A Phase I/II Trial of Vorinostat (SAHA) (NSC-701852) in Combination with Rituximab-CHOP in Patients with Newly Diagnosed Advanced Stage Diffuse Large B-Cell Lymphoma (DLBCL)
What is the purpose of this trial?
This study will be conducted in two phases:
To find a safe dose of vorinostat to be used in combination with R-CHOP (vorinostat-RCHOP).
To estimate the 2-year progression-free survival rate in patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) treated with vorinostat and R-CHOP therapy (vorinostat-R-CHOP).
To estimate the response rate (complete and partial) and 2-year overall survival rate.
To evaluate the toxicity of vorinostat-R-CHOP in patients with newly diagnosed DLBCL.
To assess whether pre-treatment acetylation status of histones, expression of MHC Class II genes, and/or percentage of CD8+ tumor infiltrating lymphocytes (TIL) correlate with progression-free survival.
To explore whether treatment with vorinostat-R-CHOP increases histone acetylation, alters expression of MHC class II proteins, or alters percentage of T-cell subsets (CD8+, CD4+, FOXP3+) or infiltrating macrophages.
To explore whether histone acetylation status of tumor tissues correlates with MHC class II expression of peripheral blood B cells and lymphocyte subsets.
To explore whether the change in systemic levels of immune cytokines with vorinostat-RCHOP correlates with lymphoma symptoms, response, progression-free or overall survival.
- 18 Years and older
- Southwestern Oncology Group (SWOG)
- August 2012
- Last Updated:
- Study HIC#:
Clinicaltrials.gov ID: Yale6605449