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Interferon

Ropeginterferon Alfa-2B for Myelofibrosis

Phase 2
Waitlist Available
Led By Jeanne Palmer
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No prior treatment for myelofibrosis (for cohort 1 only)
For cohort 1: early stage MF without currently available treatment options
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial looks at P1101 to treat patients with myelofibrosis. P1101 may help the body's natural response and slow the growth of myelofibrosis.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects for PEG-proline-interferon alpha-2b aren't listed here, similar drugs can cause flu-like symptoms, fatigue, mood changes or depression, irritation at injection site, and sometimes changes in blood counts leading to increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have not received any treatment for myelofibrosis.
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I have early stage mycosis fungoides with no treatment options left.
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My kidneys are functioning well.
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My spleen is enlarged due to myelofibrosis.
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I have intermediate-2 or high-risk myelofibrosis and cannot take or did not respond to ruxolitinib.
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I can take care of myself and am up and about more than half of my waking hours.
Select...
I have been diagnosed with myelofibrosis according to WHO standards.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Best overall response (CR, PR, or CI) as determined by International Working Group Criteria
Secondary outcome measures
Incidence of adverse events, as measured by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4)
Survival time
Other outcome measures
Changes in patient-reported symptoms and QOL as measured by MPN-SAF

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (PEG-proline-interferon alpha-2b)Experimental Treatment3 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.

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,242 Previous Clinical Trials
3,773,738 Total Patients Enrolled
7 Trials studying Primary Myelofibrosis
424 Patients Enrolled for Primary Myelofibrosis
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,352 Total Patients Enrolled
69 Trials studying Primary Myelofibrosis
6,830 Patients Enrolled for Primary Myelofibrosis
Jeanne PalmerPrincipal InvestigatorMayo Clinic

Media Library

Ropeginterferon Alfa-2B (Interferon) Clinical Trial Eligibility Overview. Trial Name: NCT02370329 — Phase 2
Primary Myelofibrosis Research Study Groups: Treatment (PEG-proline-interferon alpha-2b)
Primary Myelofibrosis Clinical Trial 2023: Ropeginterferon Alfa-2B Highlights & Side Effects. Trial Name: NCT02370329 — Phase 2
Ropeginterferon Alfa-2B (Interferon) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02370329 — Phase 2
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