Mantle Cell Lymphoma Clinical Trial
Official title:
Bortezomib* and Vorinostat as Maintenance Therapy After Autologous Transplant for Non-Hodgkin Lymphoma Using R-BEAM or BEAM Conditioning Transplant Regimen
This phase II trial studies the side effects and how well bortezomib and vorinostat work in treating patients with non-Hodgkin lymphoma (NHL) after patients' own stem cell (autologous) transplant. Bortezomib and vorinostat in the laboratory may stop the growth of lymphoma cells and make them more likely to die by blocking some of the enzymes needed for cell growth. Giving bortezomib together with vorinostat after an autologous stem cell transplant may thus kill lymphoma cells that remain after transplant.
PRIMARY OBJECTIVES:
I. Assess toxicities of combining vorinostat and bortezomib as maintenance therapy after
autologous stem cell transplant (ASCT) for NHL.
SECONDARY OBJECTIVES:
I. Ability to complete planned therapy.
II. Time to disease progression, event-free survival.
III. Overall survival.
OUTLINE:
All patients receive carmustine intravenously (IV) over 3 hours on day -7; cytarabine IV
twice daily (BID) over 3 hours and etoposide IV BID over 2 hours on days -6 to -3; and
melphalan IV over 30 minutes on day -2. Only patients with history of cluster of
differentiation (CD)20+ NHL receive additional rituximab IV on days -19 and -12. Patients
undergo ASCT on day 0. Patients then receive bortezomib IV on days 2 and 8, and vorinostat
orally (PO) once daily (QD) on days 1-14. Treatment with bortezomib and vorinostat repeats
for total of 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for at least 2 years.
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