NCT04804865Unknown不适用
Secondary Prognostic Index in RefrActory Diffuse Large B Cells Lymphoma
Weprom2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2020年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Overall survival
研究概览
简要总结
60% of patients with diffuse large B cell lymphoma are healed after first-line treatment which whatever the age. For the remaining 40% of patients (relapses and primary refractories):
- 38% of patients will be cured with a 2nd line including an autologous haematopoietic cell transplantation for those under 65 years.
- for older patients who are not eligible for a autograft: only 70% of patients will be able to receive 2nd line treatment with rates response less than 50%.
- the survival rate in patients receiving 3rd line treatment or more is 15% at 2 years. Actually, no standard of chemotherapy is offered to relapsed or refractory patients after 2 therapeutic lines. Subsequent lines lead to hospitalizations for infectious complications or transfusions without clear clinical benefit with often an impacted quality of life.
Palliative care is rarely offered as part of the treatment overall load.
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
- 否
入选标准
- •Age > 18 years old
- •died of diffuse large B cell lymphoma
- •Refractory or relapsing after 2 treatment lines for young patients (RCHOP then recovery with platinum salts and autograft) and one line for elderly patients (RCHOP)
排除标准
- •patients with HIV infection
- •solid tumor treated less than 5 years ago with the exception of skin carcinoma or carcinoma in situ of the uterine cervix treated locally
- •inclusion in a therapeutic trial
结局指标
主要结局
Overall survival
时间窗: 5 years
Time between the date of relapse or no response observed (after 2 lines of chemotherapy in young patients and one line for elderly patients) and the date of death regardless of the cause.
次要结局
- the intensity dose of chemotherapy received(6 month)
- the Cumulative Illness Rating Scale for comorbidities score in patients over 65 years old(6 month)
- Median response time after each line(5 years)
- Event-free survival since diagnosis and after each line of treatment received(5 years)
研究者
研究点 (2)
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