Study Comparing Mosunetuzumab and Lenalidomide with Other Treatments for Patients with Relapsed or Refractory Marginal Zone Lymphoma

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What is this study about?

This clinical trial is focused on studying a type of cancer called Marginal Zone Lymphoma, which can return or not respond to previous treatments. The study will explore the effectiveness of a new treatment combination of Mosunetuzumab and Lenalidomide compared to other treatments chosen by doctors. Mosunetuzumab is a type of medicine that helps the immune system target cancer cells, while Lenalidomide is a medication that affects the immune system and is used to treat certain types of cancer.

The purpose of the study is to evaluate how well the combination of Mosunetuzumab and Lenalidomide works in patients with relapsed or refractory Marginal Zone Lymphoma. Participants in the study will receive either the new combination treatment or a treatment selected by their doctor, which may include other medications like Tocilizumab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, Bendamustine, or Rituximab. Some participants may receive a placebo instead of the new treatment to compare the results.

The study will take place over several months, during which participants will receive their assigned treatment and be monitored regularly to assess the treatment’s effects on their cancer. The main goal is to see if the new treatment can help patients live longer without their cancer getting worse. Participants will have regular check-ups and tests to track their progress and any side effects they may experience. The study aims to provide valuable information that could lead to better treatment options for people with Marginal Zone Lymphoma.

1 joining the study

Upon joining the study, you will be randomly assigned to one of two groups. One group will receive a combination of mosunetuzumab and lenalidomide, while the other group will receive a treatment chosen by the investigator.

2 treatment administration

If assigned to the mosunetuzumab and lenalidomide group, you will receive mosunetuzumab as a subcutaneous injection and lenalidomide orally. The specific dosage and frequency will be determined by the study protocol.

If assigned to the investigator’s choice group, the treatment plan will be explained to you, including the medications, their dosage, and how they will be administered.

3 monitoring and follow-up

Throughout the study, regular visits will be scheduled to monitor your health and the effectiveness of the treatment. This will include physical examinations, blood tests, and imaging scans.

You will be required to report any side effects or changes in your health to the study team.

4 end of treatment

At the end of the treatment period, a final assessment will be conducted to evaluate the response to the treatment.

You will be informed about the results and any further steps or follow-up care that may be necessary.

Who Can Join the Study?

Have a diagnosis of Marginal Zone Lymphoma (MZL), which is a type of cancer that affects certain white blood cells. This includes specific subtypes like extranodal (EMZL), splenic (SMZL), nodal (NMZL), or disseminated (DMZL).
Have a measurable disease, meaning the cancer can be seen and measured on a scan. For example, a lymph node must be at least 15 mm in size, or the spleen must be larger than 13 cm.
Have adequate blood cell counts unless low counts are due to the cancer itself. This includes:
- Platelet count (cells that help with blood clotting) of at least 75 G/L, or 30 G/L if low due to cancer.
- ANC (Absolute Neutrophil Count) of at least 1 G/L, unless low due to cancer.
- Hemoglobin (a protein in red blood cells) of at least 8 g/dL, unless low due to cancer.
Have normal liver function, with bilirubin levels no more than 1.5 times the normal limit, or 3 times for those with Gilbert syndrome.
Have normal liver enzymes, with AST or ALT levels no more than 2.5 times the normal limit, unless due to cancer.
Have a creatinine clearance (a measure of kidney function) of at least 40 mL/min.
If you have had hepatitis B, you must test negative for the virus to participate.
Use effective birth control if you are a woman of childbearing potential or a man with a partner who is or could become pregnant. This is to prevent pregnancy during and after the study treatment.
Be covered by a social security system.
Understand and speak one of the official languages of the country where the study is conducted.
Have been treated with at least one but no more than three previous treatments for MZL. One of these treatments must have included a drug targeting CD20, a protein on the surface of some cancer cells.
Sign an Informed Consent Form, which means you agree to participate in the study after understanding its details.
Be at least 18 years old.
Be able to follow the study procedures and attend required hospital visits.
Have an ECOG performance score of 2 or less, which means you are able to carry out all self-care but unable to carry out any work activities.
Have symptoms that require treatment with medication.
Not be eligible for local treatments like surgery or radiation.
If you have stage I disease of EMZL, SMZL, or NMZL, you may be eligible only if you cannot have local therapy.

Who Cannot Join the Study?

