Phase I/II Randomized Study of Clofarabine, Idarubicin, and Cytarabine (CIA) versus Fludarabine, Idarubicin, and Cytarabine (FLAI) in Acute Myelogenous Leukemia and High-Risk Myelodysplastic Syndrome
The goal of this clinical research study is to learn if the combination of clofarabine, idarubicin, and cytarabine, or the combination of fludarabine, idarubicin, and cytarabine can help control AML and MDS. The safety of these study drug combinations will also be studied.
Disease Group: Leukemia
Treatment Agent: Clofarabine
Treatment Location: Only at MDACC
Phase I Primary: Determine the MTD of clofarabine to be used in portion II of the study. Phase II Primary: Compare the response rates of two different regimens CIA versus FLAI Secondary: Evaluate the durability of response, the overall and event-free survival rates, and the safety profile of 2 different regimens.
IRB Review and Approval Date: 02/02/2011
Recruitment Status: Closed
Projected Accrual: N/A
1) Sign an IRB-approved informed consent document.
2) Age 18 to 60. Patients above the age of 60 only with PI approval
3) Diagnosis of newly diagnosed AML [other than acute promyelocytic leukemia (APL)] or high-risk (intermediate-2 or high by IPSS or > 10% blasts, including CMML) MDS. Prior therapy with hydrea and the use of a single or a two day dose of cytarabine (up to 3 g/m2) for emergency use up to 24 hours prior to start of study therapy is allowed. Prior therapy for MDS or other AHD is not allowed.
4) ECOG performance status of </= 3 at study entry.
5) Organ function as defined below (unless due to leukemia): Serum creatinine </= 3 mg/dL Total bilirubin </= 2.5 mg/dL , ALT (SGPT) </= 3 x ULN or </= 5 x ULN if related to disease.
6) Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days and must agree to practice acceptable contraceptive methods. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential.
7) Cardiac ejection fraction >/= 40% (by either cardiac echo or MUGA scan). Documentation of recent (</= 6 months from screening) outside reports is acceptable.
1) Breast feeding females
2) Patients with uncontrolled active infections (viral, bacterial, and fungal are not eligible).
3) Patients with active secondary malignancy will not be eligible.