Study on the Safety and Effects of Mosunetuzumab and Lenalidomide for Patients with Follicular Lymphoma

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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 evaluating the safety and effectiveness of a treatment that combines two medications: Mosunetuzumab and Lenalidomide. Mosunetuzumab is a medication that can be given either through an injection under the skin (subcutaneously) or directly into a vein (intravenously). Lenalidomide is taken orally in the form of capsules.

The purpose of the study is to determine the best dose of the combination treatment and to compare the two methods of administering Mosunetuzumab. The study will be conducted in two stages. In the first stage, participants will receive the combination of Mosunetuzumab and Lenalidomide to evaluate safety and determine the most suitable dose. In the second stage, participants will be randomly assigned to receive Mosunetuzumab either subcutaneously or intravenously, along with Lenalidomide, to further assess safety and how the body processes the drugs.

Throughout the study, researchers will monitor participants for any side effects and measure how the drugs are absorbed and processed by the body. The study aims to find out if the combination of Mosunetuzumab and Lenalidomide is a safe and effective treatment option for patients with Follicular Lymphoma.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s objectives and procedures. The patient will be required to provide informed consent, acknowledging understanding of the study and agreeing to participate.

2 initial assessment

The patient will undergo an initial assessment to confirm eligibility. This includes a review of medical history, physical examination, and necessary laboratory tests to ensure the patient meets the inclusion criteria.

3 treatment phase – non-randomized stage

The patient will receive mosunetuzumab and lenalidomide. Mosunetuzumab can be administered either intravenously (IV) or subcutaneously (SC), while lenalidomide is taken orally. The dosage and frequency will be determined based on the patient’s response and tolerance.

During this stage, the focus is on evaluating the safety and determining the maximum tolerated dose of the combination treatment.

4 treatment phase – randomized stage

In this stage, the patient may be randomly assigned to receive mosunetuzumab either intravenously (IV) or subcutaneously (SC), in combination with lenalidomide. The objective is to compare the two methods of administration in terms of safety and how the body processes the drug.

The patient will continue to take lenalidomide orally as prescribed.

5 monitoring and follow-up

Throughout the trial, the patient will be closely monitored for any side effects or adverse reactions. Regular check-ups will include physical examinations, laboratory tests, and imaging studies to assess the response to treatment.

Adjustments to the treatment plan may be made based on the patient’s condition and any side effects experienced.

6 completion of the study

Upon completion of the treatment phase, the patient will undergo a final assessment to evaluate the overall response to the treatment. This includes a comprehensive review of the patient’s health status and any changes observed during the study.

The patient will receive information about any further follow-up or care required after the study concludes.

Who Can Join the Study?

Patients must have Follicular Lymphoma (FL), a type of blood cancer.
Patients should have an Eastern Cooperative Oncology Group Performance Status of 0, 1, or 2, which means they are fully active or have some limitations but can still take care of themselves.
Patients must have relapsed or refractory (R/R) FL, meaning the disease has returned or not responded after at least one previous treatment, which included immunotherapy or chemoimmunotherapy.
Patients who have not been treated before must need systemic therapy, as determined by a doctor using specific criteria called GELF criteria.
The disease must be confirmed as Grade 1, 2, or 3a FL and must show a protein called CD20, as checked by a local lab.
The lymphoma must be fluorodeoxyglucose avid, meaning it shows up on a special scan called a PET scan.
There must be at least one measurable lymph node larger than 1.5 cm or one measurable area outside the lymph nodes larger than 1.0 cm, as seen on a PET-CT scan.
Participants can be both male and female.
Participants must be adults, typically aged 18 and older.

Who Cannot Join the Study?

Patients who have a different type of cancer other than Follicular Lymphoma (FL) cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are not able to follow the study procedures or take the study medications as required cannot participate.
Patients who have certain medical conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial recently may not be eligible.
Patients who have allergies or reactions to the study medications cannot participate.
Patients who have certain infections or diseases that could affect the study cannot participate.
Patients who are unable to provide informed consent cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Oncopole Claudius Regaud	Toulouse	France
Hospital Universitario De Salamanca	Salamanca	Spain
Centre Hospitalier Universitaire De Lille	Lille	France

Other Sites

Site Name	City	Country
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier Universitaire De Rennes	Rennes	France
Hopital Beaujon	Clichy	France
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Hgzhdrsl Vhnl dawkpngp	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
France	Not recruiting	08.08.2020
Spain	Not recruiting	08.08.2020

Trial locations

Investigated drugs:

Mosunetuzumab is a medication being studied for its ability to treat follicular lymphoma. It works by helping the immune system target and destroy cancer cells. In this trial, researchers are looking at how safe and effective it is when given in two different ways: under the skin (subcutaneous) and directly into a vein (intravenous).

Lenalidomide is a medication used to treat certain types of blood cancers, including follicular lymphoma. It helps the immune system fight cancer and can also stop cancer cells from growing. In this study, lenalidomide is being used in combination with mosunetuzumab to see if the two drugs together are more effective than mosunetuzumab alone.

Investigated diseases:

Follicular lymphoma

Follicular Lymphoma – Follicular Lymphoma is a type of non-Hodgkin lymphoma that typically arises from B-lymphocytes, a kind of white blood cell. It is characterized by slow growth and often presents with painless swelling of lymph nodes. The disease can spread to other parts of the body, including the bone marrow and spleen. Patients may experience symptoms such as fatigue, night sweats, and weight loss. The progression of Follicular Lymphoma can vary, with some individuals experiencing long periods without symptoms. It is considered an indolent form of lymphoma, meaning it progresses slowly compared to other types.

Trial ID:

2023-507236-20-00

Protocol code:

CO41942

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Safety and Effects of Mosunetuzumab and Lenalidomide for Patients with Follicular Lymphoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?