Study on the Effectiveness and Safety of Sonrotoclax and Zanubrutinib for Adults with Relapsed or Refractory Mantle Cell Lymphoma

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What is this study about?

This clinical trial is focused on studying a type of cancer called mantle cell lymphoma, specifically in patients whose disease has returned or has not responded to previous treatments. The study will test the effectiveness and safety of a new treatment combination. The treatment involves two medications: Sonrotoclax and Zanubrutinib. Sonrotoclax is a new drug being tested, while Zanubrutinib is already used in treating certain types of cancer. The study will compare the effects of taking Sonrotoclax and Zanubrutinib together against taking a placebo with Zanubrutinib.

The purpose of the study is to see if the combination of Sonrotoclax and Zanubrutinib works better than the current standard treatment. Participants in the study will be randomly assigned to receive either the new combination or the standard treatment. The study will be conducted in a way that neither the participants nor the researchers know who is receiving which treatment, to ensure unbiased results. The study will monitor how long patients live without their disease getting worse, as well as other health outcomes.

Throughout the study, participants will take the medications orally, meaning they will swallow them. The study will last for a period of time, during which participants will have regular check-ups to monitor their health and the effects of the treatment. The goal is to gather information that could lead to better treatment options for people with relapsed or refractory mantle cell lymphoma in the future.

1 joining the study

Upon joining the study, you will be randomly assigned to one of two groups. One group will receive the combination of sonrotoclax and zanubrutinib, while the other group will receive a placebo and zanubrutinib. This process is called randomization and ensures that the study results are unbiased.

2 medication administration

If you are in the group receiving sonrotoclax and zanubrutinib, you will take these medications orally. Zanubrutinib is provided in capsule form, and sonrotoclax is provided in film-coated tablet form. The exact dosage and frequency will be explained to you by the study team.

If you are in the group receiving the placebo and zanubrutinib, you will take the placebo in place of sonrotoclax, along with zanubrutinib capsules. The placebo is also provided in film-coated tablet form.

3 regular check-ups

Throughout the study, you will have regular check-ups to monitor your health and the effects of the treatment. These check-ups will include physical examinations, blood tests, and other necessary assessments to ensure your safety and to evaluate the effectiveness of the treatment.

4 questionnaires

You will be asked to complete questionnaires about your symptoms, physical condition, and overall quality of life. These questionnaires are designed to gather information on how the treatment affects your daily life and well-being.

5 end of treatment

The treatment period will continue until the study ends or until it is determined that the treatment is no longer beneficial for you. At the end of the treatment, you will have a final assessment to evaluate your overall health and the outcomes of the study.

Who Can Join the Study?

Must have a confirmed diagnosis of mantle cell lymphoma (MCL), which is a type of cancer, based on specific medical classifications.
Must have received 1 to 5 previous treatments for MCL, including a treatment that uses an anti-CD20 monoclonal antibody, which is a type of targeted therapy for cancer.
The disease must have returned or not responded to the last treatment.
Must have a measurable disease, meaning at least one lymph node that is larger than 1.5 cm or one area outside the lymph nodes that is larger than 1 cm.
Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2, which is a scale used to assess how a disease affects a patient’s daily living abilities. A score of 0 means fully active, and 2 means capable of all self-care but unable to carry out any work activities.
Must have adequate organ function, meaning the organs are working well enough to participate in the study.
Open to both male and female participants.
Participants must be adults.

Who Cannot Join the Study?

Patients who do not have relapsed or refractory mantle cell lymphoma (R/R MCL) cannot participate. This means the study is only for those whose specific type of lymphoma has returned or did not respond to treatment.
Patients who are not within the specified age range cannot participate. The study is for adults only.
Patients who are not willing or able to follow the study procedures cannot participate.
Patients who have other serious health 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 adverse reactions to the study drugs cannot participate.
Patients who have certain infections or diseases that could affect the study results cannot participate.

Where you can join this trial?

