NCT02370329

P1101 in Treating Patients With Myelofibrosis

Phase II Study of P1101 in Early Myelofibrosis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot phase II trial studies P1101 (polyethyleneglycol \[PEG\]-proline-interferon alpha-2b) in treating patients with myelofibrosis. PEG-proline-interferon alpha-2b is a substance that can improve the body's natural response and may slow the growth of myelofibrosis.

Detailed description

PRIMARY OBJECTIVE: I. To evaluate for clinical response (complete remission \[CR\], partial remission \[PR\], or clinical improvement \[CI\]) as defined by International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) criteria in a cohort of intermediate-2/high risk myelofibrosis (MF) patients. Response in a second cohort of early stage MF patients will also be described. SECONDARY OBJECTIVES: I. To evaluate the adverse event profile of P1101 in patients with myelofibrosis by cohort (early vs intermediate-2/high risk). II. To evaluate the tolerability of P1101 in patients with myelofibrosis by cohort (early vs intermediate-2/high risk). EXPLORATORY AND CORRELATIVE RESEARCH OBJECTIVES: I. To evaluate quality of life (QOL) and patient-reported symptoms using the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) with P1101 for patients with myelofibrosis by cohort (early vs intermediate-2/high risk). II. To evaluate the impact of P1101 on bone marrow and histological features of myelofibrosis including cytogenetics, blast percentage, fibrosis, and JAK2-V617F allele burden by cohort (early vs intermediate-2/high risk). OUTLINE: Patients receive PEG-proline-interferon alpha-2b subcutaneously (SC) on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3-6 months for 3 years.

Conditions

• Primary Myelofibrosis
• Secondary Myelofibrosis

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Quality-of-Life Assessment	Ancillary studies
BIOLOGICAL	Ropeginterferon Alfa-2B	Given SC

Timeline

• Start date: 2015-08-12
• Primary completion: 2023-11-30
• Completion: 2023-11-30
• First posted: 2015-02-24
• Last updated: 2025-10-27
• Results posted: 2025-10-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study