Besponsa Post Marketing Surveillance Study
- Registration Number
- NCT04307134
- Lead Sponsor
- Pfizer
- Brief 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.
- Detailed Description
Before the approval of BESPONSA® in Korea, this non-interventional study is designated as a Post-Marketing Surveillance (PMS) Study and is a commitment to Ministry of Food and Drug Safety (MFDS), as a part of Risk Management Plan (RMP) which is required by MFDS. The safety and effectiveness information of BESPONSA® will be gathered in the setting of routine practice in Korea during the initial 6 years after the approval.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 108
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description R/R ALL Inotuzumab ozogamicin Patients diagnosed as relapsed or refractory B-cell precursor lymphoblastic leukemia (ALL)
- Primary Outcome Measures
Name Time Method Incidence of adverse events categorized according to physical organ and disease/symptom 28 days following the last administration of BESPONSA®.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Pfizer
🇰🇷Seoul, Korea, Republic of