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PI3K Inhibitor

Parsaclisib + Ruxolitinib for Myelofibrosis

Phase 3
Waitlist Available
Research Sponsored by Incyte Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have you ever been treated with ruxolitinib?
Are you currently taking ruxolitinib?
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 36 months
Awards & highlights

Study Summary

This trial will test if adding parsaclisib to ruxolitinib can help people with myelofibrosis who haven't responded well to ruxolitinib alone.

Eligible Conditions
  • Myelofibrosis
  • Primary Myelofibrosis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have received ruxolitinib treatment in the past.
Select...
You are not currently taking ruxolitinib.
Select...
You have been diagnosed with Myelofibrosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of participants achieving targeted reduction in spleen volume
Secondary outcome measures
Change in TSS
Duration of maintenance of targeted reduction in spleen volume
Number of Treatment Emergent Adverse Events (TEAE)
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group A : ruxolitinib +parsaclisibExperimental Treatment2 Interventions
Participants will receive parsaclisib starting from Day 1 for the duration of study, while continuing to receive the stable dose of ruxolitinib they were taking for the 8 weeks prior to Day 1.
Group II: Group B : ruxolitinib + placeboPlacebo Group2 Interventions
Participants will receive placebo starting from Day 1 for the duration of study, while continuing to receive the stable dose of ruxolitinib they were taking for the 8 weeks prior to Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
parsaclisib
2021
Completed Phase 2
~120
ruxolitinib
2017
Completed Phase 3
~600

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor
364 Previous Clinical Trials
54,988 Total Patients Enrolled
Albert Assad, M.D.Study DirectorIncyte Corporation
1 Previous Clinical Trials
55 Total Patients Enrolled

Media Library

Parsaclisib (PI3K Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04551053 — Phase 3
Myelofibrosis Research Study Groups: Group A : ruxolitinib +parsaclisib, Group B : ruxolitinib + placebo
Myelofibrosis Clinical Trial 2023: Parsaclisib Highlights & Side Effects. Trial Name: NCT04551053 — Phase 3
Parsaclisib (PI3K Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04551053 — Phase 3
Myelofibrosis Patient Testimony for trial: Trial Name: NCT04551053 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you provide some other examples of scientific research that has been done on parsaclisib?

"Parsaclisib was originally studied in 2002 at the National Institutes of Health Clinical Center. So far, there have been 2783 completed studies. There are presently 114 actively recruiting studies, with a large number of these trials being performed out of Morristown, New jersey."

Answered by AI

How many medical institutions are conducting this research project?

"There are 46 sites operating for this trial, including Morristown Medical Center in Morristown, Duke Cancer Center in Durham, Augusta University Medical College in Augusta, and other locations."

Answered by AI

Could you please highlight any potential dangers of parsaclisib?

"There is some evidence from prior clinical trials to support the efficacy of parsaclisib, as well as data confirming its safety. Consequently, we have rated parsaclisib a 3 on our scale."

Answered by AI

Why is parsaclisib a popular medication?

"Parsaclisib, while commonly used to treat polycythemia vera, can also be an effective intervention for patients struggling with hydroxyurea resistance or intolerance, as well as primary myelofibrosis."

Answered by AI

Who else is applying?

What state do they live in?
New York
Other
Kansas
Texas
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
University of Kansas Hospital Authority
Texas Oncology - Medical City Dallas
California Research Institute
Other

Why did patients apply to this trial?

I may be mistaken but I applied as I understood that my info was to pair me up with appropriate trials.
PatientReceived 2+ prior treatments

How responsive is this trial?

Most responsive sites:
  1. University of Kansas Hospital Authority: < 48 hours
Average response time
  • < 2 Days
Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
To Evaluate Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis Who Have Suboptimal Response to Ruxolitinib (LIMBER-304)
2021. "To Evaluate Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis Who Have Suboptimal Response to Ruxolitinib (LIMBER-304)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04551053.
~46 spots leftby Apr 2025
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