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NCT05923112 Clinical Trial

BESPONSA Injection 1 mg Special Investigation

Acute Lymphocytic Leukemia Clinical Trial

Official title:
BESPONSA® INJECTION 1 MG SPECIAL INVESTIGATION

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05923112
Other study ID # B1931024
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date July 2, 2018
Est. completion date August 16, 2024

Study information
Verified date April 2024
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to learn about the safety and effectiveness of BESPONSA. BESPONSA is approved for treatment of relapsed or refractory CD22-positive acute lymphocytic leukemia. Registration criteria for this study is all patients who starting BESPONSA from its launch to the market to April 30, 2020. All patients in this study will receive BESPONSA according to the prescriptions. Patients will be followed up as follow. - 52 weeks for patients who did not have a HSCT (Hematopoietic Stem Cell Transplant) within 52 weeks after starting BESPONSA. - Up to 52 weeks after a HSCT for patients who had a HSCT within 52 weeks after starting BESPONSA.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 200
Est. completion date August 16, 2024
Est. primary completion date August 16, 2024
Accepts healthy volunteers No
Gender All
Age group 0 Years and older
Eligibility Inclusion Criteria: - All patients prescribed BESPONSA Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Japan Pfizer Tokyo

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary The incidence of adverse drug reactions The observation period will be 52 weeks for patients not undergoing HSCT within 52 weeks after the start of BESPONSA treatment or until 52 weeks following HSCT for patients undergoing it within 52 weeks after the start of BESPONSA treatment. Up to 52 weeks
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