Standard Idarubicin and Cytarabine for the Treatment of Acute Myeloid Leukemia (AML)

Ara-C and idarubicin are designed to interfere with DNA's (the genetic material of cells)
ability to repair itself, causing cancer cells to die.

If you are found to be eligible to take part in this study, you will receive treatment with
idarubicin and ara-C for up to 8 cycles. One cycle lasts about 4-5 weeks. Cycles 1 and 2 are
called induction therapy, which is used to help induce (cause) a remission. Cycles 3 to 8 are
called consolidation therapy, which is a type of high-dose chemotherapy often given as the
second phase of a cancer treatment.

After Cycle 1, you will have a brief rest period of a few days, before you move on to Cycle
2. On Day 1 of Cycle 1, you will receive cytarabine by vein as a continuous infusion over 4
days. It will only be 3 days if you are age 60 or older. On Days 1-3 of Cycle 1, you will
receive idarubicin by vein over 1 hour once a day.

The dose of the study drugs you receive may be changed to help manage side effects (such as
nausea and diarrhea) that you may experience. Medications (given by mouth or by vein), such
as Tylenol (acetaminophen), may be given before and during treatment to help decrease the
risk of such side effects. The study doctor will specify what these medications are.

You will have blood drawn (about 2 teaspoons) for routine tests about once a week during
treatment. Starting on Days 21-28, you will have bone marrow collected every 1-2 weeks to
check the status of the disease. Blood (about 2 tablespoons) will also be drawn at least
twice a week after each cycle of therapy (beginning about 4-6 weeks from the start of
treatment each cycle) to check your blood counts.

Cycle 2 will begin after your blood counts have recovered. If at the end of Cycle 1 you have
not achieved a remission (disease has decreased), you may receive Cycle 2, which will be
similar to Cycle 1.

If the disease is responding to treatment after Cycle 2 (after completion of induction
therapy), you will receive up to 6 more cycles of therapy. These cycles are called
consolidation therapy. Consolidation therapy is a type of high-dose chemotherapy often given
as the second phase to treat cancer. For consolidation therapy, you will receive ara-C as a
continuous infusion over 3 days starting on Day 1 of Cycle 3. On Days 1 and 2 of Cycles 3 and
4, you will receive idarubicin by vein over 1 hour. Your blood (about 2 tablespoons) will be
drawn at least twice a week after each cycle to check your blood counts. Cycle 3 will begin
after your blood counts have recovered.

After completion of consolidation therapy, you may receive what is called maintenance
therapy. Maintenance therapy will start after completion of consolidation therapy.
Maintenance therapy is often given to help keep cancer in remission. It is treatment that is
given to help the original treatment keep working. You will be told if you will have
maintenance therapy as well as the drugs and drug schedule you will be on.

During consolidation and/or maintenance therapy, blood (about 2 teaspoons) will be drawn for
routine tests every 1-2 weeks. You will have bone marrow collected every 3-6 months to check
the status of the disease.

You may have treatment on this study for up to 8 cycles (induction and consolidation therapy)
or more (for maintenance therapy), depending on disease response to the study drugs. If the
disease gets worse or you experience any intolerable side effects, you will be taken off this
study, and your study doctor will discuss other treatment options with you.

Once your participation is over on this study, you will be followed-up with a phone call by
the study doctor or study nurse to check on how you are doing and if you have experienced any
intolerable side effects. The call should last about 10-15 minutes.

This is an investigational study. Idarubicin and ara-C are both FDA approved and commercially
available. Up to 200 patients will take part in this study. All will be enrolled at MD
Anderson.

Inclusion Criteria:

1. Diagnosis of 1) AML (WHO classification definition of >/= 20% blasts). Patients with
M6 AML with less than 20% blasts are eligible.

2. Patients aged 15 to 75 years are eligible. Patients must be chemo-naïve, i.e. not have
received any prior chemotherapy (except hydrea) for AML. They could have received
transfusions, hematopoietic growth factors or vitamins. Temporary measures such as
pheresis or hydrea (0.5 to 5g daily or more for up to 3 days) are allowed .

3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, 2, or 3 at
screening.

4. Serum biochemical values with the following limits: - creatinine bilirubin
5. Ability to understand and provide signed informed consent.

Exclusion Criteria:

1. Subjects with Acute Promyelocytic Leukemia (APL).

2. Presence of active systemic infection.

3. Any coexisting medical condition that in the judgment of the treating physician is
likely to interfere with study procedures or results.

4. Nursing women, women of childbearing potential with positive urine pregnancy test, or
women of childbearing potential who are not willing to maintain adequate contraception
(such as birth control pills, intrauterine device (IUD), diaphragm, abstinence, or
condoms by their partner) over the entire course of the study.