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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
41
Placebo
Cedars Sinai Medical Center
Los Angeles, California, United States
University of California at Los Angeles
Los Angeles, California, United States
Georgia Health Sciences University Medical College of Georgia
Augusta, Georgia, United States
Northwestern University Oncology
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
Number of Participants With Adverse Events
Safety monitoring was conducted throughout the study.
Time frame: 23 months
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Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Mayo Clinic - Rochester Hematology/Oncology Dept.
Rochester, Minnesota, United States
Duke University Medical Center
Durham, North Carolina, United States
Medical University of South Carolina Oncology
Charleston, South Carolina, United States
...and 25 more locations