Phase II Study of 5-azacytidine and Lintuzumab in Myelodysplastic Syndromes (MDS)
- To determine the complete response rate of the combination of lintuzumab and
azacitidine in patients with myelodysplastic syndromes.
- To define the specific toxicities of this regimen.
- To determine the overall response rate.
- To determine the relationship between pretreatment expression of Syk and clinical
- To determine whether the investigational agents modulate Syk expression and to
correlate drug-induced changes in Syk with response to treatment.
- To provide preliminary data on the biological activity of azacitidine as a
demethylating agent (changes in target gene methylation and gene expression, DNMT1
protein expression, global methylation).
- To perform exploratory studies of azacitidine-triphosphate with global DNA methylation.
- To explore the biologic role of microRNA in determining clinical response to this
regimen and achievement of the other pharmacodynamic endpoints.
OUTLINE: Patients receive azacitidine IV or subcutaneously once daily on days 1-7 and
lintuzumab IV on days 2, 7, 15, and 22 (days 2 and 15 of course 1 only). Treatment repeats
every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Treatment modifications may apply according to response.
Blood and bone marrow samples are collected periodically for pharmacodynamic studies.
After completion of study treatment, patients are followed up for 5 years.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete response rate
up to 5 years
Alison Walker, MD
Ohio State University Comprehensive Cancer Center
United States: Food and Drug Administration
|Ohio State University Medical Center||Columbus, Ohio 43210|