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Study of Rituximab and Golcadomide for Older Frail Patients with Diffuse Large B-cell Lymphoma

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a treatment for Diffuse Large B-cell non-Hodgkin Lymphoma, a type of cancer that affects the lymphatic system. The study involves a combination of two medications: Rituximab and Golcadomide. Rituximab is a protein-based medication, while Golcadomide is a chemical compound. The purpose of the study is to evaluate how effective this combination is as a first-line treatment for older patients who are considered frail and have not been treated with the standard chemotherapy regimen known as R-CHOP.

Participants in the study will receive the treatment over a period of time, with Rituximab being administered intravenously, meaning it is given through a vein, and Golcadomide taken orally in capsule form. The study aims to provide a chemo-free approach, which means it does not involve traditional chemotherapy drugs. The trial will monitor the participants' health and response to the treatment, focusing on how long they live without the disease getting worse, their overall response to the treatment, and any changes in their quality of life.

This study is particularly aimed at older patients who are not suitable for more aggressive treatments due to their frail condition. The trial will use a simplified geriatric assessment to determine the frailty of the participants. The study will continue for several years to gather comprehensive data on the effectiveness and safety of the treatment combination. Participants will be closely monitored throughout the study to ensure their well-being and to assess the outcomes of the treatment.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initiation of treatment
The treatment begins with the administration of rituximab, which is given through an intravenous route. This means the medication is delivered directly into the bloodstream through a vein.
The dosage and frequency of rituximab administration will be determined by the healthcare provider based on individual patient needs and response to treatment.
Step 2
Oral medication
In addition to rituximab, the patient will take golcadomide in the form of capsules. This medication is taken orally, meaning it is swallowed.
The specific dosage and frequency of golcadomide will be provided by the healthcare provider, tailored to the patient's condition and response.
Step 3
Treatment cycles
The treatment is organized into cycles. Each cycle includes a period of medication administration followed by a rest period to allow the body to recover.
The number of cycles and the duration of each cycle will be determined by the healthcare provider, based on the patient's progress and overall health.
Step 4
Monitoring and assessments
Throughout the trial, regular monitoring and assessments will be conducted to evaluate the patient's response to the treatment.
These assessments may include physical examinations, blood tests, and imaging studies to track the progress of the disease and the effectiveness of the treatment.
Step 5
Evaluation of treatment response
After the completion of the 6th cycle, the overall response to the treatment will be evaluated. This includes determining whether there is a partial or complete response to the therapy.
The evaluation will help in understanding the effectiveness of the treatment and in making decisions about future treatment plans.
Step 6
Quality of life assessments
Quality of life assessments will be conducted at baseline, 6 months, and 12 months using specific questionnaires designed to measure the impact of the treatment on the patient's daily life and well-being.
These assessments aim to provide a comprehensive view of how the treatment affects the patient's overall quality of life.

Who can join the trial?

15 criteria

Must be able to provide written consent and understand the study requirements.
Must have adequate kidney function, which means the kidneys are working well enough, with a creatinine clearance of at least 30 mL/min.
Must have adequate liver function, unless affected by lymphoma, with specific levels for liver enzymes and bilirubin.
Must be able to follow the study visit schedule and other study requirements.
Must be able to swallow capsules or tablets.
Must have a life expectancy of at least 3 months.
Male participants must agree to use birth control methods during the study and for at least 28 days after stopping the study drug. They should not donate sperm during this time.
Must have a confirmed diagnosis of **Diffuse Large B-cells non-Hodgkin Lymphoma (DLBCL)**, a type of cancer affecting the lymphatic system.
Must not have received any previous treatment for DLBCL.
Must be considered **frail**, which means having certain limitations in daily activities or multiple health issues, especially if aged 80 or older.
Must not be eligible for a specific type of chemotherapy called anthracycline-based chemotherapy.
Must have a cancer stage between I and IV, according to the **Ann Arbor Staging** system, which describes the extent of cancer spread.
Must have a performance status of 3 or less on the **ECOG scale**, which measures the ability to perform daily activities.
Must have at least one measurable lymph node that is 1.5 cm or larger, as seen on a CT scan.
Must have adequate blood cell counts, unless affected by lymphoma in the bone marrow.

Who cannot join the trial?

6 criteria

Patients who are not diagnosed with Diffuse Large B-cells non-Hodgkin Lymphoma cannot participate. This is a type of cancer that affects the lymphatic system, which is part of the body's immune system.
Patients who are not considered frail according to a specific evaluation called sGA cannot participate. Frail means being weaker or more delicate than usual, often due to age or health conditions.
Patients who are candidates for the standard treatment known as R-CHOP (or similar treatments) cannot participate. R-CHOP is a common chemotherapy regimen used to treat this type of lymphoma.
Patients who are not within the specified age range for the study cannot participate. The study is focused on older patients.
Both male and female patients are eligible, so gender is not an exclusion criterion.
Patients who are part of a vulnerable population are not specifically excluded, but the study does not focus on these groups.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
Azienda Ospedaliera Universitaria Senese
Siena, Italy
Responsive
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Responsive
Istituto Oncologico Veneto
Padua, Italy

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Investigated drugs

Rituximab
is a medication used to treat certain types of cancer, including non-Hodgkin lymphoma. It works by targeting and attaching to a specific protein on the surface of cancer cells, helping the immune system to destroy these cells. In this trial, rituximab is used as part of a combination therapy for older patients with a type of lymphoma.
CC-99282
, also known as golcadomide, is an investigational drug being studied for its potential to treat cancer. It is part of a new approach that does not involve traditional chemotherapy. In this trial, CC-99282 is combined with rituximab to see if it can effectively treat older patients with a specific type of lymphoma who are considered frail and not suitable for standard chemotherapy treatments.

What is already known about the treatment

Rituximab
Rituximab is administered intravenously and is currently well-established in medical literature as a treatment for certain types of lymphoma, including Diffuse Large B-cells non-Hodgkin Lymphoma (DLBCL). It is primarily used to target and destroy specific B-cells in the immune system that are involved in these cancers. Rituximab works by binding to a protein called CD20 found on the surface of B-cells, leading to their destruction. It is classified as a monoclonal antibody and is often used in combination with other therapies to enhance its effectiveness.
CC-99282
CC-99282 is an investigational drug administered orally and is currently being studied in clinical trials for its potential use in treating Diffuse Large B-cells non-Hodgkin Lymphoma (DLBCL). It is being evaluated as part of a chemo-free approach for older, frail patients who are not candidates for standard treatments. The drug is believed to work by modulating the immune system to enhance the body's ability to fight cancer cells. CC-99282 is classified as an immunomodulatory agent, and its exact mechanism of action is still under investigation.

Investigated diseases

Diffuse Large B-cell Lymphoma – This is a type of non-Hodgkin lymphoma that affects 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 start in any part of the body and may spread to other areas. Symptoms often include swollen lymph nodes, fever, night sweats, and weight loss. It is the most common type of non-Hodgkin lymphoma and can occur at any age, but it is more frequently diagnosed in older adults. The progression of the disease can vary, with some cases advancing quickly while others may develop more slowly.