A RANDOMIZED PHASE II STUDY OF TWO SCHEDULES OF DECITABINE FOR FRONTLINE THERAPY OF OLDER OR UNFIT PATIENTS WITH ACUTE MYELOID LEUKEMIA (AML)
The goal of this clinical research study is to compare how well 2 different dosing schedules of decitabine may help control AML. Decitabine is designed to damage the DNA (the genetic material) of cells, which may cause cancer cells to die.
Disease Group: Leukemia
Treatment Agent: Decitabine
Treatment Location: Only at MD Anderson
Primary: Compare the response rates of two schedules of decitabine in patients with AML 60 and older than 60 and/or unfit for standard cytotoxic chemotherapy. Secondary: Compare response durations, survivals and side effects of the two schedules. Tertiary: To examine the correlation of a number of biological and pharmacodynamics correlates with response to therapy including global and gene-specific methylation, specific somatic gene mutations, micro-RNA, and immune effector function
IRB Review and Approval Date: 02/05/2013
Recruitment Status: Open
Projected Accrual: N/A
1) Patients with previously untreated AML (by the WHO criteria, i.e.
>/= 20% blasts) Prior biologic therapies (such as growth factors) and
targeted therapies administered for the treatment of prior
myelodysplastic syndrome are allowed, with the exception of
hypomethylating agents 5-azacytidine or decitabine. Patients must have
been off such therapy for 1 week prior to entering this study and
recovered from the toxic effects of that therapy, unless there is
evidence of rapidly progressive disease. Hydroxyurea, and a single dose
of cytarabine up to 3 g/m2, is permitted for control of counts prior to treatment.
2) Patients >/= 60 are eligible if not a candidate for standard cytarabine plus anthracycline chemotherapy as determined by Kantarjian’s score (Appendix D) Patients younger than 60 may also be included if felt not to be a candidate for intensive anthracycline plus cytarabine based chemotherapy.
3) Performance 0-3 (ECOG).
4) Adequate liver function (Total bilirubin of < 2 mg/dl) unless due to hemolysis, leukemia organ infiltration or Gilbert’s syndrome and renal function (creatinine < 2.5 mg/dl).
5) Signed informed consent
1) Nursing and pregnant females. Female patients of childbearing
potential and male patients should practice effective methods of
contraception such as double barrier method. Should a woman become
pregnant or suspect she is pregnant while participating in this study,
she should inform her treating physician immediately. Negative urine
pregnancy test (women of childbearing potential)
2) Active and uncontrolled infections.
3) Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, active significant other cancers requiring chemotherapy and/or radiation therapy within past 6 months (excluding non-melanoma skin cancer) or psychiatric illness/social situations that would limit compliance with study requirements.
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