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正在招募III 期编号 NCT06520163

Comparison Study of EAP and Disease-Specific Chemotherapy Regimens in Hematopoietic Stem Cell Mobilization for Lymphoma

报名条件(概要)

  • 年龄:18 Years – 75 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

China

药品与企业信息

Etoposide药物

其他名称:VP-16

Day 1\~Day 2: 75mg/m\^2

其他名称:Ara-C

Day 1\~Day 2: 200g/m\^2, q12h

Day 6: 6mg

G-CSF药物

Starting from the 9th day, if the white blood cell count is less than 20,000/μL, administer G-CSF at a dose of 5μg/kg by subcutaneous injection until the collection is completed.

CHOP组合产品

\[Cyclophosphamide (Cy) + Doxorubicin (ADM) + Vincristine (VDS) + Prednisone (Pred) \]± Rituximab (R)

Hyper-CVAD组合产品

\[Cyclophosphamide + Doxorubicin + Vincristine + Dexamethasone (DXM)\] ± Rituximab

ID-MTX + Ara-C组合产品

\[High-Dose Methotrexate (MTX) + Cytarabine\] ± Rituximab

DA-EPOCH组合产品

\[Etoposide + Doxorubicin + Vincristine + Cyclophosphamide + Prednisone\] ± Rituximab

研发企业

The Affiliated People's Hospital of Ningbo UniversityOTHER_GOV

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

  • First Affiliated Hospital of Zhejiang University研究机构/其他
  • First Affiliated Hospital of Wenzhou Medical University研究机构/其他
  • Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University研究机构/其他
  • Jinhua People's Hospital研究机构/其他
  • The Central Hospital of Lishui City研究机构/其他
  • Shaoxing People's Hospital研究机构/其他
  • Shaoxing Second Hospital研究机构/其他
  • Zhejiang Provincial Tongde Hospital研究机构/其他
  • Taizhou Hospital研究机构/其他
  • Dongyang People's Hospital研究机构/其他
  • Affiliated Hospital of Jiaxing University研究机构/其他
  • Huzhou Central Hospital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)

This study utilizes a prospective, multicenter, randomized two-arm design to evaluate the efficacy and safety of the etoposide, cytarabine, and pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) combination therapy (EAP regimen) in mobilizing hematopoietic stem cells in patients with non-Hodgkin's lymphoma (NHL). A total of 99 NHL patients will be enrolled as research subjects and will be randomly allocated in a 2:1 ratio to compare the EAP regimen versus disease-specific chemotherapy mobilization regimen. The primary endpoint is the proportion of patients achieving the ideal collection value after a single collection (CD34+ cells ≥5×10\^6/kg).

适应症

Non-Hodgkin's LymphomaHematopoietic Stem Cell Mobilization

主动联系研究团队

总联系人(申办方/研究总部)

中国/港澳台研究中心

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: Comparison Study of EAP and Disease-Specific Chemotherapy Regimens in Hematopoietic Stem Cell Mobilization for Lymphoma
ClinicalTrials.gov Identifier: NCT06520163
Sponsor: The Affiliated People's Hospital of Ningbo University
Investigational product: Etoposide, Cytarabine, PEG-rhG-CSF, G-CSF, CHOP

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:Comparison Study of EAP and Disease-Specific Chemotherapy Regimens in Hematopoietic Stem Cell Mobilization for Lymphoma
试验编号:NCT06520163
申办方:The Affiliated People's Hospital of Ningbo University
研究药物:Etoposide、Cytarabine、PEG-rhG-CSF、G-CSF、CHOP

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 39612903@qq.com

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