Dutch-Belgian pediatric AML protocol for children with newly diagnosed acute myeloid leukemia, based on the NOPHO-AML 2004 study
Phase 1
- Conditions
- Acute Myeloid Leukemia in childrenTherapeutic area: Diseases [C] - Cancer [C04]MedDRA version: 13.1Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2009-014462-26-BE
- Lead Sponsor
- Ghent University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 140
Inclusion Criteria
- AML as defined by the diagnostic criteria
- Age < 18 years at time of study entry
- Written informed consent
Are the trial subjects under 18? yes
Number of subjects for this age range: 60
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
- Previous chemo- or radiotherapy
- AML secondary to previous bone marrow failure syndrome
- Down syndrome (DS) with age < 5 years and DS > 5 with GATA1 mutation
- Acute promyelocytic leukemia (APL)
- Juvenile myelomonocytic leukemia (JMML)
- Myelodysplastic syndrome (MDS)
- Fanconi anemia
- Positive pregnancy test
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: - To conduct an international pediatric study for AML based on the NOPHO-AML 2004 protocol with optimal outcome and less toxicity<br>- To investigate whether reduction of the number of intensive courses to five and a reduction of the total antracyclins dosage is feasible with a safe cumulative 3-years relapse rate of 40%. .<br>- To decrease toxicity in patients without an increased relapse rate.;Secondary Objective: To decrease long term effects of treatment such as cardiac toxicity.;Primary end point(s): - Complete remission (CR) achievement and reasons for failure<br>- Duration of remission, rates of relapse and deaths in first CR<br>- Overall survival<br>- Toxicity, both hematological and non-hematological, including cardiac toxicity;Timepoint(s) of evaluation of this end point: End of treatment
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable