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met minimum enrollment goal, however, enrollment was slow due to the pandemic, therefore, the study was terminated
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Evaluate patient characteristics, treatment patterns, clinical outcomes and safety of fostamatinib as second-line therapy in real-world clinical practice, for the treatment of ITP in adult patients who have an insufficient response to prior therapy (steroids ± immunoglobulins).
Evaluate patient characteristics, treatment patterns, clinical outcomes and safety of fostamatinib as second-line therapy in real-world clinical practice, for the treatment of ITP in adult patients who have an insufficient response to prior therapy (steroids ± immunoglobulins).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Initiating treatment with fostamatinib as second-line therapy |
| ||
| Treated with fostamatinib for at least 12 weeks as second-line therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fostamatinib | Drug | Fostamatinib disodium |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fostamatinib dosing | Changes in fostamatinib dosing | 12-month observation period |
| Platelet counts over time during the course of fostamatinib therapy | Platelet count and change from baseline in platelet count over time. | 12-month observation period |
| Use of concomitant medications related to ITP | Use of concomitant medications related to ITP during the study. | 12-month observation period |
| Use of ITP Rescue Medication | The number of patients with ITP rescue medication use at any time during the study. | 12-month observation period |
| Safety of fostamatinib | Evaluate continued safety of fostamatinib in ITP patients through adverse events | 12-month observation period |
| ITP-PAQ Quality of life measure | Use of the score from questionnaire to assess disease-specific quality of life in adults with ITP. | 12-month observation period |
| Treatment satisfaction measure (MSQ) | 12-month observation period | |
| SF-36 Quality of life measure | Scale of functional health and well-being from the patient's point of view. |
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Inclusion Criteria:
Exclusion Criteria:
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This two-cohort study will enroll approximately 45 patients diagnosed with ITP. Cohort 1 will enroll approximately 30 ITP patients who will begin treatment with fostamatinib as second-line therapy. Cohort 2 will enroll approximately 15 patients who have a record of at least 12 weeks of fostamatinib treatment as second-line therapy, with the intent to continue, at time of enrollment.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Research | Tamarac | Florida | 33321 | United States | ||
| Simmons Cancer Institute at Southern Illinois University |
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| 12-month observation period |
| Springfield |
| Illinois |
| 62702 |
| United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Saint Agnes Hospital | Baltimore | Maryland | 21229 | United States |
| The Center for Cancer and Blood Disorders | Bethesda | Maryland | 20817 | United States |
| Maryland Oncology Hematology, P.A | Clinton | Maryland | 20735 | United States |
| Maryland Oncology Hematology, P.A | Columbia | Maryland | 21044 | United States |
| Maryland Oncology Hematology, P.A | Rockville | Maryland | 20850 | United States |
| Maryland Oncology Hematology, P.A | Silver Spring | Maryland | 20904 | United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| Washington University | St Louis | Missouri | 63130 | United States |
| Regional Cancer Care Associates, LLC | Little Silver | New Jersey | 07739 | United States |
| New York Medical College Westchester Medical Center | Valhalla | New York | 10532 | United States |
| New York Medical College | Valhalla | New York | 10595 | United States |
| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C523665 | fostamatinib |
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