Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia

Launched by ASSOCIAZIONE ITALIANA EMATOLOGIA ONCOLOGIA PEDIATRICA · Mar 10, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for children and adolescents under 18 years old who have been diagnosed with acute promyelocytic leukemia (APL), a specific type of blood cancer. To participate, patients must have a confirmed diagnosis that shows a certain genetic marker (the PML-RARα fusion gene) in their blood. The trial is currently open and looking for participants who meet these criteria, which also include needing permission from a parent or legal guardian to join the study.

If eligible, participants can expect to receive treatment as part of this study, which aims to find out how effective the new approach is for young patients with APL. However, there are some important conditions that would prevent someone from joining, such as having severe liver or kidney problems, certain heart issues, or other serious health concerns. The goal is to help improve treatment options for children and teens with this form of leukemia while ensuring their safety throughout the trial.

Gender

ALL

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• • Patients with a clinical diagnosis of APL but subsequently found to lack PML/RARα rearrangement should be withdrawn from the study and treated on an alternative protocol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