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Study on the Safety and Effectiveness of Tafasitamab for Children with Relapsed or Refractory Acute B Lineage Leukemia

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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 Acute B Lineage Leukemia in children. This is a form of leukemia, which is a cancer of the blood and bone marrow. The study is specifically for pediatric patients who have either not responded to standard treatments or have experienced a return of the disease after treatment. The treatment being tested in this study is a medication called Tafasitamab, also known by its code name MOR00208. Tafasitamab is a type of protein designed to target and help destroy cancer cells.

The purpose of the study is to evaluate the safety and effectiveness of Tafasitamab in treating children with this type of leukemia. Participants in the study will receive the medication through an intravenous infusion, which means it will be administered directly into a vein. The study will observe participants over a period of time to see how long it takes for the leukemia to return or worsen, and to monitor any side effects or changes in the disease. The study will also look at how the medication affects the overall survival of the participants and whether it can reduce the amount of cancer cells in the body.

Throughout the study, researchers will collect information on how the medication is processed in the body and any potential side effects. The study aims to provide valuable insights into the treatment of Acute B Lineage Leukemia in children, potentially leading to better treatment options in the future. Participants will be closely monitored by healthcare professionals to ensure their safety and well-being during the trial.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
The study is designed for patients aged 3 to 18 years with a specific type of leukemia known as B-lineage acute lymphoblastic leukemia (ALL).
Eligibility requires that the disease is either resistant to standard treatments or has returned after treatment.
Participation requires informed consent from the patient or their legal representative.
Step 2
Treatment administration
The medication used in this study is called tafasitamab, administered as a solution for infusion.
The infusion is given intravenously, meaning it is delivered directly into the bloodstream through a vein.
The specific dosage and frequency of administration will be determined by the study protocol and the healthcare team.
Step 3
Monitoring and observation
The primary goal is to monitor the time until a potential relapse of leukemia or an increase in minimal residual disease (MRD) in the bone marrow.
The observation period lasts for up to 545 days, during which various health parameters will be regularly assessed.
Step 4
Evaluation of treatment success
Success is defined as survival without new MRD or an increase in MRD, and without unacceptable side effects.
Overall survival rates and the reduction of MRD will be evaluated at different points during the study.
Step 5
Safety and side effects
Safety is a key focus, with any side effects being carefully documented and assessed.
The study will track the number of relapses, any adverse events, and overall patient safety.
Step 6
Study duration
The study is expected to conclude by October 2027.
The recruitment of participants began in October 2022.

Who can join the trial?

6 criteria

Age must be between 3 and 18 years old.
Must have a type of leukemia called **B-lineage ALL**, which is a specific kind of blood cancer. It can be B, pro-B, pre-B, or c-ALL.
The leukemia must not have responded to standard treatments or must have returned after treatment.
Must have had a **stem cell transplant**, which is a procedure to replace damaged or destroyed bone marrow with healthy stem cells. This can be a first, second, or later transplant.
Must have a condition called **MRD** (Minimal Residual Disease), which means there are still some cancer cells in the body after treatment. This can be newly appearing or still present after the transplant.
Must have given **informed consent**, which means the patient or their legal representative agrees to participate in the study after understanding all the details.

Who cannot join the trial?

4 criteria

Patients who have not been diagnosed with leukemia in childhood cannot participate. Leukemia is a type of cancer that affects blood cells.
Patients who are not within the specified age range for the study cannot participate. The study is for a specific age group.
Patients who do not meet the gender requirements of the study cannot participate. The study includes both male and female participants.
Patients who are not considered part of a vulnerable population cannot participate. A vulnerable population includes groups that may need special protection or care.

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Verified sites

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

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Charite Universitaetsmedizin Berlin KöR
Berlin, Germany
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Goethe University Frankfurt
Frankfurt, Germany
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Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH
Ulm, Germany

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Investigated drugs

Tafasitamab (MOR00208) is a medication being studied for its potential to treat pediatric patients with relapsed or refractory acute B lineage leukemia. It is designed to target and bind to a specific protein on the surface of certain cancer cells, which may help the immune system to identify and destroy these cancer cells. The study aims to evaluate the safety and effectiveness of this medication in managing the disease.

Tafasitamab

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 and safety in treating pediatric patients with relapsed or refractory acute B lineage leukemia. The main therapeutic indication for Tafasitamab is leukemia in childhood. At the molecular level, Tafasitamab works by targeting and binding to a specific protein on the surface of B cells, leading to the destruction of these cancerous cells. It is classified as a monoclonal antibody, which is a type of targeted therapy designed to specifically attack cancer cells while sparing normal cells.

Investigated diseases

Leukemia in childhood – This is a type of cancer that affects the blood and bone marrow, primarily occurring in children. It involves the rapid production of abnormal white blood cells, which crowd out normal cells and impair the body's ability to fight infections. As the disease progresses, it can lead to symptoms such as fatigue, frequent infections, and easy bruising or bleeding. The abnormal cells can accumulate in various parts of the body, including the liver, spleen, and lymph nodes, causing swelling and discomfort. Over time, the disease can disrupt normal blood cell production, leading to anemia and other complications. The progression of leukemia in children can vary, with some cases advancing more quickly than others.