Phase I Study of Panobinostat + Bortezomib for Relapsed and/or Refractory Mantle Cell Lymphoma (MCL) (BUS48T)
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|ClinicalTrials.gov Identifier: NCT01504776|
Recruitment Status : Completed
First Posted : January 5, 2012
Last Update Posted : September 19, 2014
|Condition or disease||Intervention/treatment||Phase|
|Mantle Cell Lymphoma||Drug: Panobinostat Drug: Bortezomib||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of Panobinostat in Combination With Bortezomib in the Treatment of Relapsed and/or Refractory Mantle Cell Lymphoma|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||September 2014|
Experimental: Open Label Drug Therapy
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
Other Name: LBH589Drug: Bortezomib
- Dose-Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD) [ Time Frame: 3 years ]To determine the DLTs and MTD of panobinostat given in combination with bortezomib.
- Observe the activity of the combination against Mantle Cell Lymphoma (MCL) in patients treated in this Phase I study. [ Time Frame: 3 years ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01504776
|United States, Georgia|
|Georgia Regents University|
|Augusta, Georgia, United States, 30912|
|Principal Investigator:||Anand Jillella, MD||Augusta University|