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

Sponsor
Rigel Pharmaceuticals (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04904276
Collaborator
(none)
45
8
18.5
5.6
0.3

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

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

Study Type:
Observational
Anticipated Enrollment :
45 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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)
Actual Study Start Date :
May 18, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Initiating treatment with fostamatinib as second-line therapy

Drug: Fostamatinib
Fostamatinib disodium

Treated with fostamatinib for at least 12 weeks as second-line therapy

Drug: Fostamatinib
Fostamatinib disodium

Outcome Measures

Primary Outcome Measures

  1. Fostamatinib dosing [12-month observation period]

    Changes is fostamatinib dosing

  2. 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.

  3. Use of concomitant medications related to ITP [12-month observation period]

    Use of concomitant medications related to ITP during the study.

  4. Use of ITP Rescue Medication [12-month observation period]

    The number of patients with ITP rescue medication use at any time during the study.

  5. Safety of fostamatinib [12-month observation period]

    Evaluate continued safety of fostamatinib in ITP patients through adverse events

  6. 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.

  7. Treatment satisfaction measure (MSQ) [12-month observation period]

  8. 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

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
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.
Responsible Party:
Rigel Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT04904276
Other Study ID Numbers:
  • O-FOSTA-901
First Posted:
May 27, 2021
Last Update Posted:
Jul 19, 2021
Last Verified:
May 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Rigel Pharmaceuticals
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 19, 2021