Prospective evaluation of standard chemotherapy regimen of Idarubicin and Cytarabine in patients with newly diagnosed acute myeloid leukemia (AML)
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.
Disease Group: Leukemia
Treatment Agent: Cytarabine,Idarubicin
Treatment Location: Only at MDACC
Estimatated Length of Stay in Houston: 7 to 28 days
Return Visit: 2 to 3 times weekly for the first 2 months, then weekly while receiving therapy
Home Care: None
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.
IRB Review and Approval Date: 11/01/2006
Recruitment Status: Not Accepting
Projected Accrual: N/A
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) ECOG PS of 0, 1, 2, or 3 at screening.
4) 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 ULN
5) Ability to understand and provide signed informed consent.
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, IUD, diaphragm, abstinence, or condoms by their partner) over the entire course of the study.