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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 study about?

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.

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.

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.

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.

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.

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.

6 study duration

The study is expected to conclude by October 2027.

The recruitment of participants began in October 2022.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medizinische Hochschule Hannover Hanover Germany
Universitätsklinikum Freiburg Freiburg Im Breisgau Germany

Other Sites

Site Name City Country Status
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Dr. von Haunersches Kinderspital, LMU Munich Germany
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Ueaveelhhq Mqpahxd Cdyhrb Htpbtuokfrtvtskkc Hamburg Germany
Ukenwphfvodtdzfusfcym Ewrcd Aci Essen Germany
Uwzaqlzpiohadjyrshduh Dirzbsfujig Ari Duesseldorf Germany
Gpzcwp Uquhelwzoq Fwpxesrmq Frankfurt Germany
Ukbhwxfligepegcledmmu Wouepdtff Atn Wuerzburg Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Recruiting
01.10.2022

Trial locations

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.

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.

Trial ID:
2024-511336-28-00
NCT ID:
NCT05366218
Trial Phase:
Human Pharmacology (Phase I) – Other

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