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

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

Sponsors

Lead Sponsor: Rigel Pharmaceuticals

Source 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).

Overall Status Active, not recruiting
Start Date July 2016
Completion Date March 2020
Primary Completion Date December 2019
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Hemoglobin response by Week 24
Enrollment 37
Condition
Intervention

Intervention Type: Drug

Intervention Name: Fostamatinib 150 mg bid

Description: 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.

Arm Group Label: Fostamatinib 150 mg

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Rigel Pharmaceuticals Study Director Rigel Pharmaceuticals, Inc.
Location
Facility:
Banner MD Anderson Cancer Center | Gilbert, Arizona, 85234, United States
Arizona Oncology Associates, PC | Tucson, Arizona, 85711, United States
UC San Diego Moores Cancer Center | La Jolla, California, 92093, United States
Loma Linda University Cancer Center | Loma Linda, California, 92350, United States
LAC/USC Health Center | Los Angeles, California, 90033, United States
University of California at San Francisco | San Francisco, California, 94158, United States
The Oncology Institute of Hope and Innovation | Whittier, California, 90603, United States
MedStar Georgetown University Hospital | Washington, District of Columbia, 20007, United States
Mid-Florida Hematology & Oncology Centers, P.A. | Orange City, Florida, 32763, United States
Montgomery Cancer Center | Mount Sterling, Kentucky, 40353, United States
Johns Hopkins University School Of Medicine | Baltimore, Maryland, 21205, United States
Rcca Md Llc | Bethesda, Maryland, 20817, United States
Massachusetts General Hospital | Boston, Massachusetts, 02114, United States
MidMichigan Health Cancer Center | Midland, Michigan, 48640, United States
University of Minnesota | Minneapolis, Minnesota, 55455, United States
Robert Wood Johnson University Hospital | New Brunswick, New Jersey, 08903, United States
Montefiore Medical Center | Bronx, New York, 10467, United States
Roswell Park Cancer Institute | Buffalo, New York, 14263, United States
Brody School of Medicine at East Carolina University | Greenville, North Carolina, 27834, United States
W.G. "Bill" Hefner VA Medical Center | Salisbury, North Carolina, 28144, United States
Cleveland Clinic Foundation | Cleveland, Ohio, 44195, United States
The Ohio State University Wexner Medical Center | Columbus, Ohio, 43210, United States
Promedica Flower Hospital | Sylvania, Ohio, 43560, United States
M. Francisco Gonzalez, M.D., P.A. | Sumter, South Carolina, 29150, United States
Texas Oncology San Antonio Medical Center | San Antonio, Texas, 78240, United States
Clear Lake Specialties | Webster, Texas, 77598, United States
Huntsman Cancer Institute | Salt Lake City, Utah, 84112, United States
University of Utah | Salt Lake City, Utah, 84132, United States
University of Washington | Seattle, Washington, 98105, United States
West Virginia University | Morgantown, West Virginia, 26506, United States
Froedtert Hospital | Milwaukee, Wisconsin, 53226, United States
University of Alberta Hospital | Edmonton, Alberta, T6G 2B7, Canada
Hamilton Health Sciences- McMaster University Medical Centre | Hamilton, Ontario, L8N 3Z5, Canada
Victoria Hospital | London, Ontario, N6A 5W9, Canada
St. Michael's Hospital | Toronto, Ontario, M5B 1W8, Canada
Jewish General Hospital | Montreal, Quebec, H3T IE2, Canada
Location Countries

Canada

United States

Verification Date

September 2019

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Fostamatinib 150 mg

Type: Experimental

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

Acronym SOAR
Patient Data No
Study Design Info

Intervention Model: Sequential Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov