Home › Trials › NCT05327894

Treatment for infants with specific types of leukemia

Interfant-21 International Collaborative Treatment Protocol for Infants Under One Year With KMT2A-rearranged Acute Lymphoblastic Leukemia or Mixed Phenotype Acute Leukemia.

Phase 3 Interventional Princess Maxima Center for Pediatric Oncology · NCT05327894

This study is testing a new treatment using blinatumomab for infants with specific types of leukemia to see if it can help them respond better to therapy.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment160 (estimated)
Ages1 Day to 1 Year
SexAll
SponsorPrincess Maxima Center for Pediatric Oncology Academic / other
Drugs / interventionsblinatumomab, prednisone
Locations115 sites (Buenos Aires and 114 other locations)
Trial IDNCT05327894 on ClinicalTrials.gov

What this trial studies

This treatment protocol involves administering blinatumomab to infants under one year old diagnosed with KMT2A-rearranged acute lymphoblastic leukemia or mixed phenotype acute leukemia. Eligible infants will receive one cycle of blinatumomab following induction therapy, with further treatment based on their response. Medium risk patients may receive additional cycles or be treated according to standard protocols, while high risk patients may qualify for stem cell transplantation if they achieve minimal residual disease negativity. The study aims to improve treatment outcomes for this vulnerable population.

Who should consider this trial

Good fit: Ideal candidates are infants under one year old with newly diagnosed KMT2A-rearranged acute lymphoblastic leukemia or mixed phenotype acute leukemia.

Not a fit: Patients older than one year or those with KMT2A-germline leukemia or T-ALL will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates and outcomes for infants with aggressive forms of leukemia.

How similar studies have performed: Other studies have shown promise with blinatumomab in treating acute lymphoblastic leukemia, suggesting potential for success in this specific population.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. 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.
2. ≤ 365 days of age at the time of diagnosis of ALL.
3. Written informed consent of the parent(s) or other legally authorized guardian of the patient according to local law and regulations.

Exclusion criteria for blinatumomab:

1. KMT2A-wildtype patients.
2. Multilineage MPAL
3. T-ALL.
4. Age \> 365 days at the time of diagnosis.
5. Down syndrome.
6. Relapsed ALL.
7. 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.

Where this trial is running

Buenos Aires and 114 other locations

+65 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Acute Lymphoblastic LeukemiaMixed Phenotype Acute Leukemiainfant under one yearKMT2A-wildtype
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.