Overview

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

Status:
Completed
Trial end date:
2017-01-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Treatments:
Cytarabine
Idarubicin
Criteria
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.