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
- Chiba, Ehime, Hiroshima, Hokkaido, Hyōgo, Kagoshima, Kanagawa, Kyoto, Mie, Nagoya, Osaka, Saitama, Shizuoka, Tōhoku, and Tokyo, JapanSee the 20 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 Japan
- Chiba University HospitalChiba, JapanTaking people
- Ehime University HospitalEhime, JapanTaking people
- Hiroshima University HospitalHiroshima, JapanTaking people
- Hokkaido University HospitalHokkaido, JapanTaking people
- Hyogo Prefectural Kobe Childrens HospitalHyōgo, JapanTaking people
- Kagoshima University HospitalKagoshima, JapanTaking people
- Kanagawa Childrens Medical CenterKanagawa, JapanTaking people
- Kyoto Prefectural University of MedicineKyoto, JapanTaking people
- Kyoto University HospitalKyoto, JapanTaking people
- Mie University HospitalMie, JapanNo longer taking part
- Nagoya University Graduate School of MedicineNagoya, JapanTaking people
- Osaka City General HospitalOsaka, JapanTaking people
- Osaka University Graduate School of Medicine 2-2Osaka, JapanTaking people
- Saitama Prefectural Childrens Medical CenterSaitama, JapanTaking people
- Shizuoka Childrens HospitalShizuoka, JapanTaking people
- Tohoku University HospitalTōhoku, JapanTaking people
- National Center for Child Health and DevelopmentTokyo, JapanTaking people
- Nippon Medical School HospitalTokyo, JapanTaking people
- The University of Tokyo HospitalTokyo, JapanTaking people
- Tokyo Metropolitan Childre's Medical CenterTokyo, JapanNo longer taking part
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.