Status:
COMPLETED
Investigation of Clofarabine in Acute Leukemias
Lead Sponsor:
University of Texas
Conditions:
Acute Myelogenous Leukemia
Acute Lymphocytic Leukemia
Eligibility:
All Genders
12+ years
Phase:
PHASE2
Brief Summary
The goals and objectives of this project are to evaluate the antileukemic activity of the investigational agent clofarabine in patients with acute myelogenous leukemia (AML), acute lymphocytic leukemi...
Detailed Description
The specific aims of the project are (1) conduct the phase II study of clofarabine and evaluate the antileukemic efficacy in AML, ALL, and CML-accelerated and blastic phases in terms of complete respo...
Eligibility Criteria
Inclusion
- Patient is diagnosed with AML, ALL, myelodysplastic syndrome (MDS), and CML in transformation (includes CML-blastic phase and CML-accelerated phase).
- No prior chemo-, immuno-, or radio-therapy for 2 weeks before entering the study, unless progressive life-threatening leukemia as judged by the treated physician.
- Adequate liver function (bilirubin \</= 2 mg%) and renal function (creatinine \</= 2 mg%).
- Pregnant and lactating females not eligible.
- Zubrod performance status 0-2
- Adequate cardiac status
- No life-threatening conditions (e.g. infections) which may cause death within 3 weeks.
Exclusion
Key Trial Info
Start Date :
September 1 2002
Trial Type :
INTERVENTIONAL
End Date :
September 1 2005
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00098033
Start Date
September 1 2002
End Date
September 1 2005
Last Update
March 25 2015
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