NCT01034163

A Phase III Randomized, Double Blind, Placebo Controlled Multi-center Study of Panobinostat for Maintenance of Response in Patients With Hodgkin's Lymphoma (HL)

A Phase III Randomized, Double Blind, Placebo Controlled Multi-center Study of Panobinostat for Maintenance of Response in Patients With Hodgkin's Lymphoma Who Are at Risk for Relapse After High Dose Chemotherapy and Autologous Stem Cell Transplant (ASCT)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective was to provide drug to ongoing patients who were receiving panobinostat and to characterize the safety and tolerability of panobinostat in patients with HL after achieving a complete response following autologous hematopoietic stem cell transplant (AHSCT) with high dose chemotherapy (HDT). Primary objective as stated above reflects a change from the original protocol as of an amendment. The original objective was no longer feasible with only 41 of 367 patients randomized after the study was halted due to poor recruitment. An amendment was written to allow patients on panobinostat to continue their treatment until discontinuation/completion criteria were met (patients were unblinded). Therefore, the study was completed as per this amendment. No secondary objectives were included for this trial from the amendment; this was a change from the original protocol.

Conditions

• Hodgkin's Lymphoma

Interventions

Type	Name	Description
DRUG	Panobinostat
DRUG	Placebo	Placebo

Timeline

• Start date: 2010-06-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2009-12-17
• Last updated: 2016-07-07
• Results posted: 2016-07-07

Locations

35 sites across 14 countries: United States, Australia, Belgium, Brazil, Canada, France, Germany, Israel, Italy, Netherlands, New Zealand, Poland, Russia, Singapore