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
- Aarhus N, Copenhagen Oe, and Odense C, DenmarkSee the 3 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for babies up to 365 days old with newly diagnosed B-cell acute lymphoblastic leukemia or B-cell mixed phenotype acute leukemia that has a KMT2A change.
- Age
- Up to 365 days old at diagnosis (1 day to 1 year).
- Sex
- Boys and girls can both join.
- Disease stage
- Newly diagnosed B-precursor ALL or B-cell MPAL (single lineage), by the WHO 2017 classification.
- Earlier treatment
- No systemic corticosteroids above 10 mg/m2/day for more than one week, and no chemotherapy, in the 4 weeks before diagnosis. Aerosol corticosteroids are allowed.
- Biomarker or test result
- KMT2A-rearrangement is needed.
Main reasons for not taking part
- KMT2A-wildtype (no KMT2A change)
- Multilineage MPAL
- T-ALL
- Down syndrome
- Relapsed ALL
Read by machine on 9 November 2026.
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 Denmark
- Aarhus UniversityAarhus N, DenmarkTaking people
- RigshospitaletCopenhagen Oe, DenmarkTaking people
- Odense University HospitalOdense C, DenmarkTaking 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.