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Study of Mosunetuzumab and Polatuzumab Vedotin for Patients with Diffuse Large B-Cell Lymphoma After Initial Treatment or in Elderly/Unfit Untreated Patients

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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 type of cancer called Diffuse Large B-Cell Lymphoma (DLBCL). The trial is exploring the use of a treatment called Mosunetuzumab, which is a medication given either as a solution for infusion or injection. The study also involves another medication called Polatuzumab Vedotin, which is used in combination with Mosunetuzumab for certain patients. The purpose of the study is to evaluate the effectiveness and safety of these treatments in patients with DLBCL.

The study is divided into different groups. One group will receive Mosunetuzumab after their initial treatment to see if it helps in maintaining their response to the first treatment. Another group will include elderly or less fit patients who have not been treated for DLBCL before, and they will receive Mosunetuzumab either alone or in combination with Polatuzumab Vedotin. The study will monitor how well the treatments work in reducing the cancer and how safe they are for the patients.

Participants in the study will receive the treatments through intravenous (IV) infusion or subcutaneous injection, depending on the group they are in. The study will track the response of the cancer to the treatment using imaging techniques and will also keep an eye on any side effects that may occur. The goal is to find the best dose and combination of these medications to help patients with DLBCL.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes measuring any nodal or extranodal lesions and evaluating overall health status using the Eastern Cooperative Oncology Group (ECOG) Performance Status.

  2. Step 2

    Treatment assignment

    Participants are assigned to one of three cohorts based on their medical history and current health condition.

    Cohort A involves patients who have previously received treatment for Diffuse Large B-Cell Lymphoma (DLBCL) and are now receiving mosunetuzumab intravenously.

    Cohort B includes elderly or unfit patients with untreated DLBCL, receiving mosunetuzumab intravenously.

    Cohort C involves elderly or unfit patients with untreated DLBCL, receiving a combination of mosunetuzumab subcutaneously and polatuzumab vedotin intravenously.

  3. Step 3

    Medication administration

    For Cohort A, mosunetuzumab is administered as an intravenous infusion. The dosage and frequency are determined based on the patient's response to previous treatments.

    For Cohort B, mosunetuzumab is administered intravenously. The dosage and frequency are adjusted according to the patient's health status.

    For Cohort C, mosunetuzumab is given subcutaneously, and polatuzumab vedotin is administered intravenously. The combination aims to enhance treatment effectiveness.

  4. Step 4

    Monitoring and evaluation

    Throughout the trial, regular monitoring is conducted to assess the treatment's effectiveness and safety. This includes imaging tests like PET-CT scans to evaluate tumor response.

    The incidence and severity of any side effects are recorded to ensure patient safety.

  5. Step 5

    Response assessment

    The primary response assessment involves determining the complete response rate or overall response rate using PET-CT scans.

    Secondary assessments include evaluating the duration of response, progression-free survival, and overall survival.

  6. Step 6

    Completion and follow-up

    Upon completion of the treatment phase, follow-up assessments are conducted to monitor long-term outcomes and any delayed side effects.

    The trial is estimated to conclude by July 2025, with ongoing evaluations to ensure comprehensive data collection.

Who can join the trial?

8 criteria

  • For all groups, patients must have at least one measurable lump in the lymph nodes larger than 1.5 cm or outside the lymph nodes larger than 1.0 cm.
  • For all groups, patients must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2. This is a scale that helps doctors understand how well a patient can perform daily activities. In South Korea, patients 80 years or older with an ECOG score of 2 or more will not be eligible for Cohort C.
  • For Cohort A, patients must have had one previous treatment with a specific type of chemotherapy for untreated Diffuse Large B-Cell Lymphoma (DLBCL) and must have shown stable disease or partial response to this treatment according to specific criteria.
  • For Cohort C, patients must be 80 years or older, or between 65 and 79 years old and unable to receive certain chemotherapy due to:
    • Difficulty in performing at least two basic daily activities.
    • Difficulty in performing at least two more complex daily activities.
    • A score indicating at least one severe health issue, not including lymphoma, or multiple moderate health issues.
    • For Cohorts B and C, patients with an initial ECOG performance status of 3 may be considered if their condition improves to a score of 2 or less after initial treatment during the screening phase.
    • For Cohort B, patients must be 80 years or older, or between 60 and 79 years old and unable to receive full-dose chemotherapy due to poor health, difficulty in daily activities, or other health issues.

