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
- Ancona, Bari, Bergamo, Bologna, Brescia, Cagliari, Catania, Cosenza, Florence, Genoa, Monza, Naples, Padova, Palermo, Parma, Pavia, Rome, Trieste, Turin, and Verona, ItalySee the 21 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 Italy
- Azienda Ospedaliero-Universitaria delle MarcheAncona, ItalyTaking people
- University Hospital Consorziale PoliclinicoBari, ItalyTaking people
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIIIBergamo, ItalyTaking people
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere ScientificoBologna, ItalyTaking people
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaBrescia, ItalyTaking people
- ARNAS G. BrotzuCagliari, ItalyTaking people
- Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di CataniaCatania, ItalyTaking people
- Azienda Ospedaliera-Universitaria Di CosenzaCosenza, ItalyTaking people
- Azienda Ospedaliera Universitaria Meyer IRCCSFlorence, ItalyTaking people
- Giannina Gaslini Institute For Scientific Hospitalization And CareGenoa, ItalyTaking people
- Fondazione IRCCS San Gerardo dei TintoriMonza, ItalyTaking people
- Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi VanvitelliNaples, ItalyTaking people
- L'Azienda Ospedaliera Di Rilievo Nazionale Santobono-PausiliponNaples, ItalyTaking people
- Azienda Ospedale Universita PadovaPadova, ItalyTaking people
- ARNAS Civico Di Cristina BenfratelliPalermo, ItalyTaking people
- Azienda Ospedaliero Universitaria ParmaParma, ItalyTaking people
- Fondazione IRCCS Policlinico San MatteoPavia, ItalyTaking people
- Ospedale Pediatrico Bambino GesùRome, ItalyTaking people
- Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo GarofoloTrieste, ItalyTaking people
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di TorinoTurin, ItalyTaking people
- University Of Verona Medical SchoolVerona, ItalyTaking 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.