Phase II Study of Epirubicin and Rituximab in Relapsed and Refractory B-Cell Non-Hodgkin's Lymphoma and CLL
- Determine the response rate, time to progression, and overall survival of patients with
refractory or relapsed B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia
treated with epirubicin and rituximab.
- Determine the toxicity of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
OUTLINE: This is a non-randomized, open-label, multicenter study.
Patients receive epirubicin IV over 3-5 minutes once weekly for 6 weeks. Patients also
receive rituximab IV on weeks 2 and 5 during course 1 and then on weeks 1 and 4 for all
remaining courses. Treatment repeats every 8 weeks for a maximum of 3 courses in the absence
of disease progression or unacceptable toxicity.
Patients are followed every 3 months until disease progression.
PROJECTED ACCRUAL: A total of 18-38 patients will be accrued for this study within 2.5-3
Masking: Open Label, Primary Purpose: Treatment
Mitchell R. Smith, MD, PhD
Fox Chase Cancer Center
United States: Federal Government
|Fox Chase Cancer Center||Philadelphia, Pennsylvania 19111|