Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruitingRare disease

Study on the Safety of Tafasitamab and Lenalidomide for Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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), specifically in patients whose disease has worsened or not responded to previous treatments. The study is testing a combination of two treatments: tafasitamab and lenalidomide. Tafasitamab is given through an intravenous infusion, which means it is administered directly into the bloodstream, while lenalidomide is taken orally in the form of capsules.

The purpose of the study is to evaluate the safety and how the body processes these medications when used together. Participants will receive a modified dosing schedule of tafasitamab, either once every two weeks or once every four weeks, combined with lenalidomide. The study will monitor the participants over a period to observe any side effects and to determine the most suitable dose of tafasitamab when used with lenalidomide.

Throughout the study, participants will be closely observed to track the occurrence and severity of any treatment-related side effects. Additionally, the study will assess how well the combination of tafasitamab and lenalidomide works in controlling the disease. This includes measuring the response of the cancer to the treatment and how long any positive effects last. The study aims to provide valuable information that could help improve treatment options for patients with relapsed or refractory DLBCL.

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 will be informed about the trial's objectives and procedures. The patient must provide informed consent to participate.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm eligibility. This includes a review of medical history, a physical examination, and laboratory tests to ensure the patient meets the study criteria.

  3. Step 3

    Treatment initiation

    The treatment involves a combination of two medications: tafasitamab and lenalidomide.

    Tafasitamab is administered intravenously. The dosing schedule is once every two weeks or once every four weeks, depending on the phase of the study.

    Lenalidomide is taken orally in the form of capsules. The dosage and frequency will be determined by the study protocol.

  4. Step 4

    Ongoing monitoring

    Throughout the study, regular monitoring will occur to assess the patient's response to treatment and any side effects. This includes blood tests, imaging studies, and physical examinations.

  5. Step 5

    Treatment cycles

    The treatment is administered in cycles. Each cycle lasts for a specified period, after which the patient's response is evaluated.

    The study aims to determine the best dosage and schedule for tafasitamab in combination with lenalidomide.

  6. Step 6

    Completion of study

    Upon completion of the study, a final assessment will be conducted to evaluate the overall response to the treatment.

    The patient will be informed about the results and any further steps if necessary.

Who can join the trial?

17 criteria

  • Must be able to give signed informed consent, which means agreeing to participate after understanding the study details.
  • Must be at least 18 years old or the legal age in the area where the study is conducted.
  • Must have a confirmed diagnosis of one of the following:
    • Diffuse Large B-Cell Lymphoma (DLBCL) 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
    • Evidence of transformation from a low-grade lymphoma to DLBCL
    • Must provide tumor tissue for review, either from a recent sample or a new biopsy if needed.
    • Must have relapsed or refractory disease, meaning the disease has returned or not responded to treatment.
    • Must have at least one measurable disease site, which is a tumor that can be measured in size.
    • Must have received at least one but no more than three previous treatments for DLBCL, including a CD20 targeted therapy like rituximab.
    • Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2, which measures daily living abilities.
    • Must not be eligible for intensive salvage therapy, such as stem cell transplantation, due to reasons like poor health or organ function.
    • Must meet specific laboratory criteria, such as certain blood cell counts and liver function tests.
    • If previously treated with CD19 targeted therapy, must have CD19 positive lymphoma confirmed after the treatment.
    • Patients with primary refractory disease, meaning the disease did not respond to initial treatment, are eligible if they have had one to three previous treatments.

Who cannot join the trial?

8 criteria

  • Patients who have a different type of cancer other than Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) cannot participate. This is a specific type of blood cancer.
  • Patients who are not within the age range specified for the study cannot participate. The study is for certain age groups only.
  • Patients who are not able to follow the study procedures or take the study medications as required cannot participate.
  • Patients who have other serious health conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate, as the study may affect the baby.
  • Patients who have participated in another clinical trial recently may not be eligible to participate.
  • Patients who have allergies or reactions to the study medications cannot participate.
  • Patients who are unable to provide informed consent, which means they cannot understand and agree to the study, cannot participate.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Tafasitamab

    is a medication used in this study to treat patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL). It is administered intravenously and works by targeting specific proteins on the surface of cancer cells, helping the immune system to identify and destroy these cells. The study aims to evaluate the safety and effectiveness of a modified dosing regimen of tafasitamab.

  • Lenalidomide

    is another medication used in combination with tafasitamab in this study. It is an oral medication that helps to modulate the immune system and has anti-cancer properties. Lenalidomide is used to enhance the effects of tafasitamab in treating R/R DLBCL by boosting the body's immune response against cancer cells.

What is already known about the treatment

  • Tafasitamab

    Tafasitamab is administered intravenously and is currently being studied in clinical trials for its safety and effectiveness in treating relapsed or refractory diffuse large B-cell lymphoma (DLBCL). It is an antibody that targets a specific protein on the surface of B-cells, leading to the destruction of these cancerous cells. Tafasitamab is classified as a monoclonal antibody and is being evaluated for its potential to improve outcomes in patients with this type of lymphoma.

  • Lenalidomide

    Lenalidomide is taken orally and is used in combination with other medications to treat relapsed or refractory diffuse large B-cell lymphoma (DLBCL). It works by modulating the immune system and inhibiting the growth of cancer cells. Lenalidomide is classified as an immunomodulatory drug and is well-established in medical literature for its role in treating various blood cancers, including DLBCL.

Investigated diseases

Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) – This is a type of non-Hodgkin lymphoma, which is a cancer that starts in white blood cells called lymphocytes. DLBCL is characterized by large cancerous B-cells that grow rapidly in lymph nodes or other organs. When the disease is termed "relapsed," it means that it has returned after treatment. "Refractory" indicates that the disease does not respond to treatment. The progression involves the uncontrolled growth of these large B-cells, which can spread to other parts of the body. Symptoms may include swollen lymph nodes, fever, night sweats, and weight loss.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-507993-42-00Protocol codeMOR208C115Estimated enrolment51 patientsSponsorIncyte Corp.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.