Interfant-21 Treatment Protocol for Infants Under 1 Year With KMT2A-rearranged ALL or Mixed Phenotype Acute Leukemia
Interfant-21 International Collaborative Treatment Protocol for Infants Under One Year With KMT2A-rearranged Acute Lymphoblastic Leukemia or Mixed Phenotype Acute Leukemia.
Princess Maxima Center for Pediatric Oncology
160 participants
Dec 15, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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.
Exclusion Criteria7
- KMT2A-wildtype patients.
- Multilineage MPAL
- T-ALL.
- Age \> 365 days at the time of diagnosis.
- Down syndrome.
- Relapsed ALL.
- Treatment with systemic corticosteroids (equivalent prednisone \>10 mg/m2/day) for more than one week and/or any chemotherapeutic agent in the 4-week interval prior to diagnosis. Patients who received corticosteroids by aerosol are eligible for the study.
Interventions
1st 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.
2nd cycle: 15 μg/m2/day as a 4 week continuous iv infusion
Locations(112)
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NCT05327894