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Continued Treatment Study for Patients with Blood Cancers Using Tafasitamab

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on patients with hematologic cancers, which are types of cancer that affect the blood, bone marrow, and lymph nodes. The study involves a treatment using tafasitamab, a medication that is administered as a solution for infusion. Tafasitamab is a humanized monoclonal antibody, which means it is a type of protein designed to target specific cells in the body. It is used to help treat certain blood cancers by targeting and binding to a protein called CD19 found on the surface of cancer cells.

The purpose of this study is to provide continued treatment and monitor the safety of tafasitamab in patients who have already been receiving this medication in previous studies. Participants in this study will continue to receive tafasitamab as part of their treatment plan. The study will observe how patients respond to the medication over time and will monitor any side effects or adverse reactions that may occur. This ongoing treatment aims to support patients who have shown a positive response or stable disease condition with tafasitamab in earlier studies.

Throughout the study, patients will have regular visits to receive their treatment and to check on their health status. The study will last for a period of time, allowing researchers to gather important information about the long-term use of tafasitamab in treating hematologic cancers. This information will help in understanding the safety and effectiveness of the medication for patients who continue to benefit from it.

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, you will be required to provide signed informed consent. This means you agree to follow the study's requirements and restrictions as outlined in the informed consent form.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm that you are still receiving treatment with tafasitamab from a previous study and that you are tolerating the treatment well. The investigator will check if you are experiencing clinical benefits, such as complete or partial response or stable disease.

  3. Step 3

    Treatment continuation

    You will continue to receive tafasitamab as a solution for infusion. This means the medication will be administered directly into your bloodstream through an infusion. The dosage and frequency will be the same as specified in the previous study you were part of.

  4. Step 4

    Scheduled visits

    You will need to attend scheduled visits as part of the study. These visits are necessary to monitor your health and the effects of the treatment. The schedule for these visits will be provided to you by the study team.

  5. Step 5

    Safety evaluation

    Throughout the study, the safety of the treatment will be evaluated. This involves monitoring for any serious adverse events (SAEs) or other side effects. The study aims to ensure that the treatment remains safe for you.

  6. Step 6

    Study duration

    The study is expected to continue until December 31, 2027. Your participation will be required until the study ends or until it is determined that you are no longer benefiting from the treatment.

Who can join the trial?

8 criteria

  • Capable of giving signed informed consent, which means you understand the study and agree to follow its rules.
  • Currently enrolled and receiving treatment with tafasitamab from a previous clinical study.
  • Tolerating the tafasitamab treatment well at the dose specified in the previous study, as determined by the study doctor.
  • Showing a complete or partial response, or stable disease, and benefiting from the tafasitamab treatment in the previous study, as determined by the study doctor.
  • Following the rules and requirements of the previous study, as determined by the study doctor.
  • Willing and able to attend scheduled visits, follow treatment plans, and participate in other study procedures.
  • Both men and women can participate.
  • Participants can be from vulnerable populations, which means they might need extra protection or care.

Who cannot join the trial?

3 criteria

  • Patients with certain types of blood cancers, known as hematologic malignancies, cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
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Investigated drugs

Tafasitamab is a medication used in the treatment of certain types of blood cancers, known as hematologic malignancies. It works by targeting a specific protein on the surface of cancer cells, helping the body's immune system to recognize and destroy these cancer cells. This medication is typically used in patients who have already been receiving it in previous studies, and the trial aims to continue its use to ensure ongoing treatment and monitor its safety.

What is already known about the treatment

Tafasitamab – Tafasitamab is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently used in medicine to treat certain types of blood cancers, known as hematologic malignancies, and is being studied further to ensure its safety and effectiveness. The main therapeutic use of tafasitamab is to help manage these blood cancers. At the molecular level, tafasitamab works by targeting a specific protein on the surface of cancer cells, helping the immune system to recognize and destroy these cells. It is classified as a monoclonal antibody, which is a type of medication designed to target specific proteins in the body.

Investigated diseases

Hematologic malignancies – Hematologic malignancies are a group of cancers that begin in the cells of the blood or in the bone marrow, which is the soft tissue inside bones where blood cells are produced. These diseases can affect the production and function of blood cells, leading to an overproduction of abnormal cells. As the disease progresses, these abnormal cells can crowd out healthy blood cells, impairing the body's ability to fight infections, carry oxygen, and control bleeding. The progression can vary depending on the specific type of hematologic malignancy, such as leukemia, lymphoma, or myeloma. Over time, the accumulation of abnormal cells can lead to symptoms like fatigue, fever, frequent infections, and easy bruising or bleeding. The disease can also spread to other parts of the body, affecting organs and tissues beyond the blood and bone marrow.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-500765-27-00Protocol codeMOR208C216Estimated enrolment7 patientsSponsorIncyte Corp.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).