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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age1-1
SponsorPrincess Maxima Center for Pediatric Oncology

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

KMT2A-wildtype patients.

Multilineage MPAL

T-ALL.

Age > 365 days at the time of diagnosis.

Trial design

Treatments tested in this trial

  • Blinatumomab
  • Blinatumomab

Treatment groups

160 Participants
are divided into 2 treatment groups

Locations

115
Argentina
Hospital de Pediatría S.A.M.I.C. "Juan P. Garrahan" Buenos Aires Argentina
Australia
Australian and New Zealand Children's Haematology/Oncology Group ClaytonVictoria, Australia
North Adelaide- Womens and Childrens Hospital Adelaide Australia
Monash Children's Hosptial Clayton Australia

Sponsors and collaborators

Princess Maxima Center for Pediatric Oncology

Lead sponsor

University of Milano Bicocca

Collaborator

Amgen Europe B.V

Collaborator