新诊断外周 T 细胞淋巴瘤患者的前瞻性观察性国际登记。
本研究 T-Cell Project 2.0 是在国际 T 细胞非霍奇金淋巴瘤研究组(T-Cell Project 1.0: Prospective Collection of Data in Patients With Peripheral T-Cell Lymphoma)设计的前国际 PTCL 研究的基础上作为前瞻性收集数据以预测更常见的 PTCL 亚型患者的预后。 这是一项针对新诊断外周 T 细胞淋巴瘤患者的前瞻性、纵向、国际观察性研究,旨在验证这种前瞻性数据收集是否能够获得有关 T 细胞淋巴瘤的更准确信息。
该研究旨在更好地定义新的 WHO 分类的临床相关性、FDG-PET 在分期和反应评估中的作用、不同实体的预后、不同亚型的基因组景观,并研究这些疾病的最佳治疗策略现实世界人口中的肿瘤以及分子标记,并探索它们在 PTCL 中的预后或预测意义。
该研究旨在更好地定义新的 WHO 分类的临床相关性、FDG-PET 在分期和反应评估中的作用、不同实体的预后、不同亚型的基因组景观,并研究这些疾病的最佳治疗策略现实世界人口中的肿瘤。
研究概览
地位
条件
详细说明
外周 T 细胞非霍奇金淋巴瘤 (PTCL) 是一组异质性淋巴组织增生性疾病,起源于胸腺后起源的成熟 T 细胞,处于不同的分化阶段,具有不同的形态学模式、表型和临床表现。 所有亚型在男性患者中更常见,诊断时的中位年龄为 62 岁。 这种疾病通常与高复发率和不良预后相关,与 B 细胞淋巴瘤相比治疗效果差,5 年生存率 < 32%。
T 细胞淋巴瘤被广泛认为是一组复杂且异质的淋巴组织增生性疾病,通常与高复发率和不良预后相关。 由于它们的稀有性,它们仍然知之甚少。
引入新的更有效的疗法和更好的技术促使国际 T 细胞非霍奇金淋巴瘤研究小组启动了 T 细胞项目 2.0,以便对 T 细胞淋巴瘤生物学和治疗,结合现代技术的应用,进一步确定新的治疗靶点。
根据方案,患者根据治疗医师的标准实践进行评估。 注册表不需要特定的评估或访问。 注册表中捕获的数据反映了为 PTCL 患者例行收集的数据。
该研究计划收集组织样本进行集中审查。 计划对活检样本进行普通固定、冷冻保存和常规肿瘤细胞遗传学检查。 组织病理学审查小组的主席将确定区域站点,专家血液病理学家将审查材料并执行一组免疫染色(T 细胞面板 + CD20)和未在当地站点评估的标记。
添加血样采集将允许前瞻性地估计我们的 PTCL 患者队列在基线和初始治疗结束时检测 pEBVd 的频率,以表征肿瘤组织中 pEBVd 和 EBER 之间的一致性,并探索 pEBVd 和 EBER 的预后或预测意义PTCL 中可检测到 pEBVd。 最后,在国际范围内研究侵袭性 PTCL 的遗传学和致病机制。
研究类型
注册 (预期的)
联系人和位置
学习联系方式
- 姓名:Martina Manni, MSc, PhD
- 电话号码:+390594223284
- 邮箱:marmanni@unimore.it
研究联系人备份
- 姓名:Monica Civallero, MSc, PhD
- 电话号码:+390594223475
- 邮箱:monica.civallero@unimore.it
学习地点
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Kiev、乌克兰、03022
- 招聘中
- National Cancer Institute
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接触:
- Iryna Kriachok, MD
- 电话号码:+380442572156
- 邮箱:irina.kryachok@gmail.com
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接触:
- Tetiana Skrypets, MD
- 电话号码:+380502526606
- 邮箱:skrip@ua.fm
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Bari、意大利、70124
- 招聘中
- IRCCS Istituto Tumori "Giovanni Paolo II"
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接触:
- Attilio Guarini, MD
- 电话号码:0039080/5555 905
- 邮箱:attilioguarini@oncologico.bari.it
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接触:
- Angela Monica Sciacovelli, PhD
- 电话号码:0039080/5555 416
- 邮箱:angelamonicasciacovelli@gmail.com
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Palermo、意大利、90146
- 尚未招聘
- Palermo_La Maddalena
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接触:
- Maurizio Musso, MD
- 电话号码:00 39 091-688 6801
- 邮箱:mamusso53@gmail.com
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接触:
- Emilio Ianitto, MD
- 电话号码:00 39 091-680 6603
- 邮箱:emilio.iannitto@gmail.com
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Terni、意大利、05100
- 尚未招聘
- Terni-Santa Maria
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接触:
- Anna Marina Liberati, MD
- 电话号码:00390744205971
- 邮箱:marina.liberati@unipg.it
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接触:
- Viviana Appolloni, PhD
- 电话号码:00390744205971
- 邮箱:appolloniviviana@gmail.com
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Cluj Napoca、罗马尼亚、400015
- 招聘中
- Cluj Napoca_Ion Chiricuta Oncology Institute
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接触:
- Ciprian Tomuleasa, MD
- 电话号码:0040741337480
- 邮箱:ciprian.tomuleasa@umfcluj.ro
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接触:
- Catalin Vlad, MD
- 电话号码:0040264598362
- 邮箱:catalinvlad@yahoo.it
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California
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Stanford、California、美国、94305
- 尚未招聘
- Stanford University
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接触:
- Ranjana Advani, MD
- 电话号码:650-725-6456
- 邮箱:radvani@stanford.edu
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接触:
- Jessica Catherine Lam, MSc, PhD
- 电话号码:+16507230437
- 邮箱:jclam11@stanford.edu
