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

Completed · Phase 2

Conditions studied: Leukemia, Acute Myeloid Leukemia, AML

In brief

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.

Key facts

Study ID

NCT00422591

Run by

M.D. Anderson Cancer Center

People needed

175

Starts

2006-12-01

Expected to finish

2017-01-01

Last updated by the study team

2018-08-23

Who can join

Age: 15 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of 1) AML (WHO classification definition of >/= 20% blasts). Patients with M6 AML with less than 20% blasts are eligible.
• 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 .
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, 2, or 3 at screening.
• Serum biochemical values with the following limits: - creatinine </= 2.0 mg/dl - total bilirubin </= 2.0 mg/dL, unless increase is due to hemolysis - transaminases (SG PT) </= 3x upper limit of normal (ULN)
• Ability to understand and provide signed informed consent.

You may not qualify if…

• Subjects with Acute Promyelocytic Leukemia (APL).
• Presence of active systemic infection.
• Any coexisting medical condition that in the judgment of the treating physician is likely to interfere with study procedures or results.
• 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.

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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