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Histone Deacetylase (HDAC) Inhibitor

Ruxolitinib + Panobinostat for Myelofibrosis

Phase 4

Waitlist Available

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

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

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

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 years

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.

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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