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Histone Deacetylase Inhibitor

LBH589 for Myelofibrosis

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
Approved for 5 Other Conditions
No Placebo-Only Group
All Individual Drugs Already Approved

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
  • Myelofibrosis
  • Primary Myelofibrosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
Assess changes in biomarkers

Side effects data

From 2016 Phase 2 trial • 13 Patients • NCT01013597
23%
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

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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
1,635 Previous Clinical Trials
2,731,077 Total Patients Enrolled
Ronald HoffmanLead Sponsor
5 Previous Clinical Trials
376 Total Patients Enrolled
Ronald Hoffman, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
12 Previous Clinical Trials
602 Total Patients Enrolled
~1 spots leftby Nov 2025
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