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Besponsa Post Marketing Surveillance Study

NCT04307134 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 108

Last updated 2025-12-31

Study results available
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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.

Conditions

  • Hematologic Malignancy

Interventions

DRUG

Inotuzumab ozogamicin

R/R ALL who treated with Inotuzumab ozogamicin

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-09
Primary Completion
2024-12-24
Completion
2024-12-24
FDA Drug
Yes

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04307134 on ClinicalTrials.gov