NL-OMON54336
Not yet recruiting
Phase 2
Treatment study for children and adolescents with Acute Promyelocytic Leukemia - ICC APL Study 02
AIEOP- Associazione Italiana Ematologia Oncologia Pediatrica0 sites5 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- AIEOP- Associazione Italiana Ematologia Oncologia Pediatrica
- Enrollment
- 5
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
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
- •\- 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- •PML/RARa rearrangement should be withdrawn from the study and treated with an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
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
Treatment study for children and adolescents with Acute Promyelocytic LeukemiaEUCTR2017-002383-40-ITAIEOP- Associazione Italiana Ematologia Oncologia Pediatrica90
Active, not recruiting
Phase 1
Treatment study for children and adolescents with Acute Promyelocytic LeukemiaEUCTR2017-002383-40-CZAIEOP- Associazione Italiana Ematologia Oncologia Pediatrica90
Active, not recruiting
Phase 1
Treatment study for children and adolescents with Acute Promyelocytic Leukemiaacute promyelocytic leukemia (APL) in children and adolescentsTherapeutic area: Diseases [C] - Cancer [C04]EUCTR2017-002383-40-SEAIEOP- Associazione Italiana Ematologia Oncologia Pediatrica90
Active, not recruiting
Phase 1
Treatment study for children and adolescents with Acute Promyelocytic Leukemiaacute promyelocytic leukemia (APL) in children and adolescentsTherapeutic area: Diseases [C] - Cancer [C04]EUCTR2017-002383-40-FRAIEOP- Associazione Italiana Ematologia Oncologia Pediatrica90
Active, not recruiting
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