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Clinical Trials/EUCTR2017-002383-40-IT
EUCTR2017-002383-40-IT
Active, Not Recruiting
Phase 1

Treatment study for children and adolescents with Acute Promyelocytic Leukemia - ICC APL Study 02

AIEOP- Associazione Italiana Ematologia Oncologia Pediatrica0 sites90 target enrollmentOctober 15, 2018
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DrugsMylotarg

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
AIEOP- Associazione Italiana Ematologia Oncologia Pediatrica
Enrollment
90
Status
Active, Not Recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 15, 2018
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
AIEOP- Associazione Italiana Ematologia Oncologia Pediatrica

Eligibility Criteria

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
  • •\- WBC at diagnosis \=10 x 109/L
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 90
  • •F.1\.2 Adults (18\-64 years) no
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) no
  • •F.1\.3\.1 Number of subjects for this age range

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  • •Patients with a clinical diagnosis of APL but subsequently found to lack PML/RARa rearrangement should be withdrawn from the study and treated with an alternative protocol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

Outcomes

Primary Outcomes

Not specified

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