Status:
COMPLETED
Besponsa Post Marketing Surveillance Study
Lead Sponsor:
Pfizer
Conditions:
Hematologic Malignancy
Eligibility:
All Genders
19+ years
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 requ...
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...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
- Patients diagnosed as relapsed or refractory B-cell precursor lymphoblastic leukemia (ALL).
- 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:
- Any patients who does not agree that Pfizer and companies working with Pfizer use his/her information.
- Patients to whom BESPONSA® is contraindicated as per the local labeling.
- \-
Exclusion
Key Trial Info
Start Date :
July 9 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 24 2024
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT04307134
Start Date
July 9 2020
End Date
December 24 2024
Last Update
December 31 2025
Active Locations (1)
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1
Pfizer
Seoul, South Korea