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)

View Full Description

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
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 × 109/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 (see Appendix 4 for details)
Written informed consent obtained from the subject or legally authorized representative, 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
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 noninfectious pneumonia, or a past history of interstitial pneumonia at screening
Active infection with systemic manifestations (e.g., presence of bacteria, fungi, and human immunodeficiency virus [HIV] 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 h, Poorly controlled diabetes defined as HbA1c >8.0% for at least 1 year

i. Active thromboembolic complications caused by PV and abdominal hemorrhage in the active phase j. History of any malignancy within 5 years (except adequately treated non-melanoma skin cancer, prostate cancer status post resection with an undetectable prostatespecific 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) k. History of alcohol or drug abuse in the past year l. History or evidence of post-polycythemia vera-myelofibrosis (PPV-MF), essential thrombocythemia, or any non-PV MPN m. 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

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 17 Locations for this study

See Locations Near You

Baptist MD Anderson
Jacksonville Florida, 32207, United States More Info
Zachary Prutch
Contact
800-999-2449
[email protected]
University of Kansas Medical Center
Westwood Kansas, 66205, United States More Info
Zachary Prutch
Contact
800-999-2449
[email protected]
Mercy Health
Paducah Kentucky, 42003, United States More Info
Zachary Prutch
Contact
800-999-2449
[email protected]
Tulane University Medical Center
New Orleans Louisiana, 70112, United States More Info
Zachary Prutch
Contact
800-999-2449
[email protected]
American Oncology Partners of Maryland PA (Center for Cancer & Blood Disorders)
Bethesda Maryland, 20817, United States More Info
Zachary Prutch
Contact
800-999-2449
[email protected]
Washington University School of Medicine
Saint Louis Missouri, 63110, United States More Info
Zachary Prutch
Contact
800-999-2449
[email protected]
Astera HealthCare
East Brunswick New Jersey, 08816, United States More Info
Zachary Prutch
Contact
800-999-2449
[email protected]
Montefiore Medical Center
Bronx New York, 10467, United States More Info
Zachary Prutch
Contact
800-999-2449
[email protected]
Northwell Health
New Hyde Park New York, 11042, United States More Info
Zachary Prutch
Contact
800-999-2449
[email protected]
Mount Sinai
New York New York, 10029, United States More Info
Zachary Prutch
Contact
800-999-2449
[email protected]
East Carolina University
Greenville North Carolina, 27834, United States More Info
Zachary Prutch
Contact
800-999-2449
[email protected]com
Wake Forest Baptist Medical Center
High Point North Carolina, 27265, United States More Info
Zachary Prutch
Contact
800-999-2449
[email protected]
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States More Info
Zachary Prutch
Contact
800-999-2449
[email protected]
University of Tennessee Health Science Center
Memphis Tennessee, 38103, United States More Info
Zachary Prutch
Contact
800-999-2449
[email protected]
MD Anderson
Houston Texas, 77030, United States More Info
Zachary Prutch
Contact
800-999-2449
[email protected]
University of Utah
Salt Lake City Utah, 84131, United States More Info
Zachary Prutch
Contact
800-999-2449
[email protected]
University of Virginia - Emily Couric Cancer Center
Charlottesville Virginia, 22903, United States More Info
Zachary Prutch
Contact
800-999-2449
[email protected]
Tom Baker Cancer Centre
Calgary Alberta, , Canada More Info
St. Paul's Hospital
Vancouver British Columbia, , Canada More Info
Zachary Prutch
Contact
1-800-999-2449
[email protected]
Juravinski Cancer Centr - Hamilton Health Sciences
Hamilton Ontario, , Canada More Info
The Ottawa Hospital
Ottawa Ontario, , Canada More Info
Princess Margaret Hospital
Toronto Ontario, , Canada More Info
Zachary Prutch
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?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.