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Study Comparing R-MINI-CHOP and R-MINI-CHP with Polatuzumab Vedotin for Treating Diffuse Large B-Cell Lymphoma in Patients Aged 80 and Older or Frail Patients Aged 75 and Older

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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, which is a common form of non-Hodgkin lymphoma. The study is comparing two treatment options for patients who are 80 years or older, or those who are frail and 75 years or older. The treatments being compared are called R-MINI-CHOP and R-MINI-CHP combined with a medication known as Polatuzumab Vedotin (also referred to by its code name RO5541077). The purpose of the study is to evaluate how effective the combination of Polatuzumab Vedotin with R-MINI-CHP is compared to R-MINI-CHOP.

The medications involved in this study include Vincristine Sulfate, Cyclophosphamide, Doxorubicin Hydrochloride, Prednisone, and Rituximab. These are commonly used in chemotherapy, which is a type of cancer treatment that uses drugs to destroy cancer cells. The study will involve administering these medications through different methods such as intravenous infusion, which means delivering the medication directly into a vein, and subcutaneous injection, which involves injecting the medication under the skin.

Participants in the study will receive one of the treatment options over a period of time, and their health will be monitored to see how well the treatment works. The study will look at various outcomes, such as how long patients live without the disease getting worse, the duration of response to the treatment, and the overall survival rate. The study will also assess the safety of the treatments and their impact on the quality of life of the participants. The trial is expected to continue until the end of 2025.

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

    Joining the trial

    Upon joining the trial, you will be informed about the study's purpose and procedures. You will be asked to provide written consent to participate.

    You will undergo a comprehensive assessment to confirm eligibility, including age and health status checks.

  2. Step 2

    Treatment assignment

    You will be randomly assigned to one of two treatment groups: R-mini-CHOP or pola-R-mini-CHP.

    This assignment is done to compare the effectiveness of the two treatments.

  3. Step 3

    Treatment administration

    You will receive medications through different methods such as intravenous infusion or subcutaneous injection.

    The medications include vincristine sulfate, polatuzumab vedotin, cyclophosphamide, doxorubicin hydrochloride, prednisone, and rituximab.

    The frequency and dosage will be determined by the study protocol and your healthcare team.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring will be conducted to assess your response to the treatment and any side effects.

    You will have scheduled visits for health evaluations, which may include blood tests and imaging studies.

  5. Step 5

    Completion of treatment

    After completing the treatment course, your health will continue to be monitored to evaluate the long-term effects and overall outcomes.

    You will be informed about the results of the trial and any further steps if necessary.

Who can join the trial?

13 criteria

  • Age: You must be 80 years or older, or if you are considered frail, you must be 75 years or older. Frailty is determined by a special health assessment.
  • You must have a confirmed diagnosis of a type of lymphoma, which is a cancer of the lymphatic system. The specific types include:
    • Diffuse large B-cell lymphoma, including if it has changed from a slower-growing type of lymphoma.
    • Follicular lymphoma grade 3B.
    • T-cell/histiocyte-rich large B-cell lymphoma.
    • Primary cutaneous diffuse large B-cell lymphoma, leg type.
    • EBV-positive diffuse large B-cell lymphoma, not otherwise specified.
    • Primary mediastinal large B-cell lymphoma.
    • High-grade B-cell lymphoma with MYC/BCL2 rearrangement.
    • Your disease must be at Stage II-IV, which indicates the extent of cancer spread.
    • You must have at least one measurable site of disease that is more than 1.5 cm in length.
    • You must not have received any previous treatment for lymphoma.
    • Your performance status, which measures your ability to perform daily activities, must be between 0 and 3. A score of 3 is acceptable if it is related to diffuse large B-cell lymphoma.
    • You must provide written informed consent, which means you agree to participate in the study after understanding all the details.

Who cannot join the trial?

7 criteria

  • Patients with any other type of cancer that is not Diffuse Large B-Cell Lymphoma.
  • Patients who have had a previous treatment for Diffuse Large B-Cell Lymphoma.
  • Patients with serious heart problems.
  • Patients with uncontrolled infections.
  • Patients who are pregnant or breastfeeding.
  • Patients with a history of severe allergic reactions to any of the study drugs.
  • Patients with any other medical condition that the study doctors think would make it unsafe for them to participate.
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Investigated drugs

  • R-mini-CHOP

    is a combination of medications used to treat certain types of cancer, specifically lymphoma. It includes a mix of drugs that work together to kill cancer cells or stop them from growing. This combination is often used in patients who are older or may not be able to handle stronger treatments.

  • R-mini-CHP

    is similar to R-mini-CHOP but does not include one of the drugs found in R-mini-CHOP. It is used to treat the same type of cancer and is designed for patients who might be frail or older, providing a treatment option that might be easier for them to tolerate.

  • Polatuzumab vedotin

    is a medication that targets cancer cells directly. It works by attaching to a specific protein found on the surface of cancer cells and delivering a substance that can kill these cells. This targeted approach helps to minimize damage to healthy cells and is used in combination with other cancer treatments to improve their effectiveness.

What is already known about the treatment

Polatuzumab Vedotin – Polatuzumab Vedotin is administered intravenously, meaning it is given through a vein, typically in a hospital or clinic setting. It is currently being studied in clinical trials as a treatment for Diffuse Large B-Cell Lymphoma, particularly in older or frail patients. This medication works by targeting and binding to a specific protein on the surface of cancer cells, delivering a toxic substance directly to these cells to help destroy them. It is classified as an antibody-drug conjugate, which combines an antibody with a chemotherapy drug to specifically target cancer cells.

Investigated diseases

Diffuse Large B-Cell Lymphoma – This is a type of non-Hodgkin lymphoma that originates in the B-cells, which are a type of white blood cell. It typically presents as a rapidly growing mass, often in the lymph nodes, but it can also occur in other organs. The disease progresses quickly, with cancerous cells spreading to other parts of the body if not managed. Symptoms may include swelling of lymph nodes, fever, night sweats, and weight loss. As the disease advances, it can affect the body's ability to fight infections. The progression can vary, with some cases remaining localized while others spread more extensively.
Trial detailsLast updated 2 Oct 2026
Age65+ yearsPhasePhase IIITrial ID2022-502887-19-00Protocol codeNLG-LBC7Estimated enrolment309 patientsSponsorRegion Skane

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).