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
纳入标准:
初诊为外周 T 细胞或 NK/T 细胞淋巴瘤的初治患者:
- T 细胞大颗粒淋巴细胞白血病;
- NK 细胞的慢性淋巴增生性疾病;
- 侵袭性 NK 细胞白血病;
- 成人 T 细胞白血病/淋巴瘤;
- 结外 NK/T 细胞淋巴瘤,鼻型;
- 肠 T 细胞淋巴瘤;
- 肝脾 T 细胞淋巴瘤;
- 皮下脂膜炎样 T 细胞淋巴瘤;
- 外周 T 细胞淋巴瘤,未另行说明;
- 血管免疫母细胞性 T 细胞淋巴瘤和 T 滤泡辅助细胞起源的其他淋巴瘤;
- 间变性大细胞淋巴瘤,ALK阳性;
- 间变性大细胞淋巴瘤,ALK 阴性;
- 乳房植入物相关的间变性大细胞淋巴瘤。
- 18岁及以上;
- 足以进行诊断和分类并可用于集中审查的组织活检;
- 要求提供临床数据,包括疾病定位和分期实验室参数的基线信息、所采用的治疗特征以及至少 2 年的随访更新保证;
- 书面知情同意书。
排除标准:
诊断:
- 儿童期 EBV 阳性 T 细胞和 NK 细胞淋巴增生性疾病
- 蕈样肉芽肿;
- 塞扎里综合症;
- 原发性皮肤 CD30 阳性 T 细胞淋巴组织增生性疾病;
- 原发性皮肤外周 T 细胞淋巴瘤,罕见亚型;
- T细胞淋巴母细胞淋巴瘤/白血病
- T细胞幼淋巴细胞白血病
- 年龄 < 18。
学习计划
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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无进展生存期 (PFS)
大体时间:2年
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从诊断日期到疾病进展或 T 细胞淋巴瘤死亡日期计算
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2年
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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总生存期(OS)
大体时间:3 和 5 年
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从诊断之日起至因任何原因死亡
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3 和 5 年
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无进展生存期 (PFS)
大体时间:3 和 5 年
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从诊断日期到疾病进展或 T 细胞淋巴瘤死亡日期计算
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3 和 5 年
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无事件生存 (EFS)
大体时间:在 24 个月
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从诊断日期到事件发生日期计算
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在 24 个月
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完全缓解率 (CR)
大体时间:30个月
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入组后 30 个月 (CR30) 的完全缓解率(即开始治疗)
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30个月
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合作者和调查者
调查人员
- 研究主任:Massimo Federico, MD、University of Modena and Reggio Emilia, Centro Oncologico Modenese, Modena, Italy
- 首席研究员:Attilio Guarini, MD、U.O. Ematologia, IRCCS Istituto Tumori "Giovanni Paolo II"
- 首席研究员:Julie Vose, MD、Section of Hematology/Oncology, Nebraska Medical Center, USA
- 首席研究员:Miles Prince, MD、Peter MacCallum Cancer Center, Melbourne, Australia
- 首席研究员:Kim Won Seog, MD、Hematology-Oncology Samsung Medical Center, Seoul, South Korea
- 首席研究员:Dolores Caballero, MD、Instituto Biosanitaria de Salamanca, Salamanca, Spain
- 首席研究员:Francesco Zaya, MD、Azienda Sanitaria Universitaria Integrata S.M. Misericordia, Udine, Italy
- 首席研究员:Stefano Luminari, MD、S.C. Ematologia, Arcispedale S. Maria Nuova-IRCCS, Reggio Emilia, Italy
- 首席研究员:Ranjana Advani, MD、Stanford University Medical Center, Stanford, CA, USA
- 首席研究员:Andrei Shustov, MD、Seattle Cancer Care Alliance, Seattle, WA, USA
- 首席研究员:Pierluigi Porcu, MD、Hematopoietic Stem Cell Transplantation, Sidney Kimmel Cancer Center, USA
- 首席研究员:Astrid Pavlovsky, MD、Centro de Hematologia, FUNDALEU, Buenos Aires, Argentina
- 首席研究员:Carlos Chiattone, MD、Departamento de Clinica Médica, FCM da Santa Casa de Sao Paulo, Sao Paulo, Brazil
- 首席研究员:Francine Foss, MD、Yale University School of Medicine, New Haven, CT, USA
- 首席研究员:Christopher Fox, MD、Clinical Haematology, Nottingham University Hospitals NHS Trust, Nottingham, UK
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有用的网址
- Pileri S, Federico M, Fossa F, et al: Pooled analysis of biomarker data quality from the Tcell project and complete studies. Hematol Oncol 31 (Suppl.:201-270, 2013
- Fox C, Bellei M, Manni M, et al: Improved survival outcomes for patients with extra-nodal nk/t lymphoma: data from 140 patients prospectively registered in the international T-cell project. Hematol Oncol 35:1-466, 2017
研究记录日期
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