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
Locations
115Sponsors and collaborators
Princess Maxima Center for Pediatric Oncology
Lead sponsor
University of Milano Bicocca
Collaborator
Amgen Europe B.V
Collaborator