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ACTIVE NOT RECRUITING

NCT06468033

PHASE3

P1101 in Treating Patients With Early PMF or Overt PMF at Low or Intermediate-1 Risk

Sponsor: PharmaEssentia

View on ClinicalTrials.gov

Summary

This is a phase 3 double-blind clinical trial arm to test Ropeginterferon alfa-2b (P1101) in adult patients with Primary Myelofibrosis (PMF) at early stage or low to medium risk. Participants will receive the study drug/placebo bi-weekly and have an assessment visit every 4 weeks. The ratio of study drug to placebo group is 2:1.

Official title: A Randomized, Double-Blind, Placebo-Controlled Multicenter Phase III Study to Assess Efficacy and Safety of Ropeginterferon Alfa-2b (P1101) in Adult Patients With Pre-fibrotic/Early Primary Myelofibrosis (PMF) or Overt PMF at Low or Intermediate-1 Risk According to DIPSS Plus (HOPE-PMF): The Core Study and Its Extension Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2025-07-18

Completion Date

2029-01-11

Last Updated

2026-08-13

Healthy Volunteers

Conditions

Primary Myelofibrosis Myeloproliferative Neoplasm

Interventions

BIOLOGICAL

Ropeginterferon alfa-2b

Pre-filled Syringe. Dosage: up to 500mcg

OTHER

Placebo

Placebo is a look-alike substance with the intervention (Ropeginterferon alfa-2b) that contains no active drug.

Inclusion Criteria: 1. Male or female patients aged ≥18 years at the time of signing the informed consent form; 2. Patients with pre-fibrotic/early PMF (Pre-PMF) or overt primary myelofibrosis at low to intermediate-1 risk according to DIPSS plus, diagnosed according to WHO 2016 or 2022 classification; 3. 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. Hgb ≥10.0 g/dL at screening; 5. Neutrophil count ≥1.0 × 10\^9/L at screening; 6. Creatinine clearance rate ≥30 mL/min at screening (according to the Cockcroft-Gault formula); 7. 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 known contraindications to interferon α or hypersensitivity to interferon α; 2. Patients with prior interferon therapy having poor tolerability or lack of efficacy to the previous interferon therapy per investigator\'s judgement; 3. Patients with an ongoing cytoreduction (e.g., HU or IFN-α) at the time of screening if, in the Investigator's opinion, randomizing them into the placebo arm will lead to immediate rebound increase of peripheral blood counts and thus may jeopardize their health status; 4. With severe or serious diseases that, in the Investigator's opinion, may affect the patient's participation in this study; 5. History of major organ transplantation; 6. Pregnant or breastfeeding women; 7. Patients with any other diseases that will affect the study results or may weaken the compliance to protocol per the Investigator's judgment; 8. 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. 9. Eligible for JAK inhibitor therapy at screening.

Locations (73)

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

University of Kansas Medical Center (KUMC)

Kansas City, Kansas, United States

American Oncology Partners of Maryland PA (Center for Cancer and Blood Disorders)

Bethesda, Maryland, United States

Washington University School of Medicine

St Louis, Missouri, United States

Weill Medical College of Cornell University

New York, New York, United States

Stony Brook University Medical Center

Stony Brook, New York, United States

Levine Cancer Institute

Charlotte, North Carolina, United States

Duke University

Durham, North Carolina, United States

Ohio State University

Columbus, Ohio, United States

MD Anderson Cancer Center

Houston, Texas, United States

Virginia Commonwealth University

Richmond, Virginia, United States

University of Washington Medical Center - Fred Hutchinson Cancer Center

Seattle, Washington, United States

St. Michael's Hospital

Toronto, Ontario, Canada

Princess Margaret Hospital

Toronto, Ontario, Canada

Jewish General Hospital

Montreal, Quebec, Canada

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Peking University People's Hospital

Beijing, Beijing Municipality, China

The Second Affiliated Hospital of AMU

Chongqing, Chongqing Municipality, China

Southern Hospital of Southern Medical University

Guangdong, Guangdong, China

Guangdong Provincial People's Hospital

Guangzhou, Guangzhou, China

Institute of Hematology and Oncology, Harbin The First Hospital

Harbin, Heilongjiang, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Union Hospital Tong Ji Medical College

Wuhan, Hubei, China

Jiangsu Provincial Hospital

Nanjing, Jiangsu, China

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Hematology Hospital of Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Queen Mary Hospital

Hong Kong, Hong Kong, Hong Kong

Kameda General Hospital

Kamogawa, Chiba, Japan

Ehime University Hospital

Matsuyama, Ehime, Japan

Hiroshima Red Cross & Atomic-Bomb Survivors Hospital

Hiroshima, Hiroshima, Japan

Iwate Prefectural Central Hospital

Morioka, Iwate, Japan

Shonan Kamakura General Hospital

Kamakura, Kanagawa, Japan

Mie University Hospital

Tsu, Mie-ken, Japan

University of Miyazaki Hospital

Miyazaki, Miyazaki, Japan

Kansai Medical University Hospital

Hirakata, Osaka, Japan

Osaka Metropolitan University Hospital

Osaka, Osaka, Japan

Juntendo University Shizuoka Hospital

Izunokuni, Shizuoka, Japan

Juntendo University Hospital

Tokyo, Tokyo, Japan

Nerima Hikarigaoka Hospital

Tokyo, Tokyo, Japan

Nippon Medical School Hospital

Tokyo, Tokyo, Japan

Tokyo Medical University Hospital

Tokyo, Tokyo, Japan

University of Yamanashi Hospital

Chūō, Yamanashi, Japan

King Hussein Cancer Center

Amman, Amman Governorate, Jordan

National University Hospital

Singapore, Singapore, Singapore

Parkway Cancer Center

Singapore, Singapore, Singapore

Singapore General Hospital

Singapore, Singapore, Singapore

Kyungpook National University Hospital

Daegu, Daegu, South Korea

Bundang Seoul National University Hospital

Seongnam-si, Gyeonggi-do, South Korea

Chonnam National University - Hwasun Hospital

Hwasun, Jeollanam-do, South Korea

Catholic University of Korea Seoul - St. Mary's Hospital

Seocho, Seoul, South Korea

Seoul National University Hospital

Seoul, Seoul, South Korea

Severance Hospital - Shinchon

Seoul, Seoul, South Korea

Samsung Medical Center

Seoul, Seoul, South Korea

Kaohsiung Veterans General Hospital

Kaohsiung City, Kaohsiung, Taiwan

Chang Gung Memorial Hospital - Keelung

Keelung, Keelung, Taiwan

China Medical University Hospital

Taichung, Taichung, Taiwan

Chi Mei Medical Center

Tainan, Tainan, Taiwan

Chi-Mei Hospital - Liouying Branch

Tainan, Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taipei, Taiwan

Mackay Memorial Hospital - Taipei

Taipei, Taipei, Taiwan

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taipei, Taiwan

Koo Foundation Sun Yat-Sen Cancer Center

Taipei, Taipei, Taiwan

Cheng Hsin General Hospital

Taipei, Taipei, Taiwan

Taipei Municipal Wan Fang Hospital

Taipei, Taipei, Taiwan

Chang Gung Memorial Hospital - Linkou

Taoyuan, Taoyuan, Taiwan

Chang Gung Memorial Hospital - Chiayi

Chiayi City, Taiwan

Clinical Research Directory

P1101 in Treating Patients With Early PMF or Overt PMF at Low or Intermediate-1 Risk

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (73)