Dutch-Belgian pediatric AML protocol for children with newly diagnosed acute myeloid leukemia, based on the NOPHO-AML 2004 study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-014462-26-BE

Enrollment

140

Registered

2010-02-08

Start date

2010-05-04

Completion date

Unknown

Last updated

2021-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia in children MedDRA version: 13.1 Level: LLT Classification code 10000886 Term: Acute myeloid leukemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: Cytosar 100 mg Product Name: Cytarabine Pharmaceutical Form: Solution for injection INN or Proposed INN: CYTARABINE CAS Number: 147-94-4 Concentration unit: mg milligram(s) Concentration t

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - AML as defined by the diagnostic criteria - Age =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Previous chemo- or radiotherapy - AML secondary to previous bone marrow failure syndrome - Down syndrome (DS) with age 5 with GATA1 mutation - Acute promyelocytic leukemia (APL) - Juvenile myelomonocytic leukemia (JMML) - Myelodysplastic syndrome (MDS) - Fanconi anemia - Positive pregnancy test

Design outcomes

Primary

Measure	Time frame
Main Objective: - To conduct an international pediatric study for AML based on the NOPHO-AML 2004 protocol with optimal outcome and less toxicity - 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%. . - 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 - Duration of remission, rates of relapse and deaths in first CR - Overall survival - Toxicity, both hematological and non-hematological, including cardiac toxicity;Timepoint(s) of evaluation of this end point: End of treatment	—

Measure

Time frame

Main Objective: - To conduct an international pediatric study for AML based on the NOPHO-AML 2004 protocol with optimal outcome and less toxicity - 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%. . - 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 - Duration of remission, rates of relapse and deaths in first CR - Overall survival - Toxicity, both hematological and non-hematological, including cardiac toxicity;Timepoint(s) of evaluation of this end point: End of treatment

—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Belgium

Contacts

Public ContactTrial Bureau

Ghent University Hospital

Trialbureau@uzgent.be3293320500

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026