Clinical trial · Observational
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
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphocytic Leukemia | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Occurrence of adverse events
- timeFrame
- Up to 28 days after the last administration
- measure
- Risk factors related to the onset of venoocclusive liver disease/sinusoidal obstruction syndrome
- timeFrame
- Up to 52 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 0 Years
- Maximum age
- 17 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available