CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 42 enrolled
Drug / intervention
Panobinostat +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02588339
NCT02588339Phase 2Completed
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A Phase II Trial Evaluating the Use of a Histone Deacetylase Inhibitor Panobinostat for Graft Versus Host Disease (GVHD) Prevention

H. Lee Moffitt Cancer Center and Research Institute·interventional·Posted Oct 27, 2015·Updated Jul 21, 2021

In Brief

A Phase 2 clinical trial evaluating Panobinostat, Sirolimus, and 1 other intervention for Graft Versus Host Disease and GVHD. Completed, enrolled 42 participants across 1 site.

Detailed Summary

This study will test PANO in combination with tacrolimus/sirolimus (TAC/SIR) for acute GVHD prevention. The purpose of this study is to determine if Panobinostat (PANO) when used in combination with sirolimus and tacrolimus will help reduce the incidence of Graft-vs-host disease (GVHD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGraft Versus Host Disease, GVHD
CountriesUnited States
CollaboratorsNovartis

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 27, 2015
Enrollment StartMar 4, 2016
Primary CompletionDec 7, 2018
Study CompletionJul 13, 2021
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 10.7 years ago

Interventions

Panobinostatdrug

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.

Sirolimusdrug

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.

Tacrolimusdrug

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.