Randomized Phase II/III-Study on All-Trans Retinoic Acid in Combination With Induction and Consolidation Therapy as Well as Pegfilgrastim After Consolidation Therapy in Younger Patients With Newly Diagnosed Acute Myeloid Leukemia
First Induction Therapy:
- Cytarabine 100 mg/m² cont. i.v. days 1-7
- Idarubicin 12 mg/m² i.v. days 1,3,5
- Etoposide 100 mg/m² i.v. days 1-3
- ± ATRA 45 mg/m² p.o. days 6-8
- ATRA 15 mg/m² p.o. days 9-21
Second Induction Therapy:
- Cytarabine 100 mg/m² cont. i.v. days 1-7
- Idarubicin 12 mg/m² i.v. days 1 and 3
- Etoposide 100 mg/m² i.v. days 1-3
- ± ATRA 45 mg/m² p.o. days 6-8
- ATRA 15 mg/m² p.o. days 9-21
Consolidation Therapy:
cohort 1 (<= ID 336)
- Cytarabine 3 g/m² 2x/die i.v. Tag 1,3,5
- ± ATRA 15 mg/m² p.o. Tag 6-21
- Pegfilgrastim 6 mg s.c day 10
cohort 2 (> ID 336)
- Cytarabine 3 g/m² 2x/die i.v. Tag 1,2,3
- ± ATRA 15 mg/m² p.o. Tag 4-21
- Pegfilgrastim 6 mg s.c day 8
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete remission (CR)-rate after induction therapy
after the second induction cycle
No
Richard F Schlenk, Dr.
Principal Investigator
Department of Internal Medicine III, University of Ulm
Germany: Federal Institute for Drugs and Medical Devices
AMLSG07-04
NCT00151242
July 2004
August 2013
Name | Location |
---|