A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Best Supportive Care as Maintenance Therapy in Subjects with Acute Myeloid Leukemia in Complete Remission. (CC-486-AML-001)
ID Number 13-0957Principal Investigator(s)
Lewis R Silverman
Department(s) or Division(s)
Hematology and Medical Oncology
The purpose of this study is to determine if oral azacitidine (CC-486) is safe and effective as “maintenance therapy” in continuing the response you had with your last AML treatment and improving the quality of that response. Currently there is no standard treatment to maintain or improve your response and patients are usually just “observed or watched”. Your doctor may decide to follow you closely through regular physical exams and tests, but without more treatment. Since there is possibility that your disease may come back (relapse), the goal is to search for new treatments that may reduce the risk for relapse or at least to prolong the time before disease relapse.
Azacitidine belongs to a class of anti-cancer drugs known as DNA demethylating agents. These types of drugs change how diseased cells in the blood and bone marrow grow and multiply.
Vidaza®, a liquid form of azacitidine given by injections is approved in the United States (US) and the European Union (EU) for the treatment of the blood diseases myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMMoL). In the EU, Vidaza is also approved for the treatment of a specific type of AML. Overall, Vidaza is approved in over 30 countries.
However, the oral tablet form of azacitidine has not been approved in any country for any disease and is an experimental drug being tested in this study. The experimental drug is not approved by the United States Food and Drug Administration (FDA) for use except in research studies.
The study drug in this study is either oral azacitidine or placebo (sometimes called a sugar pill). Placebo looks like the study drug but is not active drug.
Recruiting Patients: Yes