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A Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia


A Phase III Randomized Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia




This Phase 3 study assesses two drug regimens as the initial treatment of patients who are at least 70 years of age and have newly diagnosed acute myeloid leukemia (AML) for whom the doctor does not recommend the use of standard intensive treatment or the patient has decided not to receive standard intensive treatment after being fully informed about its benefits and risks by his/her doctor. The two drug regimens are sapacitabine administered in alternating cycles with decitabine, or decitabine alone. The purpose of the study is to learn which drug regimen is more likely to keep AML in check as long as possible.

Study Status: Recruiting

Jessica Woodring 954-659-5538

Bethany Foster 216-444-0372

Condition Intervention Phase
Acute Myeloid Leukemia Drug: Sapacitabine and decitabine
Drug: Decitabine
Phase 3

Verified by Cyclacel Pharmaceuticals, Inc. September, 2012

Sponsored by: Cyclacel Pharmaceuticals, Inc.
Information provided by: Cyclacel Pharmaceuticals, Inc. identifier: NCT01303796

Study Type: Interventional

Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Cleveland Clinic Florida
Weston, Florida 33331
United States

Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States

Hagop Kantarjian, M.D.., Study Chair

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