Detail of the clinical trial
| Title of the trial | Phase III open-label randomized study of amonafide L-maleate in combination with cytarabine compared to daunorubicin in combination with cytarabine in patients with secondary acute myeloid leukemia (AML) |
|---|---|
| EudraCT number | 2007-004427-38 |
| Protocol number | 0001A3-300-GL |
| Sponsor | Antisoma Research Ltd., Londýn, UK |
| Indications | Hemato-oncology |
| Diagnosis | secondary acute myeloid leukemia |
| Population in clinical trial |
Adults (18-65 years) Elderly ( > 65 years) Male Female Patients |
| Year of receiving the request to Institute (SÚKL) | 2008 |
| Date of approval by Institute (SÚKL) | 2.1.2009 |
| Date of approval by EC | 5.2.2009 |
| Date of initiation CT in ČR | 13.10.2009 |
| Date of ending CT in ČR | 31.1.2011 |
| Notice | |
| Sites |
Odd. klinické hematologie, FNKV Praha 10 1. interní klinika VFN Praha 2 Institut hematologie a krevní transfuze, Praha 2 |
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