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OncoMatch/Clinical Trials/NCT04793919

Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia

Is NCT04793919 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Mylotarg and Arsenic Trioxide for acute promyelocytic leukemia.

Phase 2RecruitingAssociazione Italiana Ematologia Oncologia PediatricaNCT04793919Data as of May 2026

Treatment: Mylotarg · Arsenic Trioxide · All-trans retinoic acidThe trial is open to all patients with a diagnosis of acute promyelocytic leukemia (APL) who are PCR-positive for the PML-RARα transcript and less than 18 years of age.

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Biomarker criteria

Required: PML fusion with RARA

confirmed by the presence of PML/RARα fusion gene

Prior therapy

No prior treatment (treatment-naive required)

Cannot have received: alternative therapy

Exception: APL not initially suspected; ATRA and/or ATO not available

Patients who had received alternative therapy (APL not initially suspected; ATRA and/or ATO not available

Lab requirements

Kidney function

creatinine serum levels >2 times the normal value for age

Liver function

bilirubin serum levels >3 mg/dL, ALT/AST serum levels greater than 5 times the normal values

Cardiac function

significant arrhythmias, EKG abnormalities, L-FEV <50% or LV-FS <28%

Significant liver dysfunction (bilirubin serum levels >3 mg/dL, ALT/AST serum levels greater than 5 times the normal values); Creatinine serum levels >2 times the normal value for age; Significant arrhythmias, EKG abnormalities (*see below), other cardiac contraindications (L-FEV <50% or LV-FS <28%)

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

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