Using a Modified ALCL99 Regimen for Chinese Children with Newly Diagnosed High-risk Anapestic Large Cell Lymphoma
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Treatment-related adverse events
研究概览
简要总结
A prospective study on the efficacy of modified ALCL99 regimens in the treatment of the current Chinese pediatric and adolescent high-risk ALCL and compared with our historical data.
详细描述
Anaplastic large cell lymphoma (ALCL) accounts for 15% of pediatric and adolescent non-Hodgkin lymphomas (NHLs). In our historical study (retrospective multicenter study), the 3-year event-free survival (EFS) was 65% for 80 eligible patients treated in 10 centers between January 2009 and June 2014.
The ALCL99 trial reported a 2-year overall survival of 92% and 2-year event-free survival of 74% then become the current standard frontline treatment for pediatric ALCL. The recent long-term follow-up data from ALCL99 trial highlighted its excellent outcome. A less toxic schedule of methotrexate (MTX) 3g/m2 in a 3-hour infusion without intrathecal therapy reproduced the favorable results from previous reports of NHL-BFM90 protocol with MTX at 1g/m2 in a 3-hour infusion. Additionally, a prospective ALCL-Relapse trial by the European Inter-Group for Childhood Non-Hodgkin Lymphoma demonstrated 80% of patients with a late relapse can be cured by 24 months of vinblastine monotherapy. However, vinblastine would not be advised as a treatment option in mainland China due to its inaccessibility. A pilot experience using single-drug vinorelbine in 4 pediatric patients with relapsed ALCL with satisfactory outcome provides the rational for studying vinorelbine as a front line drug option.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must be ≤ 18 years at the time of diagnosis
- •Newly diagnosed patients with histologically confirmed high-risk anaplastic large cell lymphoma
- •No congenital immunodeficiency, HIV infection, or prior organ transplant
排除标准
- •Patients have received prior cytotoxic chemotherapy/target therapy/radiation, if any steroid applied, total prior steroids dosage > Dexamethasone 40 mg/m2 for the current diagnosis or any cancer
- •Patients have overwhelming infection, and a life expectancy of < 2 weeks
研究组 & 干预措施
High risk group
- Stage I, unresected; Stage I with "B" syndrome
- Stage II
- Stage III
- Stage IV without CNS involvement
干预措施: P regimen (Drug)
High risk group
- Stage I, unresected; Stage I with "B" syndrome
- Stage II
- Stage III
- Stage IV without CNS involvement
干预措施: Course A1 + Vin (Drug)
High risk group
- Stage I, unresected; Stage I with "B" syndrome
- Stage II
- Stage III
- Stage IV without CNS involvement
干预措施: Course B1 +Vin (Drug)
High risk group
- Stage I, unresected; Stage I with "B" syndrome
- Stage II
- Stage III
- Stage IV without CNS involvement
干预措施: Course A2 + Vin (Drug)
High risk group
- Stage I, unresected; Stage I with "B" syndrome
- Stage II
- Stage III
- Stage IV without CNS involvement
干预措施: Course B2 +Vin (Drug)
High risk group
- Stage I, unresected; Stage I with "B" syndrome
- Stage II
- Stage III
- Stage IV without CNS involvement
干预措施: Course A3 + Vin (Drug)
High risk group
- Stage I, unresected; Stage I with "B" syndrome
- Stage II
- Stage III
- Stage IV without CNS involvement
干预措施: Course B3 +Vin (Drug)
High risk group
- Stage I, unresected; Stage I with "B" syndrome
- Stage II
- Stage III
- Stage IV without CNS involvement
干预措施: Maintenance therapy (Drug)
结局指标
主要结局
Treatment-related adverse events
时间窗: Up to 3years
Number of participants with treatment-related adverse events as assessed by CTCAEv5.0
3-year event free survival (EFS)
时间窗: Up to 3 years
Calculated from the time of diagnosis to the first of the following events: progression, relapse, secondary ,malignancy or death
次要结局
- Patient compliance(Up to 3years)
- Value of early PET/CT in pediatric ALCL(Up to 3 years)
- Value of peripheral blood or bone marrow NPM-ALK or ALK-variants level in pediatric ALCL(Up to 3 years)
