A Pilot Study of IV Clofarabine for Patients With Myelodysplastic Syndrome Who Have Failed 5-azacytidine
Study Overview
This study will recruit patients who have received at least six cycles of 5-azacytidine
without response or whose disease has progressed or relapsed while on 5-azacytidine. The
first cohort of patients will receive clofarabine 10 mg/m2/day for five days and the second
cohort of patients 5 mg/m2/day for five days, both every four to six weeks. The
investigators will determine the frequency of response to the two dosages of nucleoside
analog in this group of patients. Measurement of responses will include improvement in the
peripheral blood count, reduction in the blood and platelet transfusion need and eradication
of cytogenetically abnormal clones.
- Primary Objectives
1. To determine the frequency and duration of peripheral blood responses to IV
clofarabine in MDS patients who have failed 5-azacytidine
2. To determine the frequency and duration of bone marrow responses to IV
clofarabine, including CR + PR
- Secondary Objectives
To determine whether clofarabine exhibits a DNA hypomethylating property
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Improvement in Peripheral Blood Count and Reduction in Number of Transfusions
Hematologic improvement will be an increased Hemoglobin of 1.5 g/dL or a reduction in the need for PRBC transfusions by at least 4 units over an 8 week period, at least 100% increase and an ANC of >0.5 x 10^9/L and an absolut platelet count increase of >30 x 10^9/L for patients who start at > 20 x 10^9/L, or increase from <20 x 10^9/L to >20 x 10^9/L and by at least 100%.
2-3 months
Yes
Seah Lim, MD
Principal Investigator
Texas Oncology Cancer Center
United States: Institutional Review Board
iCLO111
NCT00700011
March 2008
March 2010
Name | Location |
---|---|
Texas Oncology Cancer Center | Austin, Texas 78731 |