Observational Study of Fostamatinib as Second Line Therapy in Adult Patients With Immune Thrombocytopenia (ITP) and Insufficient Response to a Prior Therapy

Stopped early

Conditions studied: ITP, Immune Thrombocytopenia

In brief

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).

Key facts

Study ID

NCT04904276

Run by

Rigel Pharmaceuticals

People needed

16

Starts

2021-05-18

Expected to finish

2022-11-17

Last updated by the study team

2024-03-15

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Willing and able to provide written informed consent
• Diagnosis of ITP in adult patients (≥ 18 years of age) with an insufficient response to steroids ± immunoglobulins and requiring a change in therapy
• For Cohort 1, intent to initiate fostamatinib at enrollment as change in therapy
• 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

You may not qualify if…

• Any prior ITP therapy/treatment other than steroids ± immunoglobulins (e.g. rituximab, thrombopoietin receptor agonists (TPO), splenectomy)
• Participation in any interventional study during the course of this study
• Lack of historical platelet counts, at time of fostamatinib initiation for those entering Cohort 2
• Pregnant and/or nursing

Where it is running

• Advanced Research — Tamarac, Florida, United States
• Simmons Cancer Institute at Southern Illinois University — Springfield, Illinois, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Saint Agnes Hospital — Baltimore, Maryland, United States
• The Center for Cancer and Blood Disorders — Bethesda, Maryland, United States
• Maryland Oncology Hematology, P.A — Clinton, Maryland, United States
• Maryland Oncology Hematology, P.A — Columbia, Maryland, United States
• Maryland Oncology Hematology, P.A — Rockville, Maryland, United States
• Maryland Oncology Hematology, P.A — Silver Spring, Maryland, United States
• Boston Medical Center — Boston, Massachusetts, United States
• Washington University — St Louis, Missouri, United States
• Regional Cancer Care Associates, LLC — Little Silver, New Jersey, United States
• New York Medical College Westchester Medical Center — Valhalla, New York, United States
• New York Medical College — Valhalla, New York, United States

Full record on ClinicalTrials.gov

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