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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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States
Start Date
September 2, 2010
Primary Completion Date
June 17, 2015
Completion Date
October 29, 2019
Last Updated
March 18, 2020
27
ACTUAL participants
Autologous Hematopoietic Stem Cell Transplantation
PROCEDURE
Bortezomib
DRUG
Carmustine
DRUG
Cytarabine
DRUG
Etoposide
DRUG
Melphalan
DRUG
Rituximab
DRUG
Vorinostat
DRUG
Lead Sponsor
Fred Hutchinson Cancer Center
Collaborators
NCT06337318
NCT06189391
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05006716