Clofarabine, Idarubicin, and Cytarabine Combination as Induction Therapy for Younger Patients With Acute Myeloid Leukemia (AML)
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
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.
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
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
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.
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Response Rate
Overall response rate (CR+CRp) defined as Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 x 10^9/L and platelet count > 100 x 10^9/L, and normal bone marrow differential (< 5% blasts); Complete Remission without Platelet Recovery (CRp): Peripheral blood and bone marrow results as for CR, but with platelet counts of < 100 x 10^9/L; Partial Remission (PR): Blood count recovery as for CR, but with both a decrease in marrow blasts of at least 50% and not more than 5 to 25% abnormal cells in the marrow. Response evaluated within 8 weeks after induction therapy.
8 weeks after Induction therapy (induction cycle 4-6 weeks)
Stefan Faderl, MD
UT MD Anderson Cancer Center
United States: Institutional Review Board
|UT MD Anderson Cancer Center||Houston, Texas 77030|