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

B1931027

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.

2020-07-09

2025-01-02

2025-01-02

Active (not recruiting)

160

Inclusion criteria Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study: 1. Patients diagnosed as relapsed or refractory B-cell precursor lymphoblastic leukemia (ALL). 2. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. Exclusion criteria Patients meeting any of the following criteria will not be included in the study: 1. Any patients who does not agree that Pfizer and companies working with Pfizer use his/her information. 2. Patients to whom BESPONSA® is contraindicated as per the local labeling. -

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 160, 'type': 'ESTIMATED'}}

2024-03-19