Epirubicin and Rituximab in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
RATIONALE: Drugs used in chemotherapy such as epirubicin use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining epirubicin with rituximab may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combining epirubicin with rituximab in treating patients who have relapsed or refractory B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia.
|Leukemia Lymphoma||Biological: rituximab Drug: epirubicin hydrochloride||Phase 2|
|Study Design:||Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase II Study of Epirubicin and Rituximab in Relapsed and Refractory B-Cell Non-Hodgkin's Lymphoma and CLL|
|Study Start Date:||March 2003|
|Study Completion Date:||August 2005|
|Primary Completion Date:||August 2005 (Final data collection date for primary outcome measure)|
- 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 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00062296
|United States, Pennsylvania|
|Fox Chase Cancer Center|
|Philadelphia, Pennsylvania, United States, 19111|
|Study Chair:||Mitchell R. Smith, MD, PhD||Fox Chase Cancer Center|