A Safety and Efficacy Study of R935788 in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA)
SOAR
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
1 other identifier
interventional
26
2 countries
36
Brief Summary
The purpose of this study is to evaluate whether fostamatinib is safe and effective in the treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jul 2016
Typical duration for phase_2
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2015
CompletedFirst Posted
Study publicly available on registry
November 24, 2015
CompletedStudy Start
First participant enrolled
July 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedJuly 21, 2021
July 1, 2021
3.4 years
November 19, 2015
July 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hemoglobin response
Hemoglobin level of \> 10 g/dL and 2 g/dL higher than the baseline hemoglobin
by Week 24
Study Arms (1)
Fostamatinib 150 mg
EXPERIMENTALFostamatinib 150 mg bid (morning and evening) over the course of 24 weeks
Interventions
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.
Eligibility Criteria
You may qualify if:
- Subject must have had a diagnosis of primary or secondary warm antibody AIHA.
- \- Must have failed at least 1 prior treatment regimen for AIHA.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
Arizona Oncology Associates, PC
Tucson, Arizona, 85711, United States
UC San Diego Moores Cancer Center
La Jolla, California, 92093, United States
Loma Linda University Cancer Center
Loma Linda, California, 92350, United States
LAC/USC Health Center
Los Angeles, California, 90033, United States
University of California at San Francisco
San Francisco, California, 94158, United States
The Oncology Institute of Hope and Innovation
Whittier, California, 90603, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
Mid-Florida Hematology & Oncology Centers, P.A.
Orange City, Florida, 32763, United States
Montgomery Cancer Center
Mount Sterling, Kentucky, 40353, United States
Johns Hopkins University School Of Medicine
Baltimore, Maryland, 21205, United States
Rcca Md Llc
Bethesda, Maryland, 20817, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
MidMichigan Health Cancer Center
Midland, Michigan, 48640, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08903, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Brody School of Medicine at East Carolina University
Greenville, North Carolina, 27834, United States
W.G. "Bill" Hefner VA Medical Center
Salisbury, North Carolina, 28144, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
Promedica Flower Hospital
Sylvania, Ohio, 43560, United States
M. Francisco Gonzalez, M.D., P.A.
Sumter, South Carolina, 29150, United States
Texas Oncology San Antonio Medical Center
San Antonio, Texas, 78240, United States
Clear Lake Specialties
Webster, Texas, 77598, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
University of Utah
Salt Lake City, Utah, 84132, United States
University of Washington
Seattle, Washington, 98105, United States
West Virginia University
Morgantown, West Virginia, 26506, United States
Froedtert Hospital
Milwaukee, Wisconsin, 53226, United States
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7, Canada
Hamilton Health Sciences- McMaster University Medical Centre
Hamilton, Ontario, L8N 3Z5, Canada
Victoria Hospital
London, Ontario, N6A 5W9, Canada
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
Jewish General Hospital
Montreal, Quebec, H3T IE2, Canada
Related Publications (1)
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.
PMID: 35179251DERIVED
Related Links
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Rigel Pharmaceuticals
Rigel Pharmaceuticals,Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2015
First Posted
November 24, 2015
Study Start
July 1, 2016
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
July 21, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share