Bortezomib and Vorinostat as Maintenance Therapy After Autologous Stem Cell Transplant in Treating Patients With Non-Hodgkin Lymphoma
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.
Adult Diffuse Large B-Cell Lymphoma
B-Cell Non-Hodgkin Lymphoma
Mantle Cell Lymphoma
T-Cell Non-Hodgkin Lymphoma
Procedure: Autologous Hematopoietic Stem Cell Transplantation
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Bortezomib* and Vorinostat as Maintenance Therapy After Autologous Transplant for Non-Hodgkin Lymphoma Using R-BEAM or BEAM Conditioning Transplant Regimen|
- Toxicity of maintenance therapy with bortezomib and vorinostat [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]Grade of toxicity will be per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 3.
- Time to disease progression [ Time Frame: Up to 3 years post-transplant ] [ Designated as safety issue: No ]
|Study Start Date:||December 2009|
|Estimated Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
Experimental: Treatment (chemotherapy, ASCT, bortezomib, vorinostat))
All patients receive carmustine IV over 3 hours on day -7; cytarabine IV 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 CD20+ 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 PO 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.
Other Name: MOAB IDEC-C2B8Drug: Carmustine
Other Name: FDA 0345Drug: Cytarabine
Other Names:Drug: Etoposide
Other Name: LastetDrug: Melphalan
Other Name: AlkeranDrug: Bortezomib
Given IVDrug: Vorinostat
Other Names:Procedure: Autologous Hematopoietic Stem Cell Transplantation
Other Name: Autologous Stem Cell Transplantation
I. Assess toxicities of combining vorinostat and bortezomib as maintenance therapy after autologous stem cell transplant (ASCT) for NHL.
I. Ability to complete planned therapy.
II. Time to disease progression, event-free survival.
III. Overall survival.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00992446
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Leona A. Holmberg 206-667-6447|
|Principal Investigator: Leona A. Holmberg|
|Principal Investigator:||Leona Holmberg||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|