Ropeginterferon Alfa-2B for Myelofibrosis

Overseen by Jeanne Palmer, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Mayo Clinic

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This study is evaluating whether a substance can improve the body's natural response to myelofibrosis.

Research Team

Jeanne Palmer, M.D.

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for patients with myelofibrosis who have symptoms like anemia and enlarged spleen, and are in different stages of the disease. Some should not have had treatment before, while others may have tried a drug called ruxolitinib without success. Participants need to be relatively healthy otherwise, able to answer questions about their health, and willing to provide blood samples.

Inclusion Criteria

ANC >= 1000/mm^3

I have not received any treatment for myelofibrosis.

I have early stage mycosis fungoides with no treatment options left.

Exclusion Criteria

Uncontrolled simultaneous illness

Receiving any other investigational agent for the primary neoplasm

I am in cohort 1 and have a high or intermediate-2 risk disease.

Treatment Details

Interventions

• Ropeginterferon Alfa-2B (Interferon)

Trial Overview The trial is testing P1101 (PEG-proline-interferon alpha-2b), which might help the body fight myelofibrosis better by slowing its growth. The study includes tests on how this treatment affects patients' quality of life and tracks changes through lab biomarker analysis.

Participant Groups

Group I: Treatment (PEG-proline-interferon alpha-2b) Experimental Treatment 3 Interventions

Patients receive PEG-proline-interferon alpha-2b SC on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+