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正在招募III 期编号 NCT05675410

A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab

报名条件(概要)

  • 年龄:5 Years – 60 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、Canada、Puerto Rico

药品与企业信息

Biospecimen Collection治疗操作

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

Undergo blood sample collection

Bleomycin Sulfate生物制品

其他名称:Blanoxan、BleMomycine、Blenoxane、Bleo-cell、Bleo-S、Bleocin

Given IV

其他名称:ADC SGN-35、Adcetris、Anti-CD30 Antibody-Drug Conjugate SGN-35、Anti-CD30 Monoclonal Antibody-MMAE SGN-35、Anti-CD30 Monoclonal Antibody-Monomethylauristatin E SGN-35、cAC10-vcMMAE

Given IV

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 and/or PET-CT

其他名称:(-)-Cyclophosphamide、2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate、Asta B 518、B 518、B-518、B518

Given IV

其他名称:4-(Dimethyltriazeno)imidazole-5-carboxamide、5-(Dimethyltriazeno)imidazole-4-carboxamide、Asercit、Biocarbazine、Dacarbazina、Dacarbazina Almirall

Given IV

其他名称:5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)、ADM、Adriacin、Adriamycin、Adriamycin Hydrochloride、Adriamycin PFS

Given IV

Etoposide药物

其他名称:Demethyl Epipodophyllotoxin Ethylidine Glucoside、EPEG、Lastet、Toposar、Vepesid、VP 16

Given IV

研发企业

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

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

Doxorubicin Hydrochloride

Pfizer Laboratories Div Pfizer Inc

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 the effect of adding immunotherapy (brentuximab vedotin and nivolumab) to standard treatment (chemotherapy with or without radiation) to the standard treatment alone in improving survival in patients with stage I and II classical Hodgkin lymphoma. Brentuximab vedotin is in a class of medications called antibody-drug conjugates. It is made of a monoclonal antibody called brentuximab that is linked to a cytotoxic agent called vedotin. Brentuximab attaches to CD30 positive lymphoma cells in a targeted way and delivers vedotin to kill them. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs such as doxorubicin hydrochloride, bleomycin sulfate, vinblastine sulfate, dacarbazine, and procarbazine hydrochloride 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. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body's immune response. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Adding immunotherapy to the standard treatment of chemotherapy with or without radiation may increase survival and/or fewer short-term or long-term side effects in patients with classical Hodgkin lymphoma compared to the standard treatment alone.

适应症

Lugano Classification Limited Stage Hodgkin Lymphoma AJCC v8

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 Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab
ClinicalTrials.gov Identifier: NCT05675410
Sponsor: National Cancer Institute (NCI)
Investigational product: Biospecimen Collection, Bleomycin Sulfate, Brentuximab Vedotin, Computed Tomography, Cyclophosphamide

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 Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab
试验编号:NCT05675410
申办方:National Cancer Institute (NCI)
研究药物:Biospecimen Collection、Bleomycin Sulfate、Brentuximab Vedotin、Computed Tomography、Cyclophosphamide

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