P1101 in Treating Patients With Myelofibrosis

NCT02370329 | Terminated Phase 2 Results DMC FDA Drug

• 3 other identifiers: MC138FNCI-2015-0018314-001548
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Primary Myelofibrosis; Secondary Myelofibrosis

Outcome Measures

Primary Outcomes (1)

• Best Overall Response (Complete Remission, Partial Remission, or Clinical Improvement) as Determined by International Working Group Criteria

  Patients will be assessed for response according to the Revised International Working Group for Myeloproliferative Neoplasms Research and Treatment criteria.

  Up to 3 years

Secondary Outcomes (2)

• Progression-free Survival Time

  Up to 3 years

• Number of Patients Experiencing a Grade 3+ Adverse Event, as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI CTCAE v4)

  Up to 3 years

Other Outcomes (1)

• Changes in Patient-reported Symptoms and QOL as Measured by MPN-SAF

  Baseline to up to 3 years

Study Arms (1)

Treatment (PEG-proline-interferon alpha-2b)

EXPERIMENTAL

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.

Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Biological: Ropeginterferon Alfa-2B

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (PEG-proline-interferon alpha-2b)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Treatment (PEG-proline-interferon alpha-2b)

Ropeginterferon Alfa-2B BIOLOGICAL

Given SC

Also known as: AOP2014, Besremi, P-1101, P1101, PEG-P-IFN-Alfa-2b, PEG-P-IFN-Alpha-2b, PEG-Proline-Interferon Alfa-2b

Treatment (PEG-proline-interferon alpha-2b)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Evaluable myelofibrosis by IWG-MRT criteria including one or more of the following:
• Spleen \>= 5 cm below the left costal margin
• MPN-SAF total symptom score (TSS) \> 10 at baseline
• Hemoglobin \< 10 g/dL
• Confirmed diagnosis of myelofibrosis (primary myelofibrosis or myelofibrosis secondary to essential thrombocythemia or polycythemia vera) by World Health Organization (WHO) diagnostic criteria (3 major and 2 minor criteria: major criteria: megakaryocyte proliferation and atypia with either reticulin and/or collagen fibrosis, not meeting criteria for chronic myelogenous leukemia \[CML\], polycythemia vera \[PV\], myelodysplastic syndrome \[MDS\], or other myeloid neoplasm, JAK2V617F or other clonal marker or no evidence of reactive marrow fibrosis; minor criteria: leukoerythroblastosis, increased lactate dehydrogenase \[LDH\], anemia, palpable splenomegaly)
• For cohort 1: early stage MF (low or intermediate 1 stage as defined by Dynamic International Prognostic Scoring System \[DIPSS\]) without currently available treatment options
• For cohort 2: intermediate-2 or high risk MF patients as defined by DIPSS either not eligible for ruxolitinib or having failed under ruxolitinib
• No prior treatment for myelofibrosis (for cohort 1 only)
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
• Platelet count \>= 100,000/mm\^3 (obtained =\< 14 days prior to registration)
• Absolute neutrophil count (ANC) \>= 1000/mm\^3 (obtained =\< 14 days prior to registration)
• Aspartate transaminase (AST) =\< 2.5 x upper limit of normal (ULN) (obtained =\< 14 days prior to registration)
• Alanine aminotransferase (ALT) =\< 2.5 x ULN (obtained =\< 14 days prior to registration)
• Calculated creatinine clearance must be \>= 50 ml/min using the Cockcroft-Gault formula (obtained =\< 14 days prior to registration)
• Negative pregnancy test done =\< 7 days prior to registration, for women of childbearing potential only

You may not qualify if:

• Patients who have had chemotherapy or radiation =\< 2 weeks of registration
• For cohort 1 only: patients with evidence of intermediate 2 or high risk disease (according to DIPSS)
• For cohort 1 only: patients with a bone marrow biopsy with \< 15% cellularity, evidence of collagen fibrosis, osteosclerosis, or blasts \> 10% in peripheral blood or marrow (demonstrating advanced disease)
• Patients who have received a prior stem cell transplant
• Patients who have received radiation to the spleen within 3 months prior to registration
• Patients with intolerance to compounds similar to pegylated interferon alpha-2b
• Patients with evidence of \>= grade 2 peripheral sensory neuropathy
• Any of the following:
• Pregnant women
• Nursing women
• Men or women of childbearing potential who are unwilling to employ adequate contraception
• Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
• Immunocompromised patients or patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy
• Uncontrolled simultaneous illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, history of depression, or psychiatric illness/social situations that would limit compliance with study requirements
• Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Primary Myelofibrosis

Interventions

peginterferon alfa-2b

Condition Hierarchy (Ancestors)

Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Jeanne M. Palmer, MD
• Organization: Mayo Clinic Arizona

palmer.jeanne@mayo.edu

480/342-8000

Study Officials

• Jeanne Palmer, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2015
• First Posted: February 24, 2015
• Study Start: August 12, 2015
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: October 27, 2025
• Results First Posted: October 27, 2025

Record last verified: 2024-09

Locations

US (1)