Besponsa Post Marketing Surveillance Study

Pfizer

Status

Completed

Conditions

Hematologic Malignancy

Treatments

Drug: Inotuzumab ozogamicin

Study type

Observational

Funder types

Industry

Identifiers

NCT04307134

B1931027

NCT04307134 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

108 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

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