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Clinical Trials/NL-OMON54336
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  • PML/RARa rearrangement should be withdrawn from the study and treated with an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

Sponsor
AIEOP- Associazione Italiana Ematologia Oncologia Pediatrica

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