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Study on Tafasitamab with Gemcitabine, Oxaliplatin, and Rituximab for Patients with Aggressive B-cell Lymphoma

Fast replyRegistered 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 known as aggressive lymphoma, which includes various forms of B-cell lymphoma. The study is investigating the effects of a combination of medications: Gemcitabine, Oxaliplatin, Rituximab, and Tafasitamab (also known by the code name MOR208). These medications are administered through an intravenous infusion, which means they are given directly into a vein. The purpose of the study is to evaluate how well this combination of drugs works in treating patients with relapsed or refractory aggressive lymphoma, meaning the cancer has returned or has not responded to previous treatments.

Participants in the study will receive the treatment over a period of several weeks. The study will monitor the response of the lymphoma to the treatment, as well as any side effects experienced by the participants. The goal is to determine the overall response rate, which refers to how many patients experience a reduction in the size of their tumors or other signs of improvement. The study will also look at other outcomes, such as progression-free survival, which is the length of time during and after treatment that a patient lives with the disease without it getting worse, and overall survival, which is the length of time from the start of treatment that patients are still alive.

Throughout the study, the safety and tolerability of the treatment will be closely monitored. This means that researchers will keep track of any adverse effects or serious adverse effects that participants may experience. The study aims to provide valuable information about the effectiveness and safety of this treatment combination for patients with aggressive lymphoma, potentially leading to improved treatment options in the future.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current health status.

    Eligibility criteria include a confirmed diagnosis of certain types of B-cell lymphoma, previous treatment history, and specific health parameters.

  2. Step 2

    Treatment cycle initiation

    The treatment involves a combination of medications administered through intravenous infusion. These medications include rituximab, oxaliplatin, gemcitabine hydrochloride, and tafasitamab.

    The treatment is structured in cycles, with each cycle lasting a specific duration. The exact schedule and dosage are determined by the healthcare team based on individual patient needs.

  3. Step 3

    Monitoring and evaluation

    Throughout the treatment, regular monitoring is conducted to assess the response to the medications and to manage any side effects.

    Evaluations include physical examinations, blood tests, and imaging studies to track the progress of the lymphoma.

  4. Step 4

    Completion of treatment cycles

    The primary goal is to achieve a response within the first eight treatment cycles. The response is measured using specific criteria to determine the effectiveness of the treatment.

    Secondary goals include assessing progression-free survival, overall survival, and quality of life.

  5. Step 5

    Follow-up

    After completing the treatment cycles, follow-up appointments are scheduled to continue monitoring the patient's health and to evaluate long-term outcomes.

    These follow-ups help in understanding the overall impact of the treatment on the patient's condition and quality of life.

Who can join the trial?

11 criteria

  • Must have a confirmed diagnosis of certain types of **B-cell lymphoma**. This includes aggressive types and some specific forms as defined by medical guidelines.
  • Must sign a document agreeing to participate, known as **informed consent**.
  • If needed, must use **adequate contraception** to prevent pregnancy during the study.
  • Must have **relapsed** (returned) or **refractory** (not responding) disease, with at least one but no more than two previous treatments.
  • Must be **18 years or older**.
  • No available cure, especially if **65 years or older** or with a specific health score greater than 2, or after a certain type of treatment.
  • Must have at least one **measurable tumor** or **bone marrow involvement**.
  • Must have enough healthy **bone marrow**, with specific levels of **platelets** and **neutrophils** (types of blood cells).
  • Must have proper **liver and kidney function**, with specific levels of certain enzymes and substances in the blood.
  • Must have a certain level of **kidney filtration rate**, which measures how well the kidneys are working.
  • Must have a certain level of physical ability, as measured by a standard scale, unless the condition is expected to improve with treatment.

Who cannot join the trial?

5 criteria

  • Patients who have a different type of cancer than malignant B-cell lymphoma cannot participate. This is a specific type of cancer affecting certain white blood cells.
  • Patients who are not within the specified age range for the study cannot participate. The study is designed for certain age groups only.
  • Patients who are not part of the specified clinical trial groups cannot participate. The study targets specific groups of patients.
  • Patients who are not male or female cannot participate. The study includes both male and female participants.
  • Patients who are considered part of a vulnerable population cannot participate. This term refers to groups of people who might be at a higher risk of harm or exploitation.
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Investigated drugs

  • Gemcitabine

    is a medication used in cancer treatment. It works by slowing or stopping the growth of cancer cells. In this trial, it is being used to treat patients with certain types of lymphoma.

  • Oxaliplatin

    is a chemotherapy drug that is used to treat cancer. It helps to kill cancer cells by interfering with their DNA. In this study, it is combined with other medications to treat aggressive lymphoma.

  • Rituximab

    is a medication that targets specific proteins on the surface of cancer cells. It helps the immune system to find and destroy these cells. It is used in this trial to treat patients with lymphoma.

  • Tafasitamab (MOR208)

    is an experimental drug that is being tested for its effectiveness in treating lymphoma. It is designed to work with the immune system to attack cancer cells. This trial is investigating how well it works when combined with other cancer treatments.

What is already known about the treatment

  • Gemcitabine

    This medication is administered intravenously and is used in combination with other drugs for treating certain types of cancer, including malignant B-cell lymphoma. It is well-established in medical literature as a chemotherapy agent. Gemcitabine works by interfering with DNA synthesis, thereby preventing cancer cells from growing and dividing. It is classified as an antimetabolite.

  • Oxaliplatin

    Administered through an intravenous infusion, oxaliplatin is used in combination with other medications to treat aggressive forms of lymphoma. It is recognized in medical literature as a platinum-based chemotherapy drug. Oxaliplatin disrupts DNA replication in cancer cells, leading to cell death. It belongs to the class of alkylating agents.

  • Rituximab

    This medication is given by intravenous infusion and is used to treat certain types of lymphoma, including B-cell lymphoma. It is well-documented in medical literature as a monoclonal antibody. Rituximab targets a specific protein on the surface of B-cells, leading to their destruction. It is classified as a targeted therapy.

  • Tafasitamab

    Administered intravenously, tafasitamab is used in combination with other drugs for treating relapsed or refractory lymphoma. It is a newer addition to medical literature, being studied for its effectiveness in aggressive lymphomas. Tafasitamab works by binding to a protein on B-cells, enhancing the immune system's ability to destroy these cells. It is classified as a monoclonal antibody.

Investigated diseases

Malignant B-cell lymphoma – This is a type of cancer that originates in the B-cells, which are a type of white blood cell responsible for producing antibodies. It is characterized by the uncontrolled growth of these cells, leading to the formation of tumors in lymph nodes and other parts of the body. The disease can progress by spreading to other organs, including the spleen, liver, and bone marrow. Symptoms may include swollen lymph nodes, fever, night sweats, and weight loss. The progression of the disease can vary, with some forms being more aggressive than others. It is important to monitor the disease closely to understand its behavior and impact on the body.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514775-17-00Protocol code19-00153Estimated enrolment64 patientsSponsorUniversitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR

sourced from the EU Clinical Trials Register and site verification

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