A study to compare glofitamab against a drug combination for patients with relapsed or refractory mantle cell lymphoma

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What is this study about?

This study focuses on individuals with Mantle Cell Lymphoma, which is a type of blood cancer that affects the lymph nodes and other parts of the immune system. The research aims to compare the effectiveness and safety of a new treatment against standard medical options for people whose cancer has returned or has not responded to previous treatments. The study will compare glofitamab, which is used alone, to a combination of other medications chosen by the doctor. These other options may include bendamustine, rituximab, or lenalidomide.

Participants in the study will receive different types of medicine. Some medications, such as glofitamab, rituximab, and bendamustine, are given through an IV infusion, which is a method of delivering medicine directly into a vein. Other medicines, such as lenalidomide, are taken as capsules by mouth. During the study, doctors will monitor how the cancer responds to the treatment and track how long the disease remains stable without getting worse, a measure known as progression-free survival.

Who Can Join the Study?

You must have a confirmed diagnosis of Mantle Cell Lymphoma, which is a type of blood cancer, through a tissue sample (biopsy) within the last 12 months.
Your cancer must show specific biological markers, specifically overexpression of cyclin D1 or the t(11:14) genetic change, which are used to identify this specific type of lymphoma.
Your cancer must be relapsed (it has come back after treatment) or refractory (it has not responded to treatment).
A PET scan, which is an imaging test that uses a radioactive sugar to find active cancer cells, must show active disease with a Deauville score of 4 or 5, meaning the cancer cells are appearing more active than the background activity in your body.
You must have received at least one previous systemic therapy, which is a treatment like chemotherapy or medicine that travels through the entire body.
Your previous treatment must have included a BTK inhibitor, a specific type of drug used to treat this cancer, plus at least one other type of treatment.
You must have either seen your cancer grow while on a BTK inhibitor or failed to show a partial response (a decrease in cancer size) within 12 weeks of starting that drug.
You must have been able to tolerate BTK inhibitor therapy for at least 12 weeks.
You must have adequate renal function, meaning your kidneys are working well enough to maintain a creatinine clearance (a measure of how well your kidneys filter waste) of 30 mL/min or higher.
You must have adequate hematologic function, which means your blood counts, such as red blood cells and white blood cells, are at healthy levels.

Who Cannot Join the Study?

You have a history of another type of cancer (malignancy) that might make it difficult to follow the study rules or make it hard to tell if the study medicine is working correctly.
You have leukemic, non-nodal Mantle Cell Lymphoma, which is a specific form of this cancer that is found in the blood or fluid rather than in the lymph nodes (small swellings in the body that part of the immune system).
You have previously had a solid organ transplant (receiving a healthy organ from another person) or an allogeneic stem cell transplant (receiving healthy blood-forming cells from a donor).
You have previously received treatment with glofitamab, other bispecific antibodies (medicines designed to attach to two different targets at once to help the immune system find cancer), or CAR-T cell therapy (a type of treatment where a patient’s own immune cells are changed in a lab to fight cancer).
You currently have or have previously had central nervous system (CNS) lymphoma, which is cancer that affects the brain or spinal cord.
You have a severe, active infection caused by bacteria, viruses, fungi, or parasites. You must have fully recovered from any serious infection for at least 2 weeks before starting the study.
You have a history of cirrhotic liver disease, which is a serious condition where healthy liver tissue is replaced by permanent scarring.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Hopital Necker Enfants Malades	Paris	France

Other Sites

Site Name	City	Country
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Cliniche Gavazzeni S.p.A.	Bergamo	Italy
Centre Hospitalier Universitaire De Nantes	Nantes	France
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer	Barcelona	Spain
Hospital Universitario Puerta Del Mar	Cadiz	Spain
Hospital General Universitario Morales Meseguer	Murcia	Spain
Institut Curie – Site Saint-Cloud	Saint-Cloud	France
Hopital Saint Eloi	Montpellier	France
Hopital Huriez	Lille	France
Avrxikh Oalmnukicnq Novxyoinc Sm Advimur E Brkxtc E C Ajzpvi Akqehhnaxwg	Alexandria	Italy
Uxytxcx Ulqlyxpnbk Habueers	Uppsala	Sweden
Ahrodjz Oigszamtfnf Uhrectnuwmbft Ccczytwhfmag Dwfxm Sqjzoy E Dapfa Stzjdgg Du Tobwaz	Turin	Italy
Atojjzs Ushbr Susguckyz Luupyc Dn Bwkwyil	Bologna	Italy
Hgtgtado Vdre dszefufp	Barcelona	Spain
Hwkjblrk Uksgjnfbmirxl du A Cdzjhq	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
France	Recruiting	18.12.2023
Italy	Recruiting	18.12.2023
Spain	Recruiting	18.12.2023
Sweden	Recruiting	18.12.2023

Trial locations

Investigated drugs:

Glofitamab is a medication given through an intravenous infusion that works as a single agent to help treat the condition being studied.

Tocilizumab is a medication administered through an intravenous infusion used as part of the study testing.

Obinutuzumab is a medication given via intravenous infusion used as part of the study testing.

Bendamustine is a medication provided as an intravenous infusion used as a comparison treatment.

Lenalidomide is a medication taken in capsule form by mouth used as a comparison treatment.

Rituximab is a medication provided through an intravenous infusion used as a comparison treatment.

Investigated diseases:

Mantle Cell Lymphoma – This is a type of cancer that begins in the white blood cells known as B cells. These abnormal cells accumulate in the lymph nodes, spleen, and bone marrow. The disease often starts in the lymph nodes and can spread to other parts of the body. Over time, the condition may involve the blood or other organs. It typically follows a progressive course where the number of cancerous cells increases.

Trial ID:

2023-503206-37-00

Protocol code:

GO43878

Trial Phase:

Therapeutic confirmatory (Phase III)

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A study to compare glofitamab against a drug combination for patients with relapsed or refractory mantle cell lymphoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?