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Study on the Effectiveness and Safety of Cytarabine, Tafasitamab, and Lenalidomide for Patients with Relapsed 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 two types of aggressive blood cancers: Diffuse Large B-Cell Lymphoma (DLBCL) and High-Grade B-Cell Lymphoma (HGBCL). These diseases originate from mature B-cells, which are a type of white blood cell. The study aims to evaluate the effectiveness and safety of starting a second-line treatment early in patients who have experienced a relapse of these lymphomas. The treatment will be guided by the levels of tumor DNA found in the blood, which is a method to detect cancer activity.

The trial involves several medications, including Cytarabine, Tafasitamab (also known as MOR00208), Lenalidomide, Dexamethasone, Cisplatin, Bendamustine Hydrochloride, Polatuzumab Vedotin (also known as RO5541077), and Rituximab. These medications are used in various forms such as solutions for infusion, injections, and capsules. Some patients may receive a placebo as part of the study. The study will monitor the overall response rate to the second-line treatment and any significant side effects that may occur.

Participants in the study will undergo regular assessments, including blood tests to measure circulating tumor DNA and imaging tests like PET-CT scans to monitor disease progression. The study will also evaluate the quality of life of participants using a specific questionnaire. The trial is expected to continue until early 2026, with the goal of improving treatment strategies for patients with these types of lymphomas.

The research process

The trial runs in 7 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, consent is required to participate in the clinical trial. This involves understanding the study's purpose, procedures, and potential risks and benefits.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to confirm eligibility. This includes a PET/CT scan to evaluate disease progression and a review of medical history and current health status.

  3. Step 3

    Treatment commencement

    The treatment begins based on the assessment of circulating tumor-derived DNA. This involves starting a second-line treatment tailored to the patient's condition.

  4. Step 4

    Medication administration

    Medications are administered as part of the treatment plan. This includes drugs such as cytarabine, tafasitamab, lenalidomide, dexamethasone, cisplatin, bendamustine hydrochloride, polatuzumab vedotin, and rituximab. The administration routes include oral tablets and intravenous infusions, with dosages and frequency determined by the healthcare team.

  5. Step 5

    Ongoing monitoring

    Regular monitoring is conducted to assess the treatment's effectiveness and manage any side effects. This includes blood tests, imaging studies, and health assessments.

  6. Step 6

    Quality of life assessment

    The impact of the treatment on quality of life is evaluated using the EORTC QLQ-C30 questionnaire. This helps in understanding the patient's well-being during the trial.

  7. Step 7

    Completion of treatment

    Upon completion of the treatment, a final assessment is conducted to evaluate the overall response and any long-term effects. Follow-up care and monitoring may continue as needed.

Who can join the trial?

14 criteria

  • Patients must have a diagnosis of Diffuse Large B-Cell Lymphoma (DLBCL) or High-Grade B-Cell Lymphoma (HGBCL).
  • Patients should be eligible for chemotherapy treatments like R-CHOP, R-CHOP-like, Pola-R-CHP, or DA-EPOCH-R.
  • Patients must have test results available, including:
    • Mutation analysis in blood before starting first-line treatment.
    • Assessment of circulating free DNA (cfDNA) from the tumor during and after treatment.
    • PET-CT scans before and after first-line treatment.
    • Patients must sign an informed consent form to participate in the study.
    • Patients must be at least 18 years old.
    • Patients need to have a PET/CT scan to check disease progression before starting treatment.
    • Patients should have an ECOG performance status of 0-2, or 3 if the condition is due to disease progression. (ECOG is a scale to assess how a disease affects daily living abilities.)
    • Patients must agree to use effective contraception during the trial and for a specified period after the last dose of treatment.
    • Women of childbearing age must have a negative pregnancy test before the trial and agree to use effective contraception during and after the trial.
    • Patients must provide access to tissue samples from the disease diagnosis if needed.
    • Patients planning to receive Pola-R-CHP must meet specific eligibility criteria for this treatment.
    • Patients must be in complete remission confirmed by a PET-CT scan after completing first-line treatment.

Who cannot join the trial?

8 criteria

  • Patients with other types of cancer that are not related to Diffuse large B-cell lymphomas (DLBCL) or aggressive B-cell lymphomas (HGBCL) cannot participate.
  • Patients who have not completed their previous cancer treatments or have not recovered from their side effects are excluded.
  • Patients with severe heart problems or uncontrolled high blood pressure are not eligible.
  • Patients with active infections that require treatment are excluded.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients with a history of allergic reactions to similar treatments are not eligible.
  • Patients with any other serious medical conditions that could interfere with the study are excluded.
  • Patients who are unable to follow the study procedures or attend the required visits are not eligible.
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Investigated drugs

Cell-free circulating tumor DNA is a type of genetic material that can be found in the blood. In this study, it is used to help decide when to start a new treatment for patients with certain types of lymphoma, specifically DLBCL or HGBCL. By checking the levels of this DNA in the blood, doctors can determine if the cancer is coming back and if it's time to begin a second round of treatment. This approach aims to catch the cancer early and start treatment sooner, potentially improving outcomes for patients.

What is already known about the treatment

Diffuse large B-cell lymphoma (DLBCL) and High-grade B-cell lymphoma (HGBCL) treatment – This treatment is administered as a second-line therapy for patients with relapsed DLBCL or HGBCL, which are aggressive types of B-cell lymphomas. The treatment is guided by the detection of tumor DNA in the blood, allowing for early intervention. Currently, this approach is being studied in a phase II clinical trial to assess its effectiveness and safety. The main goal is to improve outcomes by starting treatment based on specific DNA markers, which helps target the cancer more precisely.

Investigated diseases

  • Diffuse Large B-Cell Lymphoma

    Diffuse Large B-Cell Lymphoma (DLBCL) is a type of non-Hodgkin lymphoma that originates from mature B-cells. It is characterized by the rapid growth of large B-cells in lymph nodes, spleen, liver, bone marrow, or other organs. The disease progresses quickly, often presenting with symptoms such as swollen lymph nodes, fever, night sweats, and weight loss. DLBCL can affect various parts of the body, leading to organ dysfunction depending on the location of the tumor. The disease can spread to other parts of the body, including the central nervous system. It is the most common type of non-Hodgkin lymphoma in adults.

  • High-Grade B-Cell Lymphoma

    High-Grade B-Cell Lymphoma (HGBCL) is an aggressive form of non-Hodgkin lymphoma that arises from mature B-cells. It is characterized by the presence of large, rapidly dividing cells that can form tumors in lymph nodes and other organs. The disease progresses quickly, often leading to symptoms such as enlarged lymph nodes, fever, night sweats, and unexplained weight loss. HGBCL can affect multiple organs, causing dysfunction depending on the tumor's location. The lymphoma can spread to other parts of the body, including the bone marrow and central nervous system. It is considered a high-grade lymphoma due to its aggressive nature and rapid progression.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518275-64-00Protocol codeIHIT/2021/1Estimated enrolment360 patientsSponsorInstytut Hematologii I Transfuzjologii

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