A Safety and Efficacy Study of R935788 in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA)
NCT ID: NCT02612558
Last Updated: 2021-07-21
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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COMPLETED
PHASE2
26 participants
INTERVENTIONAL
2016-07-31
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Fostamatinib 150 mg
Fostamatinib 150 mg bid (morning and evening) over the course of 24 weeks
Fostamatinib 150 mg bid
Fostamatinib 150 mg bid. The dose of Fostamatinib may be reduced at any time to as low as 100 mg PO once daily (qd) if dose limiting adverse events are observed.
Interventions
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Fostamatinib 150 mg bid
Fostamatinib 150 mg bid. The dose of Fostamatinib may be reduced at any time to as low as 100 mg PO once daily (qd) if dose limiting adverse events are observed.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
\- Must have failed at least 1 prior treatment regimen for AIHA.
Exclusion Criteria
* Subject with a platelet count of \< 30,000/μL.
* Subject has AIHA secondary to autoimmune disease, including systemic lupus erythematosis (SLE), or lymphoid malignancy and the underlying disease is not stable or is not well-controlled on current therapy.
* Subject has uncontrolled or poorly controlled hypertension, defined as systolic blood pressure ≥ 130 mmHg, or diastolic blood pressure ≥ 80 mmHg.
18 Years
ALL
No
Sponsors
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Rigel Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Rigel Pharmaceuticals
Role: STUDY_DIRECTOR
Rigel Pharmaceuticals,Inc.
Locations
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Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Arizona Oncology Associates, PC
Tucson, Arizona, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
Loma Linda University Cancer Center
Loma Linda, California, United States
LAC/USC Health Center
Los Angeles, California, United States
University of California at San Francisco
San Francisco, California, United States
The Oncology Institute of Hope and Innovation
Whittier, California, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Mid-Florida Hematology & Oncology Centers, P.A.
Orange City, Florida, United States
Montgomery Cancer Center
Mount Sterling, Kentucky, United States
Johns Hopkins University School Of Medicine
Baltimore, Maryland, United States
Rcca Md Llc
Bethesda, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
MidMichigan Health Cancer Center
Midland, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Brody School of Medicine at East Carolina University
Greenville, North Carolina, United States
W.G. "Bill" Hefner VA Medical Center
Salisbury, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Promedica Flower Hospital
Sylvania, Ohio, United States
M. Francisco Gonzalez, M.D., P.A.
Sumter, South Carolina, United States
Texas Oncology San Antonio Medical Center
San Antonio, Texas, United States
Clear Lake Specialties
Webster, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
University of Utah
Salt Lake City, Utah, United States
University of Washington
Seattle, Washington, United States
West Virginia University
Morgantown, West Virginia, United States
Froedtert Hospital
Milwaukee, Wisconsin, United States
University of Alberta Hospital
Edmonton, Alberta, Canada
Hamilton Health Sciences- McMaster University Medical Centre
Hamilton, Ontario, Canada
Victoria Hospital
London, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Countries
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References
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Kuter DJ, Rogers KA, Boxer MA, Choi M, Agajanian R, Arnold DM, Broome CM, Field JJ, Murakhovskaya I, Numerof R, Tong S. Fostamatinib for the treatment of warm antibody autoimmune hemolytic anemia: Phase 2, multicenter, open-label study. Am J Hematol. 2022 Jun 1;97(6):691-699. doi: 10.1002/ajh.26508. Epub 2022 Mar 3.
Related Links
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www.aihastudy.com
Other Identifiers
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C-935788-053
Identifier Type: -
Identifier Source: org_study_id
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