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Clinical Trials in Japan / NCT06476665
Active, not recruiting Observational

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

NCT06476665 · tracked via the Priya Life Science Japan tracker
Sponsor
Pfizer
Phase
Observational
Started
2024-11-07
Last updated
2026-09-25

Condition(s) studied

Acute Lymphocytic Leukemia

Study 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.

Eligibility

Sex
ALL
Min age
0 Years
Max age
17 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
Pfizer Tokyo Japan

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06476665 on ClinicalTrials.gov ↗ ← All trials in Japan