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The purpose of this study is to evaluate whether fostamatinib is safe and effective in the treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fostamatinib 150 mg | Experimental | Fostamatinib 150 mg bid (morning and evening) over the course of 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fostamatinib 150 mg bid | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin response | Hemoglobin level of > 10 g/dL and 2 g/dL higher than the baseline hemoglobin | by Week 24 |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Rigel Pharmaceuticals | Rigel Pharmaceuticals,Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner MD Anderson Cancer Center | Gilbert | Arizona | 85234 | United States | ||
| Arizona Oncology Associates, PC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35179251 | Derived | 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. |
| Label | URL |
|---|---|
| www.aihastudy.com | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 5, 2024 | |
| Reset | Apr 2, 2024 |
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|
| 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 D.C. | 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 |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | 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 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 5, 2024 | Apr 2, 2024 |
| ID | Term |
|---|---|
| C523665 | fostamatinib |
| C494814 | BID protein, human |
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