A Safety and Efficacy Study of R935788 in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA)



Status:Active, not recruiting
Conditions:Anemia, Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:18 - Any
Updated:9/7/2018
Start Date:July 2016
End Date:June 2019

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Trial Summary
Trial Overview
Inclusion Criteria

A Phase 2, Multi-Center, Open Label, Simon Two-Stage Study to Evaluate the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia

The purpose of this study is to evaluate whether fostamatinib is safe and effective in the
treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA).


Inclusion Criteria:

Subject must have had a diagnosis of primary or secondary warm antibody AIHA.

- Must have failed at least 1 prior treatment regimen for AIHA.

Exclusion Criteria:

- Subject with cold antibody AIHA, cold agglutinin syndrome, mixed type AIHA, or
paroxysmal cold hemoglobinuria.

- 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.
We found this trial at
32
sites
Roswell Park Cancer Institute
666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Phone: 716-845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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Massachusetts General Hospital
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: David Kuter, MD
Phone: 617-726-8033
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Boston, MA
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Montefiore Medical Center
3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Principal Investigator: Irina Murakhovskaya, MD
Phone: 718-920-4137
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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Univ of Minnesota
Minneapolis, Minnesota 55455
(612) 625-5000
Phone: 612-625-6919
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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Minneapolis, MN
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University of Utah
201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Phone: 801-581-4220
University of Utah Research is a major component in the life of the U benefiting...
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Salt Lake City, UT
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Univ of Washington
Seattle, Washington 98104
(206) 543-2100
Phone: 206-685-4489
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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Seattle, WA
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Johns Hopkins University School of Medicine
733 North Broadway
Baltimore, Maryland 21205
(410) 955-3182
Phone: 410-550-1711
Johns Hopkins University School of Medicine Johns Hopkins Medicine (JHM), headquartered in Baltimore, Maryland, is...
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Rcca Md, Llc
Bethesda, Maryland 20817
Phone: 240-482-0526
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Bethesda, MD
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Cleveland Clinic Foundation
2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: Alan Lichtin, MD
Phone: 216-444-6823
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Cleveland, OH
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The Ohio State University, Wexner Medical Center
410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
Principal Investigator: Kerry Rogers, MD
Phone: 614-366-9338
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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Columbus, OH
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University of Alberta Hospital
Edmonton, Alberta
Phone: 780-407-6090
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Edmonton,
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Banner MD Anderson Cancer Center
Gilbert, Arizona 85234
Phone: 480-256-3333
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Gilbert, AZ
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Brody School of Medicine at East Carolina University
Greenville, North Carolina 27834
Principal Investigator: Darla Liles, MD
Phone: 252-744-0282
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Greenville, NC
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UC San Diego Moores Cancer Center
3855 Health Sciences Dr,
La Jolla, California 92093
(858) 822-6100
Principal Investigator: Michael Choi, MD
Phone: 858-534-1765
UC San Diego Moores Cancer Center Established in 1978, UC San Diego Moores Cancer Center...
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La Jolla, CA
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Loma Linda University Cancer Center
Loma Linda, California 92354
Phone: 909-558-4050
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Loma Linda, CA
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LAC/USC Health Center
Los Angeles, California 90033
Phone: 323-865-3000
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Los Angeles, CA
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MidMichigan Health Cancer Center
4000 Wellness Drive
Midland, Michigan 48640
Phone: 989-839-1716
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Midland, MI
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Froedtert Hospital
Milwaukee, Wisconsin 53226
Principal Investigator: Joshua Field, MD
Phone: 414-937-3848
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Milwaukee, WI
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West Virginia University
Morgantown, West Virginia 26506
(304) 293-0111
Phone: 740-293-4229
West Virginia University West Virginia University, founded in 1867, has a long and rich history...
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Montgomery Cancer Center
Mount Sterling, Kentucky 40353
Phone: 859-499-1000
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Mount Sterling, KY
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Robert Wood Johnson University Hospital
New Brunswick, New Jersey 08903
Phone: 732-235-7679
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New Brunswick, NJ
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Mid Florida Hematology and Oncology Centers
Orange City, Florida 32763
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Orange City, FL
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W.G. (Bill) Hefner VA Medical Center
Salisbury, North Carolina 28144
Principal Investigator: Elizabeth Agnew, MD
Phone: 704-638-9000
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Salisbury, NC
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Huntsman Cancer Institute
Salt Lake City, Utah 84112
Principal Investigator: George M Rodgers III, MD
Phone: 801-213-2016
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Salt Lake City, UT
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Texas Oncology - San Antonio Medical Center
San Antonio, Texas 78229
Principal Investigator: Roger Lyons, MD
Phone: 210-595-5626
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San Antonio, TX
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University of California at San Francisco
San Francisco, California 94143
Phone: 415-353-2421
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San Francisco, CA
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M. Francisco Gonzalez, MD, PA
Sumter, South Carolina 29150
Phone: 803-934-8348
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Sumter, SC
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Promedica Flower Hospital
5200 Harroun Road
Sylvania, Ohio 43560
Phone: 419-824-1011
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Sylvania, OH
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Arizona Oncology Associates
Tucson, Arizona 85745
Principal Investigator: Michael Boxer, MD
Phone: 520-866-0206
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Tucson, AZ
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MedStar Georgetown University Hospital
Washington, District of Columbia 20007
Principal Investigator: Catherine Broome, MD
Phone: 202-444-8240
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Clear Lake Specialties
Webster, Texas 77598
Phone: 281-724-8335
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The Oncology Institute of Hope and Innovation
Whittier, California 90606
Principal Investigator: Richy Agajanian, MD
Phone: 562-693-4477
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