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Histone Deacetylase Inhibitor
LBH589 for Polycythemia Vera
Phase 1 & 2
Waitlist Available
Led By Ronald Hoffman, MD
Research Sponsored by Ronald Hoffman
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
LBH589 is an oral drug that targets the myelofibrosis cells in the bone marrow and induces cell death by allowing for the expression of certain suppressed genes that are important in regulating cell survival. Based on laboratory studies, the hypothesis is that this drug will selectively kill the stem cells responsible for causing myelofibrosis and result in reduction in spleen size and ultimately restoration of normal bone marrow function.
Eligible Conditions
- Polycythemia Vera
- Myelofibrosis
- Primary Myelofibrosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluation of treatment response by International Working Group for Myelofibrosis Research and Treatment (IWG-MRT)
To assess the safety and tolerability of oral LBH589 in patients with PMF, post-PV/ET MF
Secondary outcome measures
Assess changes in biomarkers
Side effects data
From 2016 Phase 2 trial • 13 Patients • NCT0101359723%
Death, NOS
8%
Colitis, infectious
8%
Neutrophils/granulocytes (ANC/AGC)
8%
Platelets
8%
Hemorrhage/bleeding
8%
CNS cerebrovascular ischemia
8%
Other
8%
Pleural effusion, non-malignant
8%
Thrombosis/thrombus/embolism
100%
80%
60%
40%
20%
0%
Study treatment Arm
LBH589
Trial Design
1Treatment groups
Experimental Treatment
Group I: LBH589Experimental Treatment1 Intervention
Dose escalation study starting at 20mg by mouth three times a week, given weekly for 24 weeks in the phase I portion of the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Panobinostat
FDA approved
Find a Location
Who is running the clinical trial?
NovartisIndustry Sponsor
1,611 Previous Clinical Trials
2,721,013 Total Patients Enrolled
5 Trials studying Polycythemia Vera
1,640 Patients Enrolled for Polycythemia Vera
Ronald HoffmanLead Sponsor
5 Previous Clinical Trials
376 Total Patients Enrolled
4 Trials studying Polycythemia Vera
363 Patients Enrolled for Polycythemia Vera
Ronald Hoffman, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
12 Previous Clinical Trials
602 Total Patients Enrolled
8 Trials studying Polycythemia Vera
461 Patients Enrolled for Polycythemia Vera
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