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Study of Glofitamab with Rituximab or Obinutuzumab and Drug Combination for Untreated Richter's Syndrome Patients

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 condition known as Richter's syndrome, which occurs when chronic lymphocytic leukemia (CLL) transforms into a more aggressive form of cancer called diffuse large B-cell lymphoma (DLBCL). The study aims to evaluate the effectiveness of a new treatment combination for patients who have not previously received treatment for Richter's syndrome. The treatment involves a combination of medications, including Glofitamab, a bispecific antibody that targets specific proteins on cancer cells, in combination with either Rituximab or Obinutuzumab, along with a chemotherapy regimen known as CHOP. CHOP includes the drugs Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone.

The purpose of the study is to determine how well this combination of treatments works in reducing the cancer in patients with Richter's syndrome. Participants in the study will receive up to six cycles of the treatment, which involves receiving the medications through an intravenous infusion, meaning the drugs are delivered directly into the bloodstream through a vein. The study will monitor the response of the cancer to the treatment over time, as well as any side effects that may occur.

Throughout the study, participants will undergo regular assessments to track the progress of the treatment. These assessments may include imaging tests and other evaluations to measure the size and activity of the cancer. The study will also look at how long the treatment effects last and the overall survival of the participants. The goal is to gather information that could lead to improved treatment options for patients with Richter's syndrome in the future.

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 a review of medical history and a physical examination.

    A biopsy is required to confirm the diagnosis of Richter's syndrome, which is a transformation of chronic lymphocytic leukemia into a high-grade lymphoma.

  2. Step 2

    Treatment cycle 1

    The first treatment cycle begins with the administration of several medications. These include doxorubicin hydrochloride, rituximab or obinutuzumab, cyclophosphamide, vincristine sulfate, and prednisone. Most of these medications are given through an intravenous infusion, except for prednisone, which is taken orally.

    The first dose of glofitamab is also administered intravenously. Hospitalization is required for monitoring during this initial administration.

  3. Step 3

    Subsequent treatment cycles

    The treatment continues for a total of six cycles. Each cycle involves the administration of the same medications: doxorubicin hydrochloride, rituximab or obinutuzumab, cyclophosphamide, vincristine sulfate, prednisone, and glofitamab.

    The cycles are repeated every three weeks, with regular monitoring and assessments to evaluate the response to treatment.

  4. Step 4

    End of treatment

    After completing six cycles of treatment, a final assessment is conducted to determine the response to the therapy.

    The primary goal is to achieve a complete metabolic response, which is evaluated using specific criteria.

  5. Step 5

    Follow-up

    Regular follow-up visits are scheduled to monitor health status and any long-term effects of the treatment.

    These visits may include physical examinations, imaging tests, and laboratory tests to ensure ongoing health and to detect any signs of disease progression.

Who can join the trial?

19 criteria

  • Must have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma that has transformed into diffuse large B-cell lymphoma (DLBCL), known as Richter's syndrome.
  • Must provide a fresh or stored tissue sample for testing.
  • Previous treatment for CLL is allowed, but not for Richter's syndrome.
  • Must be between 18 and 80 years old.
  • Must have an ECOG performance status of 0 to 2, which is a scale to assess how the disease affects daily living abilities.
  • Must have at least one measurable tumor or lymph node, or have bone marrow involvement by Richter's syndrome.
  • Must meet certain blood health criteria unless there is significant bone marrow involvement:
    • Neutrophil count (a type of white blood cell) of at least 1.5 G/L
    • Hemoglobin (a protein in red blood cells) greater than 10 g/dL
    • Platelet count (cells that help with blood clotting) of at least 75 G/L
    • Must have adequate blood clotting ability.
    • Must have proper liver function.
    • Must have a healthy heart with a left ventricular ejection fraction greater than 50%.
    • Must have adequate kidney function with a creatinine clearance of at least 40 mL/min.
    • Must test negative for active or chronic Hepatitis B infection.
    • Must test negative for Hepatitis C and HIV.
    • Must have been vaccinated against the SARS-CoV-2 virus.
    • Women of childbearing potential must have a negative pregnancy test and agree to use two effective birth control methods or remain abstinent during the study and for a specified period after treatment. Men must agree to use birth control and not donate sperm during the study and for a specified period after treatment.
    • Must be able to understand and sign a consent form and agree to follow all study procedures, including hospital stays if required.
    • Must be covered by a social security system.

Who cannot join the trial?

2 criteria

  • Patients who have already received treatment for **Richter's syndrome** cannot participate. **Richter's syndrome** is when a type of blood cancer called **chronic lymphocytic leukemia (CLL)** changes into a more aggressive form known as **high-grade lymphoma**.
  • Patients who do not have the specific type of **high-grade lymphoma** called **diffuse large B-cell lymphoma (DLBCL)** are not eligible.
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Investigated drugs

  • Glofitamab

    is a type of medication known as a bispecific antibody. It is designed to help the body's immune system target and destroy cancer cells. In this trial, glofitamab works by connecting two different proteins: one found on the surface of cancer cells and another found on immune cells. This connection helps the immune cells recognize and attack the cancer cells more effectively.

  • Rituximab

    is a medication that targets a specific protein found on the surface of certain cancer cells. It helps the immune system to identify and destroy these cancer cells. Rituximab is often used in combination with other cancer treatments to improve their effectiveness.

  • Obinutuzumab

    is another medication that targets the same protein as rituximab. It also helps the immune system to find and kill cancer cells. Obinutuzumab is used in combination with other treatments to enhance their ability to fight cancer.

  • Cyclophosphamide

    is a chemotherapy drug that works by slowing or stopping the growth of cancer cells. It is often used in combination with other medications to treat various types of cancer, including those affecting the blood and lymphatic system.

  • Doxorubicin

    is a chemotherapy medication that interferes with the growth of cancer cells. It is used to treat a variety of cancers and is often part of a combination of drugs to increase its effectiveness.

  • Vincristine

    is a chemotherapy drug that works by stopping the growth of cancer cells. It is commonly used in combination with other medications to treat different types of cancer, particularly those affecting the blood and lymphatic system.

What is already known about the treatment

Glofitamab – Glofitamab is administered as an intravenous infusion, meaning it is delivered directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness in treating Richter's syndrome, a condition where chronic lymphocytic leukemia transforms into a more aggressive form of lymphoma. The medication works by targeting specific proteins on the surface of cancer cells, helping the immune system to recognize and destroy these cells. Glofitamab is classified as a bispecific antibody, which means it can bind to two different types of proteins at the same time, enhancing its ability to fight cancer.

Investigated diseases

Richter's Syndrome – Richter's Syndrome is a condition characterized by the transformation of chronic lymphocytic leukemia (CLL) into a more aggressive form of cancer known as diffuse large B-cell lymphoma (DLBCL). This transformation leads to a rapid progression of the disease, with symptoms that may include enlarged lymph nodes, fever, night sweats, and weight loss. The disease progresses as the lymphoma cells grow and spread more quickly than the original CLL cells. This transformation can occur spontaneously or as a result of treatment for CLL. The aggressive nature of the lymphoma in Richter's Syndrome often results in a more challenging disease course. The condition requires careful monitoring and management due to its complex progression.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-501554-11-00Estimated enrolment40 patientsSponsorFrench Innovative Leukemia Organization (F.I.L.O.).

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