Status:
RECRUITING
Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia
Lead Sponsor:
Associazione Italiana Ematologia Oncologia Pediatrica
Conditions:
Acute Promyelocytic Leukemia
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE2
Brief 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.
Detailed Description
Acute promyelocytic leukemia (APL) in children has become a highly curable disease with the combination of all-trans retinoic acid (ATRA) and anthracycline-based chemotherapy with an overall remission...
Eligibility Criteria
Inclusion
- Newly diagnosed APL confirmed by the presence of PML/RARα fusion gene
- Age \<18 years
- Written informed consent by parents or legal guardians
Exclusion
- Patients with a clinical diagnosis of APL but subsequently found to lack PML/RARα rearrangement should be withdrawn from the study and treated on an alternative protocol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
Key Trial Info
Start Date :
October 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 10 2027
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT04793919
Start Date
October 9 2019
End Date
October 10 2027
Last Update
April 15 2024
Active Locations (31)
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1
Hôpital Universitaire des Enfants Reine Fabiola (Huderf)
Brussels, Belgium, 1020
2
University Hospital Motol
Prague, Czechia, 15006
3
Pediatrics and Adolescent Medicine Aarhus University Hospital
Aarhus N, Denmark, 8200
4
CHU de Bordeaux - Hôpital des Enfants
Bordeaux, France, 33076