A Phase I/II Pilot Study of the Safety and Efficacy of Rituxan (Chimeric Anti-CD20 Antibody) in Combination With Doxil (Liposomal Doxorubicin) Chemotherapy in Patients With Relapsing or Refractory Indolent or Aggressive B-Cell Lymphoma
- Determine the safety, including qualitative and quantitative toxic effects and their
duration and reversibility, of rituximab and doxorubicin HCl liposome in patients with
relapsed or refractory, indolent or aggressive CD20-positive B-cell non-Hodgkin's
- Determine the efficacy, including overall response rate and durability of objective
response, of this regimen in these patients.
- Correlate pretreatment functional, phenotypic, and genotypic characteristics of host
immune effector cells with response in patients treated with this regimen.
OUTLINE: This is an open-label, pilot study.
Patients receive rituximab IV over 3-8 hours on day 1 and doxorubicin HCl liposome IV over
1-3 hours on day 3. Treatment repeats every 21 days for 6 courses in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 4 years.
PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete response rate at 20 weeks
Myron S. Czuczman, MD
Roswell Park Cancer Institute
United States: Institutional Review Board
|Roswell Park Cancer Institute||Buffalo, New York 14263|