A Randomized Phase II Trial of Decitabine-Based Induction Strategies for Patients = 60 Years Old With Acute Myeloid Leukemia (AML)
ID Number 58-0056 (11002)Principal Investigator(s)
Celia L. Grosskreutz
Department(s) or Division(s)
Hematology and Medical Oncology
The purpose of this study is to find out what effects, good and/or bad, study treatment with decitabine alone or with the combination of bortezomib and decitabine has on you and your AML. This study treatment is a lower intensity chemotherapy treatment than the standard chemotherapy treatment for AML. The standard chemotherapy treatment for AML is not very successful in older patients; requiring prolonged hospitalization, it is often felt to be too difficult for older patients to tolerate.
Decitabine has been approved by the Food and Drug Administration (FDA) for the treatment of a different bone marrow disorder called myelodysplastic syndrome. Decitabine given as proposed in another study has helped some elderly patients with acute leukemia but it has not been FDA approved for that use. Previous studies reviewed by the FDA have been conducted in a different population of elderly AML patients treated on a different schedule. The study you are being asked to consider will determine whether this study treatment significantly improves overall survival times of older AML patients. Bortezomib has been FDA approved for the treatment of multiple myeloma, another bone marrow disorder. By itself, bortezomib has not been shown to be helpful in AML. Preliminary studies indicate that bortezomib may be helpful in AML when combined with a drug called decitabine. It is not known which of the two chemotherapy study treatments will have better results.
You may qualify to take part in this research study because you are 60 years of age or older and have been diagnosed with a bone marrow disorder called acute myeloid leukemia (AML).
Recruiting Patients: Yes