急性リンパ性白血病の小児患者におけるBESPONSA注射の安全性を調べる研究。
基本情報
- NCT ID
- NCT06476665
- ステータス
- 実施中(募集終了)
- 試験のフェーズ
- -
- 試験タイプ
- 観察
- 目標被験者数
- 7
- 治験依頼者名
- Pfizer
概要
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.
対象疾患
依頼者(Sponsor)
実施施設 (1)
Pfizer
Tokyo, Japan