Phase 2
Completed N=42
Panobinostat (LBH589): Acute Graft Versus Host Disease (aGVHD) Prevention
graft-versus-host disease · GVHD
Source: ClinicalTrials.gov NCT02588339 ↗
Enrolled (actual)
42
Serious AEs
30.8%
Results posted
Jan 2020
Primary outcomePrimary: Number of Participants Stratified by Acute Graft Versus Host Disease GVHD Stage — 6; 1 Participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Stratified by Acute Graft Versus Host Disease GVHD Stage |
6; 1 | — |
| SECONDARY Number of Participants Stratified by Chronic Graft Versus Host Disease (GVHD) Stage |
10; 2 | — |
| SECONDARY Time to Stable Engraftment |
15; 16 | — |
| SECONDARY Number of Participants With Primary Disease Relapse |
7 | — |
| SECONDARY Number of Participants With Non-relapse Mortality |
1 | — |
| SECONDARY Percentage of Participants With Overall Survival (OS) |
87 | — |
| SECONDARY Percentage of Participants With Relapse-free Survival (RFS) |
77 | — |
Eligibility Criteria
Inclusion Criteria
- Age ≥ 18 years or older at time of enrollment
- Signed informed consent
- Hematologic disorder requiring allogeneic hematopoietic cell transplantation
- Left ventricular ejection fraction (LVEF) ≥ 45% by multiple uptake gated acquisition (MUGA) scan or echocardiogram
- Forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and diffusing lung capacity oxygenation (DLCO) adjusted ≥ 50% of predicted values on pulmonary function tests
- Transaminases (AST, ALT) 4. Important modification to co-morbidity index calculation: DLCO adjusted will not be included in assessment of pulmonary risk, except those patients with DLCO adjusted 480 msec; Right bundle branch block + left anterior hemiblock (bifascicular block); Patients with myocardial infarction or unstable angina ≤ 12 months prior to starting study drug; Other clinically significant heart disease (e.g., New York Heart Association (NYHA) class III or IV , uncontrolled hypertension) as per discretion of principal investigator and/or treating physician; Patients using medications that have a relative risk of prolonging the QT interval or inducing torsade de pointes if treatment cannot be discontinued or switched to a different medication prior to starting study drug with the exception of drugs listed on Appendix B of study documents that are required for hematopoietic cell transplantation (HCT) patients.
Data sourced from ClinicalTrials.gov (NCT02588339). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.