A Phase 2, Multi-Center, Open Label, Randomized, Parallel-Group Study of A Lenalidomide (Revlimid) Regimen or A Sequential Azacitidine (Vidaza) plus Lenalidomide (Revlimid) Regimen versus Conventional Care for Therapy of Subjects 65 Years or Older with Newly Diagnosed Acute Myeloid Leukemia
ID Number 12-1229Principal Investigator(s)
Lewis R Silverman
Department(s) or Division(s)
Hematology and Medical Oncology
The purpose of this study is to see if the drug lenalidomide (Revlimid®) alone or in combination with the drug azacitidine (Vidaza®) is safe and effective for use in older people (65 years and older) with AML. This study is being conducted to determine if these drugs will help patients with AML more than currently available treatments (conventional care regimens).
Lenalidomide (Revlimid®) is an Immunomodulatory drug (IMiD®). An IMiD can change how the immune system works. Lenalidomide has not been approved for patients with AML and is experimental (being tested) in this study.
Azacitidine (Vidaza®) is an anti-cancer drug type known as DNA demethylating agents. These drugs change how diseased cells in the blood and bone marrow grow. Azacitidine is experimental (being tested) in this study.
You are being asked to participate in this research study because you have been diagnosed with acute myeloid leukemia (AML).
AML is a fast-growing cancer of the blood and bone marrow. In AML, the bone marrow makes many immature cells called blasts. Blasts normally mature into white blood cells that fight infection. However, the blasts are abnormal in AML. They do not develop and cannot fight infections. The bone marrow may also make abnormal red blood cells and/or platelets. The abnormal cells grow quickly, and crowd out the normal red blood cells, white blood cells and platelets the body needs to function adequately.
Recruiting Patients: No