Myeloproliferative Neoplasms Clinical Trial
A Phase 3 Study of Rusfertide in Patients With Polycythemia Vera
The study is designed to evaluate the safety and efficacy of rusfertide in subjects with polycythemia vera (PV) in maintaining hematocrit control and in improving symptoms of PV.
Phase 3 study in approximately 250 subjects previously diagnosed with polycythemia vera (PV) who require phlebotomy on a routine basis. There is a 32-week period during which rusfertide or placebo will be added-on to each subject's ongoing therapy for polycythemia vera which may include phlebotomy only or phlebotomy plus stable doses of either of hydroxyurea, interferon and/or ruxolitinib. All subjects who successfully complete the double blind 32-week portion of the study will receive rusfertide for 124 weeks.
Main Inclusion Criteria: All subjects must meet ALL of the following inclusion criteria to be enrolled. There are additional inclusion criteria.
Male and female subjects aged 18 (or the country specific minimum age of consent >18) years or older.
Meet revised 2016 World Health Organization (WHO) criteria for the diagnosis of polycythemia vera and have either JAK2 V617F mutation or JAK2 exon 12 mutation.
At least 3 phlebotomies due to inadequate hematocrit control in 6 months before randomization or at least 5 phlebotomies due to inadequate hematocrit control in 1 year before randomization.
CBC values immediately prior to randomization:
WBC 4000/μL to 20,000/μL (inclusive), and
Platelets 100,000/μL to 1,000,000/μL (inclusive)
Subjects receiving cytoreductive therapy at randomization must be on a stable PV therapy regimen.
Subjects treated with phlebotomy alone at randomization must have stopped cytoreductive therapy 2 to 6 months before screening.
Main Exclusion Criteria: Subjects must meet NONE of the following exclusion criteria to be enrolled. There are additional exclusion criteria.
Clinically meaningful laboratory abnormalities at Screening.
Subjects who require phlebotomy at hematocrit levels lower than 45%.
Clinically significant thrombosis (e.g., deep vein thrombosis or splenic vein thrombosis) within 2 months prior to randomization.
Active or chronic bleeding within 2 months prior to randomization.
History of invasive malignancies within the last 5 years, except localized cured prostate cancer and cervical cancer.
Subjects with non-invasive non-melanomatous (e.g., squamous cell or basal cell carcinoma) skin cancer during screening unless adequately treated before randomization.
Received Busulfan, Pipobroman or 32Phosphorus within 7 months prior to screening.
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There are 41 Locations for this study
Fresno California, 93720, United States
Greenbrae California, 94904, United States
La Jolla California, 92037, United States
Los Angeles California, 90095, United States
Palo Alto California, 94304, United States
Aurora Colorado, 80045, United States
Plantation Florida, 33322, United States
Tampa Florida, 33612, United States
Rolling Meadows Illinois, 60008, United States
Skokie Illinois, 60046, United States
Kansas City Kansas, 66160, United States
Bethesda Maryland, 20817, United States
Ann Arbor Michigan, 48109, United States
Reno Nevada, 89511, United States
New York New York, 10065, United States
Durham North Carolina, 27710, United States
Canton Ohio, 44718, United States
Portland Oregon, 97210, United States
Houston Texas, 77030, United States
Nedlands Perth, , Australia
Adelaide South Australia, 5000, Australia
Melbourne Victoria, 3004, Australia
Graz , 8036, Austria
Wels , 4600, Austria
Toronto Ontario, M5G 2, Canada
Brno , , Czechia
Olomouc , , Czechia
Praha , , Czechia
Angers Cedex 09, , France
Amiens , , France
Paris , 75010, France
Pierre-Bénite , , France
Aachen , 52074, Germany
Greifswald , 17489, Germany
Hong Kong , , Hong Kong
Budapest , 1085, Hungary
Debrecen , 4032, Hungary
Jerusalem , 12100, Israel
Jerusalem , 91031, Israel
Kfar Saba , 44281, Israel
Petach Tikva , 49100, Israel
Zerifin , 70300, Israel
Pavia , , Italy
Roma , 00168, Italy
Barcelona , 08036, Spain
Barcelona , 08916, Spain
Barcelona , 8003, Spain
Madrid , 28007, Spain
Madrid , , Spain
Valencia , 46026, Spain
Zaragoza , , Spain
Boston , PE21 , United Kingdom
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