Fludarabine and Cytarabine in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)
Leukemia, AML, MDS
About this trial
This is an interventional treatment trial for Leukemia focused on measuring Acute Myelogenous Leukemia, High-Risk Myelodysplastic Syndrome, Chronic myeloid leukemia, CML, Blast crisis, Cytarabine, Ara-C, Cytosar, DepoCyt, Cytosine arabinosine hydrochloride, Arabinosine Hydrochloride, Fludarabine, Fludarabine Phosphate, Fludara, Gemtuzumab Ozogamicin, Mylotarg
Eligibility Criteria
Inclusion Criteria:
- Sign an Internal Review Board (IRB)-approved informed consent document.
- Age >/= 12 years.
- Diagnosis of AML [other than acute promyelocytic leukemia (APL)] with refractory/relapsed disease. Patients with newly diagnosed AML will be eligible if not a candidate for intensive chemotherapy. Patients with high-risk (intermediate-2 or high by IPSS or >/=10% blasts) MDS will also be eligible. Patients with chronic myeloid leukemia (CML) in blast crisis will be eligible as well.
- Eastern Cooperative Oncology Group (ECOG) performance status of </= 3 at study entry.
Organ function as defined below (unless due to leukemia):
i. Serum creatinine </= 3 mg/dL; ii. Total bilirubin </= 3 mg/dL; iii. Alanine aminotransferase (ALT)(Serum Glutamic Pyruvate Transaminase (SGPT)) </= 5 times upper limit of normal (ULN) or </= 10 times ULN if related to disease.
- Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 7 days . Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential.
Exclusion Criteria:
- Pregnant or breastfeeding females.
- Diagnosis of acute promyelocytic leukemia (M3).
Sites / Locations
- UT MD Anderson Cancer Center
Arms of the Study
Arm 1
Experimental
Cytarabine + Fludarabine
Fludarabine 15 mg/m^2 intravenous (IV) every 12 hours for 5 days; Cytarabine 0.5 grams/m^2 IV over 2 hours every 12 hours for 5 days.