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Histone Deacetylase (HDAC) Inhibitor

Ruxolitinib + Panobinostat for Myelofibrosis

Phase 4
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient is currently enrolled in a Novartis GDD or GMA-sponsored or Incyte-sponsored clinical study, are receiving either ruxolitinib or combination of ruxolitinib and panobinostat, and fulfilled all of the requirements of the parent protocol.
Patient currently has no evidence of progressive disease, as determined by the investigator, following previous treatment with ruxolitinib or combination of ruxolitinib and panobinostat
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 years
Awards & highlights

Summary

This trial is looking at the safety of long-term treatment with ruxolitinib alone or in combination with panobinostat in patients who have previously participated in a study sponsored by Novart

Who is the study for?
This trial is for patients already enrolled in a Novartis or Incyte-sponsored study, receiving ruxolitinib alone or with panobinostat, and benefiting from it without progressive disease. They must have met all prior study requirements and shown compliance.
What is being tested?
The trial continues the use of ruxolitinib, either alone or combined with panobinostat, to assess long-term safety in treating conditions like Polycythemia Vera and Acute Myeloid Leukemia among others.
What are the potential side effects?
Possible side effects include low blood counts leading to increased infection risk, bleeding problems, dizziness, headache and fatigue. Panobinostat may add further risks such as diarrhea and heart issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am currently in a Novartis or Incyte study and meet all its requirements.
Select...
My condition hasn't worsened after treatment with ruxolitinib or its combination with panobinostat.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence and severity of AEs and SAEs
Secondary study objectives
Incidence and severity of AEs and SAEs by treatment group
Proportion of participants with clinical benefit as assessed by the investigator at scheduled visits.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Ruxolitinib monotherapy or ruxolitinib plus panobinostat in combinationExperimental Treatment2 Interventions
All participants will receive either ruxolitinib monotherapy or ruxolitinib in combination with panobinostat, at the same dose/schedule that they were taking in the parent study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ruxolitinib
2017
Completed Phase 3
~660
panobinostat
2011
Completed Phase 2
~550

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,889 Previous Clinical Trials
4,201,648 Total Patients Enrolled
19 Trials studying Primary Myelofibrosis
5,788 Patients Enrolled for Primary Myelofibrosis
~83 spots leftby Sep 2027
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