A Phase II Study of VDR (VELCADE™, DOXIL® and RITUXAN™) in Relapsed/Refractory Diffuse Large B-cell Lymphoma
- To determine the overall objective response rate (i.e., complete and partial response)
in patients with relapsed or refractory, CD20-positive, diffuse large B-cell lymphoma
treated with bortezomib, pegylated liposomal doxorubicin hydrochloride, and rituximab.
- To assess the toxicity/safety profile associated with this regimen.
- To conduct correlative translational research studies.
OUTLINE: Patients receive bortezomib IV on days 1, 4, 8, and 11, pegylated liposomal
doxorubicin hydrochloride IV on day 11, and rituximab IV on day 8. Treatment repeats every
21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Tissue and blood samples are collected periodically for correlative studies. Samples are
analyzed for expression of CD11b/CD18, CD32, CD 33, CD62, CD64, CD69, and CD56 by flow
cytometric analysis of neutrophils, NK cells, and monocytes; antibody-dependent cellular and
complement-mediated cytotoxicity; and genotypic analysis of polymorphisms by PCR. Autologous
neoplastic B-cells derived from tissue samples are used for genetic and protein profiling.
After completion of study therapy, patients are followed periodically for 4 years.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Antitumor efficacy in terms of overall, complete, and partial response rates and time to progression at weeks 9 and 21
at weeks 9 and 21
Myron S. Czuczman, MD
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|