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NCT02588339 · ClinicalTrials.gov registry record · Phase 2
Panobinostat (LBH589): Acute Graft Versus Host Disease (aGVHD) Prevention
A Phase 2 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 42
- Enrollment target
NCT02588339: Completed Phase 2 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT02588339 is a Phase 2 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 42 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02588339, a Phase 2 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 42 participants
- Enrollment target
Study 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).
Primary Outcome
Cumulative incidence of acute GVHD grades II-IV by day 100. Investigators will consider ≥43% incidence of grade II-IV aGVHD not acceptable. Investigators will use 23% incidence rate of GVHD as target. GVHD severity stage and grading and distribution will be measured weekly from day of transplant to day 90 +/- 14 using standard scoring system. Stage of GVHD will be given for each site of involvement (e.g. skin, liver, and gut), as well as a composite score for overall acute GVHD grade. Pathologic
Interventions
- DRUG Sirolimus
- DRUG Tacrolimus
- DRUG Panobinostat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2016-03-04 |
| Est. Completion | 2021-07-13 |
| Phase | Phase 2 |
What the finished NCT02588339 record still lists
NCT02588339 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 3 interventions - of which Sirolimus is the first listed.
NCT02588339 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02588339 about?
NCT02588339 is a clinical study titled "Panobinostat (LBH589): Acute Graft Versus Host Disease (aGVHD) Prevention". 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).
What is the current status of trial NCT02588339?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2016-03-04. Estimated completion is 2021-07-13.
What interventions are being tested in trial NCT02588339?
The interventions under investigation include: Sirolimus (DRUG), Tacrolimus (DRUG), Panobinostat (DRUG).
Who is sponsoring clinical trial NCT02588339?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02588339's enrollment target sits among peer trials
42 1339th of 2000 higher than 649 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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