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

Immune Thrombocytopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04904276
• Other study ID #: O-FOSTA-901
• Status: Terminated
• Start date: May 18, 2021
• Est. completion date: November 17, 2022

Study information

• Verified date: March 2024
• Source: Rigel Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: November 17, 2022
• Est. primary completion date: November 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

1. Willing and able to provide written informed consent

2. Diagnosis of ITP in adult patients (= 18 years of age) with an insufficient response to steroids ± immunoglobulins and requiring a change in therapy

3. For Cohort 1, intent to initiate fostamatinib at enrollment as change in therapy

4. 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:

1. Any prior ITP therapy/treatment other than steroids ± immunoglobulins (e.g. rituximab, thrombopoietin receptor agonists (TPO), splenectomy)

2. Participation in any interventional study during the course of this study

3. Lack of historical platelet counts, at time of fostamatinib initiation for those entering Cohort 2

4. Pregnant and/or nursing

Related Conditions & MeSH terms

• Immune Thrombocytopenia
• ITP
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia

Intervention

Drug:
• Fostamatinib
Fostamatinib disodium

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Rigel Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fostamatinib dosing	Changes in fostamatinib dosing	12-month observation period
Primary	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
Primary	Use of concomitant medications related to ITP	Use of concomitant medications related to ITP during the study.	12-month observation period
Primary	Use of ITP Rescue Medication	The number of patients with ITP rescue medication use at any time during the study.	12-month observation period
Primary	Safety of fostamatinib	Evaluate continued safety of fostamatinib in ITP patients through adverse events	12-month observation period
Primary	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
Primary	Treatment satisfaction measure (MSQ)		12-month observation period
Primary	SF-36 Quality of life measure	Scale of functional health and well-being from the patient's point of view.	12-month observation period