Patients who have a different type of cancer than the one being studied.
Patients who have not experienced a return or worsening of their condition after treatment.
Patients who are not within the specified age range for the study.
Patients who are unable to follow the study procedures or instructions.
Patients who have other serious health conditions that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients who have allergies to the study medications.
Patients who are unable to provide consent to participate in the study.
Patients who have a history of certain infections that could affect the study results.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Lille	Lille	France
Azienda Ospedaliero Universitaria Di Sassari	Sassari	Italy
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Centre Hospitalier D Avignon	Avignon	France
Centre Henri Becquerel	Rouen	France
Ospedale Vito Fazzi Lecce	Lecce	Italy
Azienda Sanitaria Universitaria Giuliano Isontina	Trieste	Italy
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.	Lisbon	Portugal
Centre Hospitalier De La Cote Basque	Bayonne	France
Centre Hospitalier Universitaire De Nice	Nice	France
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Ospedale Santa Maria Goretti Latina	Latina	Italy
Istituto Oncologico Veneto	Padua	Italy
Institut Jules Bordet	Anderlecht	Belgium
Centre Hospitalier Universitaire d’Orléans	Orléans	France
Universitaetsklinikum Regensburg AöR	Regensburg	Germany
Ospedale San Raffaele S.r.l.	Milan	Italy
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Azienda Unita Sanitaria Locale Della Romagna	Faenza	Italy
Robert Bosch Krankenhaus GmbH	Stuttgart	Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Universitair Ziekenhuis Gent	Gent	Belgium
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Klinikum Mutterhaus der Borromaeerinnen gGmbH	Trier	Germany
Klinikum der Stadt Ludwigshafen am Rhein gGmbH	Ludwigshafen Am Rhein	Germany
HELIOS Klinikum Berlin-Buch GmbH	Berlin	Germany
Centre Hospitalier Lyon Sud	Pierre Benite	France
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur	Namur	Belgium
Klinikum St Marien Amberg	Amberg	Germany
Hopital Saint Eloi	Montpellier	France
Hôpital Pontchaillou-CHU Rennes	Rennes	France
Czjhnpnfu Uaqbiiitbphpew Srlrhuvlq	Woluwe-Saint-Lambert	Belgium
Cwagfu Hihmgkmgbur Ublxaltqlrmqr Dz Diuqy	Dijon	France
Cvks Dk Nnyev	Vandoeuvre Les Nancy	France
Afeucxhrka Pchgdjuj Hzlidsgh Dk Pagqq	Paris	France
Bjnageaa Unkyclzxpb Hokgwhfb Cqpvui	Besançon	France
Acxbsds Oqpedllavez Umviunvkgkrsf Cctyhkwrltzr Ddeer Secpqk E Dirsj Stlbwxx Df Tmgijd	Turin	Italy
Ucdfwxrmkwryeharmocrk Wdwuswprl Adb	Wuerzburg	Germany
Aaxrrgu Udkiv Seubjqekj Leegjq Db Bkadhwz	Bologna	Italy
Itqubqxn df Cvkeltjlkuze Hwplctqierq Upluwriixapqo dn Scgqj Egqqfqm (rbbswcp	Saint Priest En Jarez	France
Hmjedmr Hlifj Mzakbq &pfrscc 1 rpk Gildsyq Etolhk	Creteil	France
Igxionro Pnxaoresclkhuxo Cbchpb Cmrnsq	Marseille	France

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	01.09.2023
France	Recruiting	01.09.2023
Germany	Recruiting	01.09.2023
Italy	Recruiting	01.09.2023
Portugal	Recruiting	01.09.2023

Trial locations

Investigated drugs:

Mosunetuzumab is a type of medication known as a monoclonal antibody. It is designed to help the body’s immune system find and destroy cancer cells. In this trial, mosunetuzumab is being tested to see how well it works for patients with a type of cancer called marginal zone lymphoma that has come back or has not responded to previous treatments.

Lenalidomide is a medication that helps the immune system fight cancer and also works to stop cancer cells from growing. It is often used to treat certain types of blood cancers. In this study, lenalidomide is being used in combination with mosunetuzumab to see if this combination is more effective in treating marginal zone lymphoma compared to other treatments chosen by the doctors involved in the trial.

Investigated diseases:

Marginal zone lymphoma refractory

Relapsed or Refractory Marginal Zone Lymphoma – This is a type of non-Hodgkin lymphoma that originates in the marginal zone of lymphoid tissue. It is characterized by the abnormal growth of B-cells, a type of white blood cell, which can lead to the formation of tumors in lymph nodes and other organs. The disease is termed “relapsed” when it returns after treatment and “refractory” when it does not respond to standard treatments. As the disease progresses, it may spread to other parts of the body, including the bone marrow and spleen. Symptoms can include swollen lymph nodes, fatigue, and weight loss. The progression of the disease can vary, with some cases remaining indolent for years while others may become more aggressive.

Trial ID:

2022-501810-77-00

Protocol code:

MARSUN

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Mosunetuzumab and Lenalidomide with Other Treatments for Patients with Relapsed or Refractory Marginal Zone Lymphoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?