At a glance
ClinicalIndex Comparison Record- ✓Diagnosed acute myeloid leukemia
- ✓Life expectancy of at least 12 weeks
- ✕Acute promyelocytic leukemia (APL, M3 classification)
- ✕Other active systemic malignancies
- ✕Inaspirable bone marrow
- ✕Prior chemotherapy except hydroxyurea for myeloid disorder
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Phase 3 Trial of Decitabine Versus Patient's Choice With Physician's Advice of Either Supportive Care or Low-Dose Cytarabine for the Treatment of Older Patients With Newly Diagnosed Acute Myeloid Leukemia
In Brief
A Phase 3 clinical trial evaluating Cytarabine or Supportive Care and Dacogen (decitabine) only for Acute Myeloid Leukemia. Completed, enrolled 485 participants across 108 sites in 15 countries.
Detailed Summary
The purpose of this study is to compare the results in older patients who have newly diagnosed or secondary acute myeloid leukemia (AML) and who are to either receive decitabine or patient's choice with the physician's advice of either cytarabine or supportive care medication.
Study Details
Timeline
Interventions
Patient's choice with physician's advice of either supportive care (IV fluids, nutrition, and antibiotics as needed) or cytarabine 20 mg/m\^2 subcutaneously once daily for the first 10 consecutive days of each 28 day cycle, until progression or unacceptable toxicity develops. (These represent one intervention.)
20mg/m\^2, 1 hour intravenous (IV) for 5 consecutive days of each 28 day cycle. Cycles continue until disease progression or unacceptable toxicity develops.