RecruitingPhase 2NCT04793919
Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia
Sponsor
Associazione Italiana Ematologia Oncologia Pediatrica
Enrollment
89 participants
Start Date
Oct 9, 2019
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Max Age: 18 Years
Inclusion Criteria3
- Newly diagnosed APL confirmed by the presence of PML/RARα fusion gene
- Age \<18 years
- Written informed consent by parents or legal guardians
Exclusion Criteria9
- Patients with a clinical diagnosis of APL but subsequently found to lack PML/RARα rearrangement should be withdrawn from the study and treated on an alternative protocol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
Interventions
DRUGMylotarg
See the protocol
DRUGArsenic Trioxide
See the protocol
DRUGAll-trans retinoic acid
See the protocol
Locations(31)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04793919