Overview

Omacetaxine and Low Dose Cytarabine in Older Patients With Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)

Status:
Completed
Trial end date:
2017-01-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Cephalon
Treatments:
Cytarabine
Homoharringtonine
Criteria
Inclusion Criteria:

1. Previously untreated AML (>/= 20% blasts). Patients with high-risk (intermediate-2 or
high by International Prostate Symptom Score (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. Eastern Cooperative Oncology Group (ECOG) performance status
4. Adequate hepatic (serum total bilirubin transaminase (SGPT) and/or serum glutamate oxaloacetate transaminase (SGOT) ULN) and renal function (creatinine
5. Patients must be willing and able to review, understand, and provide written consent
before starting therapy.

Exclusion Criteria:

1. New York Heart Association (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.

4. Pregnancy.

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.