NL-OMON53072招募中2 期
Risk-based, response-adapted, Phase II open-label trial of nivolumab + brentuximab vedotin (N + Bv) for children, adolescents, and young adults with relapsed/refractory (R/R) CD30 + classic Hodgkin lymphoma (cHL) after failure of first-line therapy, followed by brentuximab + bendamustine (Bv + B) for participants with a suboptimal response. - CA209-744
Bristol-Myers Squibb0 个研究点目标入组 4 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 4
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 64（—）
入选标准
- •-Patients must provide written informed consent, children and adolescents
- •should also give assent
- •-Males and females aged between 5 and 30 years, inclusive. Please note in the
- •Netherlands, only patients aged between 5 to 18 inclusive will be included in
- •-Women of child bearing potential must have a negative serum or urine pregnancy
- •test within 24 hours prior to the start of study treatment
- •-Patients must have measurable classic Hodgkin lymphoma as documented by
- •pathological and radiographic criteria
- •-Performance Level: Karnofsky above or equal to 50% for participants > 16 years
- •of age or Lansky 50 for participants equal or less than16 years of age
- •-Patients must have received first line anti-cancer therapy that failed
- •-Patients must have adequate bone marrow, renal and hepatic function
排除标准
- •-Active, known, or suspected autoimmune disease, immunodeficiency or infection
- •-Active cerebral/meningeal disease related to the underlying malignancy
- •-Patients who failed more than one line of anti-cancer therapy or are treatment
- •-Patients who previously received an allogeneic and/or autologous stem cell
- •transplant for classic Hodgkin lymphoma
- •-Prior exposure to anti-PD1, anti-PDL1, anti-PD-L2, anti-CD137 or anti- CTLA-4
- •antibody, or any other antibody or drug specifically targeting T-cell
- •co-stimulation or checkpoint pathways
- •-Prior exposure to bendamustine
研究者
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