Verified and Recommended Sites

Site Name	City	Country	Status
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie	Lublin	Poland

Verified Sites

Site Name	City	Country	Status
Medical University Of Vienna	Vienna	Austria

Other Sites

Site Name	City	Country
Ospedale Vito Fazzi Lecce	Lecce	Italy
Azienda Sanitaria Universitaria Giuliano Isontina	Trieste	Italy
Noe LGA Gesundheit Region Mitte GmbH	St. Poelten	Austria
Centro Ricerche Cliniche Di Verona S.r.l.	Verona	Italy
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
SCRI CCCIT Ges.m.b.H.	Salzburg	Austria
Kliniken Ostalb gemeinnuetzige kommunale Anstalt des oeffentlichen Rechts	Mutlangen	Germany
Hospital Clinic De Barcelona	Barcelona	Spain
Klinikum Chemnitz gGmbH	Chemnitz	Germany
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Pratia S.A.	Skorzewo	Poland
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Uouftinbmd Mhrdkqv Cjyszh Hrnwwxeutlzxerkmf	Hamburg	Germany
Ozavcovaqdwnch Ledj Gdxm	Linz	Austria
Mqxzczhftmlspxmtpohkhgwsuf Havppjubftevjrrl	Halle (Saale)	Germany
Iohbffmp Cgfxjv Dsgqnapsqrehwzxxt	L'hospitalet De Llobregat	Spain
Wafbovxtpcl Wwnzmvolewrxrgdaxfnd Caradfy Otrzzgigl I Thgvijsxfxsaq Il Mgngycuuzpk W Lqlbj	Lodz	Poland
Dkgmkdlwslkm Cukznuw Owlmdxoxh Pujcuqfpdldy I Hbxcirezzkl	Wroclaw	Poland
Atvjuvz Spk z ougt	Poznan	Poland
Iyzwzxrb Rilhzlqxw Pmc Lg Smtyvo Dtg Tiaqlj Dvfp Azewsiy Iugw Sswewu	Meldola	Italy
Cryuyq Hleuskbwpvf Rtmhjvco Uydcqjtxyddkb Du Tqces	Tours	France
Gjrbqp Ubxvdhdnmg Fzgzmggqi	Frankfurt	Germany
Kbmkupnt dqn Ujncchyyrjix Mwgouzpb Axs	Munich	Germany
Aahrsyk Uoyur Swrxpihjx Lpshfp Dg Biaaeaj	Bologna	Italy

Trial status

Country	Status	Recruitment Start
Austria	Recruiting	01.05.2025
France	Recruiting	01.05.2025
Germany	Recruiting	01.05.2025
Italy	Recruiting	01.05.2025
Poland	Not recruiting	01.05.2025
Spain	Recruiting	01.05.2025

Trial locations

Investigated drugs:

Sonrotoclax is a medication being studied for its potential to help treat a type of cancer called mantle cell lymphoma, which is a cancer of the lymphatic system. In this clinical trial, researchers are testing whether adding sonrotoclax to another medication can help stop the cancer from growing or spreading. Sonrotoclax works by targeting and blocking certain proteins in cancer cells that help them survive, which may lead to the death of these cancer cells.

Zanubrutinib is a medication used to treat certain types of blood cancers, including mantle cell lymphoma. It works by blocking a specific protein in the cancer cells that helps them grow and divide. By inhibiting this protein, zanubrutinib can slow down or stop the growth of cancer cells. In this trial, zanubrutinib is being used in combination with another medication to see if this combination is more effective in treating the cancer than using zanubrutinib alone.

Investigated diseases:

Mantle cell lymphoma

Mantle Cell Lymphoma – Mantle Cell Lymphoma is a type of non-Hodgkin lymphoma that originates from B-cells, a type of white blood cell. It typically begins in the outer edge of a lymph node called the mantle zone. The disease often progresses to involve other lymph nodes, bone marrow, and sometimes the spleen and gastrointestinal tract. As it advances, it can lead to symptoms such as swollen lymph nodes, fever, night sweats, and weight loss. The progression of the disease can vary, with some cases advancing slowly while others progress more rapidly. It is considered a rare form of lymphoma.

Trial ID:

2024-515593-27-00

Protocol code:

BGB-11417-302

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness and Safety of Sonrotoclax and Zanubrutinib for Adults with Relapsed or Refractory Mantle Cell Lymphoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?