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

Completed · Phase 2

Conditions studied: Warm Antibody Autoimmune Hemolytic Anemia

In brief

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

Key facts

Study ID

NCT02612558

Run by

Rigel Pharmaceuticals

People needed

26

Starts

2016-07-01

Expected to finish

2019-12-01

Last updated by the study team

2021-07-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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