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

Phase 3 Recruiting 160 enrolled Princess Maxima Center for Pediatric Oncology Amgen Europe B.V · collab University of Milano Bicocca · collab

Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start: 2022-12-15
Primary completion: 2027-09
Completion: 2030-09

Publications

Davis KL, Yao CC, Zimmerman JAO, Rau RE. Immunotherapy in B-Cell Acute Lymphoblastic Leukemia. J Natl Compr Canc Netw. 2025 Dec;23(12):e257067. doi: 10.6004/jnccn.2025.7067.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Blinatumomab	Monoclonal antibody	15 ug/m2	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications