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

Warm Antibody Autoimmune Hemolytic Anemia Clinical Trial

— SOAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02612558
• Other study ID #: C-935788-053
• Status: Completed
• Phase: Phase 2
• Start date: July 2016
• Est. completion date: December 2019

Study information

• Verified date: July 2021
• Source: Rigel Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Anemia, Hemolytic
• Anemia, Hemolytic, Autoimmune
• Hemolysis
• Warm Antibody Autoimmune Hemolytic Anemia

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	Hamilton Health Sciences- McMaster University Medical Centre	Hamilton	Ontario
Canada	Victoria Hospital	London	Ontario
Canada	Jewish General Hospital	Montreal	Quebec
Canada	St. Michael's Hospital	Toronto	Ontario
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	Montefiore Medical Center	Bronx	New York
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Banner MD Anderson Cancer Center	Gilbert	Arizona
United States	Brody School of Medicine at East Carolina University	Greenville	North Carolina
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	MidMichigan Health Cancer Center	Midland	Michigan
United States	Froedtert Hospital	Milwaukee	Wisconsin
United States	University of Minnesota	Minneapolis	Minnesota
United States	West Virginia University	Morgantown	West Virginia
United States	Montgomery Cancer Center	Mount Sterling	Kentucky
United States	Robert Wood Johnson University Hospital	New Brunswick	New Jersey
United States	Mid-Florida Hematology & Oncology Centers, P.A.	Orange City	Florida
United States	W.G. "Bill" Hefner VA Medical Center	Salisbury	North Carolina
United States	Huntsman Cancer Institute	Salt Lake City	Utah
United States	University of Utah	Salt Lake City	Utah
United States	Texas Oncology San Antonio Medical Center	San Antonio	Texas
United States	University of California at San Francisco	San Francisco	California
United States	University of Washington	Seattle	Washington
United States	M. Francisco Gonzalez, M.D., P.A.	Sumter	South Carolina
United States	Promedica Flower Hospital	Sylvania	Ohio
United States	Arizona Oncology Associates, PC	Tucson	Arizona
United States	MedStar Georgetown University Hospital	Washington	District of Columbia
United States	Clear Lake Specialties	Webster	Texas
United States	The Oncology Institute of Hope and Innovation	Whittier	California

Sponsors (1)

Lead Sponsor	Collaborator
Rigel Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin response	Hemoglobin level of > 10 g/dL and 2 g/dL higher than the baseline hemoglobin	by Week 24

External Links

•   www.aihastudy.com