NCT00992446

Bortezomib and Vorinostat as Maintenance Therapy After Autologous Stem Cell Transplant in Treating Patients With Non-Hodgkin Lymphoma

Bortezomib* and Vorinostat as Maintenance Therapy After Autologous Transplant for Non-Hodgkin Lymphoma Using R-BEAM or BEAM Conditioning Transplant Regimen

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Adult Diffuse Large B-Cell Lymphoma
• B-Cell Non-Hodgkin Lymphoma
• Follicular Lymphoma
• Mantle Cell Lymphoma
• Non-Hodgkin Lymphoma
• T-Cell Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
PROCEDURE	Autologous Hematopoietic Stem Cell Transplantation	Undergo ASCT
DRUG	Bortezomib	Given IV
DRUG	Carmustine	Given IV
DRUG	Cytarabine	Given IV
DRUG	Etoposide	Given IV
DRUG	Melphalan	Given IV
DRUG	Rituximab	Given IV
DRUG	Vorinostat	Given PO

Timeline

• Start date: 2010-09-02
• Primary completion: 2015-06-17
• Completion: 2019-10-29
• First posted: 2009-10-09
• Last updated: 2020-03-18
• Results posted: 2017-05-10

Locations

1 site across 1 country: United States