Clofarabine, Idarubicin, and Cytarabine Combination in Acute Myeloid Leukemia (AML) Induction
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Clofarabine; Idarubicin; Cytarabine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Induction Cycle: 20 mg/m^2 IV over approximately 1 hour daily for 5 days (days 1-5); 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; 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.
Other intervention name(s): Clofarex; Clolar; Idamycin; Ara-C; Cytosar; DepoCyt; Cytosine Arabinosine Hydrochloride
Intervention MeSH terms: Cytarabine; Clofarabine; Idarubicin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Leukemia; AML; chemotherapy-naïve; Clofarabine; Clofarex; Clolar; Idarubicin; Idamycin; Cytarabine; Ara-C; Cytosar; DepoCyt; Cytosine Arabinosine Hydrochloride