Observational Study of Fostamatinib as Second Line Therapy in Adult Patients With Immune Thrombocytopenia (ITP) and Insufficient Response to a Prior Therapy
NCT ID: NCT04904276
Last Updated: 2024-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
16 participants
OBSERVATIONAL
2021-05-18
2022-11-17
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Real World Evaluation of the Activity and Safety of Fostamatinib in Consecutive Adult Patients With ITP
NCT05613296
A Efficacy and Safety Study of Fostamatinib in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)
NCT02076412
Fostamatinib as a Single Agent or in Combination With Ruxolitinib for Treatment of Patients With Myelofibrosis With Severe Thrombocytopenia
NCT04543279
Pilot Study of Fostamatinib Disodium/R935788 for the Treatment of Adult Refractory Immune Thrombocytopenic Purpura (ITP)
NCT00706342
A Efficacy and Safety Study of R935788 in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)
NCT02076399
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Initiating treatment with fostamatinib as second-line therapy
Fostamatinib
Fostamatinib disodium
Treated with fostamatinib for at least 12 weeks as second-line therapy
Fostamatinib
Fostamatinib disodium
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Fostamatinib
Fostamatinib disodium
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
100 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Rigel Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
O-FOSTA-901
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.