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正在招募III 期编号 NCT04293562

A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations

报名条件（概要）

  • 年龄：6 Months – 21 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

United States、Australia、Canada、Puerto Rico

药品与企业信息

Allogeneic Hematopoietic Stem Cell Transplantation治疗操作

其他名称：Allogeneic、Allogeneic Hematopoietic Cell Transplantation、Allogeneic Stem Cell Transplantation、HSC、HSCT、Stem Cell Transplantation, Allogeneic

Undergo allogeneic HSCT

Asparaginase Erwinia chrysanthemi药物

其他名称：Asparaginase Erwinia chrysanthemi (Recombinant)-rywn、Asparaginase Erwinia chrysanthemi, Recombinant-rywn、Asparaginase Erwinia chrysanthemi-rywn、Crisantaspase、Crisantaspase Biobetter JZP-458、Crisantaspasum

Given IM or IV

Biospecimen Collection治疗操作

其他名称：Biological Sample Collection、Biospecimen Collected、Sample Collection、Specimen Collection

Undergo blood sample collection

Bone Marrow Aspiration治疗操作

Undergo BM aspiration

Bone Marrow Biopsy治疗操作

其他名称：Biopsy of Bone Marrow、Biopsy, Bone Marrow

BM biopsy

Computed Tomography治疗操作

其他名称：CAT、CAT Scan、Computed Axial Tomography、Computerized Axial Tomography、Computerized axial tomography (procedure)、Computerized Tomography

Undergo CT

Cytarabine药物

其他名称：.beta.-Cytosine arabinoside、1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone、1-.beta.-D-Arabinofuranosylcytosine、1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone、1-Beta-D-arabinofuranosylcytosine、1.beta.-D-Arabinofuranosylcytosine

Given IV or IT

Daunorubicin Hydrochloride药物

其他名称：Cerubidin、Cerubidine、Cloridrato de Daunorubicina、Daunoblastin、Daunoblastina、Daunoblastine

Given IV

研发企业

Children's Oncology Group研究网络

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

公开药品批准资料或正式说明书暂未提供明确的生产企业信息。

合作机构

  • National Cancer Institute (NCI)美国国立卫生研究院

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）

This phase III trial compares standard chemotherapy to therapy with liposome-encapsulated daunorubicin-cytarabine (CPX-351) and/or gilteritinib for patients with newly diagnosed acute myeloid leukemia with or without FLT3 mutations. Drugs used in chemotherapy, such as daunorubicin, cytarabine, and gemtuzumab ozogamicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. CPX-351 is made up of daunorubicin and cytarabine and is made in a way that makes the drugs stay in the bone marrow longer and could be less likely to cause heart problems than traditional anthracycline drugs, a common class of chemotherapy drug. Some acute myeloid leukemia patients have an abnormality in the structure of a gene called FLT3. Genes are pieces of DNA (molecules that carry instructions for development, functioning, growth and reproduction) inside each cell that tell the cell what to do and when to grow and divide. FLT3 plays an important role in the normal making of blood cells. This gene can have permanent changes that cause it to function abnormally by making cancer cells grow. Gilteritinib may block the abnormal function of the FLT3 gene that makes cancer cells grow. The overall goals of this study are, 1) to compare the effects, good and/or bad, of CPX-351 with daunorubicin and cytarabine on people with newly diagnosed AML to find out which is better, 2) to study the effects, good and/or bad, of adding gilteritinib to AML therapy for patients with high amounts of FLT3/ITD or other FLT3 mutations and 3) to study changes in heart function during and after treatment for AML. Giving CPX-351 and/or gilteritinib with standard chemotherapy may work better in treating patients with acute myeloid leukemia compared to standard chemotherapy alone.

适应症

Acute Myeloid Leukemia

主动联系研究团队

这项试验目前在中国大陆没有研究中心

这种情况下，直接发"入组咨询"往往会被回复"您所在地区没有中心"。更有效的做法是申请同情用药／扩展准入（由主治医生一同提出），或询问能否到最近的境外中心参加。下面已为您切换到对应的信件版本。

查看完整申请路径与成功率说明 →

研究中心联系方式

问自己是否符合条件、如何预筛

我的病情档案

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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: A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations
ClinicalTrials.gov Identifier: NCT04293562
Sponsor: Children's Oncology Group
Investigational product: Allogeneic Hematopoietic Stem Cell Transplantation, Asparaginase Erwinia chrysanthemi, Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy

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：A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations
试验编号：NCT04293562
申办方：Children's Oncology Group
研究药物：Allogeneic Hematopoietic Stem Cell Transplantation、Asparaginase Erwinia chrysanthemi、Biospecimen Collection、Bone Marrow Aspiration、Bone Marrow Biopsy

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 oncologyresearch@peds.uab.edu

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