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The goal of this clinical research study is to learn if the combination of clofarabine, cytarabine, and idarubicin can help to control Acute Myeloid Leukemia (AML) in patients who are between the ages of 18 and 60 years old. The safety of this study drug combination will also be studied.
The Study Drugs Clofarabine is designed to interfere with the growth and development of cancer cells.
Idarubicin is designed to cause breaks in DNA (the genetic material of cells) of cancer cells and interfere with their growth and development.
Cytarabine is designed to insert itself into DNA of cancer cells and stop the DNA from repairing itself.
Signing this consent form does not mean that you will be able to take part in this study. You will have "screening tests" to help the doctor decide if you are eligible to take part in this study. The following tests and procedures will be performed:
- Your complete medical history will be recorded.
- You will have a physical exam, including measurement of your weight and vital signs (blood pressure, breathing rate, heart rate, and temperature).
- You will be asked about any other drugs you may be taking.
- You will be asked how well you are able to perform the normal activities of daily living (performance status).
- Blood (about 2 tablespoons) will be drawn for routine tests.
- You will have either an echocardiogram or a multiple gated acquisition (MUGA) scan to check your heart function.
- You will have a bone marrow aspirate to check the status of the disease. To collect a bone marrow aspirate, an area of the hip is numbed with anesthetic, and a small amount of bone marrow is withdrawn through a large needle.
- Women who are able to become pregnant must have a negative blood (about 1 teaspoon) or urine pregnancy test.
The study doctor will discuss the screening test results with you. If the screening tests show that you are not eligible to take part in the study, you will not be enrolled. Other treatment options will be discussed with you.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive the study drug combination over 1 or 2 "Induction Cycles" of treatment. Whether or not you receive a second Induction Cycle depends on the disease's response to the first Induction Cycle. Each Induction Cycle will last about 4-6 weeks, depending on your reaction to the study drugs. During each Induction -Cycle, you will receive the study drugs by the following schedule:
- Clofarabine, by vein, over 1-2 hours on Days 1-5.
- Cytarabine, by vein, over 2-3 hours on Days 1-5.
- Idarubicin, by vein, over about 30-60 minutes on Days 1-3.
If the disease shows a response to the treatment during the Induction Cycle(s), you may continue to receive up to 6 "Consolidation Cycles" of treatment. Each Consolidation Cycle will last about 3-7 weeks, depending on your reaction to the study drugs. During each Consolidation Cycle, you will receive the study drugs by the following schedule:
- Clofarabine, by vein, over 1-2 hours on Days 1-3.
- Cytarabine, by vein, over 2-3 hours on Days 1-3.
- Idarubicin, by vein, over 30-60 minutes on Days 1-2.
On Day 1 of every cycle:
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- Blood (about 1-2 teaspoons) will be drawn for routine tests.
Throughout the study, you will have blood and bone marrow tests to check the status of the disease and to help the doctor decide if you need additional cycles of treatment. Blood (about 2 tablespoons each time) will be drawn 2 times each week for routine tests during the Induction Cycles. This blood will also be drawn every week during the Consolidation Cycles.
About 3 weeks after you first receive the study drugs, you will have a bone marrow aspirate to check the status of the disease. After that, you will have a bone marrow aspirate every 2 weeks (or more often if your doctor thinks it is needed). However, if the routine blood tests show that there is still leukemia present, these bone marrow samples may not need to be collected.
You will need to stay in Houston for up to the first 5 weeks of treatment. After that, you will need to return to Houston to receive treatment, but you can have check-up visits and blood tests with your local doctor in between treatments.
Length of Study You will be able to receive the study drugs for up to 8 cycles (a maximum of 2 induction cycles and 6 consolidation cycles). You will be taken off study if the disease gets worse or you experience any intolerable side effects.
After you have stopped taking the study drug, blood (about 1 tablespoon each time) will be drawn 1 time each month for 2 years to check the status of the disease. After 2 years, this blood will be drawn every 3-6 months. If the doctor thinks it is needed, you will also have a physical exam every 6 months.
Within 8 weeks after you have stopped taking the study drug, you will also have an echocardiogram or a MUGA scan to check your heart function.
This is an investigational study. Cytarabine and idarubicin are both FDA approved and commercially available for the treatment of patients with AML. Clofarabine is FDA approved and commercially available for the treatment of patients with ALL. The use of this drug combination for the treatment of AML is investigational.
Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Acute Myeloid Leukemia
Clofarabine, Idarubicin, Cytarabine
UT MD Anderson Cancer Center
M.D. Anderson Cancer Center
Published on BioPortfolio: 2014-08-27T03:17:32-0400
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