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
- Amiens Cedex 1, Besancon Cedex, Bordeaux, Grenoble Cedex 9, Lille Cedex, Lyon, Marseille, Montpellier, Nantes, Nice, Paris, Poitiers, Reims, Rennes, Rouen Cedex, St Etienne Cedex 2, Strasbourg Cedex 2, Toulouse Cedex 9, and Vandoeuvre Les Nancy, FranceSee the 19 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 France
- Centre Hospitalier Universitaire Amiens PicardieAmiens Cedex 1, FranceTaking people
- Besancon University Hospital CenterBesancon Cedex, FranceTaking people
- Centre hospitalier Universitaire de BordeauxBordeaux, FranceTaking people
- Centre Hospitalier Universitaire Grenoble AlpesGrenoble Cedex 9, FranceTaking people
- Centre Hospitalier Universitaire De LilleLille Cedex, FranceTaking people
- Hospices Civils de LyonLyon, FranceTaking people
- Assistance Publique Hôpitaux de MarseilleMarseille, FranceTaking people
- Centre Hospitalier Universitaire de MontpellierMontpellier, FranceTaking people
- Centre Hospitalier Universitaire de NantesNantes, FranceTaking people
- Centre Hospitalier Universitaire de NiceNice, FranceTaking people
- Assistance Publique Hopitaux de ParisParis, FranceTaking people
- Centre Hospitalier Universitaire de PoitiersPoitiers, FranceTaking people
- Centre Hospitalier Universitaire ReimsReims, FranceTaking people
- Centre Hospitalier Universitaire de RennesRennes, FranceTaking people
- CHU De RouenRouen Cedex, FranceTaking people
- Centre Hospitalier Universitaire De Saint EtienneSt Etienne Cedex 2, FranceTaking people
- Les Hopitaux Universitaires De StrasbourgStrasbourg Cedex 2, FranceTaking people
- Centre Hospitalier Universitaire De ToulouseToulouse Cedex 9, FranceTaking people
- CHRU De NancyVandoeuvre Les Nancy, FranceTaking 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.