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Clinical Trial 19639
A Randomized Phase II/III Trial of Novel Therapeutics versus Azacitidine in Newly Diagnosed Patients with Acute Myeloid Leukemia (AML) Or High-Risk Myelodysplastic Syndrome (MDS), Age 60 or Older
The purpose of this study is to compare any good and bad effects of using different new treatment options to one of the current standard treatment options given for patients with AML or MDS who cannot tolerate or do not want to get intensive chemotherapy.
1.1 Primary Objectives: a. Phase II Component: To select, based on overall survival, any or all of the Novel Therapeutic regimens for further testing against azacitidine in patients age 60 and older with newly diagnosed acute myeloid leukemia (AML) or myelodysplastic syndrome with excessive blasts-2 (MDS-EB-2). b. Phase III Component: To compare overall survival of the "Novel Therapeutic" regimens selected in the Phase II portion of the trial to azacitidine in these patient populations. 1.2 Secondary Objectives: a. To estimate the frequency and severity of toxicities of the regimens in these patient populations. b. To estimate response rates, event-free survival, and relapse-free survival for these regimens in these patient populations. 1.3 Additional Objectives: a. To investigate associations between cytogenetic and molecular abnormalities (including FLT3) and outcomes for each of the regimens in these patient populations. b. To bank specimens for future correlative studies.