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

Phase 2

Completed

• Conditions: Warm Antibody Autoimmune Hemolytic Anemia
• Interventions: Drug: Fostamatinib 150 mg bid

• Registration Number: NCT02612558
• Lead Sponsor: Rigel Pharmaceuticals

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-19
• Study First Submitted QC: 2015-11-19
• Study First Posted: 2015-11-24
• Study Start: 2016-07
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-19
• Last Update Posted: 2021-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Fostamatinib 150 mg	Fostamatinib 150 mg bid	Fostamatinib 150 mg bid (morning and evening) over the course of 24 weeks

Primary Outcome Measures

Name	Time	Method
Hemoglobin response	by Week 24	Hemoglobin level of \> 10 g/dL and 2 g/dL higher than the baseline hemoglobin

Trial Locations

Locations (36)

MidMichigan Health Cancer Center; 🇺🇸 Midland, Michigan, United States

Robert Wood Johnson University Hospital; 🇺🇸 New Brunswick, New Jersey, United States

Johns Hopkins University School Of Medicine; 🇺🇸 Baltimore, Maryland, United States

Mid-Florida Hematology & Oncology Centers, P.A.; 🇺🇸 Orange City, Florida, United States

Banner MD Anderson Cancer Center; 🇺🇸 Gilbert, Arizona, United States

M. Francisco Gonzalez, M.D., P.A.; 🇺🇸 Sumter, South Carolina, United States

Hamilton Health Sciences- McMaster University Medical Centre; 🇨🇦 Hamilton, Ontario, Canada

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

Montgomery Cancer Center; 🇺🇸 Mount Sterling, Kentucky, United States

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States

Brody School of Medicine at East Carolina University; 🇺🇸 Greenville, North Carolina, United States

Promedica Flower Hospital; 🇺🇸 Sylvania, Ohio, United States

Clear Lake Specialties; 🇺🇸 Webster, Texas, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

The Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States

W.G. "Bill" Hefner VA Medical Center; 🇺🇸 Salisbury, North Carolina, United States

The Oncology Institute of Hope and Innovation; 🇺🇸 Whittier, California, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Arizona Oncology Associates, PC; 🇺🇸 Tucson, Arizona, United States

University of Alberta Hospital; 🇨🇦 Edmonton, Alberta, Canada

Victoria Hospital; 🇨🇦 London, Ontario, Canada

Jewish General Hospital; 🇨🇦 Montreal, Quebec, Canada

West Virginia University; 🇺🇸 Morgantown, West Virginia, United States

MedStar Georgetown University Hospital; 🇺🇸 Washington, District of Columbia, United States

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

University of California at San Francisco; 🇺🇸 San Francisco, California, United States

Rcca Md Llc; 🇺🇸 Bethesda, Maryland, United States

University of Washington; 🇺🇸 Seattle, Washington, United States

Froedtert Hospital; 🇺🇸 Milwaukee, Wisconsin, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Texas Oncology San Antonio Medical Center; 🇺🇸 San Antonio, Texas, United States

Huntsman Cancer Institute; 🇺🇸 Salt Lake City, Utah, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States