Yet Recruiting
5
CHU d'Amiens
Amiens, France
Actively Recruiting
6
CH d'Avignon - Hopital Henri Duffaut
Avignon, France
Actively Recruiting
7
CH de la Côte Basque - Hôpital de Bayonne
Bayonne, France
Actively Recruiting
8
CHRU Besançon - Hôpital Minjoz
Besançon, France
Actively Recruiting
9
Institut Bergonié
Bordeaux, France
Actively Recruiting
10
Chu Estaing
Clermont-Ferrand, France
Actively Recruiting
11
CHU Henri Mondor
Créteil, France
Actively Recruiting
12
CHU de Dijon
Dijon, France
Actively Recruiting
13
CHU de Grenoble - Hôpital Albert Michallon
La Tronche, France
Actively Recruiting
14
CHRU de LILLE - Claude Huriez
Lille, France
Actively Recruiting
15
Institut Paoli Calmette
Marseille, France
Actively Recruiting
16
CH Saint-Eloi
Montpellier, France
Actively Recruiting
17
CHU de Nancy - Brabois
Nancy, France
Actively Recruiting
18
Centre Catherine de Sienne
Nantes, France
Actively Recruiting
19
CHU de Nantes - Hôtel Dieu
Nantes, France
Actively Recruiting
20
Centre Antoine Lacassagne
Nice, France
Actively Recruiting
21
CHU de Nice
Nice, France
Actively Recruiting
22
CHR d'Orléans
Orléans, France
Actively Recruiting
23
APHP - Hôpital Saint Louis
Paris, France
Actively Recruiting
24
CHU Lyon Sud
Pierre-Bénite, France
Actively Recruiting
25
CHU de Rennes - Hôpital de Pontchaillou
Rennes, France
Actively Recruiting
26
Centre Henri Becquerel
Rouen, France
Actively Recruiting
27
Institut de Cancérologie de la Loire Lucien Neuwirth
Saint-Priest-en-Jarez, France
Actively Recruiting
28
KLINIKUM ST. MARIEN AMBERG - Hämatologie/Onkologie
Amberg, Germany
Not Yet Recruiting
29
Helios Klinikum Berlin-Buch - Klinik für Hämatologie und Stammzelltransplantation
Berlin, Germany
Not Yet Recruiting
30
UNIVERSITAETSKLINIKUM SCHLESWIG-HOLSTEIN - Med. Klinik II - Hämatologie und Onkologie
Kiel, Germany
Not Yet Recruiting
31
KLINIKUM DER STADT LUDWIGSHAFEN - Hämatologie
Ludwigshafen, Germany
Actively Recruiting
32
UNIVERSITATSKLINIKUM REGENSBURG - Klinik für Innere Medizin III
Regensburg, Germany
Not Yet Recruiting
33
ROBERT BOSCH KRANKENHAUS - Hämatologie, Onkologie und Palliativmedizin
Stuttgart, Germany
Not Yet Recruiting
34
MUTTERHAUS DER BORROMAERINNEN - Hämatologie
Trier, Germany
Not Yet Recruiting
35
UNIV KLINIKUM ULM - INNERE MEDIZIN III - Hämatologie
Ulm, Germany
Not Yet Recruiting
36
UNIVERSITY WURZBURG - Hämatologie
Würzburg, Germany
Not Yet Recruiting
37
POLICLINICO SANT'ORSOLA-MALPIGHI - Ematologia
Bologna, Italy
Not Yet Recruiting
38
INSTITUTO ONCOLOGICO VENETO I.R.C.C.S - Ematologia
Castelfranco Veneto, Italy
Not Yet Recruiting
39
AZIENDA OSPEDALIERA S. CROCE E CARLE CUNEO - Ematologia
Cuneo, Italy
Not Yet Recruiting
40
SAPIENZA UNIVERSIT DI ROMA - POLO PONTINO - OSPEDALE S. MARIA GORETTI LATINA - UOC Ematologia
Latina, Italy
Not Yet Recruiting
41
OSPEDALE VITO FAZZI LECCE - Hematologia
Lecce, Italy
Not Yet Recruiting
42
OSPEDALE SAN RAFFAELE - Unità di Ricerca Clinica Linfomi Dipartimento di Onco-ematologia
Milan, Italy
Not Yet Recruiting
43
AZIENDA OSPEDALIERO UNIVERITARIA DI MODENA - Ematologia
Modena, Italy
Not Yet Recruiting
44
POLICLINICO SAN MATTEO - SC Ematologia
Pavia, Italy
Not Yet Recruiting
45
OSPEDALE S. MARIA DELLE CROCI - Dipartimento di Oncologia ed Ematologia
Ravenna, Italy
Not Yet Recruiting
46
AOU CITTA DELLA SALUTE E DELLA SCIENZA DI TORINO - Ematologia
Torino, Italy
Not Yet Recruiting
47
OSPEDALE MAGGIORE ASUGI - UCO Ematologia
Trieste, Italy
Not Yet Recruiting
48
INSTITUTO PORTUGUES DE ONCOLOGIA DE LISBOA FRANCISCO GENTIL - Departamento Hematologia
Lisbon, Portugal, 1099
Actively Recruiting
Research Team
C
Christine STEPHAN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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