A Phase II Study of Omacetaxine (OM) and Low Dose Cytarabine (LDAC) in Older Patients with Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)
The goal of this clinical research study is to learn if omacetaxine given with cytarabine can help to control the disease in patients with AML or high-risk MDS. The safety of the study drugs will also be studied.
Disease Group: Leukemia
Treatment Agent: Cytarabine,Omacetaxine Mepesuccinate
Treatment Location: Only at MDACC
Sponsor: Cephalon, Inc.
Phase IIa Portion Evaluate toxicity of the schedule of OM for 3 days and Cytarabine for 7 days in 6 patients. Determine safety and Phase IIb schedule. Phase IIb Portion Evaluate efficacy of the combination in older patients with AML or high-risk MDS. a. Primary endpoint: achievement of complete response (CR) b. Secondary endpoints: evaluation of CR duration, disease-free survival, survival, regimen toxicity, and induction mortality.
IRB Review and Approval Date: 07/14/2011
Recruitment Status: Not Accepting
Projected Accrual: N/A
1) Previously untreated AML (>/= 20% blasts). Patients with high-risk
(intermediate-2 or high by IPSS or =10% blasts) MDS will also be
eligible. Prior therapy with hydroxyurea, biological or targeted therapy
(e.g. flt3 inhibitors, other kinase inhibitors, azacitidine), or
hematopoietic growth factors is allowed. A single or a two day dose of
cytarabine (up to 3 g/m2) for emergency use is also allowed as prior therapy.
2) Age >/= 60 years.
3) ECOG performance status </= 2.
4) Adequate hepatic (serum total bilirubin </= 1.5 x ULN, SGPT and/or SGOT </= 2.5 x ULN) and renal function (creatinine </= 2.0 mg/dL).
5) Patients must be willing and able to review, understand, and provide written consent before starting therapy.
1) NYHA class III or IV heart disease, active ischemia or any other
uncontrolled cardiac condition such as angina pectoris, clinically
significant cardiac arrhythmia and requiring therapy, uncontrolled
hypertension (blood pressure >/= 160 systolic and >/= 110
diastolic not responsive to antihypertensive medication), diabetes
mellitus, or congestive heart failure.
2) Myocardial infarction in the previous 12 weeks (from the start of treatment).
3) Active and uncontrolled disease/infection as judged by the treating physician.
5) Acute promyelocytic leukemia (APL).
6) Women of childbearing potential and men who do not practice contraception. Non-childbearing is defined as >/= 1 year postmenopausal or surgically sterilized.
7) Women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation.
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