Study on Mosunetuzumab and Lenalidomide for Patients with Follicular Lymphoma After Previous Treatment

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What is this study about?

This clinical trial is focused on studying a type of cancer called follicular lymphoma, which is a form of non-Hodgkin lymphoma. The study is investigating the effectiveness and safety of different treatment combinations for patients who have experienced a return or persistence of this cancer after receiving at least one previous treatment. The treatments being studied include a combination of Mosunetuzumab and Lenalidomide, and a combination of Rituximab and Lenalidomide. Mosunetuzumab is administered as a solution for infusion, which means it is given directly into the bloodstream through a vein, while Lenalidomide is taken orally in the form of capsules. Rituximab is also given as an infusion.

The purpose of the study is to compare how well these treatment combinations work in controlling the disease and to assess their safety. The study is divided into different parts, with some patients receiving Mosunetuzumab and Lenalidomide, and others receiving Rituximab and Lenalidomide. There is also a part of the study where all patients receive Mosunetuzumab and Lenalidomide without randomization. The study will monitor the patients over a period to see how the treatments affect the progression of the disease and to observe any side effects that may occur.

Throughout the study, patients will receive regular check-ups and assessments to track their response to the treatment. The study aims to provide valuable information on the best treatment options for managing follicular lymphoma, helping to improve outcomes for patients with this condition. The trial is expected to continue until 2029, allowing for comprehensive data collection and analysis.

1 joining the study

Upon joining the study, the patient is assigned to one of the treatment arms. The study involves evaluating the effectiveness and safety of different medication combinations for treating follicular lymphoma.

2 treatment arm assignment

The patient may be placed in one of three arms: Arm A, Arm B, or Arm C. Each arm involves different combinations of medications.

3 medication administration

In Arm A, the patient receives mosunetuzumab through an intravenous infusion and lenalidomide orally. The dosage of lenalidomide may vary between 5 mg, 10 mg, 15 mg, or 20 mg capsules.

In Arm B, the patient receives rituximab through an intravenous infusion and lenalidomide orally, with similar dosage options as Arm A.

In Arm C, the patient receives mosunetuzumab and lenalidomide in a non-randomized single-arm extension, with the same administration methods and dosage options.

4 monitoring and evaluation

Throughout the study, the patient’s response to treatment is monitored. This includes assessing progression-free survival, overall survival, and response rates.

Regular evaluations are conducted to monitor the patient’s health, including physical functioning and any side effects experienced.

5 completion of study

The study is estimated to conclude by April 2029. Upon completion, the patient’s overall response to the treatment will be assessed, and any further treatment options will be discussed.

Who Can Join the Study?

  • Must have a confirmed diagnosis of follicular lymphoma (a type of blood cancer) that is CD20 positive and falls within Grades 1-3a.
  • Need to require systemic therapy, which means treatment that affects the whole body, based on the size of the tumor or specific criteria known as GELF criteria.
  • Must have received at least one previous treatment for lymphoma, which included either immunotherapy (treatment that uses the body’s immune system to fight cancer) or chemoimmunotherapy (a combination of chemotherapy and immunotherapy).
  • Must have a sample of the tumor and the pathology report available at the time of relapse or persistence to confirm the diagnosis of follicular lymphoma.
  • Must agree to follow all local requirements of the lenalidomide risk minimization plan, which includes a global program to prevent pregnancy while on the medication.
  • Must have adequate hematologic (related to blood) and organ function, meaning the blood and organs are working well enough to participate in the study.
  • Both male and female participants are eligible.

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 follicular lymphoma.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to follow the study procedures or take the study medications as required.
  • Patients who have other serious health conditions that could 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 or their ingredients.
  • Patients who have had certain treatments for their cancer recently.
  • Patients who have an active infection that requires treatment.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Hopital Saint Antoine Paris France
Centre Antoine Lacassagne Nice France
Centre Hospitalier Universitaire De Nimes Nimes France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Vivantes Netzwerk fuer Gesundheit GmbH Berlin Germany
Hospital General Universitario Morales Meseguer Murcia Spain
Instytut Hematologii I Transfuzjologii Warsaw Poland
Azienda Ospedaliera di Padova Padua Italy
Centre Henri Becquerel Rouen France
Pratia Hematologia Sp. z o.o. Katowice Poland
Virgen del Rocío University Hospital Sevilla Spain
Universitaetsklinikum Regensburg AöR Regensburg Germany
Centre Hospitalier Universitaire De Montpellier Montpellier France
Universita’ Politecnica Delle Marche Ancona Italy
Centre Hospitalier De La Cote Basque Bayonne France
Centre Hospitalier Metropole Savoie Chambery France
Centre Hospitalier Universitaire De Nantes Nantes France
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Centre Hospitalier Universitaire De Rennes Rennes France
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Cdnoco Hlsqpdejvnf Urzypxguflnrl Rtreh Reims France
Mqqfbmjvbqzjvmgehcrbqlwvir Hutiatvauogdceel Halle (Saale) Germany
Sfwxzsmt Pepqdhtrg Swx z outy Gdynia Poland
Alvyybi Ozjomaoagfx Oqfudbwz Rewgvbp Vzhbs Saogg Cmlfjust Palermo Italy
Apbxavnqpt Ppyerxqd Hakcnyxj Dt Ppdqa Paris France
Hdallgzy Uiatnegvhkfiu Dxxvdute Donostia / San Sebastian Spain
Akniacg Ugbvo Sgtjclgir Lnqqau Dn Buuejvx Bologna Italy
Uurrjbvouytkgf Cwifojr Kxaycnxak Gdansk Poland
Fiywmgfzr Ppzu Lv Iqqounqwdolct Bakizmovv Dtg Hpyruyks Usqgmsumxxtug Lf Piy Madrid Spain
Iptncwsr Pquwyffglvppaxv Cbdpmq Cntibs Marseille France
Hmwepvzj Uzuvrzbxydfvkc Szjtdmruyb &zgupey Hajhlsv dq Hykvczoaxud STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
29.11.2021
Germany Germany
Not recruiting
29.11.2021
Italy Italy
Not recruiting
29.11.2021
Poland Poland
Not recruiting
29.11.2021
Spain Spain
Not recruiting
29.11.2021

Trial locations

Mosunetuzumab is a medication being studied for its effectiveness in treating follicular lymphoma. It is used in combination with another medication to see if it can help control the disease better than existing treatments. This medication works by targeting specific cells in the immune system to help fight the cancer.

Lenalidomide is a medication that is often used in combination with other drugs to treat certain types of cancer, including follicular lymphoma. It helps the immune system attack cancer cells and can also stop the growth of new blood vessels that tumors need to grow.

Rituximab is a medication that is commonly used to treat various types of lymphoma. It works by targeting a specific protein on the surface of cancer cells, helping the immune system to destroy these cells. In this trial, it is used in combination with lenalidomide to compare its effectiveness against the new combination therapy.

Investigated diseases:

Relapsed/Refractory Follicular Lymphoma – This is a type of non-Hodgkin lymphoma that originates from B-lymphocytes, a kind of white blood cell. It is characterized by the recurrence or persistence of the disease after initial treatment. The disease typically progresses slowly, but it can become more aggressive over time. Patients may experience symptoms such as enlarged lymph nodes, fatigue, and night sweats. The condition is often marked by periods of remission and relapse. As it progresses, it may require different therapeutic approaches to manage the symptoms and control the disease.

Trial ID:
2023-505807-21-00
Protocol code:
GO42909
Trial Phase:
Therapeutic confirmatory (Phase III)

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