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-SE
• 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: 2021-07-27
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: A
• 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
- If applicable, female participants must have pregnancy test by beta-HCG dosing and be negative.
- Patients of child-bearing or child-fathering potential must be willing to practice and must contact their physician. With their physician, they must agree on the most appropriate approach for birth control from the time of enrollment in this study and for 3 months after receiving the latest infusion.

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Patients with a clinical diagnosis of APL but subsequently found to lack PML/RARa rearrangement should be withdrawn from the study and treated with an alternative protocol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