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.
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.
KMT2A-wildtype patients.
Multilineage MPAL
T-ALL.
Age > 365 days at the time of diagnosis.
Sequential
Blinatumomab
Drug1st cycle: 15 μg/m2/day as a 4 week continuous IV infusion for patients with a M1 marrow. For patients with a M2/M3 marrow a step-dosing strategy is required with a dose of 5 μg/m2/day in week 1 followed by 15 μg/m2/day in weeks 2, 3, and 4.
Blinatumomab
Drug2nd cycle: 15 μg/m2/day as a 4 week continuous iv infusion
Event free survival (EFS).
The primary endpoint is EFS, defined as the time from diagnosis to resistance to induction, relapse, death from any cause or second malignancy (whichever occurs first), or time to last follow-up (censored) for patients without events.
Overall survival
The endpoints for analysis by risk group will be EFS, cumulative incidence (or percentage) of resistance to induction, cumulative incidence of relapse (CIR), death in complete remission (CR) and second malignancy.
Endpoints by risk group
The endpoints for analysis by risk group will be EFS, cumulative incidence (or percentage) of resistance to induction, cumulative incidence of relapse (CIR), death in complete remission (CR) and second malignancy.
Outcome for the entire study cohort and according to risk group
Outcome for the entire study cohort and according to risk group will be evaluated in terms of the protocol specific definition of EFS follows: the time from diagnosis to, resistance to proto-col, relapse, death from any cause or second malignancy (whichever occurs first), or time to last follow-up for patients without events. Cumulative incidence (or percentage) of resistance, CIR, death in CR and second malignancy will also be estimated.
Minimal Residual Disease
MRD response as defined in the protocol and frequencies of MRD levels
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Princess Maxima Center for Pediatric Oncology
Lead sponsor
University of Milano Bicocca
Collaborator
Amgen Europe B.V
Collaborator
