NL-OMON51982RecruitingPhase 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 enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 12
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 0 to 1 (—)
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
- •2. CNS involvement (CNS2/CNS3/TLP+ status) at the EOI. Patients with CNS
- •disease at the time of diagnosis are eligible if CNS1 status is achieved prior
- •to the start of the first blinatumomab cycle (lumbar puncture at ~day 33 of
- •induction).
- •3. Proven hypersensitivity to the active substance or any of the excipients in
- •blinatumomab.
- •4. Patients who have received a live vaccine 28 days prior to blinatumomab
- •administration or plan to receive a live vaccine prior to B-cell recovery after
- •the last dose of blinatumomab.
- •If exclusion criteria for blinatumomab are met, the patient should be treated
- •according to the protocol but without blinatumomab.
Investigators
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