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NCT Number: NCT06476665

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Acute Lymphocytic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

0 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. Occurrence of adverse events

    Time frame: Up to 28 days after the last administration

  2. Risk factors related to the onset of venoocclusive liver disease/sinusoidal obstruction syndrome

    Time frame: Up to 52 weeks

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

BESPONSA INJECTION 1MG SPECIAL INVESTIGATION (PEDIATRIC INVESTIGATION)

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Jun 26, 2024
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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