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NCT06476665Active, not recruiting

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

BESPONSA INJECTION 1MG SPECIAL INVESTIGATION (PEDIATRIC INVESTIGATION)

Source: ClinicalTrials.gov · Last updated 25 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
12 (actual)
First submitted
20 Jun 2024
Start date
7 Nov 2024
Primary completion date
22 Jun 2029
Lead sponsor
Pfizer
NCT number
NCT06476665

What you commit to

  • Study type: Observational
  • Participants enrolled: 12
  • From 7 Nov 2024 to the primary completion date, 22 Jun 2029
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • None

Who the study is looking for

  • 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

Age in the registry: 0 years to 17 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Pfizer
Coordinator of this site? Confirm its status
TokyoJapanUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.