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

Primary Purpose

Warm Antibody Autoimmune Hemolytic Anemia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Fostamatinib 150 mg bid
Sponsored by
Rigel Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Warm Antibody Autoimmune Hemolytic Anemia focused on measuring Warm antibody autoimmune hemolytic anemia (AIHA)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Banner MD Anderson Cancer Center
  • Arizona Oncology Associates, PC
  • UC San Diego Moores Cancer Center
  • Loma Linda University Cancer Center
  • LAC/USC Health Center
  • University of California at San Francisco
  • The Oncology Institute of Hope and Innovation
  • MedStar Georgetown University Hospital
  • Mid-Florida Hematology & Oncology Centers, P.A.
  • Montgomery Cancer Center
  • Johns Hopkins University School Of Medicine
  • Rcca Md Llc
  • Massachusetts General Hospital
  • MidMichigan Health Cancer Center
  • University of Minnesota
  • Robert Wood Johnson University Hospital
  • Montefiore Medical Center
  • Roswell Park Cancer Institute
  • Brody School of Medicine at East Carolina University
  • W.G. "Bill" Hefner VA Medical Center
  • Cleveland Clinic Foundation
  • The Ohio State University Wexner Medical Center
  • Promedica Flower Hospital
  • M. Francisco Gonzalez, M.D., P.A.
  • Texas Oncology San Antonio Medical Center
  • Clear Lake Specialties
  • Huntsman Cancer Institute
  • University of Utah
  • University of Washington
  • West Virginia University
  • Froedtert Hospital
  • University of Alberta Hospital
  • Hamilton Health Sciences- McMaster University Medical Centre
  • Victoria Hospital
  • St. Michael's Hospital
  • Jewish General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fostamatinib 150 mg

Arm Description

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

Outcomes

Primary Outcome Measures

Hemoglobin response
Hemoglobin level of > 10 g/dL and 2 g/dL higher than the baseline hemoglobin

Secondary Outcome Measures

Full Information

First Posted
November 19, 2015
Last Updated
July 19, 2021
Sponsor
Rigel Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02612558
Brief Title
A Safety and Efficacy Study of R935788 in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA)
Acronym
SOAR
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

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rigel Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Warm Antibody Autoimmune Hemolytic Anemia
Keywords
Warm antibody autoimmune hemolytic anemia (AIHA)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fostamatinib 150 mg
Arm Type
Experimental
Arm Description
Fostamatinib 150 mg bid (morning and evening) over the course of 24 weeks
Intervention Type
Drug
Intervention Name(s)
Fostamatinib 150 mg bid
Other Intervention Name(s)
R935788, R788, Fostamatinib, Tavalisse
Intervention 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.
Primary Outcome Measure Information:
Title
Hemoglobin response
Description
Hemoglobin level of > 10 g/dL and 2 g/dL higher than the baseline hemoglobin
Time Frame
by Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rigel Pharmaceuticals
Organizational Affiliation
Rigel Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Banner MD Anderson Cancer Center
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Facility Name
Arizona Oncology Associates, PC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Facility Name
UC San Diego Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Loma Linda University Cancer Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92350
Country
United States
Facility Name
LAC/USC Health Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of California at San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
The Oncology Institute of Hope and Innovation
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
MedStar Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Mid-Florida Hematology & Oncology Centers, P.A.
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Facility Name
Montgomery Cancer Center
City
Mount Sterling
State/Province
Kentucky
ZIP/Postal Code
40353
Country
United States
Facility Name
Johns Hopkins University School Of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Rcca Md Llc
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
MidMichigan Health Cancer Center
City
Midland
State/Province
Michigan
ZIP/Postal Code
48640
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Robert Wood Johnson University Hospital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Brody School of Medicine at East Carolina University
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
W.G. "Bill" Hefner VA Medical Center
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Promedica Flower Hospital
City
Sylvania
State/Province
Ohio
ZIP/Postal Code
43560
Country
United States
Facility Name
M. Francisco Gonzalez, M.D., P.A.
City
Sumter
State/Province
South Carolina
ZIP/Postal Code
29150
Country
United States
Facility Name
Texas Oncology San Antonio Medical Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Clear Lake Specialties
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Froedtert Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Hamilton Health Sciences- McMaster University Medical Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
Victoria Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T IE2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35179251
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.
Results Reference
derived
Links:
URL
http://www.aihastudy.com
Description
www.aihastudy.com

Learn more about this trial

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

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