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



Status:Active, not recruiting
Conditions:Orthopedic, Hematology
Therapuetic Areas:Hematology, Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:4/4/2019
Start Date:February 23, 2016
End Date:December 2020

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A Phase II Trial Evaluating the Use of a Histone Deacetylase Inhibitor Panobinostat for Graft Versus Host Disease (GVHD) 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).


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) < 3 times upper limit of normal (ULN) values

- Creatinine clearance calculated ≥ 50 mL/min

- Karnofsky Performance Status Score ≥ 60%.

- Human leukocyte antigen (HLA) matched 8/8 (A, B, C, DRB1) related or unrelated donor

Exclusion Criteria:

- Active infection not controlled with appropriate antimicrobial therapy

- HIV, hepatitis B (HBcAb positive but HBsAg negative with undetectable viral load are
eligible), or hepatitis C infection

- Sorror's co-morbidity factors with total score > 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 < 50% who are excluded from
the trial.

- Anti-thymocyte globulin (ATG) as part of the conditioning regimen

- Cyclophosphamide as part of the conditioning regimen or for GVHD prophylaxis

- Pregnancy

- Histone deacetylase (HDAC), DAC, HSP90 inhibitors or valproic acid for the treatment
of cancer within 30 days

- Patients who will need valproic acid for any medical condition during the study or
within 5 days prior to first PANO treatment

- Impaired cardiac function or clinically significant cardiac diseases, including any
one of the following: Any history of ventricular fibrillation or torsade de pointes;
Bradycardia defined as heart rate (HR)< 45 bpm (Patients with pacemakers are eligible
if HR ≥ 45 bpm); Screening electrocardiogram (ECG) with a QTcF > 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.
We found this trial at
1
site
12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
Principal Investigator: Lia Perez, M.D.
Phone: 813-745-1218
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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mi
from
Tampa, FL
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