OncoMatch/Clinical Trials/NCT04793919
Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia
Is NCT04793919 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Mylotarg and Arsenic Trioxide for acute promyelocytic leukemia.
Treatment: Mylotarg · Arsenic Trioxide · All-trans retinoic acid — The 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: PML fusion with RARA
confirmed by the presence of PML/RARα fusion gene
Demographics
Prior therapy
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.
Frequently asked questions
Is NCT04793919 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require PML?
Yes, PML fusion with RARA is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 18 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages