ITPNCT04904276
Observational Study of Fostamatinib as Second Line Therapy in Adult Patients With Immune Thrombocytopenia (ITP) and Insufficient Response to a Prior Therapy
An observational study of ITP and Immune Thrombocytopenia, run by Rigel Pharmaceuticals at 14 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- ITP, Immune Thrombocytopenia
- What is being tested?
- Fostamatinib
- How many people
- 16 participants
- Where
- 14 sitesUnited States
- Study dates
- 18 May 2021to 17 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Saint Agnes Hospital
Baltimore, Maryland, 21229
The Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817
Boston Medical Center
Boston, Massachusetts, 02118
Maryland Oncology Hematology, P.A
Clinton, Maryland, 20735
Maryland Oncology Hematology, P.A
Columbia, Maryland, 21044
University of Kansas Medical Center
Kansas City, Kansas, 66160
Regional Cancer Care Associates, LLC
Little Silver, New Jersey, 07739
Maryland Oncology Hematology, P.A
Rockville, Maryland, 20850
Maryland Oncology Hematology, P.A
Silver Spring, Maryland, 20904
Simmons Cancer Institute at Southern Illinois University
Springfield, Illinois, 62702
Washington University
St Louis, Missouri, 63130
Advanced Research
Tamarac, Florida, 33321
New York Medical College Westchester Medical Center
Valhalla, New York, 10532
New York Medical College
Valhalla, New York, 10595
About this study
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)
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).
Read the 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).
- Conditions
- ITP, Immune Thrombocytopenia
- Being tested
- Fostamatinib
- Keywords
- Immune Thrombocytopenia, ITP
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FostamatinibDrug
Fostamatinib disodium
| Study group | Role | What they receive |
|---|---|---|
| Initiating treatment with fostamatinib as second-line therapy | Not described Receives: Drug: Fostamatinib | |
| Treated with fostamatinib for at least 12 weeks as second-line therapy | Not described Receives: Drug: Fostamatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fostamatinib dosing
Changes in fostamatinib dosing
Measured: 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.
Measured: 12-month observation period
Use of concomitant medications related to ITP
Use of concomitant medications related to ITP during the study.
Measured: 12-month observation period
Use of ITP Rescue Medication
The number of patients with ITP rescue medication use at any time during the study.
Measured: 12-month observation period
Safety of fostamatinib
Evaluate continued safety of fostamatinib in ITP patients through adverse events
Measured: 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.
Measured: 12-month observation period
Treatment satisfaction measure (MSQ)
Measured: 12-month observation period
SF-36 Quality of life measure
Scale of functional health and well-being from the patient's point of view.
Measured: 12-month observation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start18 May 2021
- Primary completion17 Nov 2022
- Study completion17 Nov 2022
Why it stopped: met minimum enrollment goal, however, enrollment was slow due to the pandemic, therefore, the study was terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ITPStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rigel Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04904276
- Sponsor's protocol ID
- O-FOSTA-901
- Status last verified
- Mar 2024
- First submitted
- 13 Apr 2021
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04904276
- Acronym / sponsor ID
- O-FOSTA-901
- Conditions
- ITP, Immune Thrombocytopenia
- Keywords
- Immune Thrombocytopenia, ITP
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: met minimum enrollment goal, however, enrollment was slow due to the pandemic, therefore, the study was terminated
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Rigel PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 18 May 2021 (actual)
- Primary completion
- 17 Nov 2022 (actual)
- Study completion
- 17 Nov 2022 (actual)
- First posted
- 27 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Initiating treatment with fostamatinib as second-line therapy | – | Drug: Fostamatinib |
| Treated with fostamatinib for at least 12 weeks as second-line therapy | – | Drug: Fostamatinib |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FostamatinibFostamatinib disodium | Drug | Initiating treatment with fostamatinib as second-line therapy, Treated with fostamatinib for at least 12 weeks as second-line therapy |
Primary outcome
Fostamatinib dosing
Time frame: 12-month observation period
Changes in fostamatinib dosing
Platelet counts over time during the course of fostamatinib therapy
Time frame: 12-month observation period
Platelet count and change from baseline in platelet count over time.
Use of concomitant medications related to ITP
Time frame: 12-month observation period
Use of concomitant medications related to ITP during the study.
Use of ITP Rescue Medication
Time frame: 12-month observation period
The number of patients with ITP rescue medication use at any time during the study.
Safety of fostamatinib
Time frame: 12-month observation period
Evaluate continued safety of fostamatinib in ITP patients through adverse events
ITP-PAQ Quality of life measure
Time frame: 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)
Time frame: 12-month observation period
SF-36 Quality of life measure
Time frame: 12-month observation period
Scale of functional health and well-being from the patient's point of view.
Results and safety
The study was stopped early (reason given: met minimum enrollment goal, however, enrollment was slow due to the pandemic, therefore, the study was terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ITP and Immune Thrombocytopenia, run by Rigel Pharmaceuticals at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: met minimum enrollment goal, however, enrollment was slow due to the pandemic, therefore, the study was terminated). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fostamatinib dosing (time frame: 12-month observation period). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.