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临床试验/NCT06598722
NCT06598722进行中(未招募)2 期

The Efficacy and Safety of BCL-2 Inhibitors Combined with the HyperCVAD Regimen in the Treatment of Newly Diagnosed T-lymphoblastic Leukemia/ Lymphoma

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 206 人开始时间: 2024年8月7日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
进行中(未招募)
发起方
入组人数
206
试验地点
1
主要终点
Evaluate the best complete remission rate (CR)

研究概览

简要总结

The experimental group included patients diagnosed with T-ALL/LBL (T-lymphoblastic leukemia/ lymphoma) at initial diagnosis, who received treatment with BCL-2 inhibitors combined with the Hyper CVAD regimen. The control group consisted of patients diagnosed with T-ALL/LBL from multiple centers, for whom basic information, disease information, treatment details, and efficacy data were collected. Propensity score matching was conducted with historical data (matching factors included age, gender, initial LDH levels, and the presence or absence of a large mediastinal mass at diagnosis) to compare the advantages and disadvantages of the experimental regimen with previous induction treatment protocols. The primary endpoint was the complete remission (CR) rate after induction chemotherapy, while secondary endpoints included duration of remission (DOR), progression-free survival (PFS), overall survival (OS), and the occurrence of adverse events. This study aims to provide a more effective and safer treatment option for patients with T-LBL.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

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

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

BCL-2 inhibitors combined with the HyperCVAD regimen for newly diagnosed T-ALL/LBL

Experimental

干预措施: BCL-2 inhibitors combined with the HyperCVAD regimen (Drug)

propensity score matching with historical data

Other

干预措施: Propensity score matching historical data (Other)

结局指标

主要结局

Evaluate the best complete remission rate (CR)

时间窗: at the end of cycle 4 of chemotherapy(each cycle is 28 days)

AE

时间窗: at the end of cycle 2(each cycle is 28 days)

adverse events during research

The best overall response rate

时间窗: at the end of cycle 2(each cycle is 28 days)

complete remission and partial remission

次要结局

  • PFS(2 year)
  • Duration of remission(1 year)
  • OS(2 year)
  • the proportion of successful bridging to allogeneic hematopoietic stem cell transplantation(the end of the study)

研究者

发起方
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xianmin Song, MD

Investigator Official Title

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

研究点 (1)

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