SEAMLESS Study Design
Sapacitabine (CYC682), an orally-available nucleoside analogue, is currently being studied in SEAMLESS, an ongoing, Phase 3, registration-directed trial in elderly patients aged 70 years or older with newly diagnosed AML who are not candidates for or have refused induction chemotherapy. SEAMLESS is being conducted under a Special Protocol Assessment (SPA) agreement that Cyclacel reached with the U.S. Food and Drug Administration (FDA). Patients who received hypomethylating agents for prior myelodysplastic syndromes or myeloproliferative diseases are excluded from SEAMLESS. Patients in the control arm of SEAMLESS will receive decitabine alone, while in the experimental arm of SEAMLESS, patients will receive intravenous decitabine at 20 mg/m2 per day for five consecutive days of a 4-week cycle (odd cycles) alternating with sapacitabine at 300 mg orally twice per day for three days per week for two weeks of a 4-week cycle (even cycles). The primary efficacy endpoint is overall survival. A prespecified interim analysis for futility will be performed and reviewed by the Data Safety Monitoring Board.
54 th Annual Meeting of the American Society of Hematology (ASH)
|Title:||Pooled analysis of elderly patients with newly diagnosed AML treated with sapacitabine and decitabine administered in alternating cycles|
|Date/Time:||Sunday, December 9, 2012, 6:00 PM – 8:00 PM Eastern Time|
|Hall B1-B2, Level 1, Building B (Georgia World Congress Center)|
|Session:||615. Acute Myeloid Leukemia – Therapy, excluding Transplantation: Poster II|