Study on Golcadomide for Patients with Relapsed or Refractory Large B-Cell Lymphoma in the Brain

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What is this study about?

This clinical trial is focused on studying the effectiveness of a medication called Golcadomide for treating certain types of lymphoma, which is a cancer of the lymphatic system. Specifically, the study is looking at patients with large B-cell lymphoma that affects the brain. This includes cases where the lymphoma has returned after treatment, known as relapsed, or has not responded to previous treatments, known as refractory. The study also includes patients with secondary central nervous system lymphoma, which means the cancer has spread to the brain from other parts of the body.

The purpose of the study is to evaluate how well Golcadomide works in treating these types of lymphoma. Participants in the study will receive the medication in the form of a capsule taken by mouth. The study will monitor the participants over a period of time to observe the effects of the treatment. Some participants may receive a placebo, which is a substance with no active medication, to compare the results. The study aims to see if the medication can help achieve a significant reduction in the cancer, measured by the number of patients who experience a complete or partial remission.

Throughout the study, various aspects will be assessed, such as the time it takes for the best response to occur, the duration of the response, and the overall survival of the participants. The study will also look at the side effects of the treatment and how it affects the participants’ quality of life. Additionally, researchers will explore how the medication behaves in the body, including its presence in the spinal fluid compared to the blood, and investigate any genetic factors that might influence the response to treatment. The study is expected to continue until 2028, with recruitment starting in 2025.

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 must be at least 18 years old and meet specific health criteria, such as having a certain type of lymphoma and previous treatments.

2 initial assessments

Before starting the treatment, you will undergo several assessments. These may include blood tests and imaging tests like MRI to evaluate your current health status and the extent of the lymphoma.

3 treatment with golcadomide

You will begin treatment with golcadomide, which is taken orally in the form of a capsule.

The dosage, frequency, and duration of administration will be determined by the study protocol and your healthcare provider.

4 regular monitoring

Throughout the study, you will have regular visits to monitor your response to the treatment. This includes checking for any side effects and assessing the effectiveness of the medication.

You may be asked to complete questionnaires about your quality of life and undergo cognitive function tests.

5 end of treatment evaluation

At the end of the treatment period, you will have a final evaluation to determine the overall response to the treatment.

This will involve similar assessments to those conducted at the start of the study, such as imaging tests and blood tests.

Who Can Join the Study?

Must be at least 18 years old.
Must have a diagnosis of one of the following:
- Secondary central nervous system lymphoma
- Relapsed primary large B-cell lymphoma of the central nervous system
- Refractory primary large B-cell lymphoma of the central nervous system
For Cohort A: Must have received prior high-dose methotrexate-based chemotherapy.
For Cohort B: Must have a diagnosis of aggressive malignant B-cell lymphoma based on a tissue sample, including:
- Follicular lymphoma (FL) grade 3B or transformed FL
- Diffuse large B-cell lymphoma (DLBCL)
- High-grade B-cell lymphoma (HGBCL) with MYC and BCL2 rearrangements
For Cohort B: Must have progression or relapse with central nervous system (CNS) involvement, with or without systemic relapse.
For Cohort B: Must have CNS involvement confirmed by at least one of the following:
- Clear evidence of lymphoma in the cerebrospinal fluid (CSF)
- Clinical and MRI evidence of leptomeningeal involvement
- Brain lesion with uniform contrast enhancement suspected for lymphoma, along with systemic progression or recurrence
- Biopsy-proven brain involvement of previously diagnosed systemic non-Hodgkin lymphoma (NHL)
Must have a WHO performance status of 2 or less. (This is a measure of how well you can perform daily activities.)
Must understand and voluntarily sign an Informed Consent Form before any study-related procedures.
Must be willing and able to follow the study visit schedule and other study requirements.
Must have a hemoglobin level greater than 5 mmol/l. (Hemoglobin is a protein in red blood cells that carries oxygen.)
Must have an absolute neutrophil count (ANC) greater than 1.0×10⁹/l without growth factor support for 7 days. (Neutrophils are a type of white blood cell important for fighting infections.)
Must have a platelet count greater than 75×10⁹/l without transfusions for 7 days. (Platelets help with blood clotting.)
Must agree not to participate in any other interventional study while on this study’s treatment without approval from the Principal Investigator.

Who Cannot Join the Study?

Patients with secondary central nervous system lymphoma cannot participate. This is a type of cancer that has spread to the central nervous system from another part of the body.
Patients with relapsed primary large B-cell lymphoma of the central nervous system are excluded. This means the cancer has returned after treatment.
Patients with refractory primary large B-cell lymphoma of the central nervous system cannot join. This means the cancer does not respond to treatment.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
University Hospital Maastricht	Maastricht	The Netherlands
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Algemeen Ziekenhuis Delta	Roeselare	Belgium
Stichting Radboud University Medical Center	Nijmegen	The Netherlands
St. Antonius Ziekenhuis	Nieuwegein	The Netherlands
Spaarne Gasthuis	Hoofddorp	The Netherlands
Lkckw Uvpgpelpuiqs Mccpagp Cklrutz (uhmfp	Leiden	The Netherlands
Uizlxulolxnt Mxzddbt Cabnvgd Gnxnmphnr	Groningen	The Netherlands
Exyyfva Uvniqtfxenrt Mchammj Ceoyrtu Rjrdjcybg (tgdhigu Mst	Rotterdam	The Netherlands
Sdf Edfpkfxsx Hohigrld Trdkoyl	Tilburg	The Netherlands

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	01.06.2025
The Netherlands	Recruiting	01.06.2025

Trial locations

Investigated drugs:

Golcadomide

Golcadomide (CC-99282) is a medication being studied for its potential to help treat certain types of lymphoma, which is a cancer of the lymphatic system. In this trial, it is being tested on patients who have a type of lymphoma that affects the central nervous system, either as a primary condition or as a secondary spread from another area. The goal of using Golcadomide is to see if it can help reduce the size of the cancer or make it disappear completely, which is known as achieving remission. This medication is part of a phase 2 study, which means it is being tested to see how well it works and to gather more information about its safety.

Secondary Central Nervous System Lymphoma – This disease occurs when cancerous lymphocytes, a type of white blood cell, spread to the central nervous system from other parts of the body. It typically involves the brain, spinal cord, or the tissues surrounding these areas. The disease progresses as these malignant cells multiply and form tumors, which can disrupt normal brain and spinal cord functions. Symptoms may include headaches, seizures, and neurological deficits depending on the tumor’s location. As the disease advances, it can lead to increased intracranial pressure and further neurological complications. The progression can vary, with some cases showing rapid development of symptoms.

Relapsed Primary Large B-cell Lymphoma of the Central Nervous System – This condition refers to the recurrence of a type of non-Hodgkin lymphoma that initially developed in the central nervous system. It primarily affects the brain and spinal cord, where large B-cells, a type of lymphocyte, become cancerous. The disease progresses as these cells grow uncontrollably, forming tumors that can interfere with neurological functions. Symptoms often include cognitive changes, motor deficits, and other neurological impairments. As the disease relapses, it can lead to more severe neurological symptoms and complications. The progression is marked by the return and potential worsening of previous symptoms.

Refractory Primary Large B-cell Lymphoma of the Central Nervous System – This disease is characterized by a type of non-Hodgkin lymphoma that does not respond to initial treatment and persists in the central nervous system. It involves the proliferation of malignant large B-cells within the brain and spinal cord. The progression of the disease is marked by the continued growth of these cancerous cells, leading to tumor formation. Symptoms can include neurological deficits, cognitive changes, and other brain-related issues. As the disease remains unresponsive to treatment, it can cause increasing neurological impairment. The progression is often associated with persistent and potentially worsening symptoms.

Trial ID:

2024-517051-12-00

Protocol code:

HO176

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Golcadomide for Patients with Relapsed or Refractory Large B-Cell Lymphoma in the Brain

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