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OncoMatch/Clinical Trials/NCT05327894

Interfant-21 Treatment Protocol for Infants Under 1 Year With KMT2A-rearranged ALL or Mixed Phenotype Acute Leukemia

Is NCT05327894 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Blinatumomab and Blinatumomab for acute lymphoblastic leukemia.

Phase 3RecruitingPrincess Maxima Center for Pediatric OncologyNCT05327894Data as of May 2026

Treatment: Blinatumomab · BlinatumomabThis 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.

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Extracted eligibility criteria

Cancer type

Acute Lymphoblastic Leukemia

Acute Myeloid Leukemia

Biomarker criteria

Required: KMT2A (MLL) rearrangement

Excluded: KMT2A (MLL) wild-type

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: systemic corticosteroids (prednisone)

Exception: corticosteroids by aerosol

Treatment with systemic corticosteroids (equivalent prednisone >10 mg/m2/day) for more than one week in the 4-week interval prior to diagnosis. Patients who received corticosteroids by aerosol are eligible for the study.

Cannot have received: chemotherapeutic agent

any chemotherapeutic agent in the 4-week interval prior to diagnosis

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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