Clinical trial NCT00422591
Conditions: Leukemia Acute Myeloid Leukemia AML
Keywords: Cytarabine, Idarubicin Leukemia Acute Myeloid Leukemia AML Cytarabine Idarubicin
Sponsor: M.D. Anderson Cancer Center
Start date: 2006-12-01; Completion date: 2017-01-01
Enrollment: 175 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this clinical research study is to find out if standard chemotherapy given with idarubicin and Cytarabine (ara-C) can help to control AML.

Objectives:

To determine the complete response (CR) rate, event-free survival (EFS) and overall survival (OS) of patients with newly diagnosed acute myeloid leukemia (AML) receiving standard combination chemotherapy with Idarubicin and cytarabine.

Detailed description:
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.

Arms: arm 1: Idarubicin 12 mg/m2 IV over 1 hour daily x 3 (days 1-3). Cytarabine 1.5 g/m2 IV over 24 hours daily on day 1-4 (age \<60 years) or days 1-3 (age \> 60 years).
Interventions: intervention 1: Cytarabine intervention 2: Idarubicin
Intervention descriptions: intervention 1: 1.5 g/m2 IV over 24 hours daily on day 1-4 (age \<60 years) or days 1-3 (age \> 60 years). intervention 2: 12 mg/m2 IV over 1 hour daily x 3 (days 1-3)

Protocol documents: