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Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Non-Hodgkin's Lymphoma

2017年10月19日 更新者:Robin Joyce、Beth Israel Deaconess Medical Center

A Phase II Study of Yttrium-90-Labeled Ibritumomab Tiuxetan (Zevalin) Radioimmunotherapy as First Line Treatment in Indolent Non-Hodgkin's Lymphoma

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others, such as yttrium Y 90 ibritumomab tiuxetan, find cancer cells and help kill them or carry cancer-killing substances to them without harming normal cells. Giving rituximab together with yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving rituximab together with yttrium Y 90 ibritumomab tiuxetan works in treating patients with indolent non-Hodgkin's lymphoma.

研究概览

详细说明

OBJECTIVES:

Primary

  • Determine 12-week overall and complete response rate in patients with indolent non-Hodgkin's lymphoma treated with rituximab and yttrium Y 90 ibritumomab tiuxetan as first-line treatment.

Secondary

  • Determine 1-year event-free survival of patients treated with this regimen.
  • Determine time to progression and time to next antilymphoma therapy in patients treated with this regimen.
  • Determine the molecular response rate in patients treated with this regimen.
  • Determine the hematological and non-hematological toxicity of this regimen in these patients.
  • Assess the quality of life of patients treated with this regimen.

OUTLINE: This is an open-label, multicenter study.

Patients receive rituximab IV followed, no more than 4 hours later, by indium In 111 ibritumomab tiuxetan (for imaging) IV over 10 minutes on day 1. If biodistribution is acceptable, patients receive rituximab IV followed, no more than 4 hours later, by a single dose of yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 7, 8, or 9 in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, weeks 6, 10, and 14, every 3 months for 2 years, and then every 6 months for 2 years.

After completion of study treatment, patients are followed weekly for 3 months, every 3 months for 2 years, and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 18-28 patients will be accrued for this study within 2 years.

研究类型

介入性

注册 (实际的)

12

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

    • Massachusetts
      • Boston、Massachusetts、美国、02215
        • Beth Israel Deaconess Medical Center
    • New Hampshire
      • Lebanon、New Hampshire、美国、03756-0002
        • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
    • Vermont
      • Burlington、Vermont、美国、05401-3498
        • Vermont Cancer Center at University of Vermont

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 至 120年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

DISEASE CHARACTERISTICS:

  • Histologically confirmed indolent non-Hodgkin's lymphoma (NHL), including 1 of the following histologic subtypes:

    • Grade1 or 2 follicular lymphoma
    • Small lymphocytic lymphoma (SLL)
    • Marginal zone B-cell lymphoma
  • CD20-positive disease confirmed by immunohistochemistry or flow cytometry
  • Bidimensionally measurable disease

    • At least 1 lesion measuring ≥ 2.0 cm in a single dimension by CT scan
  • Less than 25% bone marrow involvement with lymphoma by bilateral iliac crest bone marrow aspiration and biopsy within the past 6 weeks
  • No clinically significant impaired bone marrow reserve as evidenced by any of the following:

    • Hypocellular marrow, as evidenced by 1 of the following:

      • ≤ 15% cellularity
      • Marked reduction in bone marrow precursors
    • Platelet count < 100,000/mm^3
    • Absolute neutrophil count < 1,500/mm^3
    • History of failed stem cell collection
    • Prior myeloablative therapy
  • No greater than 5,000/mm^3 circulating tumor cells in peripheral blood
  • Requires antilymphoma therapy, as indicated by any of the following:

    • Systemic symptoms
    • B symptoms
    • Cytopenias
    • Malaise
    • Organ compromise
    • Discomfort
    • Pain
    • Disfigurement
    • Rapidly progressive disease
    • Undue anxiety related to not receiving treatment
  • No transformation to intermediate or high-grade NHL
  • No known brain metastases or CNS involvement by lymphoma NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS:

Age

  • Over 18

Performance status

  • ECOG 0-2 OR
  • WHO 0-2 OR
  • Karnofsky 70-100%

Life expectancy

  • More than 3 months

Hematopoietic

  • See Disease Characteristics
  • WBC ≥ 3,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Lymphocyte count < 5,000/mm^3 (for patients with SLL )

Hepatic

  • Bilirubin ≤ 2.0 mg/dL
  • AST and ALT ≤ 2.5 times upper limit of normal

Renal

  • Creatinine ≤ 2.0 mg/dL OR
  • Creatinine clearance > 60 mL/min

Cardiovascular

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Immunologic

  • No anti-murine antibody reactivity (in patients with prior exposure to murine antibodies or proteins)
  • No ongoing or active infection
  • No history of allergic reaction attributed to compounds of similar chemical or biologic composition to yttrium Y 90 ibritumomab tiuxetan

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 1 year after study treatment
  • No other active malignancy except non-melanoma skin cancer
  • No other serious nonmalignant disease that would preclude study participation
  • No psychiatric illness or social situation that would preclude study compliance
  • No other uncontrolled illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 4 weeks since prior pegfilgrastim
  • More than 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF)

Chemotherapy

  • No prior chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior external beam radiotherapy to > 25% of active bone marrow (involved field or regional)

Surgery

  • More than 4 weeks since prior major surgery except diagnostic surgery

Other

  • No prior systemic antilymphoma therapy
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent anticancer therapy
  • No other concurrent investigational agents
  • No other concurrent antilymphoma therapy

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:Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan

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
Response Rate (Complete Response, Unconfirmed Complete Response, and Partial Response) at 12 Weeks
大体时间:14 weeks

INTERNATIONAL WORKSHOP RESPONSE CRITERIA FOR NON HODGKIN'S LYMPHOMA

Cheson BD, Horning SJ, Coiffier B, Shipp MA, Fisher RI, Connors JM, et al. Report of an international workshop to standardize response criteria for non Hodgkin's lymphoma. J Clin Oncol 1999;17(4):1244-53.

14 weeks
EFS
大体时间:1 year
Event = Death, second malignancy , disease progression.
1 year

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。

调查人员

  • 学习椅:Robin Joyce, MD、Beth Israel Deaconess Medical Center

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

2004年5月1日

初级完成 (实际的)

2012年5月1日

研究完成 (实际的)

2015年3月1日

研究注册日期

首次提交

2005年5月3日

首先提交符合 QC 标准的

2005年5月3日

首次发布 (估计)

2005年5月4日

研究记录更新

最后更新发布 (实际的)

2017年11月21日

上次提交的符合 QC 标准的更新

2017年10月19日

最后验证

2017年10月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

在美国制造并从美国出口的产品

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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