Idarubicin, Cytarabine, and Tipifarnib in Treating Patients With Newly Diagnosed Myelodysplastic Syndromes or Acute Myeloid Leukemia
Adult Acute Basophilic Leukemia, Adult Acute Eosinophilic Leukemia, Adult Acute Megakaryoblastic Leukemia (M7)
About this trial
This is an interventional treatment trial for Adult Acute Basophilic Leukemia
Eligibility Criteria
Inclusion Criteria: Diagnosis of 1) AML (WHO classification definition of > 20% blasts), or 2) high risk MDS (defined as the presence of > 10% blasts) Patients must be chemo-naïve, i.e. not have received any prior chemotherapy (except hydrea) for AML or MDS; they could have received transfusions, hematopoietic growth factors or vitamins; temporary measures such as pheresis or hydrea (0.5 to 5g daily for up to 3 days) are allowed ECOG PS of 0-1 at screening Creatinine =< 2 mg/dl Total bilirubin =< 2 mg/dL, unless increase is due to hemolysis Transaminases (SGPT) =< 2.5 x ULN Ability to take oral medication Ability to understand and provide signed informed consent Exclusion Criteria: Subjects with APL Presence of active systemic infection Any coexisting medical condition that in the judgment of the treating physician is likely to interfere with study procedures or results Nursing women, women of childbearing potential with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception (such as birth control pills, IUD, diaphragm, abstinence, or condoms by their partner) over the entire course of the study Known allergy to imidazole drugs (such as clotrimazole, ketoconazole, miconazole, econazole, fenticonazole, isoconazole, sulconazole, tioconazole, terconazole)
Sites / Locations
- M D Anderson Cancer Center
Arms of the Study
Arm 1
Experimental
Arm I
See Detailed Description