The purpose of this study is to determine the safety and establish the maximum tolerated dose (MTD) of omacetaxine in combination with azacitidine and G-CSF in patients with relapsed and/or refractory MDS.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Comparison of different doses of omacetaxine in combination with azacitidine and G-CSF
Comparison of different doses of omacetaxine in combination with azacitidine and G-CSF
Comparison of different doses of omacetaxine in combination with azacitidine and G-CSF
University of Florida Health Shands Cancer Hospital
Gainesville, Florida, United States
The maximum tolerated dose (MTD) of omacetaxine in combination with azacitidine and G-CSF in patients with relapsed and/or refractory low- and intermediate-risk MDS.
Time frame: 28 days
Number of participants with Hematologic Improvement (HI) as measured by hemoglobin, platelet count and neutrophil count.
Time frame: 12 months
Number of participants with disease response as defined by International Working Group (IWG) 2006 criteria.
Time frame: 12 months
Number of participants who achieve complete remission and how long the response lasts
Time frame: 24 months
Length of time of survival for participants
Time frame: 24 months
Incidences of Grade 3/4 adverse events directly related to the drug combination
Time frame: 24 months
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