Clinical trial NCT01025154
Conditions: Acute Myeloid Leukemia
Keywords: Leukemia AML chemotherapy-naïve Clofarabine Clofarex Clolar Idarubicin Idamycin Cytarabine Ara-C Cytosar DepoCyt Cytosine Arabinosine Hydrochloride
Sponsor: M.D. Anderson Cancer Center
Start date: 2010-01-01; Completion date: 2013-02-01
Enrollment: 63 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
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.

Detailed description:
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.

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 3-10 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.

Study Visits:

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 1-2 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.

Follow-up Scan:

Within 8 weeks after you have stopped taking the study drug, you will have an echocardiogram or a Multiple gate acquisition scan (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 acute lymphoblastic leukemia (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.

Arms: arm 1: Induction Cycle: Clofarabine 20 mg/m\^2 intravenous (IV) daily for 5 days; Idarubicin 10 mg/m\^2 IV daily for 3 days; Cytarabine 1 g/m\^2 IV daily for 5 days
Interventions: intervention 1: Clofarabine intervention 2: Idarubicin intervention 3: Cytarabine
Intervention descriptions: intervention 1: Induction Cycle: 20 mg/m\^2 IV over approximately 1 hour daily for 5 days (days 1-5) intervention 2: Induction Cycle: 10 mg/m\^2 IV over approximately 30 minutes daily for 3 days (days 1-3), following clofarabine by 1 to 2 hours intervention 3: Induction Cycle: 1 g/m\^2 IV over approximately 2 hours daily for 5 days (days 1-5), follow clofarabine by 3 to 6 hours.

Protocol documents: