Clinical Trial

Interfant-21 Treatment Protocol for Infants Under 1 Year With KMT2A-rearranged ALL or Mixed Phenotype Acute Leukemia

Study acronym: Interfant-21
Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 2 changes
notable Trial sites expanded: 115 -> 124 locations 2026-07-11
notable Trial sites expanded: 112 -> 115 locations 2026-04-14
Trial Details
NCT Number NCT05327894
Lead Sponsor Princess Maxima Center for Pediatric Oncology
Collaborators: University of Milano Bicocca, Amgen Europe B.V
Conditions Acute Lymphoblastic Leukemia, Mixed Phenotype Acute Leukemia
Enrollment 160 participants
Start Date 2022-12-15
Primary Completion 2027-09 (estimated)
Study Completion 2030-09 (estimated)
Updated on ClinicalTrials.gov 2026-07-10