NCT04307134

Besponsa Post Marketing Surveillance Study

Korean Post Marketing Surveillance Study to Observe Safety and Effectiveness of BESPONSA (REGISTERED)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 108 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hematologic Malignancy

Interventions

Type	Name	Description
DRUG	Inotuzumab ozogamicin	R/R ALL who treated with Inotuzumab ozogamicin

Timeline

• Start date: 2020-07-09
• Primary completion: 2024-12-24
• Completion: 2024-12-24
• First posted: 2020-03-13
• Last updated: 2025-12-31
• Results posted: 2025-12-31

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated drug study