EFFICACY OF ANTI-CD20 ANTIBODY IN LYMPHOCYTE PREDOMINANT HODGKIN'S DISEASE

抗 CD20 抗体在淋巴细胞为主型霍奇金病中的疗效

基本信息

  • 批准号:
    7605162
  • 负责人:
  • 金额:
    $ 2.11万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2007
  • 资助国家:
    美国
  • 起止时间:
    2007-02-15 至 2007-11-30
  • 项目状态:
    已结题

项目摘要

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Given the effectiveness of an anti-CD20 antibody in treating follicular low-grade lymphoma (by targeting the CD20 cell surface antigen), we hypothesize that this antibody will show equal effectiveness in the treatment of indolent, CD20-positive Lymphocyte-Predominant Hodgkin's Disease (LPHD). Experimental Design: This is a single-arm, prospective, two-stage, phase II trial. Accrual of 13 patients (at an approximate rate of 2-3 per month) will be necessary for the first phase. If response is demonstrated in 3/13 patients, the study will continue until an accrual of 43 patients is reached. Patients will be followed at frequent intervals for response and duration of response, until disease progression or two years post-treatment. Within 2 weeks of enrollment, the patients will start therapy. Each patient will receive anti-CD20 antibody 375 mg/m2 intravenous infusion given as an outpatient every week x 4 treatments. Endpoints: The primary endpoint of this study is an evaluation of the complete response rate of untreated and recurrent LPHD in response to the use of Rituximab (anti-CD20, Rituxan). Secondary endpoints will be to measure disease-free and progression-free intervals. Analytical Methods: Disease measurements will be made radiographically by CT scan, and toxicities will be measured using the Eastern Cooperative Oncology Group (ECOG) toxicity criteria. Clinical response will be defined by reduction in the sum of the bidimensional products of measured representative tumor lesions. Positive responses will include Partial Responses (PR) or Complete Responses (CR). Confirmed complete responses will be determined as a primary criteria for efficacy. Duration of response and disease-free survival will also be measured as separate criteria for efficacy. Partial responses will also be measured as a secondary endpoint for efficacy. Additionally, progression free survival will also be measured. All subjects who receive at least one dose of medication will be assessed for clinical safety and tolerability. The treatment period will include the time from the first dose of antibody to six months following the last dose of antibody.
这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金, 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 鉴于抗CD20抗体在治疗滤泡性低度恶性淋巴瘤方面的有效性(通过靶向CD20细胞表面抗原),我们假设这种抗体在治疗以CD20阳性的淋巴细胞为主的惰性霍奇金氏病(LPHD)方面将表现出同样的有效性。 实验设计: 这是一项单臂、前瞻性、两阶段、II期试验。第一阶段将需要累积13名患者(大约每月2-3名)。如果13名患者中有3名患者有反应,这项研究将继续进行,直到达到43名患者的累积人数。将定期跟踪患者的反应和持续时间,直到疾病进展或治疗后两年。 在登记后的两周内,患者将开始治疗。每例患者均接受抗CD20抗体375 mg/m2的静脉滴注,每周一次,共4次。 终端: 这项研究的主要终点是评估未治疗和复发的LPHD在使用利妥昔单抗(抗CD20,利妥昔)后的完全应答率。次要终点将是测量无疾病和无进展的间期。 分析方法: 疾病测量将通过CT扫描进行放射学测量,毒性将使用东方合作肿瘤学小组(ECOG)毒性标准进行测量。临床反应将通过测量的代表性肿瘤病变的二维乘积总和的减少来定义。阳性反应包括部分反应(PR)或完全反应(CR)。确认的完全应答将被确定为疗效的主要标准。反应持续时间和无病存活率也将作为疗效的单独标准进行衡量。 部分反应也将作为疗效的次要终点进行测量。此外,无进展存活率也将被测量。所有接受至少一剂药物治疗的受试者都将接受临床安全性和耐受性评估。治疗期将包括从第一剂抗体到最后一剂抗体后六个月的时间。

项目成果

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SANDRA J. HORNING其他文献

SANDRA J. HORNING的其他文献

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{{ truncateString('SANDRA J. HORNING', 18)}}的其他基金

Autografting for Lymphoma
自体移植治疗淋巴瘤
  • 批准号:
    8260362
  • 财政年份:
    2011
  • 资助金额:
    $ 2.11万
  • 项目类别:
Autografting for Lymphoma
自体移植治疗淋巴瘤
  • 批准号:
    7212897
  • 财政年份:
    2007
  • 资助金额:
    $ 2.11万
  • 项目类别:
CLINICAL TRIAL: EVALUATE THE EFFICACY OF ANTI-CD20 ANTIBODY IN LYMPHOCYTE PREDOM
临床试验:评估抗 CD20 抗体在前淋巴细胞中的功效
  • 批准号:
    7717845
  • 财政年份:
    2007
  • 资助金额:
    $ 2.11万
  • 项目类别:
EFFICACY OF ANTI-CD20 ANTIBODY IN LYMPHOCYTE PREDOMINANT HODGKIN'S DISEASE
抗 CD20 抗体在淋巴细胞为主型霍奇金病中的疗效
  • 批准号:
    7375191
  • 财政年份:
    2005
  • 资助金额:
    $ 2.11万
  • 项目类别:
EFFICACY OF ANTI-CD20 ANTIBODY IN LYMPHOCYTE PREDOMINANT HODGKIN'S DISEASE
抗 CD20 抗体在淋巴细胞为主型霍奇金病中的疗效
  • 批准号:
    7202019
  • 财政年份:
    2004
  • 资助金额:
    $ 2.11万
  • 项目类别:
TREATMENT OF PATIENTS WITH LARGE B-CELL LYMPHOMA
大 B 细胞淋巴瘤患者的治疗
  • 批准号:
    7202057
  • 财政年份:
    2004
  • 资助金额:
    $ 2.11万
  • 项目类别:
A Phase II Study: Rituximab, rhuMAb VEGF (bevacizumab)
II 期研究:利妥昔单抗、rhuMAb VEGF(贝伐珠单抗)
  • 批准号:
    6980946
  • 财政年份:
    2003
  • 资助金额:
    $ 2.11万
  • 项目类别:
Evaluate the Efficacy of Anti-CD20 Antibody in Hodgkin's
评估抗 CD20 抗体在霍奇金氏病中的疗效
  • 批准号:
    6980890
  • 财政年份:
    2003
  • 资助金额:
    $ 2.11万
  • 项目类别:
AUTOGRAFTING FOR LYMPHOMA
自体移植治疗淋巴瘤
  • 批准号:
    6395686
  • 财政年份:
    2000
  • 资助金额:
    $ 2.11万
  • 项目类别:
PHASE II STUDY OF IODINE 131 ANTI BI ANTIBODY FOR NON HODGKINS LYMPHOMA
碘131抗双抗体治疗非霍奇金淋巴瘤的II期研究
  • 批准号:
    6486028
  • 财政年份:
    2000
  • 资助金额:
    $ 2.11万
  • 项目类别:

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