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Study of Rituximab, Polatuzumab Vedotin, and Glofitamab for Untreated Aggressive B-cell Lymphoma in Patients Over 60 Not Eligible for Full R-CHOP

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 type of cancer called aggressive B-cell lymphoma, which is a fast-growing cancer that affects a type of white blood cell. The study is testing a combination of treatments for patients who have not received any previous treatment for this disease and are over 60 years old. The treatments being studied include rituximab, polatuzumab vedotin, and glofitamab. These medications are given through an intravenous infusion, which means they are administered directly into the bloodstream through a vein.

The purpose of the study is to evaluate how effective this combination of treatments is for patients who are not eligible for a standard chemotherapy regimen known as R-CHOP. The study will involve a series of treatment cycles, where patients will receive the medications over a period of time. The study will monitor the patients' response to the treatment, including how long they remain free from disease progression and their overall survival rates. The study will also look at the safety of the treatment and any side effects that may occur.

Throughout the study, patients will be closely monitored by healthcare professionals to ensure their safety and to assess the effectiveness of the treatment. The results from this study will help in planning future research and may lead to new treatment options for patients with aggressive B-cell lymphoma. The study aims to provide valuable information that could improve the care and outcomes for patients with this type of cancer.

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 required to provide written informed consent. This indicates understanding and willingness to comply with the study protocol and treatments.

    The patient must meet specific health criteria, including adequate liver, kidney, and blood function, and must not have any active infections such as hepatitis or SARS-CoV-2.

  2. Step 2

    Initial assessment

    The patient undergoes a thorough health assessment to confirm eligibility. This includes tests to ensure the patient has not received prior systemic lymphoma therapy and has a confirmed diagnosis of aggressive B-cell lymphoma.

  3. Step 3

    Treatment phase

    The treatment involves a combination of medications administered through intravenous infusion. These medications include rituximab, polatuzumab vedotin, and glofitamab.

    The treatment is divided into cycles, with specific dosages and schedules determined by the study protocol. The patient receives these medications over a series of cycles, with regular monitoring to assess response and adjust treatment as necessary.

  4. Step 4

    Monitoring and evaluation

    Throughout the treatment, the patient's health and response to the medication are closely monitored. This includes regular medical evaluations and imaging tests to track the progress of the lymphoma.

    The study aims to evaluate the effectiveness of the treatment combination, focusing on progression-free survival and overall response rates.

  5. Step 5

    Consolidation phase

    After completing the initial treatment cycles, the patient enters a consolidation phase. This phase aims to maintain the response achieved during the treatment phase and further reduce the risk of lymphoma progression.

    The consolidation phase involves continued administration of the study medications, with adjustments based on the patient's response and any side effects experienced.

  6. Step 6

    Follow-up

    Following the completion of the treatment and consolidation phases, the patient enters a follow-up period. This involves regular check-ups to monitor long-term health outcomes and any potential late effects of the treatment.

    The follow-up period is crucial for assessing the duration of response and overall survival, as well as identifying any long-term side effects or secondary health issues.

Who can join the trial?

15 criteria

  • The patient must provide written consent and be willing to follow the study rules and treatments.
  • The patient should have a life expectancy of at least 12 weeks, as judged by the doctor.
  • The patient must have good liver function, which includes specific levels of liver-related substances in the blood.
  • The patient must have good blood health, including certain levels of white blood cells, platelets, and hemoglobin.
  • The patient must have good kidney function, shown by specific levels of creatinine in the blood or a calculated measure of kidney function.
  • The patient must test negative for certain infections, including hepatitis B, hepatitis C, and HIV.
  • The patient must not have an active COVID-19 infection and must test negative for COVID-19 before joining the study.
  • The patient must be over 60 years old.
  • The patient must not be eligible for a full dose of a specific chemotherapy treatment called R-CHOP.
  • The patient must have a confirmed diagnosis of aggressive B-cell lymphoma.
  • The patient must have at least one measurable area of lymphoma that shows up on a specific type of scan called FDG PET.
  • The patient must have biopsy material available for review.
  • Female patients who can have children and male patients with female partners who can have children must agree to use effective birth control or remain abstinent during the study and for a certain period after the last dose of study drugs.
  • The patient must not have received any previous treatment for lymphoma.
  • The patient must have an ECOG performance status of 2 or less, which is a measure of how well they can perform daily activities.

Who cannot join the trial?

4 criteria

  • Patients who have already received treatment for their aggressive B-cell lymphoma cannot participate.
  • Patients who are eligible for a full dose of a specific chemotherapy regimen called R-CHOP are not allowed to join the study.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who belong to certain vulnerable groups may be excluded from the study.
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Investigated drugs

  • Rituximab

    is a medication used in this trial that helps the immune system target and destroy cancer cells. It is often used to treat certain types of lymphoma and works by attaching to a specific protein on the surface of cancer cells, marking them for destruction by the body's immune system.

  • Polatuzumab vedotin

    is an antibody-drug conjugate used in the trial. It combines an antibody with a chemotherapy drug. The antibody part helps deliver the chemotherapy directly to the cancer cells, which can help reduce damage to healthy cells and improve the effectiveness of the treatment.

  • Glofitamab

    is a bispecific antibody used in the trial. It is designed to bind to both the cancer cells and the immune cells, bringing them together. This helps the immune system to better recognize and attack the cancer cells, potentially improving the treatment outcomes for patients with aggressive B-cell lymphoma.

What is already known about the treatment

  • Rituximab

    This medication is administered intravenously and is currently well-established in medical practice and literature. It is primarily used to treat certain types of B-cell lymphomas, including aggressive B-cell lymphoma. Rituximab works by targeting a specific protein on the surface of B-cells, leading to their destruction. It is classified as a monoclonal antibody.

  • Polatuzumab Vedotin

    Administered intravenously, this medication is an antibody-drug conjugate used in the treatment of aggressive B-cell lymphoma. It combines a monoclonal antibody with a chemotherapy agent, delivering the drug directly to cancer cells. This targeted approach helps to destroy cancer cells while minimizing damage to healthy cells.

  • Glofitamab

    This medication is given intravenously and is currently being studied for its effectiveness in treating aggressive B-cell lymphoma. It is a bispecific antibody that binds to both cancer cells and immune cells, helping the immune system to recognize and destroy the cancer cells. Glofitamab is part of a newer class of immunotherapy drugs.

Investigated diseases

Aggressive B-cell Lymphoma – Aggressive B-cell lymphoma is a type of non-Hodgkin lymphoma characterized by the rapid growth of cancerous B-cells, which are a type of white blood cell. This disease often presents with symptoms such as swollen lymph nodes, fever, night sweats, and weight loss. It can affect various parts of the body, including lymph nodes, spleen, and other organs. The progression of the disease can be swift, leading to the spread of cancerous cells to other areas. It is typically diagnosed through a combination of physical examinations, imaging tests, and biopsies. Treatment often involves chemotherapy, immunotherapy, or a combination of both, tailored to the patient's specific condition and health status.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-513949-37-00Estimated enrolment126 patientsSponsorInstitut fuer Klinische Krebsforschung IKF GmbH

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