JPRN-jRCT1080223715已完成4 期
A Retrospective Study of Safety and Efficacy for Re-treatment of Brentuximab-Vedotin (BV) in Patients With Relapsed/Refractory (R/R) classical Hodgkin Lymphoma (cHL)/ systemic Anaplastic Large-cell Lymphoma (sALCL)
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 28
研究概览
简要总结
In this study, the efficacy was confirmed of retreatment with brentuximab vedotin in patients with cHL or sALCL who had achieved PR or CR with previous brentuximab vedotin therapy in Japan. AEs in patients with brentuximab vedotin retreatment did not include unexpected AEs and were generally manageable with dose modification or interruption.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- ot applicable 至 ot applicable（—）
- 性别
- All
入选标准
- •(1) cHL or sALCL patients with CD30 positive
- •(2) Patients who previously experienced a CR or PR with first brentuximab vedotin treatment and subsequently experienced disease progression or relapse were administered brentuximab vedotin retreatment*.
- •*Definition of brentuximab vedotin retreatment
- •1) Discontinued treatment of brentuximab vedotin as prior therapy after experienced a CR or PR.
- •2) At least single dose of brentuximab vedotin was administered after discontinued treatment of brentuximab vedotin and subsequently experienced disease progression or relapse.
- •3) Treatment of brentuximab vedotin after 6 weeks or more passed from the date of final dose of prior treatment of brentuximab vedotin.
- •4) Not the treatment of brentuximab vedotin as consolidation after SCT (stem cell transplantation).
- •5) Monotherapy of retreatment of brentuximab vedotin (not concomitant use with other antitumor agent)
- •6) Re-retreatment (in the case that retreatment of brentuximab vedotin was administered after discontinued retreatment of brentuximab vedotin described above) is handled as a set of retreatment).
- •(3) A patient who agreed with informed consent prior to the study enrollment.
排除标准
- •(1) Patients judged by the investigator or subinvestigator to be ineligible for enrollment in the study (such as patients who may be coerced to give consent)
研究者
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