Study on Brentuximab Vedotin, Lenalidomide, and Rituximab for Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma

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What is this study about?

This clinical trial is focused on studying a type of cancer called relapsed or refractory diffuse large B-cell lymphoma (DLBCL). This condition occurs when the cancer returns or does not respond to treatment. The study is testing a combination of medications to see how well they work together. The medications being studied are Brentuximab Vedotin, Lenalidomide, and Rituximab. Brentuximab Vedotin is a medication that targets cancer cells, Lenalidomide is an immunomodulatory drug that helps the immune system fight cancer, and Rituximab is a monoclonal antibody that targets specific proteins on cancer cells.

The purpose of the study is to evaluate how these medications work together in treating patients with DLBCL. Participants in the study will receive either the combination of Brentuximab Vedotin, Lenalidomide, and Rituximab or a combination that includes a placebo instead of Brentuximab Vedotin. A placebo is a substance with no active medication. The study will compare the effects of these treatments over a period of time to see which is more effective in preventing the cancer from getting worse.

Throughout the study, participants will receive the medications through subcutaneous injections, which means the medication is given under the skin, and oral capsules, which are taken by mouth. The study will monitor the participants’ health and the progression of their cancer to gather information on the effectiveness and safety of the treatment combinations. The goal is to find out if the combination of these medications can help improve the outcomes for patients with relapsed or refractory DLBCL.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current health status.

A series of tests and evaluations are performed to ensure the patient meets the study criteria, such as age, health condition, and previous treatments.

2 treatment assignment

Patients are randomly assigned to one of two treatment groups. One group receives a combination of brentuximab vedotin, lenalidomide, and rituximab, while the other group receives a placebo instead of brentuximab vedotin.

The assignment is double-blind, meaning neither the patient nor the study team knows which group the patient is in.

3 treatment administration

Brentuximab vedotin is administered via subcutaneous injection. The dosage and frequency are determined by the study protocol.

Lenalidomide is taken orally in the form of 5 mg hard capsules. The dosage and frequency are specified in the study protocol.

Rituximab is also administered via subcutaneous injection, with dosage and frequency outlined in the study protocol.

4 monitoring and follow-up

Regular monitoring is conducted to assess the patient’s response to treatment and to identify any side effects. This includes physical exams, blood tests, and imaging studies.

Follow-up visits are scheduled according to the study timeline to ensure ongoing evaluation of the patient’s health and treatment efficacy.

5 completion of treatment

The treatment phase continues until the study’s end date or until the patient completes the prescribed course of treatment.

Upon completion, a final assessment is conducted to evaluate the overall outcomes and any long-term effects of the treatment.

Who Can Join the Study?

Patients must have relapsed or refractory diffuse large B-cell lymphoma (DLBCL), which means the cancer has returned or not responded to treatment.
Patients must be 18 years or older.
Patients must have had at least two previous treatments for their disease.
Patients must not be eligible for HSCT (a type of stem cell transplant) or CAR-T therapy (a type of cell therapy) due to medical reasons or other issues like financial or geographic barriers.
Patients must have a tumor tissue sample sent to a lab to check for a protein called CD30.
Patients must have a performance status score of 0 to 2, which measures their ability to perform daily activities.
Patients must have a type of disease that can be seen on a PET scan and measured on a CT scan.
Patients must have certain blood test results within specific ranges, such as:
- Neutrophil count (a type of white blood cell) of at least 1000/μL.
- Platelet count of at least 50,000/μL.
- Hemoglobin level of at least 8.0 g/dL.
- Bilirubin level within normal limits, unless they have certain conditions.
- Kidney function with an estimated filtration rate of at least 45 mL/min.
- Liver enzymes (ALT and AST) within certain limits.
Patients who can have children must agree to use birth control and not donate sperm or eggs during the study and for 12 months after the last dose of the study drug.
Patients who are HIV positive must meet specific health criteria, such as having a certain level of CD4+ T-cells and being on stable HIV treatment.
Patients must provide written consent to participate in the study.

