Panobinostat (LBH589): Acute Graft Versus Host Disease (aGVHD) Prevention

PHASE2CompletedINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

March 4, 2016

Primary Completion Date

December 7, 2018

Study Completion Date

July 13, 2021

Conditions
Graft Versus Host DiseaseGVHD
Interventions
DRUG

Panobinostat

Panobinostat (PANO) will begin 5 days (Day -5) before transplant day (Day 0). All participants will take PANO by mouth once a day, three times a week (48 hours apart), every week for 26 weeks (approximately 6 months). PANO will be provided by Novartis as 5-mg pink gelatin capsules.

DRUG

Sirolimus

Sirolimus will be given the day before transplant and continued daily for at least one year. SIR will be administered starting on day -1 and thereafter. Dosing will be adjusted to maintain therapeutic targets per Moffitt institutional standards.

DRUG

Tacrolimus

Tacrolimus as an infusion or as a pill will begin 3 days before transplant (day -3) and following Moffitt institutional guidelines for dosing. Tacrolimus will be given for at least 50 days and participants will remain on Tacrolimus for as long as it is necessary per standard of care.

Trial Locations (1)

33612

H. Lee Moffitt Cancer Center and Research Institute, Tampa

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis

INDUSTRY

lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER