Treatment study for children and adolescents with Acute Promyelocytic Leukemia

Phase 1

• Conditions: acute promyelocytic leukemia (APL) in children and adolescents; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-002383-40-IT
• Lead Sponsor: AIEOP- Associazione Italiana Ematologia Oncologia Pediatrica

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-15
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

- Newly diagnosed APL confirmed by the presence of PML/RARa fusion gene
- Age <18 years
- Written informed consent by parents or legal guardians
- WBC at diagnosis =10 x 109/L

Are the trial subjects under 18? yes
Number of subjects for this age range: 90
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients with a clinical diagnosis of APL but subsequently found to lack PML/RARa rearrangement should be withdrawn from the study and treated with an alternative protocol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 grade 2 or greater
- Concurrent active malignancy
- Uncontrolled life-threatening infections
- Pregnant or lactating females
- Patients who had received alternative therapy (APL not initially suspected; ATRA and/or ATO not available)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified