Status:
COMPLETED
Standard Idarubicin and Cytarabine for the Treatment of Acute Myeloid Leukemia (AML)
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Leukemia
Acute Myeloid Leukemia
Eligibility:
All Genders
15-75 years
Phase:
PHASE2
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 ...
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 s...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT00422591
Start Date
December 1 2006
End Date
January 1 2017
Last Update
August 23 2018
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030