Study on Lenalidomide, Tafasitamab, and Rituximab for Treating Diffuse Large B-Cell Lymphoma in Patients Aged 80 and Older

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What is this study about?

This clinical trial is focused on studying the effectiveness of a combination of medications for treating Diffuse Large B-Cell Lymphoma, a type of cancer that affects the lymphatic system. The treatment being tested includes a combination of three medications: Lenalidomide, Tafasitamab, and Rituximab. Lenalidomide is taken orally in the form of capsules, Tafasitamab is administered through an intravenous infusion, and Rituximab is given as a solution for injection or infusion.

The purpose of the study is to evaluate how well this combination of medications works in patients who are 80 years old or older. Participants will receive these treatments over a series of cycles, with the goal of assessing the overall response rate, which measures how the cancer responds to the treatment. The study will also monitor the safety of the medications and their impact on the quality of life of the participants.

Throughout the study, participants will undergo regular assessments to track their progress and any changes in their condition. The study aims to provide valuable information on the potential benefits and risks of using this combination of medications for treating elderly patients with Diffuse Large B-Cell Lymphoma.

1 joining the study

Upon joining the study, you will be required to sign an Informed Consent Form. This form confirms that you understand the study and agree to participate.

You will undergo initial assessments to ensure you meet the study’s eligibility criteria, such as having a confirmed diagnosis of Diffuse Large B-Cell Lymphoma and being 80 years or older.

2 treatment initiation

The treatment involves a combination of medications: rituximab, tafasitamab, and lenalidomide. These medications are used to treat your condition.

Rituximab is administered as a solution for infusion, which means it is given through a vein. Tafasitamab is also given as an infusion. Lenalidomide is taken orally in the form of capsules.

3 treatment cycles

The treatment is organized into cycles. Each cycle lasts for a specific period, during which you will receive the medications at scheduled intervals.

The study aims to evaluate the effectiveness of the treatment after three cycles or if the treatment is permanently discontinued earlier.

4 monitoring and assessments

Throughout the study, your health and response to the treatment will be closely monitored. This includes regular medical assessments and imaging tests like PET-CT scans.

These assessments help determine how well the treatment is working and ensure your safety during the study.

5 end of participation

Your participation in the study will conclude after the specified treatment cycles or if you choose to withdraw from the study.

At the end of your participation, final assessments will be conducted to evaluate your overall response to the treatment.

Who Can Join the Study?

Patient must understand and voluntarily sign an Informed Consent Form before any study-specific assessments or procedures are conducted.
Patients should be able to receive the R-miniCHOP regimen, which means having a left ventricular ejection fraction greater than 50% and being in good general condition according to the investigator’s judgment.
Patients should be able to receive adequate prevention or treatment for thromboembolic events (blood clots), using aspirin or low molecular weight heparin.
Patient must have a histologically proven CD20+ diffuse large B-cell lymphoma (DLBCL) according to the WHO classification 2017, including all clinical subtypes.
Patient must have Positron-Emission Tomography (PET)-positive disease, which means the disease is detectable using a PET scan.
Patient must have previously untreated high-grade B-cell lymphoma.
Patient must be aged 80 years or older at the time of signing the informed consent form.
Patient must be at Ann Arbor stage I, II, III, or IV, which refers to the extent of the lymphoma in the body.
Patient must have an ECOG performance status of 2 or less, which measures the patient’s level of functioning.
Patient must have a minimum life expectancy of 3 months.
Male patients must practice complete abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions, and for 4 months following study drug discontinuation, even if they have undergone a successful vasectomy.

Who Cannot Join the Study?

Patients who do not have Diffuse Large B-Cell Lymphoma cannot participate.
Patients who are not in the specified age range for the study cannot participate.
Patients who are part of a vulnerable population cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Lille	Lille	France

Other Sites

Site Name	City	Country
Centre Hospitalier D Avignon	Avignon	France
Centre Hospitalier De La Cote Basque	Bayonne	France
Grand Hopital De Charleroi	Charleroi	Belgium
Centre Henri Becquerel	Rouen	France
Centre Hospitalier Sud Francilien	Corbeil Essonnes	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
CHU Helora	La Louviere	Belgium
Centre hospitalier universitaire de Liege	Liege	Belgium
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur	Namur	Belgium
Groupement Des Hopitaux De L’Institut Catholique De Lille	lomme	France
CHRU De Nancy	Vandoeuvre Les Nancy	France
Cfufqplwj Uybcryetyjubxf Sdfvxgkjk	Woluwe-Saint-Lambert	Belgium
Acrabvnesp Pqorchhi Hftldkfl Dn Ppyvr	Paris	France
Cazxsj Hdsqmygojdi Ew Umyxqosywuenp Dv Lykioxv	Limoges	France
Bxcveqlz Ujcrratdae Hmkkhqst Ctfrcf	Besançon	France
Iaumjfjf dg Chbguwfvljao Hfnmfmddxtt Ukdoibgtrjzln dp Sgrap Ewatapo (mrwqhpv	Saint Priest En Jarez	France

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	02.08.2021
France	Not recruiting	02.08.2021

Trial locations

Investigated drugs:

Lenalidomide is a medication that helps the immune system fight cancer. It works by stopping the growth of cancer cells and reducing the blood supply to tumors. In this trial, it is used to treat a type of cancer called Diffuse Large B-Cell Lymphoma in elderly patients.

Tafasitamab is an antibody that targets a specific protein on the surface of cancer cells. By attaching to this protein, it helps the immune system recognize and destroy the cancer cells. This medication is used in combination with others to improve the treatment of Diffuse Large B-Cell Lymphoma.

Rituximab is a medication that also targets cancer cells by attaching to a specific protein on their surface. It helps the immune system to find and eliminate these cells. In this trial, rituximab is used alongside other medications to enhance the treatment’s effectiveness for patients with Diffuse Large B-Cell Lymphoma.

Investigated diseases:

Diffuse large B-cell lymphoma

Diffuse Large B-Cell Lymphoma – Diffuse Large B-Cell Lymphoma is a type of non-Hodgkin lymphoma that originates in the B cells, which are a type of white blood cell. It is characterized by rapidly growing tumors in the lymph nodes, spleen, liver, bone marrow, or other organs. The disease often begins with a painless swelling in the neck, armpit, or groin due to enlarged lymph nodes. As it progresses, it can spread to other parts of the body, including the central nervous system. Symptoms may include fever, night sweats, and weight loss. The progression of the disease can vary, with some cases advancing quickly while others may develop more slowly.

Trial ID:

2023-507286-25-00

Protocol code:

VERLEN

NCT ID:

NCT04974216

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Lenalidomide, Tafasitamab, and Rituximab for Treating Diffuse Large B-Cell Lymphoma in Patients Aged 80 and Older

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?