Conditions: Acute Myeloid Leukemia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 105
Healthy volunteers: no

Brief summary:
The objective is to treat elderly AML and MDS patients with sapacitabine.

Detailed description:
The main objective of this study is to learn which sapacitabine treatment is more likely to keep the cancer in check for at least one year in AML patients who are at least 70 years of age or older and in MDS patients who are at least 60 years of age.

Arms:
arm 1: 200 mg b.i.d. x 7 days every 3-4 weeks arm 2: 300 mg b.i.d. x 7 days every 3 - 4 weeks arm 3: 400 mg b.i.d. x 3 days/week x 2 weeks every 3 - 4 weeks arm 4: 200 mg b.i.d. x 7 consecutive days every 4 weeks arm 5: 300 mg q.d. x 7 consecutive days every 4 weeks arm 6: 300 mg b.i.d. x 3 consecutive days per week for 2 weeks every 4 weeks arm 7: 200 mg b.i.d. x 7 consecutive days every 4 weeks arm 8: 300 mg q.d. x 7 consecutive days every 4 weeks arm 9: 100 mg q.d. x 5 consecutive days per week for 2 weeks every 4 weeks

Interventions: intervention 1: Sapacitabine, Arm A intervention 2: Sapacitabine, Arm B intervention 3: Sapacitabine, Arm C intervention 4: Sapacitabine, Arm D intervention 5: sapacitabine, Arm E intervention 6: sapacitabine, Arm F intervention 7: Sapacitabine, Arm G intervention 8: Sapacitabine, Arm H intervention 9: Sapacitabine, Arm I
Intervention descriptions: intervention 1: 200 mg b.i.d. x 7 days every 3-4 weeks intervention 2: 300 mg b.i.d. x 7 days every 3 - 4 weeks intervention 3: 400 mg b.i.d. x 3 days/week x 2 weeks every 3 - 4 weeks intervention 4: 200 mg b.i.d. x 7 consecutive days every 4 weeks intervention 5: 300 mg q.d. x 7 consecutive days every 4 weeks intervention 6: 300 mg b.i.d. x 3 consecutive days per week for 2 weeks every 4 weeks intervention 7: 200 mg b.i.d. x 7 consecutive days every 4 weeks intervention 8: 300 mg q.d. x 7 consecutive days every 4 weeks intervention 9: 100 mg q.d. x 5 consecutive days per week for 2 weeks every 4 weeks

Protocol document:
Prot_SAP_000.pdf: