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Efficacy and Safety Study of Fostamatinib Disodium Tablets to Treat T-Cell Lymphoma
NCT00798096 · View on ClinicalTrials.gov ↗
Study Summary
Patients meeting specific inclusion and exclusion criteria will be enrolled in two stages, 19 patients in Stage 1 and 36 patients in Stage 2. Stage 2 will enroll if 4 or more patients exhibit a response at Week 8 or later in the study. All enrolled patients will be treated with Fostamatinib Disodium until disease progression. Efficacy will be assessed by tumor measurements using CT and PET (when indicated) scans and physical exam at baseline, and scans and physical exam of all disease-involved areas every 8 weeks until progression. Safety will be assessed by periodic physical exams, clinical laboratory studies, and adverse events. All patients will have a follow-up visit 30 days following last study drug treatment. Blood samples for PK assessment will be obtained from all patients enrolled in Stage 1 at protocol defined intervals.
Conditions Studied
Interventions
- DRUG Fostamatinib Disodium
Study Locations (10)
California
- Research Site — San Francisco
- Research Site — Stanford
Georgia
- Research Site — Atlanta
Massachusetts
- Research Site — Boston
Minnesota
- Research Site — Rochester
Nebraska
- Research Site — Omaha
New York
- Research Site — New York
Texas
- Research Site — Houston
British Columbia
- Research Site — Vancouver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2009-03 |
| Est. Completion | 2010-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00798096
The ClinicalTrials.gov registry entry for NCT00798096 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rigel Pharmaceuticals, which has 68 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with T Cell Lymphoma appearing as the primary indexed condition, and to 1 intervention — of which Fostamatinib Disodium is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00798096 reports 10 study locations spanning 9 distinct geographic areas — top geographies include California, Georgia, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00798096 about?
NCT00798096 is a clinical study titled "Efficacy and Safety Study of Fostamatinib Disodium Tablets to Treat T-Cell Lymphoma". Patients meeting specific inclusion and exclusion criteria will be enrolled in two stages, 19 patients in Stage 1 and 36 patients in Stage 2. Stage 2 will enroll if 4 or more patients exhibit a response at Week 8 or later in the study. All enrolled patients will be treated with Fostamatinib Disodium...
What is the current status of trial NCT00798096?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2009-03. Estimated completion is 2010-04.
What conditions does trial NCT00798096 study?
This clinical trial studies the following conditions: T Cell Lymphoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00798096?
The interventions under investigation include: Fostamatinib Disodium (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00798096?
This trial is sponsored by Rigel Pharmaceuticals, which has 68 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00798096 being conducted?
This trial has 10 study locations across California, Georgia, Massachusetts, Minnesota, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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