Study:
A Phase III Randomized Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia
Rationale:
n/a
Purpose:
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
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.
ClinicalTrials.gov 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
n/a