Tests blinatumomab in infants with a genetic type of leukemia
Tests blinatumomab in infants under one year with KMT2A-rearranged acute leukemia.
Plain-language title generated from the registry record
Registry title: Interfant-21 Treatment Protocol for Infants Under 1 Year With KMT2A-rearranged ALL or Mixed Phenotype Acute Leukemia
Key facts
- Where
- Aachen, Augsburg, Berlin, Bonn, Bremen, Cologne, Dortmund, Dresden, Duesseldorf, Erlangen, Frankfurt Am Main, Freiburg im Breisgau, Giessen, Halle Saale, Hamburg, Hanover, Heidelberg, Kiel, Krefeld, Mainz, Muenster, Munich, Stuttgart, Tuebingen, and Ulm, GermanySee the 25 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- How old is the patient who may join a trial?
- What type of cancer has the patient been diagnosed with?
- Is this cancer newly diagnosed, or has it come back or not responded to treatment?
Source: NCT05327894, who can take part
Where in Germany
- Universitaetsklinikum Aachen AöRAachen, GermanyTaking people
- Universitaetsklinikum AugsburgAugsburg, GermanyTaking people
- Charite Universitaetsmedizin Berlin KöRBerlin, GermanyTaking people
- Universitaetsklinikum Bonn AöRBonn, GermanyTaking people
- Gesundheit Nord gGmbH Klinikverbund BremenBremen, GermanyTaking people
- University Hospital Cologne AöRCologne, GermanyTaking people
- Klinikum Dortmund gGmbHDortmund, GermanyTaking people
- Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöRDresden, GermanyTaking people
- Universitaetsklinikum Duesseldorf AöRDuesseldorf, GermanyTaking people
- Universitaetsklinikum Erlangen AöRErlangen, GermanyTaking people
- Universitaetsklinikum Frankfurt AöRFrankfurt Am Main, GermanyTaking people
- Medical Center- University of FreiburgFreiburg im Breisgau, GermanyTaking people
- Justus-Liebig-Universitaet GiessenGiessen, GermanyTaking people
- Universitaetsklinikum Halle (Saale) AöRHalle Saale, GermanyTaking people
- University Medical Center Hamburg-EppendorfHamburg, GermanyTaking people
- Medizinische Hochschule HannoverHanover, GermanyTaking people
- Universitaetsklinikum Heidelberg AöRHeidelberg, GermanyTaking people
- Universitaetsklinikum Schleswig-Holstein AöRKiel, GermanyTaking people
- HELIOS Klinikum Krefeld GmbHKrefeld, GermanyTaking people
- Johannes Gutenberg University MainzMainz, GermanyTaking people
- Universitaetsklinikum Muenster AöRMuenster, GermanyTaking people
- Klinikum rechts der Isar der TU Muenchen AöRMunich, GermanyTaking people
- Klinikum Der Landeshauptstadt Stuttgart gKAöRStuttgart, GermanyTaking people
- Universitaetsklinikum Tuebingen AöRTuebingen, GermanyTaking people
- Universitaetsklinikum Ulm AoRUlm, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Princess Maxima Center for Pediatric Oncology
- Trial code
- NCT05327894EU 2022-502503-30-00
- Record updated
- 19 October 2026
- Original description
This study is a treatment protocol with blinatumomab for infants under 1 year old who are diagnosed with acute lymphoblastic leukemia with a specific unfavorable genetic alteration. The purpose of the study is to improve the outcome of this disease in infants.Read full original descriptionShow less
Interfant-21 International Collaborative Treatment Protocol for Infants Under One Year With KMT2A-rearranged Acute Lymphoblastic Leukemia or Mixed Phenotype Acute Leukemia.
This study is a treatment protocol with blinatumomab for infants under 1 year old who are diagnosed with acute lymphoblastic leukemia with a specific unfavorable genetic alteration. The purpose of the study is to improve the outcome of this disease in infants.
Inclusion: Patients with newly diagnosed B- precursor ALL or B-cell MPAL (single lineage) according to the WHO classification of tumours of haematopoietic and lymphoid tissues (revised 4th edition 2017), with KMT2A-rearrangement; ≤ 365 days of age at the time of diagnosis of ALL; Written informed consent of the parent(s) or other legally authorized guardian of the patient according to local law and regulations.
Exclusion: Treatment with systemic corticosteroids (equivalent prednisone >10 mg/m2/day) for more than one week and/or any chemotherapeutic agent in the 4-week interval prior to diagnosis. Patients who received corticosteroids by aerosol are eligible for the study; If exclusion criteria for blinatumomab are met, the patient should be treated according to the protocol but without blinatumomab; Down syndrome; Age > 365 days at the time of diagnosis; KMT2A-wildtype patients; Multilineage MPAL; T-ALL; Relapsed ALL.