Phase
Condition
Leukemia (Pediatric)
Bone Marrow Disorder
Red Blood Cell Disorders
Treatment
sapablursen
Clinical Study ID
Ages 18-90 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria
Meet modified World Health Organization (WHO) 2016 diagnostic criteria for polycythemia vera (PV) at the time of clinical diagnosis
Participant must be phlebotomy dependent.
Participants do not need to be on cytoreductive therapy and do not need to have been previously treated with cytoreductive therapy. If the patient was previously on cytoreductive therapy it must have been discontinued at least 3 months prior to Screening, with all associated AEs resolved. If the patient is currently on cytoreductive therapy they must be on a stable dose of hydroxyurea, recombinant or PEGylated interferon, or ruxolitinib for at least 3 months prior to Screening.
Exclusion Criteria
Meets criteria for post-polycythemia vera myelofibrosis (PPV-MF) as defined by the International Working Group- Myeloproliferative Neoplasms Research and Treatment (IWG-MRT)
Moderate to severe splenic pain or spleen-related organ obstruction
Active or chronic bleeding within 1 month of Screening, significant concurrent/recent coagulopathy, history of immune thrombocytopenic purpura (ITP)
Known primary or secondary immunodeficiency
Active infection with human immunodeficiency virus (HIV), hepatitis C, or hepatitis B.
Active infection requiring systemic antiviral or antimicrobial therapy or active novel coronavirus disease (Covid-19) infection
Malignancy within 5 years, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or non-metastatic prostate cancer that has been successfully treated
Surgery requiring general anesthesia within 1 month prior to Screening
Study Design
Study Description
Connect with a study center
Blacktown Hospital
Blacktown, New South Wales 2148
AustraliaSite Not Available
St. George Hospital
Kogarah, New South Wales 2217
AustraliaSite Not Available
Calvary Mater Newcastle Hospital
Waratah, New South Wales 2298
AustraliaSite Not Available
Border Medical Oncology Research Unit
Albury, 2640
AustraliaSite Not Available
Box Hill Hospital
Box Hill, 3128
AustraliaSite Not Available
The Perth Blood Institute
West Perth, 6005
AustraliaSite Not Available
McGill University Health Centre
Montreal, Quebec H4A 3J1
CanadaSite Not Available
Semmelweis Egyetem Belgyógyászati és Hematológiai Klinika
Budapest, 1088
HungarySite Not Available
Debreceni Egyetem Klinikai Központ
Debrecen, 4032
HungarySite Not Available
Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie, Klinika Hematoonkologii i Transplantacji Szpiku
Lublin, 20-081
PolandSite Not Available
Szpital Wojewódzki w Opolu
Opole, 45-064
PolandSite Not Available
Wojewódzki Szpital Specjalistyczny Sp. z o.o.
Słupsk, 76-200
PolandSite Not Available
MICS Centrum Medyczne Toruń
Toruń, 87-100
PolandSite Not Available
Lincoln County Hospital
Lincoln, England LN2 5QY
United KingdomSite Not Available
United Lincolnshire Hospitals NHS Trust
Lincoln, England LN2 5QY
United KingdomSite Not Available
Oxford University Hospitals NHS Foundation Trust
Oxford, England OX37LE
United KingdomSite Not Available
University College London Hospitals NHS Foundation Trust
London, NW1 2PG
United KingdomSite Not Available
Sandwell and West Birmingham Hospitals NHS Trust
West Bromwich, B71 4HJ
United KingdomSite Not Available
O'Neal Comprehensive Cancer Center University of Alabama at Birmingham
Birmingham, Alabama 35249
United StatesSite Not Available
Mayo Clinic Hospital
Phoenix, Arizona 85054
United StatesSite Not Available
PCR Oncology
Arroyo Grande, California 93420
United StatesSite Not Available
UCLA Health - Beverly Hills Cancer Care
Beverly Hills, California 90212
United StatesSite Not Available
UCLA Health - Burbank Cancer Care
Burbank, California 91505
United StatesSite Not Available
City of Hope National Medical Center
Duarte, California 91010
United StatesSite Not Available
Norris Comprehensive Cancer Center
Los Angeles, California 91011
United StatesSite Not Available
UCLA
Los Angeles, California 90095
United StatesSite Not Available
University of California Irvine
Orange, California 92868
United StatesSite Not Available
UCLA Health - Pasadena Cancer Care
Pasadena, California 91105
United StatesSite Not Available
UCLA Health -Westlake Village Cancer Care
Westlake Village, California 91361
United StatesSite Not Available
Innovative Clinical Research Institute
Whittier, California 90603
United StatesSite Not Available
Medstar Georgetown University Hospital
Washington, District of Columbia 20007
United StatesSite Not Available
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesSite Not Available
Summit Medical Group
Florham Park, New Jersey 07932
United StatesSite Not Available
John Theurer Cancer Center
Hackensack, New Jersey 07601
United StatesSite Not Available
Herbert Irving Comprehensive Cancer Center
New York, New York 10032
United StatesActive - Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United StatesSite Not Available
Atrium Health Levine Cancer Institute
Charlotte, North Carolina 28204
United StatesSite Not Available
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina 27157
United StatesSite Not Available
Gabrail Cancer Center Research
Canton, Ohio 44718
United StatesSite Not Available
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United StatesSite Not Available
University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
Mays Cancer Center
San Antonio, Texas 78229
United StatesSite Not Available
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United StatesSite Not Available
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