Phase II Study to Establish Gene Expression Models Predicting Survival of Diffuse Large B-Cell Lymphoma Patients Treated With R-CHOP
- Determine a list of genes and construct a survival prediction model(s) that will
predict the overall survival at 30 months of patients with diffuse large B-cell
lymphoma treated with rituximab, cyclophosphamide, doxorubicin hydrochloride,
vincristine, and prednisone.
- Determine the usefulness of biomarkers associated with the antitumor effects of
rituximab (e.g., immunoglobulin G Fc receptor genotypes, CD20 protein expression, and
gene expression profiles) in predicting overall survival of patients treated with this
- Compare the ability of constructed survival models to predict survival of these
- Determine the ability of the models and/or biomarkers associated with the antitumor
effects of rituximab to predict 24-month time to treatment failure, defined as disease
progression, death, or initiation of new treatment.
- Determine the overall response rate (complete and partial response rate) at the end of
- Collect a series of fixed tissue samples with annotated clinical information and state
of the art therapy for future studies.
OUTLINE: This is a prospective study.
Patients receive rituximab IV over 4-8 hours, cyclophosphamide IV over 2 hours, doxorubicin
hydrochloride IV, and vincristine IV on day 1 and oral prednisone on days 1-5. Treatment
repeats every 21 days for up to 4 courses in the absence of disease progression or
unacceptable toxicity. Patients with responding disease after completion of course 4 receive
4 additional courses of therapy.
Paraffin-embedded tissue blocks and immunohistochemical slides are collected at baseline for
RNA-based gene array studies, real-time polymerase chain reaction gene expression studies,
polymorphism analysis, tissue-array immunohistochemical studies, and immunoglobulin G Fc
receptor genotypes determination.
After completion of study treatment, patients are followed every 3 months for 2 years, every
6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 213 patients will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall survival at 30 months
At study completion
Izidore S. Lossos, MD
University of Miami Sylvester Comprehensive Cancer Center
United States: Food and Drug Administration
|Stanford University||Stanford, California 94305|
|University of Miami Sylvester Comprehensive Cancer Center - Miami||Miami, Florida 33136|