Who Cannot Join the Study?

Patients with other types of cancer besides relapsed or refractory diffuse large B-cell lymphoma (DLBCL) cannot participate. This means if you have a different kind of cancer, you are not eligible.
Patients who have not experienced a return of their lymphoma after treatment or whose lymphoma has not stopped responding to treatment are excluded. In simple terms, if your lymphoma is not coming back or is still responding to treatment, you cannot join.
Patients who are not within the specified age range for the study cannot participate. This means if you are too young or too old according to the study’s age limits, you are not eligible.
Patients who are not able to follow the study procedures or who have conditions that make it unsafe for them to participate are excluded. This means if you have health issues that make it risky or difficult to be part of the study, you cannot join.
Patients who are pregnant or breastfeeding are not allowed to participate. This means if you are expecting a baby or nursing, you cannot be part of the study.
Patients who have participated in another clinical trial recently may be excluded. This means if you have been part of another study not long ago, you might not be eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Institut Gustave Roussy	Villejuif	France
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Centre Henri Becquerel	Rouen	France
Centre Hospitalier Le Mans	Le Mans	France
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
Rigshospitalet	Copenhagen	Denmark
CHU Helora	La Louviere	Belgium
Centre Hospitalier Sud Francilien	Corbeil Essonnes	France
Pratia S.A.	Skorzewo	Poland
Hopital Saint Antoine	Paris	France
Centre Antoine Lacassagne	Nice	France
Centre Hospitalier De Perpignan	Perpignan	France
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy	Warsaw	Poland
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hospital Del Mar	Barcelona	Spain
Istituto Tumori Bari Giovanni Paolo II	Bari	Italy
Hospital San Pedro De Alcantara	Caceres	Spain
Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie	Olsztyn	Poland
ZNA Stuivenberg	Antwerp	Belgium
Centre Hospital Region Metz Thionville	Metz	France
Azienda Sanitaria Universitaria Giuliano Isontina	Trieste	Italy
PRATIA MCM Kraków	Cracow	Poland
Uzp Mhzeegiamvta	Yvoir	Belgium
Cqly Dq Nfwkg	Vandoeuvre Les Nancy	France
Hpycjlrf Dc Lh Sxxac Ccrn I Snvn Pqw	Barcelona	Spain
Mmuzzmizg Ibmkiwpwyu Covcgdcc Swqujgpp Skh z omvu	Warsaw	Poland
Ckhtoe Hxrnqivwtko Ez Uvwkapfsptspm De Luhacig	Limoges	France
Uxaxqqkkit Ot Afbdovt	Edegem	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	22.04.2021
Czechia	Not recruiting	22.04.2021
Denmark	Not recruiting	22.04.2021
France	Not recruiting	22.04.2021
Italy	Not recruiting	22.04.2021
Poland	Not recruiting	22.04.2021
Spain	Not recruiting	22.04.2021

Trial locations

Investigated drugs:

Brentuximab Vedotin is a medication used in this trial to treat patients with a type of cancer called diffuse large B-cell lymphoma (DLBCL). It works by targeting and destroying cancer cells, helping to slow down or stop the growth of the tumor.

Lenalidomide is another medication used in the trial. It helps the immune system fight cancer by affecting the way the immune cells work. It can also stop cancer cells from growing and spreading.

Rituximab is a medication that targets specific proteins on the surface of cancer cells. It helps the immune system to identify and destroy these cancer cells, which can help in treating DLBCL.

Diffuse Large B-Cell Lymphoma (DLBCL) – This 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, or other organs. The disease can occur at any age but is more common in older adults. Symptoms may include swollen lymph nodes, fever, night sweats, and weight loss. DLBCL can be classified as relapsed or refractory when it does not respond to initial treatment or returns after treatment. The progression of the disease can vary, with some cases advancing quickly while others may progress more slowly.

Trial ID:

2023-503384-41-00

Protocol code:

SGN35-031

NCT ID:

NCT04404283

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Brentuximab Vedotin, Lenalidomide, and Rituximab for Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?