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Besponsa Post Marketing Surveillance Study

Sponsor
Pfizer (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04307134
Collaborator
(none)
160
Enrollment
1
Location
56.8
Anticipated Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Inotuzumab ozogamicin

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 at minimum 160 subjects administered in the setting of routine practice in Korea during the initial 6 years after the approval.

Study Design

Study Type:
Observational
Anticipated Enrollment :
160 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Korean Post Marketing Surveillance Study to Observe Safety and Effectiveness of BESPONSA (REGISTERED)
Actual Study Start Date :
Jul 9, 2020
Anticipated Primary Completion Date :
Jan 2, 2025
Anticipated Study Completion Date :
Apr 2, 2025

Arms and Interventions

Arm Intervention/Treatment
R/R ALL

Patients diagnosed as relapsed or refractory B-cell precursor lymphoblastic leukemia (ALL)

Drug: Inotuzumab ozogamicin
R/R ALL who treated with Inotuzumab ozogamicin

Outcome Measures

Primary Outcome Measures

  1. Incidence of adverse events categorized according to physical organ and disease/symptom [28 days following the last administration of BESPONSA®.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
0 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pfizer Seoul Korea, Republic of

Sponsors and Collaborators

  • Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT04307134
Other Study ID Numbers:
  • B1931027
First Posted:
Mar 13, 2020
Last Update Posted:
Nov 24, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Pfizer
Refractory and relapsed B-cell ALL
Additional relevant MeSH terms:
Inotuzumab Ozogamicin

Study Results

No Results Posted as of Nov 24, 2021