An observational study in Lymphoma, T-Cell, Peripheral, sponsored by Celgene. Completed at 1 site in Japan. Per ClinicalTrials.gov, last updated 2023-12-06.
Sponsored by Celgene · Observational
To ascertain the safety and efficacy of Istodax® in actual clinical settings in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) who receive Istodax.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 150 is above the median of 136 across 625 observational studies indexed under Lymphoma.
Browse Lymphoma studies →Celgene is the lead sponsor of 419 studies on the registry; 13 are open to participants now.
Of its 100 completed or terminated interventional studies of FDA-regulated products, 29 (29%) have results posted.
Counted across the registry records on this site, refreshed daily.
Since the number of patients with PTCL was 48 and 131 in the Japanese and overseas clinical studies, respectively, the number of subjects to be surveyed was established at 130 to allow comparison of results between this survey and Japanese clinical study, or between this survey and overseas clinical study.
Among events that were established as the key survey items of this survey, QT interval prolonged had the lowest incidence (3.8%) in the overseas/Japanese clinical studies of Istodax in patients with PTCL. When 130 subjects are collected, it would be possible to collect at least 1 case of an event that occurs at the frequency of 2.3% with a reliability of 95%. Thus, assuming that adverse events occur under the actual use conditions at similar frequencies as in clinical studies, it would be possible to obtain at least 1 case of all events that have been established as the key survey items.
Exclusion Criteria:
N/A
Among patients with relapsed or refractory peripheral T-Cell lymphoma, patients who received Istodax will be targeted in this surveillance
Drug: Istodax
Istodax
Adverse Events (AEs)
Number of participants with adverse event
Time frame: Up to approximately 5 years
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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