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临床试验/NCT06295211
NCT06295211已完成不适用

Brentuximab Vedotin Combined With Bendamustine Supercharge, a Low-toxicity and Efficient Salvage Regimen for Primary Refractory or First-relapsed Classic Hodgkin Lymphoma: Long-term Results of a Retrospective Monocenter Study.

Federico II University0 个研究点目标入组 32 人开始时间: 2013年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
32
主要终点
Overall survival

研究概览

简要总结

This is a retrospective, monocenter and non-interventional study. Data were retrospectively collected from all patients who completed the BV-Bs scheme in the time period between 1 September 2013 and 1 September 2023.

详细描述

This is a retrospective, monocenter and non-interventional study. Data were retrospectively collected from all patients who completed the BV-Bs scheme in the time period between 1 September 2013 and 1 September 2023.

The regimen consisted of 3-day outpatient intravenous infusions of 1.8 mg/kg Bv on Day 1 of each 3-week cycle (as established by Younes and colleagues) sequentially combined with bendamustine (at least 24 hours after Bv, precisely on days 2 and 3 of the treatment cycle; as reported by Picardi et al) at a fixed dose of 120 mg/m2 per day.

All patients who achieved at least partial remission were considered eligible for peripheral blood stem cell (PBSC) collection (performed with granulocyte colony-stimulating factor [G-CSF] and endoxan or plerixafor, if necessary) and proceeded to ASCT at any time beyond cycle 4.

The anti-tumor activity of this treatment regimen was assessed according to the Lugano criteria at the end of the combination treatment.

Prior to the first cycle of Bv-Bs, all patients underwent a clinical evaluation that included assessment of B symptoms, World Health Organization performance status, and measurement of palpable lesions. In particular, imaging procedures were conducted after the second and fourth cycles or prior to ASCT. The response was based on international criteria (Cheson et al, 2016). PET scans were considered positive or negative based on the Deauville 5-point scale criteria.

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 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • patients age between 18 years and 60 years;
  • histological confirmation of CD30+ subtype cHL at first relapse or at refractory (patients who have failed to achieve complete remission at the end of treatment with 4-6 cycles of ABVD or who have progressed early during front-line treatment [after 2 cycles of ABVD] with interim FDG-PET/CT with Deauville scale score of 5 [primary refractory patients])
  • treatment with at least 1 cycle of Bs and Bv at doses of 120 mg/m2 and 1.8 mg/kg, respectively
  • metabolically active disease measurable at fluoro-desossi-glucose-positron emission tomography/computed tomography (FDG-PET/CT)
  • EGOG performance status 0-2 (or 3, if due to illness).

排除标准

  • patients not fulfilling inclusion criteria

结局指标

主要结局

Overall survival

时间窗: 10 year period

survival

次要结局

  • Progression overall survival(10 year period)
  • Response to treatment(at end of 4 cycles treatment (each cycle of 28 days))
  • Incidence of treatment emergent adverse events(during 4 cycles of treatment (each cycle of 28 days))

研究者

发起方
Federico II University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marco Picardi

professor

Federico II University

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