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Non-Hodgkin Lymphoma in Elderly Patients Above the Age of 80 in the Rituximab Era

2014年6月30日 更新者:Dr. Sigrun Hallmeyer、Oncology Specialists, S.C.

Retrospective Analysis of Histologies, Pattern of Care, and Outcomes of Non-Hodgkin Lymphoma in Elderly Patients Above the Age of 80 in the Rituximab Era: A Report From the Chicago Lymphoma Consortium

This is an exploratory analysis that is investigating the pattern of care in patients over the age of 80 who were diagnosed with non-Hodgkin lymphoma (NHL). This study will look at the dose intensity and density implemented in this patient population to calculate whether patients received the full course of therapy, received less duration of treatment, or received lower doses of the drugs administered. Furthermore, the investigators would explore time to disease progression for these patients regardless of the treatment received and investigate whether patient outcomes differ based on the type of therapy or dose intensity/density given.

This study is looking at retrospectively evaluating patients with NHL who are over the age of 80 at our institution between 2001-2007. It is anticipated that about 50 patients will be included in this study.

研究概览

地位

完全的

详细说明

Non-Hodgkin Lymphoma (NHL) is a malignant disease of the lymphoid and hematopoetic system with an annual incidence of 60,000 cases/year in the United States accounting for over 18,000 deaths annually. NHL is a heterogeneous malignancy with a median age of 65 at the time of diagnosis. Most clinical trials that have established current standards of care did not include elderly patients, especially those who are above the age of 80. Reasons for such under representation are not well-defined but several factors are hypothesized. Patients above the age of 80 have many co-morbid conditions that might exclude them from enrollment on clinical studies that are usually designed for more fit individuals. In addition, investigators are often reluctant to propose trials to elderly patients as their response to therapy might be suboptimal compared with younger patients affecting the overall data.

Well-designed published studies as to how patients over the age of 80 are being managed in the community or academic setting are lacking. There is no agreed-upon treatment algorithm for these patients and recommended approach varies based on the treating physician, the institution, and each individual patient.

Some physicians chose to offer dose reductions while others might omit chemotherapy and use monoclonal antibodies alone. Furthermore, treatment duration and the number of cycles given might vary considerably in this patient subgroup for a variety of reasons, mainly toxicity. In addition, it is unclear whether the histologic distribution of NHL is similar in older patients. In other words, it is not clear whether patients over the age of 80 are commonly diagnosed with diffuse large cell lymphoma (DLCL) and follicular lymphoma (FL) similar to younger individuals. Most importantly, these expected variations in treatment strategies might have inferior outcomes when compared to younger patient population. Looking at histologic subtype, treatment strategies, and outcomes in patients over the age of 80 is useful for patients and physicians alike. It is plausible that our current standards do not apply to this very-older patient population arguing for offering them clinical trials or novel agents even as an initial approach. On the other hand, we might discover that these older patients fare well despite these variations arguing that their disease biology is different especially if we note changes in histologic distribution.

研究类型

观察性的

注册 (实际的)

50

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

80年 至 80年 (年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

概率样本

研究人群

This study is looking at retrospectively evaluating patients with NHL who are over the age of 80 at our institution between 2001-2007.

描述

Inclusion Criteria:

  • Patients with any NHL diagnosis regardless of histology who are over the age of 80 at the time of diagnosis will be included and analyzed.
  • Data on age, gender, performance status, and major co-morbid conditions will be collected.
  • Histology of the diagnosed NHL will be recorded. The grade (1, 2, or 3) for those who were diagnosed with follicular lymphoma will also be recorded.
  • Stage of the disease, presence of bulky nodes and B symptoms will also be recorded.
  • PET scan results if available.
  • Type of treatment received will be recorded.
  • Responses to therapy.
  • Outcomes of treatment implemented and toxicities incurred.
  • Subsequent therapies if applicable.

Exclusion Criteria:

  • None. All charts of patients who are above the age of 80 at the time of NHL diagnosis will be analyzed.

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

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。

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

2009年5月1日

初级完成 (实际的)

2011年2月1日

研究完成 (实际的)

2011年4月1日

研究注册日期

首次提交

2009年5月14日

首先提交符合 QC 标准的

2009年5月14日

首次发布 (估计)

2009年5月15日

研究记录更新

最后更新发布 (估计)

2014年7月1日

上次提交的符合 QC 标准的更新

2014年6月30日

最后验证

2014年6月1日

更多信息

与本研究相关的术语

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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