WHO ICTRP trial

Dutch-Belgian pediatric AML protocol for children with newly diagnosed acute…

EUCTR2009-014462-26-BE · EU Clinical Trials Register · Not Recruiting

Key facts

Trial ID EUCTR2009-014462-26-BE
Public title Dutch-Belgian pediatric AML protocol for children with newly diagnosed acute myeloid leukemia, based on the NOPHO-AML 2004 study
Scientific title Dutch-Belgian pediatric AML protocol for children with newly diagnosed acute myeloid leukemia, based on the NOPHO-AML 2004 study
Primary sponsor Ghent University Hospital
Registry EU Clinical Trials Register
Recruitment status Not Recruiting
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries Belgium
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) ;Therapeutic…
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 type: equal Concentration number: 100…
Registration date Aug 2, 2010
Target size 140
Secondary IDs DB-AML-01
Registry page clinicaltrialsregister.eu

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