The purpose of this study is to determine the safety and clinical efficacy of the combination of panobinostat plus bortezomib.
This is a phase I single arm, open label, multi-center (3 participating sites) dose escalation study of oral panobinostat administered Monday-Wednesday-Friday (MWF) weekly x 4 weeks, utilizing 3+3 dosing scheme (15, 20, 25 mg) in combination with a fixed dose of bortezomib 1.3 mg/m2 administered as a short intravenous (IV) infusion of 3-5 seconds every week x 4 weeks, representing one cycle. Each week, bortezomib will be administered IV prior to the oral dose of panobinostat. There will be sub-investigators participating in this study who will enroll at sub-sites.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Dose escalation study of oral panobinostat administered Monday-Wednesday-Friday (MWF) weekly x 4 weeks, utilizing 3+3 dosing scheme (15, 20, 25 mg) in combination with a fixed dose of bortezomib 1.3 mg/m2 administered as a short intravenous (IV)infusion of 3-5 seconds every week x 4 weeks, representing one cycle. Each week, bortezomib will be administered IV prior to the oral dose of panobinostat
Georgia Regents University
Augusta, Georgia, United States
Dose-Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD)
To determine the DLTs and MTD of panobinostat given in combination with bortezomib.
Time frame: 3 years
Observe the activity of the combination against Mantle Cell Lymphoma (MCL) in patients treated in this Phase I study.
Pre-treatment primary MCL cells derived from the bone marrow and/or peripheral blood of patients enrolled in this clinical trial will be isolated and treated ex vivo with panobinostat and/or bortezomib. IC50 values for each agent, as well as the combination indices values for the two agents will be determined and correlated with clinical response. Pre-treatment and 24 hour post-treatment primary MCL cells from patients who have circulating MCL cells in the peripheral blood will be isolated, as above.
Time frame: 3 years
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