英文原题:A Non-interventional Study of Participants With BPDCN Treated With Chemotherapy
A Non-interventional Study of Participants With BPDCN Treated With Chemotherapy
这是一项分期未标注的注册临床试验,评估细胞治疗用于肿瘤的安全性、可行性及初步疗效。当前状态:招募中。计划入组 140 例。试验地点:欧洲 · 奥胡斯、欧登塞、贝桑松、博比尼(共 67 个中心)。登记号:NCT07785180。
不限性别 · ≥ 18 Years
纳入标准: • 开始BPDCN一线治疗时年龄≥18岁;参加者可以在世、已死亡或无法联系(按当地法规允许的范围)。自2016年5月起,至少接受化疗方案作为BPDCN一线治疗。 • 根据临床、实验室和影像学评估(如按机构常规实施)诊断为BPDCN,并通过免疫组织化学或流式细胞术证实特定免疫表型,尤其是CD4、CD56和CD123。 • 参加者或其法定授权代表已签署知情同意及隐私授权表(当地法规要求时)。 排除标准: • 一线治疗BPDCN时接受过研究性药物。 • 在干预性临床试验中接受BPDCN一线治疗。
Inclusion Criteria: * Alive, deceased, or unreachable participants (as permitted by local regulation), aged ≥18 years at the start of first-line treatment for BPDCN, and treated with chemotherapy regimens (at a minimum) as first-line treatment for BPDCN from May 2016 * Diagnosed with BPDCN, based on clinical, laboratory, and imaging (where performed per institutional practice) assessments, with a demonstration of a specific immunophenotype (either by immunohistochemistry or flow cytometry), particularly CD4, CD56, and CD123 * Participants (or their legally authorized representatives) who have signed the informed consent and privacy form, where required as per local regulation Exclusion Criteria: * Participant has received an investigational agent as first-line therapy for BPDCN * Participant has received first-line therapy for BPDCN in an interventional clinical trial
以上为辅助阅读译文。是否适合入组须由主治医生判断,最终以登记平台与研究者确认为准。
主要终点:Objective Response Rate · Baseline through Month 18;Composite Complete Response · Baseline through Month 18;Number of Participants Bridged to Stem Cell Transplant · Baseline through Month 18;Duration of Response · Baseline through Month 18;Real-world Progression-free Survival · Baseline through Month 18;Overall Survival · Baseline through Month 18
次要终点:Time to Next Treatment;Number of Different First-line Treatment Regimens and Sequences Received
自2016年5月起至少接受化疗方案作为一线治疗的成人BPDCN参加者。
本研究的主要目的是调查化疗药物治疗BPDCN患者的有效性和安全性,并为前瞻性ELZONRIS登记研究(STML-401-0521)提供对照组数据。
The main goal of this study is to investigate the effectiveness and safety of chemotherapy agents in the treatment of participants with BPDCN and to provide comparator arm data to the prospective ELZONRIS registry study (STML-401-0521).
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