Omacetaxine and Low Dose Cytarabine in Older Patients With Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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)|
- Complete Remission Rate (CR) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]Complete response (CR) defined as: Peripheral blood counts, no circulating blasts, neutrophil count ≥ 1.0 ×109/L, platelet count ≥ 100 ×109/L, bone marrow aspirate and biopsy, ≤5% blasts, no detectable auer rods, no extramedulary leukemia
|Study Start Date:||July 2011|
|Estimated Primary Completion Date:||July 2017 (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.Drug: Cytarabine
20 mg subcutaneously every 12 hours (+/- 3 hours) for 7 days (Days 1-7). Each cycle will be 4-7 weeks.
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Omacetaxine is designed to block certain proteins, which may cause cancer cells to die.
Cytarabine is designed to insert itself into DNA (the genetic material of cells) of cancer cells and stop the DNA from repairing itself.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive omacetaxine and cytarabine as an injection under the skin. You will receive instructions on how to give these injections to yourself. You will be given a Research Medication Diary to record the drugs you take each day. You must bring the Research Medication Diary and any unused drugs with you to each study visit. You will also be told how to properly store the drugs.
On Days 1-3 of each cycle, you will give yourself an injection of omacetaxine every 12 hours (+/- 3 hours).
On Days 1-7 of each cycle, you will give yourself an injection of cytarabine every 12 hours (+/- 3 hours).
Each cycle will be 4-7 weeks, depending on how well the disease responds to the study drugs.
Depending on how the disease responds to the study drugs, the number of days you receive your injections may stay the same, increase, or decrease. Your doctor will discuss this with you.
On Day 1 of each cycle, you will have a physical exam.
Women who are able to become pregnant must have a negative blood (about 1/2 teaspoon) or urine pregnancy test within 3 days before receiving the first dose of study drug.
Blood (about 1 tablespoon) will be drawn every week for routine tests. Once you have a response to treatment, blood will then be drawn every 2-4 weeks while you are receiving treatment. If your doctor thinks it is needed, you may have more blood samples drawn during Cycles 1 and 2.
On Day 21 of Cycle 1 (+/- 7 days), then every 4 weeks after that, you will have a bone marrow aspiration and/or biopsy to check the status of the disease. If the doctor thinks it is needed, these may be done more or less often, depending on your response to treatment.
Length of Study:
You may receive up to 24 cycles of treatment. You will be taken off study early if the disease gets worse or intolerable side effects occur.
Once you stop taking the study drugs, you will have follow-up for 5 years.
Every 4-8 weeks, blood (about 1 tablespoon) will be drawn for routine tests. If you cannot return to the clinic, you may have blood drawn at a clinic close to your home.
Every 3-6 months, you will be contacted during a clinic visit and asked how you are doing. If you cannot make it to the clinic for this visit, you will be called. The phone call should last about 5 minutes.
This is an investigational study. Omacetaxine is FDA approved to treat patients with certain types of leukemia. Its use in this study is investigational. Cytarabine is FDA approved and commercially available for the treatment of AML. The use of these drugs in combination is investigational.
Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01272245
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Hagop Kantarjian, MD||M.D. Anderson Cancer Center|