NL-OMON51982
Recruiting
Phase 3
International collaborative treatment protocol for infants under one year with KMT2A-rearranged acute lymphoblastic leukemia or mixed phenotype acute leukemia - Interfant-21
Prinses Máxima Centrum voor Kinderoncologie0 sites12 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Prinses Máxima Centrum voor Kinderoncologie
- Enrollment
- 12
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients with newly diagnosed B\- precursor ALL or B\-cell MPAL according to
- •the WHO classification of tumours of haematopoietic and lymphoid tissues
- •(revised 4th edition 2017, with KMT2A\-rearrangement.
- •2\. \<\= 365 days of age at the time of diagnosis of ALL.
- •3\. Written informed consent of the parents or other legally authorized
- •guardian of the patient according to local law and regulations.
Exclusion Criteria
- •1\. KMT2A\-germline patients.
- •2\. T\-ALL.
- •3\. Age \> 365 days at the time of diagnosis.
- •4\. Relapsed ALL.
- •5\. 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.
- •Additional exclusion criteria for blinatumomab:
- •1\. CD19 negative B\-precursor ALL at diagnosis
Outcomes
Primary Outcomes
Not specified
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