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临床试验/NCT06422247
NCT06422247已完成不适用

Observational Study in Japanese Patients With Peripheral T-Cell Lymphoma Who Received Second-Line Therapy

Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 307 人开始时间: 2024年4月5日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
307
试验地点
1
主要终点
Overall survival (OS)

研究概览

简要总结

The purpose of this study is to describe the therapeutic practices and the prognosis of patients with relapsed or refractory peripheral T-cell lymphoma in Japan

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female participants with a confirmed diagnosis of the specific subtypes of peripheral T-cell lymphoma (PTCL) according to The World Health Organization (WHO) classification of lymphoid neoplasm, 4th edition defined by WHO and International Agency for Research on Cancer (IARC).
  • Participates aged ≥18 years of age at diagnosis of PTCL.
  • Participates who have been treated with a systemic therapy for PTCL and have initiated a systemic therapy as a second-line therapy for relapsed or refractory PTCL between April 1, 2018 and March 31, 2023.

排除标准

  • Participates who have medical history of peripheral T-cell lymphoma (PTCL) treatment by unapproved drug in Japan as of 31 March 2024 or off-label drug for PTCL in Japan as of 31 March
  • Participates who have medical history of participation to a separately defined registration study for regulatory approval in PTCL.
  • Participates who have medical history of PTCL treatment in a separately defined clinical study with intervention by on-label regimen for PTCL.
  • Participates judged to be inappropriate for enrollment in this study by the site investigator.

研究组 & 干预措施

Relapsed or refractory peripheral T-cell lymphoma initiating second-line systemic therapy

干预措施: Systemic therapy (Drug)

结局指标

主要结局

Overall survival (OS)

时间窗: From baseline until date of death from any cause or last known alive date, assessed up to 6 years

次要结局

  • Frequency of treatment regimen by treatment line(End date of each treatment-line of therapy, assessed up to 6 years)
  • Time to next treatment line or death (TTNT)(From date of first-line therapy initiation until death from any cause or last known alive date, assessed up to 6 years)
  • Participant baseline demographics(Baseline)
  • Participant baseline clinical characteristics(Baseline)
  • Participant treatment sequence from initial diagnosis(From date of initial diagnosis until death from any cause or last known alive date, assessed up to 6 years)

研究者

发起方
Bristol-Myers Squibb
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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