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Study to Evaluate the Efficacy and Safety of Treatment With Bendamustine in Combination With Ofatumumab in Previously Untreated Patients With Indolent B-Cell Non-Hodgkin's Lymphoma (NHL)

2012年7月24日 更新者：Cephalon

An Open-Label Study to Evaluate the Efficacy and Safety of Treatment With Bendamustine in Combination With Ofatumumab in Previously Untreated Patients With Indolent B-Cell Non-Hodgkin's Lymphoma (NHL)

The primary objective of the study is to determine the efficacy, as measured by overall response (complete response + partial response) of bendamustine in combination with ofatumumab in previously untreated patients with indolent B-Cell Non-Hodgkin's Lymphoma (NHL).

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

50

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 以色列
      • Haifa、以色列、31096
        • Cephalon Investigational Site
      • Nahariya、以色列、22100
        • Cephalon Investigational Site
  • 比利时
      • Bruxelles、比利时、1000
        • Cephalon Investigational Site
      • Bruxelles、比利时、1200
        • Cephalon Investigational Site
      • Gent、比利时
        • Cephalon Investigational Site
  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35294-3300
        • University of Alabama at Birmingham
      • Birmingham、Alabama、美国、35235
        • Birmingham Hematology and Oncology Associates, LLC
    • California
      • Beverly Hills、California、美国、90211-1850
        • Tower Cancer Research Foundation
    • Connecticut
      • Stamford、Connecticut、美国、06902
        • Hematology Oncology, P.C.
    • Florida
      • Boynton Beach、Florida、美国、33435
        • University Cancer Institute
      • New Port Richey、Florida、美国、34655
        • Florida Cancer Institute - New Hope
    • Georgia
      • Dublin、Georgia、美国、31021
        • Dublin Hematology Oncology Care P.C.
      • Marietta、Georgia、美国、30060
        • Northwest Georgia Oncology Center
      • Tucker、Georgia、美国、30084
        • Georgia Cancer Specialists
    • Illinois
      • Niles、Illinois、美国、60714
        • Cancer Care and Hematology Specialists of Chicagoland
    • Iowa
      • Sioux City、Iowa、美国、51101
        • Siouxland Hematology-Oncology Assoc. LLP
    • Kentucky
      • Hazard、Kentucky、美国、41701
        • Kentucky Cancer Clinic
    • Maryland
      • Westminster、Maryland、美国、21157
        • Carroll County Cancer Center
    • Missouri
      • Jefferson City、Missouri、美国、65109
        • Columbia Comprehensive Cancer Care Clinic
    • Nevada
      • Las Vegas、Nevada、美国、89135
        • Nevada Cancer Institute
    • New Jersey
      • Somerville、New Jersey、美国、08876
        • Somerset Hematology Oncology Associates
    • New York
      • Buffalo、New York、美国、14263
        • Roswell Park Cancer Institute
      • Lake Success、New York、美国、11042
        • Monter Cancer Center
    • North Dakota
      • Bismarck、North Dakota、美国、58504
        • Mid Dakota Clinic
    • Oregon
      • Portland、Oregon、美国、97239
        • Oregon Health Sciences University
    • Pennsylvania
      • Pittsburgh、Pennsylvania、美国、15232
        • University of Pittsburgh Medical Center - Cancer Institute
    • South Carolina
      • Greenville、South Carolina、美国、29605
        • Cancer Centers of the Carolinas
    • Tennessee
      • Memphis、Tennessee、美国、38138
        • The West Clinic
    • Texas
      • Bedford、Texas、美国、76022
        • Texas Oncology, P.A.
      • Houston、Texas、美国、77030-4009
        • MD Anderson Cancer Center
      • Longview、Texas、美国、75601
        • Longview Cancer Center
      • Lubbock、Texas、美国、79410
        • Joe Arrington Cancer Research
      • McAllen、Texas、美国、78503
        • Texas Oncology, P.A.
      • San Antonio、Texas、美国、78229
        • Cancer Care Centers of South Texas
      • Waco、Texas、美国、76712
        • Texas Oncology
      • Webster、Texas、美国、77598
        • Texas Oncology, P.A.
      • Wichita Falls、Texas、美国、76310
        • US Oncology Research - Texoma Cancer Center
    • Virginia
      • Fairfax、Virginia、美国、22031
        • Fairfax/Northern Virginia Hematology/Oncology
    • Washington
      • Yakima、Washington、美国、98902
        • Yakima Valley Memorial Hospital/North Start Lodge

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Key Inclusion Criteria:

  • The patient has histopathologic confirmation of one of the protocol-specific CD20+ B-cell non-Hodgkin's lymphomas. Tissue diagnostic procedures must be performed within 6 months of study entry and with biopsy material available for review.

