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

Stopped early · Phase 1

Conditions studied: Leukemia

In brief

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.

Key facts

Study ID

NCT02141477

Run by

M.D. Anderson Cancer Center

People needed

2

Starts

2015-05-06

Expected to finish

2017-06-22

Last updated by the study team

2018-02-13

Who can join

Age: 70 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Age >/= 70 years.
• Eastern Cooperative Oncology Group (ECOG) performance status </= 2.
• Adequate hepatic (serum total bilirubin </= 1.5 x ULN, serum glutamate pyruvate transaminase (SGPT) and/or SGOT </= 2.5 x ULN) and renal function (creatinine </= 2.0 mg/dL).
• Patients must be willing and able to review, understand, and provide written consent before starting therapy.
• Men of childbearing potential who agree to use contraception prior to study entry and for the duration of participation.

You may not qualify if…

• 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.
• Myocardial infarction in the previous 12 weeks (from the start of treatment).
• Active and uncontrolled disease/infection as judged by the treating physician.
• Acute promyelocytic leukemia (APL).

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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