NL-OMON54697招募中2 期
AERN study: Abscopal Effect of Radiotherapy and Nivolumab in anti-PD1 Pretreated Relapsed or Refractory classical Hodgkin Lymphoma - An international multicenter Phase II trial - AERN study
niversity of Cologne0 个研究点目标入组 3 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
- 3
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
- 18 至 99（—）
入选标准
- •- Relapsed/refractory cHL with progression while treated with an anti-PD1
- •antibody or
- •Relapsed/refractory cHL with stable disease for > 6 months as best response to
- •ongoing anti-PD1 antibody therapy
- •- At least two distinct FDG-avid HL-lesions with at least 5 cm distance between
- •them, and one of them considered eligible for irradiation with 20Gy
- •- One but the irradiated lesion has to be outside the 10% isodose in RT
- •planning confirmed by the Central Response Evaluation Panel (CREP)
- •- Age 18 years and older, all sexes
排除标准
- •- Nodular lymphocyte-predominant HL or grey-zone lymphoma
- •- Evidence of active, non-infectious lung disorder with DLCOc < 50%
- •- History of long-term or ongoing ingestion of immunosuppressive agents >10mg
- •prednisone/d
- •- Any other serious disease or organ dysfunction which might impair protocol
- •Note: Patients on antiretroviral therapy (ART) with controlled HIV infection
- •(defined as sufficient ART compliance, non-measurable HIV and CD4+ T helper
- •cells > 200/µL) may be enrolled, if considered eligible for study treatment by
- •the investigator.
- •- Prior allogeneic stem-cell transplantation (alloSCT), if one or more of the
- •following conditions are met:
- •a. AlloSCT conducted <12 months prior to registration for the screening phase
- •b. Requiring continued immunosuppression beyond 7d) at registration for the
- •screening phase
- •c. History of acute graft-versus-host disease >= grade3
- •d. History of chronic graft-versus-host disease >= grade3
研究者
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