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Study on the Safety and Effectiveness of Polatuzumab Vedotin with Rituximab, Gemcitabine, and Oxaliplatin for Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

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 Diffuse Large B-Cell Lymphoma (DLBCL), which is a form of non-Hodgkin lymphoma. The study is specifically looking at patients whose DLBCL has returned or has not responded to previous treatments. The trial is testing a combination of medications to see if they can improve treatment outcomes for these patients. The medications being studied include Polatuzumab Vedotin, known by its code name RO5541077, and Rituximab, which are both given as infusions. These are combined with two chemotherapy drugs, Gemcitabine and Oxaliplatin, which are also administered through infusions. Some patients will receive all four medications, while others will receive only Rituximab, Gemcitabine, and Oxaliplatin, along with a placebo.

The purpose of the study is to evaluate the safety and effectiveness of the combination treatment compared to the standard treatment without Polatuzumab Vedotin. The study will monitor how well patients respond to the treatment and how long they live after receiving it. It will also look at any side effects, with a particular focus on a condition called peripheral neuropathy, which involves nerve damage that can cause weakness, numbness, and pain, usually in the hands and feet.

Participants in the study will receive their treatments through intravenous infusions, which means the medication is delivered directly into a vein. The study will take place over a period of time, with regular check-ups to monitor the patients' health and response to the treatment. The trial aims to provide valuable information that could lead to better treatment options for patients with relapsed or refractory DLBCL.

The research process

The trial runs in 4 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, eligibility is confirmed based on specific criteria such as having relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and previous treatment history.

    A performance status assessment is conducted to ensure adequate physical condition for participation.

  2. Step 2

    Treatment phase

    The treatment involves two groups: one receiving Polatuzumab Vedotin in combination with Rituximab, Gemcitabine, and Oxaliplatin (Pola-R-GemOx), and the other receiving Rituximab, Gemcitabine, and Oxaliplatin (R-GemOx) alone.

    All medications are administered through intravenous infusion.

    The specific dosages and frequency of administration are determined by the study protocol and medical team.

  3. Step 3

    Monitoring and assessments

    Regular monitoring is conducted to evaluate the safety and effectiveness of the treatment.

    Assessments focus on overall survival, incidence of side effects, and specific attention to peripheral neuropathy, which is a type of nerve damage that can cause weakness, numbness, and pain.

  4. Step 4

    Completion of treatment

    The treatment phase continues until the study's end date or until the medical team decides it is appropriate to stop.

    Final assessments are conducted to evaluate the outcomes and any long-term effects of the treatment.

Who can join the trial?

8 criteria

  • The patient must have a confirmed diagnosis of **diffuse large B-cell lymphoma (DLBCL)**, which is a type of cancer affecting the lymphatic system.
  • The disease must have either come back after treatment (**relapsed**) or not responded to treatment (**refractory**).
  • The patient must have received at least one previous treatment that involved medication given through the bloodstream (**systemic therapy**).
  • The patient must have at least one tumor that can be measured in two directions, which helps doctors track the size of the tumor.
  • The patient must have a performance status score of 0, 1, or 2 according to the **Eastern Cooperative Oncology Group (ECOG)** scale, which measures how well a patient can perform daily activities.
  • The patient must have adequate **hematological function**, meaning their blood cell levels are within a safe range.
  • The study is open to both male and female patients.
  • The study includes patients who are considered part of a vulnerable population, meaning they may need extra protection or care.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of cancer than the one being studied cannot participate.
  • Patients who have not experienced a return or worsening of their cancer after treatment cannot participate.
  • Patients who have certain other health conditions that might interfere with the study cannot participate.
  • Patients who are currently pregnant or breastfeeding cannot participate.
  • Patients who are unable to follow the study procedures or attend study visits cannot participate.
  • Patients who have had a recent major surgery or are recovering from surgery cannot participate.
  • Patients who are currently participating in another clinical trial cannot participate.
  • Patients who have had an allergic reaction to any of the study drugs or similar drugs cannot participate.
  • Patients who have certain infections that are not well controlled cannot participate.
  • Patients who have a history of certain heart problems cannot participate.
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Investigated drugs

  • Polatuzumab Vedotin

    is a medication used in this trial to treat patients with relapsed or refractory diffuse large B-cell lymphoma. It is an antibody-drug conjugate that targets cancer cells and delivers a chemotherapy agent directly to them, helping to destroy the cancer cells while minimizing damage to healthy cells.

  • Rituximab

    is a medication that is part of the treatment regimen in this trial. It is a monoclonal antibody that targets a specific protein on the surface of certain cancer cells, helping the immune system to identify and destroy these cells.

  • Gemcitabine

    is a chemotherapy drug used in this trial. It works by interfering with the DNA of cancer cells, preventing them from growing and dividing, which helps to slow down or stop the progression of the cancer.

  • Oxaliplatin

    is another chemotherapy drug included in the treatment regimen. It works by damaging the DNA in cancer cells, which prevents them from multiplying and can lead to cell death, helping to reduce the size of tumors and control the spread of cancer.

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 relapsed or refractory diffuse large B-cell lymphoma (DLBCL). It is often used in combination with other drugs like Rituximab, Gemcitabine, and Oxaliplatin. 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 chemotherapy drug.

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 can start in any part of the body and may spread to other areas, including the bone marrow and central nervous system. Symptoms often include swollen lymph nodes, fever, night sweats, and weight loss. DLBCL is considered aggressive due to its fast progression, but it is also one of the most common and treatable forms of lymphoma.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512537-33-00Protocol codeMO40598Estimated enrolment284 patientsSponsorF. Hoffmann-La Roche AG

sourced from the EU Clinical Trials Register and site verification

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