NL-OMON54336Not yet recruitingPhase 2
Treatment study for children and adolescents with Acute Promyelocytic Leukemia - ICC APL Study 02
AIEOP- Associazione Italiana Ematologia Oncologia Pediatrica0 sites5 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 5
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 0 to 17 (—)
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
- •- 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 the most appropriate approach for birth control from the time of
- •enrollment in this study and for 3 months after receiving the latest infusion.
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- •PML/RARa rearrangement should be withdrawn from the study and treated with an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 >5x the normal values)
- •- Creatinine serum levels >2 times the normal value for age
- •- Significant arrhythmias, ECG abnormalities, 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)
Investigators
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Not Applicable
TREATMENT STUDY FOR CHILDREN AND ADOLESCENTS WITH ACUTE PROMYELOCYTIC LEUKEMIA - ICC APL STUDY 01EUCTR2008-002311-40-ITA.I.E.O.P. - ASSOCIAZIONE ITALIANA EMATOLOGIA ONCOLOGIA PEDIATRICA300