A Randomized, Open-label, Safety and Efficacy Study of Ibrutinib in Pediatric and Young Adult Patients With Relapsed or Refractory Mature B-cell Non-Hodgkin Lymphoma

The purpose of this study is to confirm that the pharmacokinetics of ibrutinib in pediatric participants is consistent with that in adults (part 1) and to assess efficacy (event-free survival \[EFS\]) of ibrutinib in combination with rituximab, ifosfamide, carboplatin, and etoposide (RICE) or rituximab, vincristine, ifosfamide, carboplatin, and idarubicin (RVICI) background therapy compared to RICE or RVICI background therapy alone (part 2).

本研究的目的分为两个部分：第一部分为确认依鲁替尼（ibrutinib）在儿童受试者中的药代动力学特征与成人受试者一致；第二部分为评估依鲁替尼联合RICE方案（利妥昔单抗、异环磷酰胺、卡铂、依托泊苷）或RVICI方案（利妥昔单抗、长春新碱、异环磷酰胺、卡铂、伊达比星）背景治疗，相较于单独采用上述RICE或RVICI背景治疗方案的疗效（无事件生存期，event-free survival, EFS）。