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Study on Golcadomide and Valemetostat Tosylate for Patients with Relapsed or Refractory Non-Hodgkin Lymphomas

Verified siteRegistered drugNo placebo
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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 group of diseases known as Non-Hodgkin Lymphomas (NHL), which are types of cancer that affect the lymphatic system. The study is particularly interested in cases where the disease has returned or has not responded to previous treatments, known as relapsed or refractory Non-Hodgkin Lymphomas. The specific types of NHL being studied include Marginal Zone Lymphoma, Diffuse Large B-Cell Lymphoma, Mantle Cell Lymphoma, Primary Central Nervous System Lymphoma, and Follicular B-Cell Non-Hodgkin's Lymphoma.

The trial will investigate a new medication called Golcadomide (also known by its code name CC-99282), which is taken orally in capsule form. This medication will be tested both on its own and in combination with other treatments for NHL, including Rituximab, Obinutuzumab, Tafasitamab, and Valemetostat Tosylate. Rituximab is a monoclonal antibody, which is a type of protein made in the laboratory that can bind to substances in the body, including cancer cells. The purpose of the study is to determine the safety and tolerability of Golcadomide alone and in combination with these other treatments, as well as to find the best dose to use in future studies.

Participants in the study will receive the medication and be monitored for any side effects or changes in their condition. The study will also look at how the body processes the medication and its preliminary effectiveness in treating the disease. The trial is designed to gather important information that could lead to new treatment options for people with relapsed or refractory NHL.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

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

    Eligibility criteria include being 18 years or older, having a history of certain types of non-Hodgkin lymphomas, and meeting specific health parameters.

  2. Step 2

    Treatment phase 1

    The first phase of treatment involves taking CC-99282 alone. This is an oral medication taken in capsule form.

    The dosage and frequency are determined based on individual health assessments and the study's guidelines.

  3. Step 3

    Combination treatment

    If eligible, the next phase involves a combination treatment. CC-99282 is administered alongside other medications such as rituximab, obinutuzumab, tafasitamab, or valemetostat.

    Rituximab is given intravenously, while other medications may be taken orally or intravenously, depending on the specific combination.

  4. Step 4

    Monitoring and evaluation

    Throughout the trial, regular monitoring is conducted. This includes checking vital signs, performing laboratory tests, and assessing overall health.

    The effectiveness of the treatment is evaluated using specific criteria to measure response rates and survival outcomes.

  5. Step 5

    Completion and follow-up

    Upon completion of the treatment cycles, a final assessment is conducted to evaluate the overall response to the treatment.

    Follow-up visits may be scheduled to monitor long-term health outcomes and any potential side effects.

Who can join the trial?

10 criteria

  • The person must be at least 18 years old when they sign the consent form to join the study.
  • The person must have a history of a type of cancer called **NHL** (Non-Hodgkin's Lymphoma), which includes specific types like **DLBCL** (Diffuse Large B-Cell Lymphoma), **FL** (Follicular Lymphoma), **MZL** (Marginal Zone Lymphoma), **MCL** (Mantle Cell Lymphoma), and **PCNSL** (Primary Central Nervous System Lymphoma). The disease must have come back or not responded to treatment.
  • The person must have an **ECOG performance status** of 0, 1, or 2. This is a scale that measures how well a person can perform daily activities, with 0 being fully active and 2 meaning they can do some activities but may need rest.
  • The person must have certain blood test results:
    • **Absolute neutrophil count (ANC)**: At least 1.5 x 10^9/L, or at least 1 x 10^9/L if the bone marrow is involved, without support from growth factors for 7 days (or 14 days if using a specific type called pegfilgastrim).
    • **Hemoglobin (Hgb)**: At least 8 g/dL.
    • **Platelets**: At least 75 x 10^9/L, or at least 50 x 10^9/L if the bone marrow is involved, without needing a transfusion for 7 days.
    • **Serum bilirubin**: No more than 1.5 times the upper limit of normal.
    • **AST/SGOT and ALT/SGPT**: No more than 2.5 times the upper limit of normal. These are liver enzymes.
    • **Estimated serum creatinine clearance**: More than 30 mL/min, which measures kidney function. For certain groups, it must be at least 45 mL/min.
    • The person must agree to follow the **CC-99282 Pregnancy Prevention Plan** to prevent pregnancy during the study.

