Dutch- Belgian pediatric acute myeloid leukemia (AML) protocol.

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28546

Enrollment

110

Registered

2009-11-25

Start date

2010-02-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Newly diagnosed acute myeloid leukaemia in children and adolescents.

Interventions

Patients will be treated with two induction courses and depending on the riskgroup, one to three consolidation courses. Cytarabine- arabinoside, etoposide and anthracyclines are the backbone chemother

Eligibility

Inclusion criteria

Inclusion criteria: 1. Primary diagnosed AML as defined by the diagnostic criteria; 2. Age lower than 19 years at time of study entry; 3. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. Previous chemo- or radiotherapy; 2. AML secondary to previous bone marrow failure syndrome; 3. Down syndrome (DS) with age 5 yrs with GATA1 mutation; 4. Acute promyelocytic leukemia (APL); 5. Juvenile myelomonocytic leukemia (JMML); 6. Myelodysplastic syndrome (MDS); 7. Fanconi anemia; 8. Positive pregnancy test.

Design outcomes

Primary

Measure	Time frame
1. To conduct an international pediatric study for AML based on the NOPHO-AML 2004 protocol with optimal outcome and less toxicity; 2. To reduce cumulative anthracycline dosage to reduce the number of intensive courses to 5.	—

Secondary

Measure	Time frame
To monitor cardiotoxicity by echocardiography.	—

Contacts

Public ContactK.M. Pal, van der-de Bruin

TNO Quality of Life, P.O. Box 2215

KM.vanderPal@pg.tno.nl+31 (0)71 5181836

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)