BESPONSA Injection 1 mg Special Investigation

Completed

• Conditions: Acute Lymphocytic Leukemia

• Registration Number: NCT05923112
• Lead Sponsor: Pfizer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-02
• Study First Submitted: 2023-06-20
• Study First Submitted QC: 2023-06-20
• Study First Posted: 2023-06-28
• Primary Completion: 2024-09-06
• Study Completion: 2024-09-06
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 421

Inclusion Criteria

• All patients prescribed BESPONSA

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence of adverse drug reactions	Up to 52 weeks	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.

Trial Locations

Locations (1)

Pfizer; 🇯🇵 Tokyo, Japan