Who cannot join the trial?

17 criteria

  • Patients who have a different type of cancer other than Diffuse Large B-Cell Lymphoma (DLBCL).
  • Patients who have not received first-line therapy for DLBCL.
  • Patients who have a serious medical condition that might interfere with the study treatment.
  • Patients who are pregnant or breastfeeding.
  • Patients who have an active infection that requires treatment.
  • Patients who have had another cancer within the last 5 years, except for certain skin cancers or in situ cancers.
  • Patients who have received certain treatments for DLBCL that are not allowed in the study.
  • Patients who have a known allergy to the study drugs or similar drugs.
  • Patients who have a history of certain heart problems.
  • Patients who have a history of certain lung problems.
  • Patients who have a history of certain liver problems.
  • Patients who have a history of certain kidney problems.
  • Patients who have a history of certain blood disorders.
  • Patients who have a history of certain immune system disorders.
  • Patients who have a history of certain neurological disorders.
  • Patients who have a history of certain psychiatric disorders.
  • Patients who are unable to comply with the study procedures.
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Investigated drugs

  • Mosunetuzumab

    is a medication being studied for its ability to help patients with diffuse large B-cell lymphoma (DLBCL). It is used in two different ways in this trial. First, it is given to patients who have already received initial treatment for DLBCL and have shown some response, to see if it can further reduce the cancer. Second, it is given to elderly or unfit patients who have not yet been treated for DLBCL, to see if it can help control the cancer. The study is also looking at how safe and tolerable the medication is, and how it behaves in the body.

  • Polatuzumab Vedotin

    is another medication being tested in this trial. It is used in combination with mosunetuzumab for elderly or unfit patients who have not been treated for DLBCL before. The trial aims to see if this combination can effectively reduce the cancer and to understand the safety and behavior of polatuzumab vedotin when used with mosunetuzumab.

What is already known about the treatment

  • Mosunetuzumab

    This medication is administered intravenously or subcutaneously and is currently being studied in clinical trials for its effectiveness in treating Diffuse Large B-Cell Lymphoma (DLBCL). It is being evaluated as a consolidation therapy following first-line immunochemotherapy and as a monotherapy or in combination with Polatuzumab Vedotin in elderly or unfit patients with previously untreated DLBCL. Mosunetuzumab works by engaging T-cells to target and destroy cancerous B-cells, acting as a bispecific antibody. It falls under the pharmacological classification of monoclonal antibodies.

  • Polatuzumab Vedotin

    This medication is administered intravenously and is being studied in combination with Mosunetuzumab for the treatment of elderly or unfit patients with previously untreated Diffuse Large B-Cell Lymphoma (DLBCL). It is designed to deliver a cytotoxic agent directly to cancer cells, thereby reducing the growth of the tumor. Polatuzumab Vedotin is classified as an antibody-drug conjugate, which combines the targeting ability of a monoclonal antibody with the cancer-killing ability of a chemotherapy drug.

Investigated diseases

Diffuse Large B-Cell Lymphoma (DLBCL) – This is a type of non-Hodgkin lymphoma that originates in the B-cells, which are a type of white blood cell responsible for producing antibodies. It is characterized by rapidly growing tumors in the lymph nodes, spleen, liver, or other organs. The disease often presents with symptoms such as swollen lymph nodes, fever, night sweats, and weight loss. DLBCL can progress quickly, requiring prompt medical attention. It is the most common form of non-Hodgkin lymphoma and can occur at any age, though it is more prevalent in older adults. The progression and symptoms can vary significantly among individuals, making it a complex condition to manage.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-507498-16-00Protocol codeGO40554Estimated enrolment179 patientsSponsorF. Hoffmann-La Roche AG

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