A Multicentre, Single Arm, Observational Phase IV Study to Assess the Safety and Efficacy of Nelarabine in Children and Young Adults (up to 21 Years of Age) With Relapsed or Refractory T-Lineage Acute Lymphoblastic Leukaemia or Lymphoblastic Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Neurological adverse events
研究概览
简要总结
This international, multicentre, single arm, phase IV study will assess the safety and efficacy of nelarabine in children and young adults with relapsed or refractory T-lineage acute lymphoblastic leukaemia (T-ALL) or lymphoblastic lymphoma (T-LBL) whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. It is a post-authorisation safety study (PASS) conducted for the purpose of confirming the safety profile and the clinical benefit of nelarabine under licensed conditions of use. The study is observational, non-interventional, and will include approximately 40 children and young adults (up to 21 years of age).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≤ 21 years of age
- •Relapsed or refractory T-lineage acute lymphoblastic leukaemia (T-ALL) or lymphoblastic lymphoma (T-LBL)
- •Prior treatment with at least two chemotherapy regimens
- •Selected for treatment with nelarabine
排除标准
- •Known hypersensitivity to the active substance.
- •Women of childbearing potential who are unable or unwilling to use adequate contraceptive measures
- •Males with partners of child bearing potential who are not willing to use condoms or abstinence
- •Patients with persistent neurological toxicity (CTC grade > = grade 2)
- •Adolescents (aged 16 years and over) and adults for whom the physician prescribes the 1500mg/m2 dose of nelarabine.
研究组 & 干预措施
Nelarabine
nelarabine 650mg/m2 IV daily for 5 days. repeat every 21 days.
干预措施: nelarabine (Drug)
结局指标
主要结局
Neurological adverse events
时间窗: Up to one year after treatment
次要结局
- Other adverse events(Up to one year after treatment)
- clinical response rate and survival(one year)