At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II, Multicenter, Simon Two-Stage Study of Fostamatinib Disodium in Patients With Relapsed or Refractory T-Cell Lymphoma
In Brief
A Phase 2 clinical trial evaluating Fostamatinib Disodium for T Cell Lymphoma. Completed, enrolled 18 participants across 10 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
200 mg PO BID