drugset / Trial / NCT00487448
SMD_FLAG-IDA_98: FLAG-IDA in Induction Treatment of High Risk Myelodysplastic Syndromes or Secondary Acute Myeloblastic Leukemia
NaSingle-groupOpen-labelTreatment
Summary
Association group of therapeutic specialities authorized in a remission induction treatment(FLAG-IDA: fludarabine, cytarabine, G-CSF (lenograstim) and idarubicin) and an intensive postremission treatment with authorized therapeutic association specialities and with/without Autologous Hemopoietic Stem Cell Transplantation or Bone Marrow Transplantation in Patients With High Risk Myelodysplastic Syndromes or Secondary Acute Myeloblastic Leukemia.
Timeline
- Start
- 1998-07
- Primary completion
- 2007-05
- Completion
- 2007-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cytarabine | Small molecule | 200 mg/m2 | Intravenous |
| Subject | Cytarabine | Small molecule | 2 g | Intravenous |
| Subject | Fludarabine | Small molecule | 30 mg/m2 | Intravenous |
| Subject | Idarubicin | Small molecule | 10 mg/m2 | Intravenous |
| Background | Lenograstim | Protein / enzyme biologic | 10 ug/kg | Subcutaneous |
| Background | Lenograstim | Protein / enzyme biologic | 263 ug | Subcutaneous |
| Background | Lenograstim | Protein / enzyme biologic | 300 ug/m2 | Subcutaneous |