A Single-arm, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of P1101 in Adults With ET
NCT ID: NCT05482971
Last Updated: 2025-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
91 participants
INTERVENTIONAL
2022-09-29
2027-03-31
Brief Summary
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Detailed Description
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Ropeginterferon alfa-2b-njft (P1101) may represent an effective, well-tolerated treatment with the ability to provide a deeper response and superior control of important blood parameters with the potential to alter the course of the disease and prevent progression to post-ET myelofibrosis (MF) and/or secondary acute myeloid leukemia (sAML). Ropeginterferon alfa-2b-njft (P1101) is currently being evaluated in comparison to ANA in the ongoing global Phase 3 clinical study, SURPASS ET.
Enrolled patients will receive P1101 over 13 months followed by an extension period.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ropeginterferon alfa-2b (P1101)
Pre-filled Syringe, Q2W, SC injection
Ropeginterferon alfa-2b-njft (P1101)
Ropeginterferon alfa-2b-njft (P1101)
Interventions
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Ropeginterferon alfa-2b-njft (P1101)
Ropeginterferon alfa-2b-njft (P1101)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subjects diagnosed with ET according to the World Health Organization (WHO) 2016 criteria.
3. Subjects that are cytoreductive treatment-naïve, or pre-exposed to HU and/or ANA, as specified below (according to Investigator's judgment and documented in the patient's medical record):
a. Cytoreductive-naïve patients must be in need of cytoreductive treatment, defined as having at least one of the following:
i. Progressive leukocytosis and/or thrombocytosis
ii. Disease-related symptoms (i.e., pruritus, night sweats, fatigue)
iii. Vasomotor/microvascular disturbances, not responsive to aspirin (including headache, chest pain or erythromelalgia, etc.)
iv. High-risk (history of thrombosis at any age; or age \>60 years with JAK2 mutation)
b. Patients previously exposed to HU will be classified as either:
i. Documented formal HU resistance or intolerance
ii. HU stopped without documented formal resistance/intolerance due to insufficient blood count control or toxicity. The last HU dose must be \>7 days prior the first dose of P1101.
4. Adequate hepatic function defined as bilirubin ≤1.5 × upper limit normal (ULN), prothrombin time (PT) (international normalized ratio, \[INR\]) ≤1.5 x ULN, albumin \>3.5 g/dL, alanine aminotransferase (ALT) ≤2.0 x ULN, aspartate aminotransferase ≤2.0 x ULN at screening.
5. Creatinine clearance ≥40 mL/min (by Cockcroft-Gault equation).
6. 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.
7. Written informed consent obtained from the subject and ability for the subject to comply with the requirements of the study.
8. Platelet count \>450 × 109/L at screening
9. Both ANA-naïve and ANA-pretreated subjects are eligible for the study, regardless of the reason to terminate ANA use
Exclusion Criteria
2. Subjects who stopped prior interferon alfa therapy due to low efficacy or poor tolerability
3. Any contraindications or hypersensitivity to IFN-α and/or its excipients
4. Co-morbidity with severe or serious condition that, in the Investigator's opinion, would jeopardize the safety of the subject or their compliance with the protocol, including significant cardiac disease (including New York Heart Association Class III-IV congestive heart failure and clinically significant arrhythmias) and pulmonary hypertension
5. History of major organ transplantation
6. Pregnant or lactating females
7. Subjects with any significant medical conditions that, in the opinion of the Investigator, would compromise the results of the study or may impair compliance with the requirements of the protocol, including but not limited to:
1. Documented autoimmune disease at screening or in the history (e.g., thyroid dysfunction, hepatitis, idiopathic thrombocytopenic purpura, scleroderma, psoriasis, or any arthritis of autoimmune origin)
2. Clinically relevant pulmonary infiltrates, pneumonia, and pneumonitis at screening that, in the Investigator's opinion, would jeopardize the safety of the subject or their compliance with the protocol
3. Infections with systemic manifestations (e.g., bacterial, fungal, or human immunodeficiency virus \[HIV\], except hepatitis B \[HBV\] and/or hepatitis C \[HCV\],at screening)
4. Evidence of severe retinopathy (e.g., cytomegalovirus retinitis \[CMV\], macular degeneration) or clinically relevant ophthalmological disorder (due to diabetes mellitus or hypertension)
5. History or presence of clinically relevant depression
6. Previous suicide attempts or at any risk of suicide at screening, in the judgment of the Investigator
7. History or presence of clinically significant neurologic diseases
8. History of any malignancy within 5 years (except adequately treated nonmelanoma 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)
9. History of alcohol or drug abuse within the last year
10. History or evidence of any other MPN
8. Use of any investigational drug \<4 weeks prior to the first dose of study drug or not recovered from effects of prior administration of any investigational agent
9. Presence of more than one driver mutation (e.g., V617F JAK2 and CALR, CALR and MPL, V617F JAK2 and MPL)
10. Prior use of JAK inhibitors
18 Years
ALL
No
Sponsors
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PharmaEssentia
INDUSTRY
Responsible Party
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Principal Investigators
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Oleh Zagrijtschuk, MD, PhD
Role: STUDY_DIRECTOR
PharmaEssentia Corporation
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
City of Hope National Medical Center
Duarte, California, United States
Marin Cancer Care
Greenbrae, California, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Yale University School of Medicine - Yale Cancer Center
New Haven, Connecticut, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
The Winship Cancer Institute Emory University
Atlanta, Georgia, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States
Mercy Health - Paducah Medical Oncology and Hematology
Paducah, Kentucky, United States
Tulane University Medical Center
New Orleans, Louisiana, United States
Greater Baltimore Medical Center
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Washington University School of Medicine - Division of Oncology
St Louis, Missouri, United States
Cancer Care Specialists
Reno, Nevada, United States
Astera HealthCare
East Brunswick, New Jersey, United States
John Theurer Cancer Center At Hackensack UMC
Hackensack, New Jersey, United States
Weill Medical College of Cornell University
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
University of North Carolina (UNC) - Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
East Carolina University
Greenville, North Carolina, United States
Regional Medical Oncology Center
Wilson, North Carolina, United States
University of Tennessee Health Science Center
Memphis, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
University of Virginia - Emily Couric Cancer Center
Charlottesville, Virginia, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
University of Calgary Tom Baker Cancer Centre
Calgary, Alberta, Canada
St. Paul's Hospital - Providence Health Care
Vancouver, British Columbia, Canada
Juravinski Cancer Centre
Hamilton, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Countries
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References
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Masarova L, Reeves BN, El Chaer F, Foltz L, Tashi T, Abu-Zeinah G, Lucas J, Halpern AB, Maze D, Qin A, Safah H, Lan F, O'Connell CL, Goel S, Rein L, Fang B, How J, Babu S, Li Z, Cerquozzi S, Oh ST, Hunter AM, Podoltsev N, Vachhani P, Yacoub A, Cunningham JM, Hillis C, Otoukesh S, Zagrijtschuk O, Castro H, Bose P. A multicenter study to assess efficacy, safety, and tolerability of ropeginterferon alfa-2b-njft in patients with essential thrombocythemia in the US and Canada: EXCEED-ET trial. Front Med (Lausanne). 2025 Apr 17;12:1548590. doi: 10.3389/fmed.2025.1548590. eCollection 2025.
Other Identifiers
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EXCEED ET / A22-301
Identifier Type: -
Identifier Source: org_study_id
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