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Study of Mosunetuzumab and Drug Combination for Untreated Patients with Richter's Syndrome

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 is a transformation of chronic lymphocytic leukemia into a more aggressive form of lymphoma. The study will explore the effectiveness of a treatment combination called M-CHOP, which includes the medications mosunetuzumab, vincristine sulfate, doxorubicin hydrochloride, cyclophosphamide monohydrate, and prednisone. These medications are administered to patients who have not previously received treatment for this condition.

The purpose of the study is to evaluate how well this combination works in treating patients with Richter's syndrome. Participants will receive the treatment over a period of time, with regular monitoring to assess their response. The study will involve a series of treatment cycles, each lasting a few weeks, during which the medications will be given intravenously, except for prednisone, which is taken orally. The study will also include a comparison with a placebo to determine the effectiveness of the treatment.

Throughout the study, participants will be closely monitored for any side effects and their overall health will be assessed regularly. The study aims to provide valuable information on the potential benefits of the M-CHOP treatment combination for patients with Richter's syndrome, helping to improve future treatment options for this condition.

The research process

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

  1. Step 1

    Joining the study

    Upon joining the study, the patient will begin the treatment phase designed to evaluate the effectiveness of a combination of medications for treating Richter's syndrome.

  2. Step 2

    Treatment initiation

    The treatment involves a combination of medications known as M-CHOP, which includes vincristine sulfate, doxorubicin hydrochloride, cyclophosphamide monohydrate, mosunetuzumab, and prednisone.

    Vincristine sulfate, doxorubicin hydrochloride, cyclophosphamide monohydrate, and mosunetuzumab are administered through an intravenous route, meaning they are given directly into a vein.

    Prednisone is taken orally in the form of tablets.

  3. Step 3

    Medication schedule

    The specific dosage and frequency of each medication will be determined by the healthcare provider based on the study protocol.

    The treatment is structured in cycles, with each cycle consisting of a specific schedule for medication administration.

  4. Step 4

    Monitoring and assessments

    Throughout the treatment, regular monitoring and assessments will be conducted to evaluate the patient's response to the medication.

    These assessments may include imaging tests such as PET/CT scans to check for changes in the condition.

  5. Step 5

    End of induction (EoI)

    After completing the initial treatment cycles, an evaluation will be conducted to determine the effectiveness of the treatment.

    The primary goal is to achieve complete remission, which means no detectable disease in the body.

  6. Step 6

    Follow-up

    Following the end of induction, the patient will continue to be monitored for any changes in their condition.

    This phase includes regular follow-up visits to assess long-term outcomes and any potential side effects.

Who can join the trial?

11 criteria

  • Must be able to give signed informed consent, which means you understand and agree to the study's requirements and restrictions.
  • Women who can have children must agree to avoid pregnancy by either not having heterosexual intercourse or using very effective birth control methods during the study and for a certain time after the last dose of the study drugs.
  • Men must agree to avoid fathering a child by either not having heterosexual intercourse or using a condom during the study and for a certain time after the last dose of the study drugs. They must also agree not to donate sperm during this period.
  • Must be between 18 and 79 years old at the time of signing the consent form.
  • Must be able to follow the study procedures and attend required hospital visits, as judged by the study doctor.
  • Must have an Eastern Cooperative Oncology Group (ECOG) performance score of 2 or less, which is a way to measure how well you can perform daily activities.
  • Must be an adult patient with previously untreated **Richter's syndrome**, a type of cancer, specifically the diffuse large B cell variant, confirmed by specific medical criteria.
  • Must have evidence of **CD20 positive disease**, which is a specific marker found on certain cancer cells, confirmed by special tests.
  • Must have adequate bone marrow function, which means your blood cell counts are at acceptable levels, unless low counts are clearly due to cancer involvement.
  • Must have a measured or estimated creatinine clearance of at least 45 mL/min, which is a test to check how well your kidneys are working.
  • Must have a life expectancy of more than 3 months.

Who cannot join the trial?

3 criteria

  • Patients who have already received treatment for **Richter's syndrome** cannot participate. **Richter's syndrome** is a condition where a type of blood cancer called chronic lymphocytic leukemia changes into a more aggressive form of lymphoma.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, are not eligible for this study.
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Investigated drugs

  • Mosunetuzumab

    is an experimental medication being studied for its potential to treat certain types of blood cancers. In this trial, it is combined with other medications to see if it can help patients with a condition called Richter's Syndrome, which is a transformation of chronic lymphocytic leukemia into a more aggressive form of lymphoma.

  • CHOP

    is a combination of four different chemotherapy drugs used to treat certain types of cancer, including lymphomas. It includes Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone. These medications work together to kill cancer cells or stop them from growing and dividing. In this trial, CHOP is used alongside Mosunetuzumab to see if the combination is more effective in treating Richter's Syndrome.

What is already known about the treatment

Mosunetuzumab – This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating Richter's syndrome, a type of lymphoma. It is a monoclonal antibody that targets specific proteins on cancer cells, helping the immune system to recognize and destroy these cells. Mosunetuzumab is classified as an immunotherapy agent and is being evaluated for its potential to improve outcomes in patients who have not previously received treatment for this condition.

Investigated diseases

Richter's Syndrome – This is a condition where chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) transforms into a more aggressive type of lymphoma, usually diffuse large B-cell lymphoma (DLBCL). The disease progression involves a sudden change in the behavior of the cancer cells, leading to rapid growth and spread. Patients may experience symptoms such as enlarged lymph nodes, fever, night sweats, and weight loss. The transformation is often identified through a biopsy, which shows the change in the type of lymphoma. This syndrome is considered a complication of CLL/SLL and requires different management strategies compared to the original condition.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-505621-13-00Protocol codeGELLC-9-RICHTEREstimated enrolment34 patientsSponsorGrupo Espanol De Leucemia Linfocitica Cronica

sourced from the EU Clinical Trials Register and site verification

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