NCT06476665

A Study to Learn About the Safety of BESPONSA Injection in Pediatric Patients With Acute Lymphocytic Leukemia.

BESPONSA INJECTION 1MG SPECIAL INVESTIGATION (PEDIATRIC INVESTIGATION)

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 7 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 0 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to learn about the safety of BESPONSA for pediatric patients. . BESPONSA is approved for treatment of relapsed or refractory CD22-positive acute lymphocytic leukemia for pediatric patients. A type of leukemia (blood cancer) that comes on quickly and is fast growing. In acute lymphocytic leukemia, there are too many lymphoblasts (early-stage white blood cells) in the blood and bone marrow. Also called ALL. The registration criteria for this study are: * Never used BESPONSA before * \<18 years at the start of treatment with BESPONSA All patients in this study will receive BESPONSA according to the prescriptions. Patients will be followed up as follow. * Treatment phase: From the day of treatment initiation (Day 1) to Day 28 post-treatment to collect information on safety (e.g., adverse events). * Follow-up phase: From Day 29 post-treatment to Week 52 to collect information on VOD/SOS.

Conditions

• Acute Lymphocytic Leukemia

Timeline

• Start date: 2024-11-07
• Primary completion: 2029-06-22
• Completion: 2029-06-22
• First posted: 2024-06-26
• Last updated: 2025-08-19

Locations

1 site across 1 country: Japan