Omacetaxine and Low Dose Cytarabine in Older Patients With Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)
Verified June 2014 by M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
First received: January 6, 2011
Last updated: June 30, 2014
Last verified: June 2014
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.
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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)
Primary Outcome Measures:
- Complete Remission Rate (CR) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||July 2016 (Final data collection date for primary outcome measure)
Experimental: Omacetaxine and Cytarabine
Omacetaxine 1.25 mg/m2 SQ every 12 hours x 3 days + Cytarabine 20 mg SQ x 7 days of 4-7 week cycle.
1.25 mg/m2 subcutaneously (SQ) every 12 hours (+/- 3 hours) for 3 days (Days 1-3). Each cycle will be 4-7 weeks.
20 mg subcutaneously every 12 hours (+/- 3 hours) for 7 days (Days 1-7). Each cycle will be 4-7 weeks.
- Cytosine Arabinosine Hydrochloride
|Ages Eligible for Study:
||60 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- Age >/= 60 years.
- ECOG performance status </= 2.
- 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).
- Patients must be willing and able to review, understand, and provide written consent before starting therapy.
- 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.
- 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).
- Women of childbearing potential and men who do not practice contraception. Non-childbearing is defined as >/= 1 year postmenopausal or surgically sterilized.
- Women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01272245
|Contact: Hagop Kantarjian, MD
|UT MD Anderson Cancer Center
|Houston, Texas, United States, 77030 |
|Principal Investigator: Hagop Kantarjian, MD |
M.D. Anderson Cancer Center
||Hagop Kantarjian, MD
||UT MD Anderson Cancer Center
No publications provided
||M.D. Anderson Cancer Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 6, 2011
||June 30, 2014
||United States: Food and Drug Administration
Keywords provided by M.D. Anderson Cancer Center:
Acute Myelogenous Leukemia
High-Risk Myelodysplastic Syndrome
Cytosine Arabinosine Hydrochloride
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 23, 2014
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Bone Marrow Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs