Conditions: Hodgkin's Lymphoma
Keywords: Phase III randomized double blind placebo controlled multi-center study panobinostat Hodgkin's lymphoma at risk for relapse autologous stem cell transplant
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 41
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Participants received 45 mg orally 3 times a week (TIW), every other week (QOW), arm 2: Participants received matching placebo to PAN TIW, QOW.

Interventions: intervention 1: Panobinostat intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: Placebo

Protocol document: