A Study to Learn About the Safety of BESPONSA Injection in Pediatric Patients With Acute Lymphocytic Leukemia.
- Conditions
- Acute Lymphocytic Leukemia
- Registration Number
- NCT06476665
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 3
- 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
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Pfizer
šÆšµTokyo, Japan