  • The patient meets 1 of the following need-for-treatment criteria:

    1. Presence of at least 1 of the following B-symptoms:

      • fever (>38ºC) of unclear etiology
      • night sweats
      • weight loss of greater than 10% within the prior 6 months
    2. large tumor mass (bulky disease) characterized by lymphomas with a diameter of more than 3 cm in 3 or more regions or by a lymphoma with a diameter of more than 7 cm in 1 region
    3. presence of lymphoma-related complications
    4. hyperviscosity syndrome due to monoclonal gammopathy
  • The patient's tumor is verified to be CD20+ positive from current or previous excisional or incisional tissue diagnostic procedures performed within 6 months of study entry.
  • The screening phase CT scan (based on local evaluation) shows:
  • 2 or more clearly demarcated lesions with a largest diameter ≥1.5 cm, or
  • 1 clearly demarcated lesion with a largest diameter ≥2.0 cm
  • The patient was not previously treated for indolent lymphoma (with the exception of a single course of local radiation therapy not exceeding 2 adjacent lymph node regions).
  • The patient has adequate hematologic and hepatic function.
  • The patient has Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
  • The patient has serum creatinine of 2.0 mg/dL or less or creatinine clearance of 30 mL/min or more, based on the Cockcroft-Gault method, or from a 24-hour urine collection.
  • The patient is willing to comply with contraception requirements.

Key Exclusion Criteria:

The patient:

  • Has small lymphocytic lymphoma or mantle cell lymphoma.
  • Has documented history of central nervous system (CNS) lymphomatous involvement.
  • Has or has had an active malignancy, other than NHL, within the past 3 years except for localized prostate cancer without evidence of bone metastases, bladder, cervical, or breast carcinoma in-situ, or non-melanoma skin cancer .
  • Has New York Heart Association (NYHC) Class III or IV heart failure, uncontrolled arrythmias or unstable angina, electrocardiographic evidence of active ischemia or active conduction system abnormalities, or myocardial infarction within the last 6 months.
  • Has known human immunodeficiency virus (HIV) infection.
  • Has acute or chronic hepatitis B or hepatitis C infection.
  • Is a pregnant or lactating woman. (Any women becoming pregnant during the study will be withdrawn from the study.)
  • Has any serious uncontrolled, medical or psychological disorder that would impair the ability of the subject to receive study drugs.
  • Has received another investigational agent within 30 days of study entry.
  • Has known hypersensitivity to mannitol.
  • Has Ann Arbor stage I disease.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Bendamustine and Ofatumumab
There are 6 planned and 2 optional 28-day cycles in which participants are administered both bendamustine and ofatumumab in the following doses: Bendamustine administered at 90 mg/m^2 intravenously (iv) on study days 1 and 2. Ofatumumab administered at 300 mg iv on day 1 and 1000 mg iv on day 8 of cycle 1. Ofatumumab administered at 1000 mg iv on day 1 of all additional cycles.
药品：Bendamustine hydrochloride
Bendamustine will be administered at 90 mg/m^2 as a 30-minute intravenous (iv) infusion on days 1 and 2 of each cycle.
其他名称：
  • 特兰达
  • CEP-18083
药品：Ofatumumab
Ofatumumab will be administered at 300 mg as an iv infusion on day 1 and 1000 mg on day 8 of cycle 1 and 1000 mg on day 1 of each subsequent cycle.
其他名称：
  • 阿泽拉

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR), as Determined by the International Working Group (IWG) Criteria As Assessed by Investigators
大体时间：up to Week 32
The IWG criteria (Cheson et al 2007) for a CR is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A PR is at least a 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase should be observed in the size of other nodes, liver or spleen, and no new sites of disease should be observed.
up to Week 32

次要结果测量

结果测量
措施说明
大体时间
Percentage of Participants With a Best Overall Response of Complete Response (CR), as Determined by the International Working Group (IWG) Criteria As Assessed by Investigators
大体时间：up to Week 32
The IWG criteria (Cheson et al 2007) for a CR is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.
up to Week 32

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Cephalon

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2010年5月1日

初级完成 (实际的)

2011年7月1日

研究完成 (实际的)

2011年10月1日

研究注册日期

首次提交

2010年4月14日

首先提交符合 QC 标准的

2010年4月20日

首次发布 (估计)

2010年4月22日

研究记录更新

最后更新发布 (估计)

2012年8月28日

上次提交的符合 QC 标准的更新

2012年7月24日

最后验证

2012年7月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • C18083/2048
  • 2009-016725-34 (EudraCT编号)

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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