Clinical trial NCT02612558: A Safety and Efficacy Study of R935788 in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Warm Antibody Autoimmune Hemolytic Anemia
Keywords: Warm antibody autoimmune hemolytic anemia (AIHA)
Lead sponsor: Rigel Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-11-24
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Hemoglobin response
timeFrame: by Week 24
Secondary outcomes:
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Center
state: Arizona
city: Tucson
country: United States
facility: Arizona Oncology Associates, PC
state: Arizona
city: La Jolla
country: United States
facility: UC San Diego Moores Cancer Center
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Cancer Center
state: California
city: Los Angeles
country: United States
facility: LAC/USC Health Center
state: California
city: San Francisco
country: United States
facility: University of California at San Francisco
state: California
city: Whittier
country: United States
facility: The Oncology Institute of Hope and Innovation
state: California
city: Washington
country: United States
facility: MedStar Georgetown University Hospital
state: District of Columbia
city: Orange City
country: United States
facility: Mid-Florida Hematology & Oncology Centers, P.A.
state: Florida
city: Mount Sterling
country: United States
facility: Montgomery Cancer Center
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins University School Of Medicine
state: Maryland
city: Bethesda
country: United States
facility: Rcca Md Llc
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Midland
country: United States
facility: MidMichigan Health Cancer Center
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: New Brunswick
country: United States
facility: Robert Wood Johnson University Hospital
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Greenville
country: United States
facility: Brody School of Medicine at East Carolina University
state: North Carolina
city: Salisbury
country: United States
facility: W.G. "Bill" Hefner VA Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Sylvania
country: United States
facility: Promedica Flower Hospital
state: Ohio
city: Sumter
country: United States
facility: M. Francisco Gonzalez, M.D., P.A.
state: South Carolina
city: San Antonio
country: United States
facility: Texas Oncology San Antonio Medical Center
state: Texas
city: Webster
country: United States
facility: Clear Lake Specialties
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
city: Milwaukee
country: United States
facility: Froedtert Hospital
state: Wisconsin
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Hamilton
country: Canada
facility: Hamilton Health Sciences- McMaster University Medical Centre
state: Ontario
city: London
country: Canada
facility: Victoria Hospital
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
affiliation: Rigel Pharmaceuticals,Inc.
name: Rigel Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: 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.