Spots Global Cancer Trial Database for A Single-arm, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of P1101 in Adults With ET
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Trial Identification
Brief Title: A Single-arm, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of P1101 in Adults With ET
Official Title: A Single-arm, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Ropeginterferon Alfa-2b-njft (P1101) in Adult Patients With Essential Thrombocythemia
Study ID: NCT05482971
Conditions
Interventions
Study Description
Brief Summary: A Single-arm, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Ropeginterferon alfa-2b-njft (P1101) in Adult Patients with Essential Thrombocythemia
Detailed Description: PharmaEssentia is developing a pegylated (PEG) IFN-α product, P1101, for the treatment of Essential Thrombocythemia (ET) as lack of disease modifying therapies in essential ET constitutes a serious issue in modern hematology. 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, 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, Saint 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
Montefiore Medical Center, Bronx, New York, 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
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
Contact Details
Name: Ray Urbanski, MD, PhD
Affiliation: PharmaEssentia USA Corporation
Role: STUDY_DIRECTOR
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