Who cannot join the trial?

13 criteria

  • Patients with other types of cancer that are not listed in the study.
  • Patients who have serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had a recent heart attack or severe heart problems.
  • Patients who have an active infection that requires treatment.
  • Patients who have a history of allergic reactions to the study drugs.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have a mental health condition that could affect their ability to participate.
  • Patients who have had a major surgery within the last 4 weeks.
  • Patients who have received certain treatments for their lymphoma within a specific time frame before the study.
  • Patients who have a known history of HIV, hepatitis B, or hepatitis C.
  • Patients who have any other condition that the study doctors believe would make it unsafe for them to participate.
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Investigated drugs

  • CC-99282

    is an experimental small molecule being tested for its safety and effectiveness in treating relapsed or refractory non-Hodgkin lymphomas. It is taken orally and is being studied both on its own and in combination with other medications to see how well it works and how the body processes it.

  • Rituximab

    is a medication used to treat certain types of cancer, including non-Hodgkin lymphomas. It works by targeting specific cells in the immune system to help the body fight cancer.

  • Obinutuzumab

    is another medication used to treat non-Hodgkin lymphomas. It is designed to attach to certain cells in the immune system, helping to destroy cancer cells.

  • Tafasitamab

    is a medication that targets specific proteins on the surface of cancer cells in non-Hodgkin lymphomas. It helps the immune system to identify and attack these cancer cells.

  • Valemetostat

    is an investigational drug being studied for its potential to treat non-Hodgkin lymphomas. It may be used alone or in combination with rituximab to see if it can improve treatment outcomes.

What is already known about the treatment

CC-99282 – This medication is administered orally and is currently being studied in clinical trials for its safety and effectiveness in treating various types of non-Hodgkin lymphomas, including marginal zone lymphoma, diffuse large B-cell lymphoma, mantle cell lymphoma, primary central nervous system lymphoma, and follicular B-cell non-Hodgkin's lymphoma. It is in the early stages of research, with ongoing studies assessing its potential as a standalone treatment or in combination with other anti-lymphoma agents like rituximab, obinutuzumab, tafasitamab, or valemetostat. CC-99282 works by targeting specific molecular pathways involved in the growth and survival of cancer cells, aiming to inhibit their proliferation. It is classified as a small molecule therapeutic agent, focusing on disrupting cancer cell processes at the molecular level.

Investigated diseases

  • Marginal Zone Lymphoma

    This is a type of non-Hodgkin's lymphoma that originates in the marginal zone of lymphoid tissue, which is part of the immune system. It typically progresses slowly and may initially present with symptoms such as swollen lymph nodes or fatigue. Over time, it can spread to other parts of the body, including the bone marrow and spleen.

  • Diffuse Large B-Cell Lymphoma

    This is an aggressive form of non-Hodgkin's lymphoma characterized by rapidly growing tumors in the lymph nodes, spleen, liver, or other organs. It often presents with symptoms like fever, night sweats, and weight loss. The disease can progress quickly, requiring prompt medical attention.

  • Mantle Cell Lymphoma

    This is a rare type of non-Hodgkin's lymphoma that arises from B-cells in the outer edge of a lymph node follicle, known as the mantle zone. It is typically aggressive and may present with symptoms such as swollen lymph nodes, fever, and fatigue. The disease can spread to other parts of the body, including the bone marrow and gastrointestinal tract.

  • Primary Central Nervous System Lymphoma

    This is a rare form of non-Hodgkin's lymphoma that occurs in the brain, spinal cord, or eye. It can cause neurological symptoms such as headaches, seizures, or changes in personality. The disease is confined to the central nervous system and does not usually spread to other parts of the body.

  • Follicular B-Cell Non-Hodgkin's Lymphoma

    This is a slow-growing type of non-Hodgkin's lymphoma that originates from B-cells in the lymph nodes. It often presents with painless swelling of lymph nodes and may progress over several years. The disease can eventually spread to other organs, including the bone marrow and spleen.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-515690-10-00Protocol codeCC-99282-NHL-001Estimated enrolment438 patientsSponsorCelgene Corp.

sourced from the EU Clinical Trials Register and site verification

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