Overview

Omacetaxine and Decitabine in Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndrome (MDS)

Status:
Terminated
Trial end date:
2017-06-22
Target enrollment:
0
Participant gender:
All
Summary
This clinical research study is made up of 2 phases. The goal of Phase 1 of the study is to test the safety of the combination of omacetaxine and decitabine and to find the best dose to give to future patients. The goal of Phase 2 of the study is to learn if this dose can help to control AML and/or MDS. The safety will then continue to be studied.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Teva Pharmaceuticals USA
Treatments:
Azacitidine
Decitabine
Homoharringtonine
Criteria
Inclusion Criteria:

1. Previously untreated AML (>/= 20% blasts) or AML M6. 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. No prior
chemotherapy is allowed except for 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 >/= 70 years.

3. Eastern Cooperative Oncology Group (ECOG) performance status
4. Adequate hepatic (serum total bilirubin transaminase (SGPT) and/or SGOT mg/dL).

5. Patients must be willing and able to review, understand, and provide written consent
before starting therapy.

6. Men of childbearing potential who agree to use contraception prior to study entry and
for the duration of participation.

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), uncontrolled 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. Acute promyelocytic leukemia (APL).