Observational Study of Fostamatinib as Second Line Therapy in Adult Patients With Immune Thrombocytopenia (ITP) and Insufficient Response to a Prior Therapy
Study Details
Study Description
Brief Summary
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).
Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
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).
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Initiating treatment with fostamatinib as second-line therapy
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Drug: Fostamatinib
Fostamatinib disodium
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Treated with fostamatinib for at least 12 weeks as second-line therapy
|
Drug: Fostamatinib
Fostamatinib disodium
|
Outcome Measures
Primary Outcome Measures
- Fostamatinib dosing [12-month observation period]
Changes is fostamatinib dosing
- Platelet counts over time during the course of fostamatinib therapy [12-month observation period]
Platelet count and change from baseline in platelet count over time.
- Use of concomitant medications related to ITP [12-month observation period]
Use of concomitant medications related to ITP during the study.
- Use of ITP Rescue Medication [12-month observation period]
The number of patients with ITP rescue medication use at any time during the study.
- Safety of fostamatinib [12-month observation period]
Evaluate continued safety of fostamatinib in ITP patients through adverse events
- ITP-PAQ Quality of life measure [12-month observation period]
Use of the score from questionnaire to assess disease-specific quality of life in adults with ITP.
- Treatment satisfaction measure (MSQ) [12-month observation period]
- SF-36 Quality of life measure [12-month observation period]
Scale of functional health and well-being from the patient's point of view.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Willing and able to provide written informed consent
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Diagnosis of ITP in adult patients (≥ 18 years of age) with an insufficient response to steroids ± immunoglobulins and requiring a change in therapy
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For Cohort 1, intent to initiate fostamatinib at enrollment as change in therapy
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For Cohort 2, currently undergoing treatment with fostamatinib as second line therapy for at least 12 weeks, with the intent to continue, at the time of enrollment
Exclusion Criteria:
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Any prior ITP therapy/treatment other than steroids ± immunoglobulins (e.g. rituximab, thrombopoietin receptor agonists (TPO), splenectomy)
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Participation in any interventional study during the course of this study
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Lack of historical platelet counts, at time of fostamatinib initiation for those entering Cohort 2
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Pregnant and/or nursing
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Simmons Cancer Institute at Southern Illinois University | Springfield | Illinois | United States | 62702 |
2 | Maryland Oncology Hematology, P.A | Clinton | Maryland | United States | 20735 |
3 | Maryland Oncology Hematology, P.A | Columbia | Maryland | United States | 21044 |
4 | Maryland Oncology Hematology, P.A | Rockville | Maryland | United States | 20850 |
5 | Maryland Oncology Hematology, P.A | Silver Spring | Maryland | United States | 20904 |
6 | Boston Medical Center | Boston | Massachusetts | United States | 02118 |
7 | Washington University | Saint Louis | Missouri | United States | 63130 |
8 | Regional Cancer Care Associates, LLC | Little Silver | New Jersey | United States | 07739 |
Sponsors and Collaborators
- Rigel Pharmaceuticals
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- O-FOSTA-901