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low- or high-intensity therapies (e.g., AML-like treatment regimens) in clinical trials whenever possible.

3. Patients at great risk for progressing to AML: Patients with increased BM blasts and/or poor risk cytogenetics have a high likelihood of transforming to AML, and AML arising in a patient with MDS has an extremely poor prognosis. Thus, allogeneic stem cell transplant should be considered for such poor prognosis MDS patients as soon as possible. Many MDS patients will not be suitable transplant candidates based on their performance status, other complicating medical problems, age, or lack of a suitable donor. Improvements in unrelated donor transplantation may provide more hope for these patients in the future. A major risk for these patients post-stem cell transplant is disease relapse. Whether using 5-azacytidine, or standard AML induction therapy, to reduce the BM blast count prior to transplantation will improve transplant outcomes, is not known. It is a vitally important question to address. Patients who are not eligible for a stem cell transplant should be treated with 5-azacytidine, or with investigational therapy in the setting of a clinical trial.

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