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.

Publication details

54 th Annual Meeting of the American Society of Hematology (ASH)
Abstract: 2630
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 

The abstract is available online through the annual meeting section of the American Society of Hematology's website at .

About Acute Myeloid Leukemia (AML)

AML is a cancer of the blood cells that progresses rapidly and if not treated, could be fatal in a few months. AML is generally a disease of older people and is uncommon before the age of 40. The average age of a patient with AML is about 67 years. There are more than 12,300 new cases of AML, of which about half are elderly aged 70 years or older. Nearly 9,000 deaths are caused by this cancer each year in the United States. A review of The University of Texas MD Anderson Cancer Center's historical experience with front-line intensive induction chemotherapy for AML patients aged 70 years or older demonstrated that while 45% achieved a complete remission, median overall survival was only 4.6 months and was associated with a 4-week death rate of 26% and a 8-week death rate of 36% (Kantarjian, H, et al, Blood, doi:10.1182/blood-2010-03-276485).

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