Prospective Study of the Prognostic Value of New Markers in Adults With ALK-positive Large Anaplastic Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 15
- 主要终点
- Prognostic value of biological parameters on the complete metabolic response rate (MCR)
研究概览
简要总结
The study aims to evaluate the prognostic value on the complete metabolic response rate (MCR), the incidence of relapse / progression, the Progression Free Survival (PFS) and the Overall Survival (OS).
- at diagnosis
- after the first cycle of CHOEP (early evaluation)
- at the end of treatment
详细描述
ALK-positive anaplastic large cell (anaplastic large-cell lymphoma, ALCL) is a rare adult disease for which almost all published studies are retrospective. The overall survival (OS) at 5 years varies from 70 to 87%. A recent international pooled analysis showed that the International Prognostic Index (IPI) had good predictive value for the PFS and the OS.
In children, new prognostic factors have been identified: the titre of circulating anti-ALK antibodies (inverse correlation between the antibody titre and the prognosis), the detection of a NPM-ALK transcript in the blood at diagnosis (minimal disseminated disease, MDD); correlation between MDD positivity and pejorative prognosis) and its minimal residual disease (MRD), and the histological subtype (common versus small cells / lymphohistiocytic).
The predictive value of the oncogenic profile of ALK-positive ALCL and circulating tumor DNA will be studied in this study.
- At diagnosis (before starting treatment):
- Cycle 2 Day 1 (before starting cycle 2 treatment):
- At the end of treatment evaluation:
40 patients treated with 6 cycles of CHOEP every 3 weeks and 1 lumbar puncture at diagnosis with intrathecal prophylaxis with methotrexate will be included prospectively.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Over 18 years old Diagnosed with Anaplastic large-cell lymphoma ALK+
- •Planned treatment : 6 cycles of CHOEP 21
- •Planned lumbar puncture at diagnosis or at the first cycle with intrathecal prophylaxis with methotrexate (15 mg) at the first cycle
- •Planned interim positron emission tomograph (PET)-scan after 3 cycles of treatment and at the end of treatment according to the center standard of care
排除标准
- •Involvement of the central nervous system
- •Intent of Autologous stem-cell transplant in first line
结局指标
主要结局
Prognostic value of biological parameters on the complete metabolic response rate (MCR)
时间窗: Day 0
次要结局
- Prognostic value of biological parameters on the incidence of relapse(1 month)
- Prognostic value of biological parameters on the incidence relapse(2 years)
- Prognostic value of biological parameters on the complete metabolic response rate (MCR)(2 years)
- Prognostic value of biological parameters on the Progression Free Survival (PFS)(2 years)
- Prognostic value of biological parameters on the Overall Survival (OS)(2 years)