Decitabine in Treating Patients With Previously Untreated Acute Myeloid Leukemia
Completed · Phase 2
Conditions studied: Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Secondary Acute Myeloid Leukemia, Untreated Adult Acute Myeloid Leukemia
In brief
This phase II trial is studying how well decitabine works in treating patients with previously untreated acute myeloid leukemia. Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing
Key facts
- Study ID
- NCT00492401
- Run by
- National Cancer Institute (NCI)
- People needed
- 55
- Starts
- 2007-05-01
- Expected to finish
- 2014-10-01
- Last updated by the study team
- 2016-06-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically or cytologically confirmed acute myeloid leukemia (AML) meeting 1 of the following criteria:
- At least 60 years of age and not a candidate for or refused standard induction treatment
- Poor risk cytogenetics
- AML following antecedent hematologic disorder
- Therapy-related AML
- Secondary AML
- No granulocytic sarcoma as sole site of disease
- No active CNS disease or CNS relapse
- ECOG performance status 0-2
- Life expectancy > 6 months
- Total bilirubin < 2.0 mg/dL
- Creatinine < 2.0 mg/dL
- AST and ALT < 2.5 times upper limit of normal
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No NYHA class III or IV congestive heart failure
- No uncontrolled infection
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to decitabine that are not easily managed
- No other uncontrolled illness including, but not limited to, any of the following:
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Serious cardiac arrhythmia
- Psychiatric illness or social situations that would preclude compliance with study requirements
- No active second malignancy involving the blood or marrow or likely to progress and require therapy in the next 6 months
Where it is running
- Ohio State University Medical Center — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
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