A Phase I Study of Panobinostat in Combination With Bortezomib in the Treatment of Relapsed and/or Refractory Mantle Cell Lymphoma

Status
Active
Cancer Type
Non-Hodgkin Lymphoma
Trial Phase
Phase I
Eligibility
18 and over, Male and Female
Study Type
Treatment
NCD ID
NCT01504776
Protocol IDs
CLBH589BUS48T (primary)
Study Sponsor
Anand P. Jillella, MD

Summary

The purpose of this study is to determine the safety and clinical efficacy of the combination of panobinostat plus bortezomib.

Objectives

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.