Ropeginterferon + Ruxolitinib for Myelofibrosis

Overseen By Tsewang Tashi, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Utah

Must be taking: Ruxolitinib

Must not be taking: Investigational agents

Disqualifiers: Severe psychiatric disorders, Autoimmune disease, Organ transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this clinical trial is to learn if the study drug ropeginterferon alfa- 2b added to, standard of care, ruxolitinib is safe and effective in treating patients with Myelofibrosis.

Are You a Good Fit for This Trial?

Inclusion Criteria

Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines

I am willing to follow birth control and safe sex guidelines during the study.

I have a JAK2, CALR, or MPL gene mutation present in at least 20% of my cells.

Exclusion Criteria

My liver cirrhosis is classified as Child-Pugh B or C.

I do not have any serious, uncontrolled illnesses right now.

Receiving other investigational agents

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ropeginterferon alfa-2b added to standard of care ruxolitinib to assess safety and tolerability

24 weeks

Regular visits for monitoring adverse events and treatment response

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Periodic visits for long-term safety and efficacy assessment

What Are the Treatments Tested in This Trial?

Interventions

• Ropeginterferon Alfa-2b

How Is the Trial Designed?

Group I: Treatment: All Patients Experimental Treatment 2 Interventions

This study will investigate the safety and tolerability of ropeginterferon alfa- 2b added on to standard of care ruxolitinib.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

PharmaEssentia

Industry Sponsor

Trials

24

Recruited

2,800+