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临床试验/NCT04881838
NCT04881838招募中3 期

Using a Modified ALCL99 Regimen for Chinese Children with Newly Diagnosed High-risk Anapestic Large Cell Lymphoma

Children's Cancer Group, China1 个研究点 分布在 1 个国家目标入组 172 人开始时间: 2021年3月1日最近更新:
适应症
干预措施
相关药物

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

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

Experimental
  1. Stage I, unresected; Stage I with "B" syndrome
  2. Stage II
  3. Stage III
  4. Stage IV without CNS involvement

干预措施: P regimen (Drug)

High risk group

Experimental
  1. Stage I, unresected; Stage I with "B" syndrome
  2. Stage II
  3. Stage III
  4. Stage IV without CNS involvement

干预措施: Course A1 + Vin (Drug)

High risk group

Experimental
  1. Stage I, unresected; Stage I with "B" syndrome
  2. Stage II
  3. Stage III
  4. Stage IV without CNS involvement

干预措施: Course B1 +Vin (Drug)

High risk group

Experimental
  1. Stage I, unresected; Stage I with "B" syndrome
  2. Stage II
  3. Stage III
  4. Stage IV without CNS involvement

干预措施: Course A2 + Vin (Drug)

High risk group

Experimental
  1. Stage I, unresected; Stage I with "B" syndrome
  2. Stage II
  3. Stage III
  4. Stage IV without CNS involvement

干预措施: Course B2 +Vin (Drug)

High risk group

Experimental
  1. Stage I, unresected; Stage I with "B" syndrome
  2. Stage II
  3. Stage III
  4. Stage IV without CNS involvement

干预措施: Course A3 + Vin (Drug)

High risk group

Experimental
  1. Stage I, unresected; Stage I with "B" syndrome
  2. Stage II
  3. Stage III
  4. Stage IV without CNS involvement

干预措施: Course B3 +Vin (Drug)

High risk group

Experimental
  1. Stage I, unresected; Stage I with "B" syndrome
  2. Stage II
  3. Stage III
  4. 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)

研究者

发起方
Children's Cancer Group, China
申办方类型
Network
责任方
Sponsor

研究点 (1)

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