Phase II Clinical and Pharmacodynamic Investigation of Clofarabine in Acute Leukemias
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 response (CR) rate, response duration, and survival; and (2) analyze the
relationship between cellular uptake and retention of clofarabine triphosphate (the active
metabolite), inhibition of DNA synthesis, and clinical outcome.
- 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
- 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
Type of Study:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Hagop M Kantarjian, MD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
- Acute Myelogenous Leukemia
- Acute Lymphocytic Leukemia
- Chronic Myelogenous Leukemia
- investigational drug clofarabine
- AML, ALL, CML-accelerated phase, CML-blastic phase
- Chronic Myelogenous Leukemia - accelerated phase
- Chronic Myelogenous Leukemia - blastic phase
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive