Acute Myelogenous Leukemia Clinical Trial
Official title:
Phase II Clinical and Pharmacodynamic Investigation of Clofarabine in Acute Leukemias
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 leukemia (ALL), and chronic myelogenous leukemia (CML) in accelerated and blastic phases.
Status | Completed |
Enrollment | 64 |
Est. completion date | September 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 12 Years and older |
Eligibility |
- 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. |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Texas |
Cortes JE, Gandhi V, et al. Clofarabine (2-chloro-9-(deoxy-2-fluoro-b-D-arabinosfuranosyl)adenine) is active for patients with refractory or relapsed acute leukemia. #739 ASH 2002.
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