A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients with PV
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Male or female subjects aged ≥18 years at the time of signing the informed consent form
2. Subjects diagnosed with PV according to the 2008 or 2016 World Health Organization (WHO) criteria
3. Subjects with good liver function at screening, which is defined as total bilirubin ≤1.5 × upper limit of normal (ULN), international normalized ratio (INR) ≤1.5 × ULN, albumin \>3.5 g/dL, alanine aminotransferase (ALT) ≤2.0 × ULN, and aspartate aminotransferase (AST) ≤2.0 × ULN
4. Hemoglobin (HGB) ≥10 g/dL for females, and HGB ≥11 g/dL for males at screening
5. Neutrophil count ≥1.5 × 10\^9/L at screening
6. Creatinine clearance rate ≥40 mL/min at screening (according to the Cockcroft-Gault formula)
7. Males and females of childbearing potential, as well as all women \<2 years after the onset of menopause, must agree to use an acceptable form of birth control until 60 days following the last dose of the study drug, and females must agree to not breastfeed during the study
8. Written informed consent obtained from the subject and ability for the subject to comply with the requirements of the study
Exclusion Criteria:
1. Any contraindications to interferon alfa or hypersensitivity to interferon alfa
2. Subjects who stopped prior to interferon alfa therapy due to low efficacy or poor tolerability
3. Subjects with severe or serious diseases that the Investigator determines may affect the subject's participation in this study
4. History of major organ transplantation
5. Pregnant or breastfeeding women
6. Subjects with any other diseases that the Investigator determines will affect the study results or may weaken the compliance to protocol, including but not limited to:
1. Prior or current autoimmune thyroid disease (clinical symptoms of hyper- or hypo-thyroidism), except subjects with controlled thyroid replacement therapy, could be enrolled
2. Other documented autoimmune diseases (such as hepatitis, immune thrombocytopenia \[ITP\], scleroderma, psoriasis, or any autoimmune arthritis)
3. Clinically significant pulmonary infiltration, infectious pneumonia, and non-infectious pneumonia, or a past history of interstitial pneumonia at screening
4. Active infection with systemic manifestations (e.g., presence of bacteria, fungi, and/or human immunodeficiency virus \[HIV\] at screening, excluding hepatitis B \[HBV\] and/or hepatitis C \[HCV\] at screening)
5. Evidence of severe retinopathy (e.g., cytomegalovirus \[CMV\]-induced retinitis, macular degeneration) or clinically significant eye diseases (due to diabetes or hypertension)
6. History or presence of clinically relevant depression per Investigator's judgment
7. Previously had suicidal attempts or has any risk for suicidal tendency at screening
8. Poorly controlled diabetes defined as HbA1c \>8.0% for at least 1 year
9. Active thromboembolic complications caused by PV and abdominal hemorrhage in the active phase
10. History of any malignancy within 5 years (except adequately treated non-melanoma skin cancer, prostate cancer status post resection with an undetectable prostate-specific antigen (PSA), curative treated in-situ cancer of the cervix, ductal carcinoma in situ (DCIS) of the breast, Stage 1 Grade 1 endometrial carcinoma, or other solid tumors including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for ≥2 years prior to study)
11. History of alcohol or drug abuse in the past year
12. History or evidence of post-polycythemia vera-myelofibrosis (PPV-MF), essential thrombocythemia, or any non-PV MPN
13. Presence of blast cells in the peripheral blood in the past 12 weeks
7. Use any investigational drug \<4 weeks prior to the first dose of study drug, or not recovered from effects of prior administration of any investigational drug
8. Any subject requiring a legally authorized representative
Primary outcome measure(s)
Compare efficacy, safety, and tolerability of P1101 utilizing 250-350-500 mcg compared to the current labeled dosing through assessing the proportion of subjects that are in a complete hematologic response at Week 24. — 24 weeks CHR is defined as hematocrit (HCT) \<45%, white blood cell (WBC) count \<10 × 10\^9/L, platelets (PLT) ≤400 × 10\^9/L in the absence of phlebotomy in the previous 12 weeks.
Trial sites (23)
Facility
City
Region
Status
Baptist MD Anderson
Jacksonville
Florida
Fort Wayne Medical Oncology and Hematology
Fort Wayne
Indiana
University of Kansas Medical Center
Westwood
Kansas
Mercy Health
Paducah
Kentucky
Tulane University Medical Center
New Orleans
Louisiana
American Oncology Partners of Maryland PA (Center for Cancer & Blood Disorders)
Bethesda
Maryland
Washington University School of Medicine
St Louis
Missouri
Astera HealthCare
East Brunswick
New Jersey
Mount Sinai
New York
New York
Montefiore Medical Center
The Bronx
New York
University of North Carolina Lineberger Comprehensive Cancer Center
Chapel Hill
North Carolina
East Carolina University
Greenville
North Carolina
Wake Forest Baptist Medical Center
High Point
North Carolina
University of Tennessee Health Science Center
Memphis
Tennessee
MD Anderson
Houston
Texas
University of Utah
Salt Lake City
Utah
University of Virginia - Emily Couric Cancer Center
Charlottesville
Virginia
Tom Baker Cancer Centre
Calgary
Alberta
St. Paul's Hospital
Vancouver
British Columbia
Juravinski Cancer Center - Hamilton Health Sciences
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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