At a glance
ClinicalIndex Comparison RecordN/ACompleted· 108 enrolled
Drug / intervention
Inotuzumab ozogamicindrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Korean Post Marketing Surveillance Study to Observe Safety and Effectiveness of BESPONSA (REGISTERED)
In Brief
An observational study evaluating Inotuzumab ozogamicin for Hematologic Malignancy. Completed, enrolled 108 participants across 1 site.
Detailed Summary
Besponsa is approved for the treatment of R/R B-cell ALL in Korea. In accordance with the Standards for Re-examination of New Drug, it is required to conduct a PMS. Post marketing surveillance is required to determine any problems or questions associated with besponsa after marketing in Korea, with regard to the following clauses under conditions of general clinical practice. Therefore, through this study, effectiveness and safety of besponsa will be observed.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsHematologic Malignancy
CountriesSouth Korea
Collaborators--
Timeline
N/ACompletedFinished
202120222023202420252026
First PostedMar 2020
Enrollment StartJul 2020
Primary CompletionDec 2024
TodayJul 2026
First PostedMar 13, 2020
Enrollment StartJul 9, 2020
Primary CompletionDec 24, 2024
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 6.3 years ago
Interventions
Inotuzumab ozogamicindrug
R/R ALL who treated with Inotuzumab ozogamicin