Phase II Trial of Bortezomib and Vorinostat in Mantle Cell and Diffuse Large B-Cell Lymphomas
I. To estimate the response rates of patients with recurrent mantle cell lymphoma or
recurrent and/or refractory diffuse large B-cell lymphoma treated with combination therapy
comprising bortezomib and vorinostat.
I. To assess the safety and tolerability of this regimen in these patients. II. To observe
progression-free survival and response duration in patients treated with this regimen.
III. To observe the relationship between pretreatment lymphoma cell nuclear relA and
response in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to prior autologous
stem cell transplantation (yes vs no).
Patients receive oral vorinostat once daily on days 1-5 and 8-12. Patients also receive
bortezomib IV on days 1, 4, 8, and 11. Treatment repeats every 3 weeks in the absence of
disease progression, unacceptable toxicity, or requirement for palliative irradiation.
Patients who experience a complete or partial response after at least 1 year of study
therapy may discontinue treatment while remaining on study and then resume treatment at the
time of disease progression.
Archival or recent biopsy tissue specimens are obtained at baseline for laboratory
correlative studies. Samples are analyzed by IHC for expression of Rel A protein as a
predictive marker of response.
After completion of study therapy, patients are followed periodically.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rates (complete and partial response)
Response will be assessed according to the Revised Response Criteria for Malignant Lymphoma.
From baseline to at lease every 12 weeks
H. Lee Moffitt Cancer Center and Research Institute
United States: Food and Drug Administration
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|
|Weill Medical College of Cornell University||New York, New York 10021|
|Vanderbilt University||Nashville, Tennessee 37232-6305|
|University of North Carolina||Chapel Hill, North Carolina 27599|
|Virginia Commonwealth University||Richmond, Virginia|