Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia

• Status: Recruiting
• Trial end date: 2024-10-10
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Associazione Italiana Ematologia Oncologia Pediatrica
• Treatments: Arsenic Trioxide; Gemtuzumab; Tretinoin

Criteria

Inclusion Criteria:

• Newly diagnosed APL confirmed by the presence of PML/RARα fusion gene

• Age <18 years

• Written informed consent by parents or legal guardians

Exclusion Criteria:

• Patients with a clinical diagnosis of APL but subsequently found to lack PML/RARα rearrangement should be withdrawn from the study and treated on an alternative protocol

• 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%)

• Neuropathy

• Concurrent active malignancy

• Uncontrolled life-threatening infections

• Pregnant or lactating female

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