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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06476665

Enrollment

Registered

2024-06-26

Start date

2024-11-07

Completion date

2029-06-22

Last updated

2026-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphocytic Leukemia

Brief 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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

0 Years to 17 Years

Healthy volunteers

Inclusion criteria

1. Patients with relapsed or refractory CD22-positive ALL 2. Patients who have never used BESPONSA before 3. Patients aged \<18 years at the start of treatment with BESPONSA

Exclusion criteria

* None

Design outcomes

Primary

Measure	Time frame
Occurrence of adverse events	Up to 28 days after the last administration
Risk factors related to the onset of venoocclusive liver disease/sinusoidal obstruction syndrome	Up to 52 weeks

Countries

Japan

Contacts

STUDY_DIRECTORPfizer CT.gov Call Center

Pfizer

Outcome results