Myeloproliferative Neoplasms Clinical Trial

A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients With PV

Summary

A Phase IIIb, Single-Arm, Multicenter Study to Assess Efficacy, Safety, and Tolerability of Ropeginterferon alfa-2b-njft (P1101) in Adult Patients with Polycythemia Vera (PV)

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Full Description

Polycythemia vera (PV) is the most common type of chronic myeloproliferative neoplasm (MPN), with an annual reported incidence of up to 2.6/100,000. This is a long-term debilitating and life-threatening disease because it is associated with the risk of thrombosis, bleeding, and progression to myelofibrosis (MF) and secondary acute myeloid leukemia (sAML)

Ropeginterferon alfa-2b-njft (P1101), which gained US marketing authorization in November 2021, is the only interferon alfa approved for the treatment of PV.

This study aims to evaluate the efficacy, tolerability, and safety of ropeginterferon alfa-2b-njft (P1101) in US and Canadian PV patients, utilizing an optimized dosing regimen.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Male or female subjects aged ≥18 years at the time of signing the informed consent form
Subjects diagnosed with PV according to the 2008 or 2016 World Health Organization (WHO) criteria
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
Hemoglobin (HGB) ≥10 g/dL for females, and HGB ≥11 g/dL for males at screening
Neutrophil count ≥1.5 × 10^9/L at screening
Creatinine clearance rate ≥40 mL/min at screening (according to the Cockcroft-Gault formula)
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
Written informed consent obtained from the subject and ability for the subject to comply with the requirements of the study

Exclusion Criteria:

Any contraindications to interferon alfa or hypersensitivity to interferon alfa
Subjects who stopped prior to interferon alfa therapy due to low efficacy or poor tolerability
Subjects with severe or serious diseases that the Investigator determines may affect the subject's participation in this study
History of major organ transplantation
Pregnant or breastfeeding women

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:

Prior or current autoimmune thyroid disease (clinical symptoms of hyper- or hypo-thyroidism), except subjects with controlled thyroid replacement therapy, could be enrolled
Other documented autoimmune diseases (such as hepatitis, immune thrombocytopenia [ITP], scleroderma, psoriasis, or any autoimmune arthritis)
Clinically significant pulmonary infiltration, infectious pneumonia, and non-infectious pneumonia, or a past history of interstitial pneumonia at screening
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)
Evidence of severe retinopathy (e.g., cytomegalovirus [CMV]-induced retinitis, macular degeneration) or clinically significant eye diseases (due to diabetes or hypertension)
History or presence of clinically relevant depression per Investigator's judgment
Previously had suicidal attempts or has any risk for suicidal tendency at screening
Poorly controlled diabetes defined as HbA1c >8.0% for at least 1 year
Active thromboembolic complications caused by PV and abdominal hemorrhage in the active phase
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)
History of alcohol or drug abuse in the past year
History or evidence of post-polycythemia vera-myelofibrosis (PPV-MF), essential thrombocythemia, or any non-PV MPN
Presence of blast cells in the peripheral blood in the past 12 weeks
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
Any subject requiring a legally authorized representative

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 3

Estimated Enrollment:

100

Study ID:

NCT05481151

Recruitment Status:

Recruiting

Sponsor:

PharmaEssentia

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There are 19 Locations for this study

See Locations Near You

Baptist MD Anderson
Jacksonville Florida, 32207, United States More Info
Poonam Neki
Contact
[email protected]
Fort Wayne Medical Oncology and Hematology
Fort Wayne Indiana, 46804, United States More Info
Phil Hutson
Contact
260-312-2219
[email protected]
University of Kansas Medical Center
Westwood Kansas, 66205, United States More Info
Jacob Patterson
Contact
913-588-8693
[email protected]
Mercy Health
Paducah Kentucky, 42003, United States More Info
Barbie Warner
Contact
270-441-4343
[email protected]
Tulane University Medical Center
New Orleans Louisiana, 70112, United States More Info
American Oncology Partners of Maryland PA (Center for Cancer & Blood Disorders)
Bethesda Maryland, 20817, United States More Info
Delphine Thomas
Contact
301-571-2016
[email protected]
Washington University School of Medicine
Saint Louis Missouri, 63110, United States More Info
Karyn Gordon
Contact
314-362-0156
[email protected]
Astera HealthCare
East Brunswick New Jersey, 08816, United States More Info
Percy Yeung
Contact
732-387-3378
[email protected]
Montefiore Medical Center
Bronx New York, 10467, United States More Info
Noelle Townsend
Contact
718-430-2377
[email protected]
Mount Sinai
New York New York, 10029, United States More Info
Mikaela Dougherty
Contact
646-369-4578
[email protected]
University of North Carolina Lineberger Comprehensive Cancer Center
Chapel Hill North Carolina, 27599, United States More Info
Jewell Jessup, PhD
Contact
800-999-2449
[email protected]
East Carolina University
Greenville North Carolina, 27834, United States More Info
Denise Brigham
Contact
252-744-4924
[email protected]
Wake Forest Baptist Medical Center
High Point North Carolina, 27265, United States More Info
Mitchell Davidsz
Contact
[email protected]
University of Tennessee Health Science Center
Memphis Tennessee, 38103, United States More Info
Suzhen Gong
Contact
901-448-2234
[email protected]
MD Anderson
Houston Texas, 77030, United States More Info
Nichole Ard
Contact
713-745-4657
[email protected]
University of Utah
Salt Lake City Utah, 84131, United States More Info
Nicole Fisher
Contact
801-587-7604
[email protected]
University of Virginia - Emily Couric Cancer Center
Charlottesville Virginia, 22903, United States More Info
Cory Caldwell
Contact
434-297-4182
[email protected]
Tom Baker Cancer Centre
Calgary Alberta, , Canada More Info
Jewell Jessup, PhD
Contact
800-999-2449
[email protected]
St. Paul's Hospital
Vancouver British Columbia, , Canada More Info
Tathiana Ruiz
Contact
604-682-2344
[email protected]
Juravinski Cancer Center - Hamilton Health Sciences
Hamilton Ontario, , Canada More Info
Christopher Hillis, PhD
Contact
905-387-9495
[email protected]
The Ottawa Hospital
Ottawa Ontario, K1H 8, Canada More Info
Dana Maassen
Contact
613-737-8899
[email protected]
St. Michael's Hospital
Toronto Ontario, M5B 1, Canada More Info
Jewell Jessup, PhD
Contact
800-999-2449
[email protected]
Princess Margaret Hospital
Toronto Ontario, , Canada More Info
Jewell Jessup, PhD
Contact
1-800-999-2449
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 3

Estimated Enrollment:

100

Study ID:

NCT05481151

Recruitment Status:

Recruiting

Sponsor:


PharmaEssentia

How clear is this clinincal trial information?

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