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正在招募III 期编号 NCT04043494

International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma

报名条件（概要）

  • 年龄：不限 – 18 Years
  • 性别：不限
  • 健康志愿者：不接受

完整入排标准请以官方页面为准。

开展国家/地区

Austria、Belgium、China、Czechia、Denmark、Finland、France、Germany、Hungary、Ireland、Israel、Italy

药品与企业信息

Cyclophosphamide药物

Part of standard chemotherapy and included in the experimental treatment phase protocol Ib\* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)

Cytarabine药物

No involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase protocol Ib\* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2). Involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib\* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)

Dexamethasone药物

Part of the experimental therapy in Randomization R1 (Protocol Ia-Dexamethasone) and in Randomization R2 (Intensified Protocol M)

Daunorubicin药物

Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib\* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)

Doxorubicin药物

Part of standard chemotherapy

Ifosfamide药物

Part of the experimental therapy in Randomization R2 (Intensified Protocol M)

6-Mercaptopurine药物

Part of standard chemotherapy and included in the experimental treatment phase protocol Ib\* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)

Methotrexate药物

Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib\* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)

研发企业

University Hospital Muenster研究机构/其他

试验官方登记的主要申办方；研究机构申办时会显示相应机构名称。

生产企业

Methotrexate

Hospira, Inc.

合作机构

  • Deutsche Krebshilfe e.V., Bonn (Germany)研究机构/其他

研发企业与生产企业可能不是同一家。研究阶段药品可能尚未公布生产企业；生产企业仅取自美国上市原研药说明书所列企业（不含仿制药），不作推测；仅在其他国家上市的药品暂无法显示。

研究简介（原文）

Primary objectives: * Randomization R1, all patients eligible: To examine, whether the cumulative incidence of relapses with involvement of the CNS (CNS relapse, pCICR) can be decreased by a modified induction therapy including dexamethasone (experimental arm) instead of prednisone (standard arm) * Randomization R2, only patients with high risk LBL eligible: to examine, whether the probability of event-free survival (pEFS) in these patients can be improved by receiving an intensified treatment arm versus a standard treatment arm (as used in the EURO-LB 02)

适应症

Lymphoblastic Lymphoma, Childhood

主动联系研究团队

总联系人（申办方／研究总部）

问自己是否符合条件、如何预筛

我的病情档案

管理档案

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英文版（发给研究团队）

Dear Study Team,

I am a patient in China and I am interested in participating in your clinical trial:

Study Title: International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma
ClinicalTrials.gov Identifier: NCT04043494
Sponsor: University Hospital Muenster
Investigational product: Cyclophosphamide, Cytarabine, Dexamethasone, Daunorubicin, Doxorubicin

About me:
- Age: (please fill in)
- Sex: (please fill in)
- Confirmed diagnosis and stage: (please fill in)
- Biomarkers / genetic testing: not available
- Prior and current treatments: (please fill in)
- Performance status (ECOG): not assessed
- Current location: China
- Travel ability: (please fill in)

Could you please let me know:
1. Whether I might be eligible for this study;
2. Which site would be closest and most practical for me, and whether remote pre-screening is possible;
3. What documents (medical records, pathology or imaging reports, recent labs) I should prepare for pre-screening.

I can provide English translations of my medical records. Thank you very much for your time and help.

Kind regards,
(your name)
(your email / phone with country code)

中文对照（供您核对）

尊敬的研究团队：

我是一位来自中国的患者，希望咨询参加以下临床试验的可能：

研究名称：International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma
试验编号：NCT04043494
申办方：University Hospital Muenster
研究药物：Cyclophosphamide、Cytarabine、Dexamethasone、Daunorubicin、Doxorubicin

我的基本情况：
- 年龄：（请填写）
- 性别：（请填写）
- 确诊疾病与分期：（请填写）
- 基因／标志物检测：暂无
- 既往及当前治疗：（请填写）
- 体能状态（ECOG）：未评估
- 目前所在城市：中国
- 可前往范围：（请填写）

想请教三个问题：
1. 我是否可能符合本研究的入组标准？
2. 哪个中心对我最方便可行？能否远程预筛？
3. 预筛需要准备哪些资料（病历、病理、影像、近期化验）？

我可以提供英文翻译版病历。感谢您的时间与帮助。

顺祝安康
（您的姓名）
（您的邮箱／带国际区号的电话）
用邮件客户端发送给 LBL2018@ukmuenster.de

提示：请与主治医生一起发信——由医生署名的申请，回复率远高于患者单独发信。首封邮件不要附身份证号等敏感信息。研究团队通常在 3–10 个工作日内回复，两周无回音可礼貌追问一次。

下一步怎么做？

  1. 把本页信息带给您的主治医生，评估是否适合参加。
  2. 点击下方按钮打开官方注册页，查看研究中心联系方式。
  3. 直接联系研究团队咨询报名事宜（通常有中文同声翻译服务可协助沟通）。
在 ClinicalTrials.gov 查看官方页面