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Study on the Effectiveness and Safety of Polatuzumab Vedotin, Rituximab, and CHP in Patients with Untreated 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 type of cancer called Diffuse Large B-Cell Lymphoma (DLBCL), which is a common form of non-Hodgkin lymphoma. The study is investigating the effectiveness and safety of a treatment combination that includes the drugs Polatuzumab Vedotin, Rituximab, and a chemotherapy regimen known as CHP (Cyclophosphamide, Doxorubicin, and Prednisone). This combination is being compared to another treatment regimen called R-CHOP, which includes Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone.

The purpose of the study is to evaluate how well the new combination of Polatuzumab Vedotin, Rituximab, and CHP works in treating patients who have not received any prior treatment for their DLBCL. The study will also assess the safety of this treatment. Participants in the trial will receive their assigned treatment and will be monitored over a period of time to see how their disease responds. The study will involve regular check-ups and assessments to track the progress of the disease and any side effects from the treatment.

Throughout the study, participants will receive their treatments through intravenous (IV) infusions, which means the medication will be given directly into a vein. The trial aims to determine if the new treatment combination can improve outcomes for patients with DLBCL compared to the standard R-CHOP regimen. The study will help researchers understand if the new combination can help patients live longer without their disease getting worse.

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 is randomly assigned to one of two treatment groups. This assignment is done to compare the effectiveness and safety of two different treatment combinations for diffuse large B-cell lymphoma (DLBCL).

  2. Step 2

    Treatment group assignment

    The patient will receive either the combination of polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) or the combination of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP).

  3. Step 3

    Medication administration

    Medications are administered through intravenous infusion. This means the drugs are given directly into a vein using a needle or tube.

    The specific dosage and frequency of each medication will be determined by the study protocol and the healthcare team overseeing the trial.

  4. Step 4

    Monitoring and assessments

    Throughout the trial, the patient's health and response to treatment are closely monitored. This includes regular medical assessments and imaging tests such as CT or MRI scans to measure the size of any tumors.

    The patient's progress is evaluated using criteria specifically designed for assessing lymphoma.

  5. Step 5

    End of treatment evaluation

    At the end of the treatment period, the patient's response to the therapy is assessed. This includes determining whether the cancer has responded to treatment and evaluating any side effects experienced during the trial.

  6. Step 6

    Follow-up period

    After completing the treatment, the patient enters a follow-up period. During this time, the patient's health continues to be monitored to assess long-term outcomes and any late effects of the treatment.

Who can join the trial?

16 criteria

  • The patient must have **previously untreated** **Diffuse Large B-Cell Lymphoma (DLBCL)**. This means they have not received any treatment for this type of cancer before.
  • The patient must have a **CD20-positive** DLBCL, which is a specific marker found on the surface of certain cancer cells.
  • The patient must have one of the following specific types of DLBCL as classified by the World Health Organization (WHO) in 2016:
    • DLBCL, not otherwise specified (NOS), including germinal center B-cell type and activated B-cell type
    • T-cell/histiocyte-rich large B-cell lymphoma
    • Epstein-Barr virus-positive DLBCL, NOS
    • ALK-positive large B-cell lymphoma
    • HHV8-positive DLBCL, NOS
    • High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, known as double-hit or triple-hit lymphoma
    • High-grade B-cell lymphoma, NOS
    • The patient must have an **International Prognostic Index (IPI) score** between 2 and 5. This score helps to predict the outcome of the disease.
    • The patient must have an **Eastern Cooperative Oncology Group (ECOG) Performance Status** of 0, 1, or 2. This is a scale used to assess how the disease affects the patient's daily living abilities.
    • The patient must have a **life expectancy** of at least 12 months.
    • The patient must have at least one **bi-dimensionally measurable lesion**. This means a tumor that can be measured in two dimensions and is larger than 1.5 cm in its longest dimension, as seen on a CT or MRI scan.
    • The patient must have a **left ventricular ejection fraction (LVEF)** of at least 50%. This is a measure of how well the heart is pumping blood, assessed through a heart scan or ultrasound.
    • The study is open to both **male and female** patients.
    • The study includes patients from **vulnerable populations**, which may include groups like the elderly or those with certain disabilities.

Who cannot join the trial?

4 criteria

  • Patients who have already received treatment for **Diffuse large B-cell lymphoma (DLBCL)** cannot participate. This means if you have been treated for this type of cancer before, you are not eligible.
  • Patients who are not within the specified age range for the study cannot participate. The study has specific age requirements.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
  • Patients who do not meet other specific health criteria set by the study cannot participate. These criteria are designed to ensure the safety and effectiveness of the study.
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Investigated drugs

  • Polatuzumab Vedotin

    is a medication used in this trial to treat diffuse large B-cell lymphoma. It is designed to target and destroy cancer cells by delivering a toxic substance directly to them, helping to stop the growth and spread of the cancer.

  • Rituximab

    is a medication that works by targeting specific proteins on the surface of cancer cells. It helps the immune system to recognize and destroy these cancer cells, making it an important part of the treatment for lymphoma.

  • Cyclophosphamide

    is a chemotherapy drug that works by slowing or stopping the growth of cancer cells. It is used in combination with other medications to enhance the overall effectiveness of the treatment.

  • Doxorubicin

    is another chemotherapy drug used in this trial. It works by interfering with the DNA inside cancer cells, preventing them from growing and dividing. This helps to reduce the size of the tumor and control the spread of the disease.

  • Prednisone

    is a type of steroid that is used to reduce inflammation and suppress the immune system. In cancer treatment, it helps to enhance the effects of chemotherapy and manage some of the side effects associated with cancer therapies.

  • Vincristine

    is a chemotherapy medication that works by stopping the growth of cancer cells. It is used in combination with other drugs to improve the treatment outcomes for patients with lymphoma.

What is already known about the treatment

  • Polatuzumab Vedotin

    This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating previously untreated diffuse large B-cell lymphoma (DLBCL). It is being evaluated in combination with rituximab and other chemotherapy agents. Polatuzumab vedotin works by targeting and binding to a specific protein on the surface of cancer cells, delivering a toxic agent that helps to kill these cells. It is classified as an antibody-drug conjugate, which combines the targeting ability of an antibody with the cancer-killing ability of a drug.

  • Rituximab

    Administered intravenously, rituximab is a well-established medication used in the treatment of various types of lymphoma, including diffuse large B-cell lymphoma (DLBCL). It is part of the standard treatment regimen and works by targeting a specific protein on the surface of B-cells, leading to their destruction. Rituximab is classified as a monoclonal antibody and is widely recognized in medical literature for its role in cancer therapy.

Investigated diseases

Diffuse Large B-Cell Lymphoma (DLBCL) – This is a type of non-Hodgkin lymphoma that affects B-lymphocytes, 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 often presents with symptoms such as swollen lymph nodes, fever, night sweats, and weight loss. DLBCL can occur in both adults and children, but it is more common in older adults. The progression of the disease can vary, with some cases advancing quickly while others may develop more slowly. It is considered an aggressive form of lymphoma, requiring prompt medical attention.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516904-40-00Protocol codeGO39942Estimated enrolment1 000 patientsSponsorF. Hoffmann-La Roche AG

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