A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of wAIHA

Completed · Phase 3 · Has a placebo group

Conditions studied: Warm Antibody Autoimmune Hemolytic Anemia

In brief

The primary objective of this study is to assess the efficacy of fostamatinib in subjects with warm antibody autoimmune hemolytic anemia (wAIHA).

Key facts

Study ID

NCT03764618

Run by

Rigel Pharmaceuticals

People needed

90

Starts

2019-04-24

Expected to finish

2022-04-11

Last updated by the study team

2023-05-25

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject must have a diagnosis of primary or secondary warm Antibody Autoimmune Hemolytic Anemia (wAIHA) as documented by a positive direct antiglobulin test (DAT) specific for anti-IgG or anti-IgA.
• Have failed or not tolerated at least one prior wAIHA treatment regimen, including steroids, rituximab, azathioprine, cyclophosphamide, cyclosporine, MMF, danazol, vincristine, ESA or splenectomy (folate, iron or other supplements do not fulfill this criterion).
• Have haptoglobin <LLN or total bilirubin >ULN or lactate dehydrogenase (LDH) >ULN.
• At screening, subject's hemoglobin level must be ≤9 g/dL OR if hemoglobin value >9 g/dL and <10 g/dL, subject must be on an allowed wAIHA treatment AND the subject must have documented symptoms related to anemia (e.g., weakness, dizziness, fatigue, shortness of breath, chest pain).
• Karnofsky performance status (KPS) ≥70.
• Subject's concurrent treatment for wAIHA may consist of no more than two of any of the following agents: azathioprine, steroids, ESAs, mycophenolate mofetil, dapsone or danazol at a stable dose

You may not qualify if…

• Subject with other types of Antibody Autoimmune Hemolytic Anemia (AIHA) (e.g., cold antibody AIHA, cold agglutinin syndrome, mixed type AIHA, or paroxysmal cold hemoglobinuria).
• Subject has AIHA secondary to autoimmune disease, including systemic lupus erythematosus (SLE), or lymphoid malignancy if the underlying disease is not stable or is not well-controlled on current therapy, per investigator medical judgement.
• Subject has uncontrolled or poorly controlled hypertension, defined as systolic blood pressure ≥135 mmHg or diastolic blood pressure ≥85 mmHg, whether or not the subject is receiving anti-hypertensive treatment.
• Subject has one or more of the following laboratory abnormalities at screening: neutrophil count of <1,000/μL or platelet count of <30,000/μL, unless due to Evans syndrome; transaminase levels (i.e., alanine aminotransferase [ALT] or aspartate aminotransferase [AST]) >1.5 x ULN.
• Has documented active hepatitis B or hepatitis C infection or HIV infection.

Where it is running

• Mayo Clinic Hospital — Phoenix, Arizona, United States
• Arizona Oncology Associates, PC--HOPE Division — Tucson, Arizona, United States
• Moores UC San Diego Cancer Center — La Jolla, California, United States
• University of Southern California — Los Angeles, California, United States
• Harbor UCLA - Lundquist Institute — Torrance, California, United States
• The Oncology Institute of Hope and Innovation — Whittier, California, United States
• Banner MD Anderson Cancer Center at North Colorado Medical Center — Greeley, Colorado, United States
• Georgetown University - Lombardi Comprehensive Cancer Center — Washington D.C., District of Columbia, United States
• Cancer Specialists of North Florida — Jacksonville, Florida, United States
• Piedmont Cancer Institute — Atlanta, Georgia, United States
• Affiliated Oncologists — Chicago Ridge, Illinois, United States
• John Hopkins Bayview Medical Center — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
• Rutgers - Robert Wood Johnson Medical School — New Brunswick, New Jersey, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Duke Cancer Network — Clayton, North Carolina, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Texas Oncology - Baylor Research Institute — Dallas, Texas, United States
• Clear Lake Specialties, Research Dept. — Webster, Texas, United States
• American Oncology Network Vista Oncology Division — Olympia, Washington, United States
• Swedish Cancer Institute — Seattle, Washington, United States
• University of Washington — Seattle, Washington, United States
• Versiti Wisconsin, Inc. — Milwaukee, Wisconsin, United States
• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

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