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Study on the Safety and Effectiveness of Tafasitamab and Lenalidomide for Patients with Relapsed or Refractory Diffuse Large 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 called Diffuse Large B-Cell Lymphoma (DLBCL), which is a form of non-Hodgkin lymphoma. The study is investigating the effects of a treatment combination that includes Tafasitamab and Lenalidomide. Tafasitamab is a humanized monoclonal antibody, which is a type of protein designed to target specific cells, and it is also known by the code name MOR00208. Lenalidomide is a medication that helps the immune system fight cancer and is taken in capsule form.

The purpose of this study is to evaluate the safety and effectiveness of this treatment combination in patients whose DLBCL has returned or has not responded to previous treatments. Participants in the study will receive the treatment over a period of up to 12 months. The study will monitor how well the treatment works and any side effects that may occur. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the treatment.

Throughout the study, participants will have regular check-ups and tests to assess their response to the treatment. The study aims to provide valuable information on whether this combination of Tafasitamab and Lenalidomide can be a beneficial treatment option for patients with relapsed or refractory DLBCL. The results will help determine if this treatment can improve outcomes for patients with this challenging condition.

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 study

    Upon joining the study, the participant will be required to provide consent and confirm their understanding of the study procedures.

    Eligibility will be confirmed through a review of medical history and necessary diagnostic tests.

  2. Step 2

    Initial assessments

    Initial assessments will include a tumor biopsy and a bone marrow biopsy or aspirate collection, if applicable.

    These assessments are necessary to confirm the diagnosis of Diffuse Large B-Cell Lymphoma (DLBCL).

  3. Step 3

    Treatment phase

    The treatment involves the administration of two medications: tafasitamab and lenalidomide.

    Tafasitamab will be given as an intravenous infusion. The specific dosage and frequency will be determined by the study protocol.

    Lenalidomide will be taken orally in the form of capsules. The dosage may vary, and the participant will be instructed on the correct dosage and schedule.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring will be conducted to assess the participant's response to the treatment.

    This will include physical examinations, blood tests, and imaging studies as required by the study protocol.

    The primary goal is to evaluate the overall response rate (ORR), which measures the percentage of participants achieving a complete or partial response.

  5. Step 5

    End of treatment

    Upon completion of the treatment phase, a final assessment will be conducted to determine the participant's response.

    The duration of response (DOR) will be evaluated, which is the time from the first documented complete or partial response until disease progression or death.

Who can join the trial?

10 criteria

  • Must be 18 years or older at the time of giving consent.
  • Must be able to understand and willing to sign a written Informed Consent Form (ICF), which is a document that explains the study and what is expected from participants.
  • Must have a confirmed diagnosis of one of the following types of Diffuse Large B-Cell Lymphoma (DLBCL):
    • Diffuse large B-cell lymphoma not otherwise specified
    • T cell/histiocyte-rich large B-cell lymphoma
    • Epstein-Barr virus positive DLBCL of the elderly
    • Grade 3b follicular lymphoma
    • Composite lymphoma with a DLBCL component and a subsequent DLBCL relapse
    • Evidence of transformation from a low-grade lymphoma (like follicular lymphoma, marginal zone lymphoma, or chronic lymphocytic leukemia) into DLBCL, with a subsequent DLBCL relapse
    • Must be willing to undergo a tumor biopsy, which is a procedure to remove a small sample of tissue for examination. This can be done through different methods like incisional, excisional, or core needle biopsy, or using a previous biopsy sample from the last 3 years.
    • Must be willing to undergo bone marrow biopsy/aspirate collections if needed. This involves taking a small sample of bone marrow, which is the soft tissue inside bones, to check for disease.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of cancer than Diffuse large B-cell lymphoma (DLBCL).
  • Patients who are eligible for HDC/ASCT, which stands for high-dose chemotherapy and autologous stem cell transplant. This is a treatment where high doses of medicine are used to kill cancer cells, and then the patient's own stem cells are given back to help the body recover.
  • Patients who do not meet the age requirements for the study.
  • Patients who are not able to follow the study procedures or instructions.
  • Patients who have other medical conditions that might interfere with the study treatment.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have allergies or reactions to the study medications.
  • Patients who have an active infection that requires treatment.
  • Patients who have a history of other serious diseases that might affect their participation.
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Investigated drugs

  • Tafasitamab

    is a medication used in this study to treat patients with a type of blood cancer called diffuse large B-cell lymphoma (DLBCL). It works by targeting specific proteins on the surface of cancer cells, helping the immune system to recognize and destroy these cells.

  • Lenalidomide

    is another medication used in combination with tafasitamab in this study. It helps to boost the immune system and can also directly attack cancer cells. This combination aims to improve the treatment outcomes for patients with relapsed or refractory DLBCL who are not suitable for high-dose chemotherapy or stem cell transplant.

What is already known about the treatment

  • Tafasitamab

    Tafasitamab is administered intravenously, meaning it is given directly into a vein. It is currently being studied in clinical trials for its effectiveness in treating diffuse large B-cell lymphoma (DLBCL), particularly in patients who have relapsed or are refractory to other treatments. The medication works by targeting a specific protein on the surface of B-cells, leading to the destruction of these cancerous cells. Tafasitamab is classified as a monoclonal antibody, which is a type of targeted cancer therapy.

  • Lenalidomide

    Lenalidomide is taken orally in the form of a capsule. It is being evaluated in combination with tafasitamab for its potential to treat diffuse large B-cell lymphoma (DLBCL) in patients who have not responded to previous treatments. Lenalidomide works by modulating the immune system and inhibiting the growth of cancer cells. It belongs to a class of drugs known as immunomodulatory agents, which help enhance the body's immune response against cancer.

Investigated diseases

Diffuse Large B-Cell Lymphoma (DLBCL) – This is a type of non-Hodgkin lymphoma that originates in the B-cells, which are a type of white blood cell. It is characterized by rapidly growing tumors in the lymph nodes, spleen, liver, bone marrow, or other organs. DLBCL can cause symptoms such as swelling of lymph nodes, fever, night sweats, and weight loss. The disease can progress quickly, requiring prompt medical attention. It is the most common form of non-Hodgkin lymphoma and can occur at any age, though it is more frequently diagnosed in older adults. The progression of DLBCL can vary, with some cases responding well to treatment while others may be more challenging to manage.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505579-53-00Protocol codeINCMOR 0208-305Estimated enrolment88 patientsSponsorIncyte Corp.

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