Feasibility and Outcomes of Allogeneic HCT Compared to Chemotherapy in Older AML Patients
2019年11月12日 更新者：Fred Hutchinson Cancer Center
Feasibility and Outcomes of Allogeneic Hematopoietic Cell Transplantation (HCT) Compared to Conventional Therapy for Older and Medically Infirm Patients Diagnosed With Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes: A Prospective Observational Study
The purpose of this study is to compare treatment methods and outcomes of patients diagnosed with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).
研究概览
地位
完全的
详细说明
This is a prospective multicenter observational study in a Consortium of collaborating institutions investigating how often older and medically infirm patients who are diagnosed with Acute Myeloid Leukemia (AML) or high-risk myelodysplastic syndromes (MDS) and treated with induction chemotherapy undergo allogeneic HCT.
Investigators will look at the rate of undergoing allogeneic HCT among older and medically infirm AML and high-risk MDS patients compared to younger and relatively healthier patients.
Investigators will also compare the characteristics and outcomes of patients who did versus did not proceed to allogeneic HCT.
A number of outcomes will be assessed including mortality, morbidity, and quality of life (QOL).
Baseline information will be collected on different domains of QOL, geriatric assessment, health status measures, AML features, and socioeconomic status.
Information will help physicians and patients to decide on best treatment choices for AML and high-risk MDS in older and medically infirm patients.
研究类型
观察性的
注册 (实际的)
703
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
-
-
California
-
Stanford、California、美国、94305
- Stanford Cancer Institute
-
-
Illinois
-
Chicago、Illinois、美国、60611
- Northwestern Memorial Hospital
-
-
Maryland
-
Baltimore、Maryland、美国、21201
- University of Maryland
-
-
Missouri
-
Saint Louis、Missouri、美国、63110
- Washington University School of Medicine
-
-
New Jersey
-
Hackensack、New Jersey、美国、07601
- The John Theurer Cancer Center at Hackensack University Medical Center
-
-
New York
-
Buffalo、New York、美国、14263
- Roswell Park Cancer Institute
-
-
North Carolina
-
Durham、North Carolina、美国、27710
- Duke University
-
-
Ohio
-
Cleveland、Ohio、美国、44195
- Cleveland Clinic
-
-
Pennsylvania
-
Philadelphia、Pennsylvania、美国、19104
- University of Pennsylvania Abramson Cancer Center
-
-
Utah
-
Salt Lake City、Utah、美国、84112
- University of Utah Huntsman Cancer Institute
-
-
Washington
-
Seattle、Washington、美国、98109
- Fred Hutchinson Cancer Research Center
-
Seattle、Washington、美国、98109
- SCCA Network Clinics
-
-
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 80年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
The study population will include non-M3 AML (including first relapsed and primary refractory AML) and high-risk MDS, MPN, and MF adult patients considered for chemotherapy at FHCRC and the Seattle Cancer Care Alliance Network and other Core institutions (Stanford School of Medicine, Cleveland Clinic, Northwestern University, University of Utah, University of Pennsylvania, Washington University in St. Louis, Roswell Park Cancer Institute, Hackensack University, University of Maryland, and Duke University).
描述
Inclusion Criteria
Patients with new diagnoses of non-M3 AML or high-risk MDS, myeloproliferative neoplasms (MPN), or myelofibrosis (MF) (showing 10% or more blasts in bone marrow) who:
- Present for an AML-like treatment that could plausibly produce a complete remission (CR); for example intensive induction chemotherapy, low dose single agent chemotherapy, hypomethylation agent, or a similar therapy
- Possibility to retrieve follow-up records from the collaborating institution or treating primary care physician
- Patients with primary refractory or first relapse presenting for salvage chemotherapy will be allowed
- Patients of 18 years of age or older, and are being treated by the adult AML service.
- Able to speak and read English.
- Willing and able to provide informed consent.
Exclusion Criteria
- Patients of ≤17 years of age or who are 18 or older and receive treatment under the pediatric AML service.
- Patients older than 80 years
- Patients with <6 months projected survival due to active second malignancy or other medical problem.
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
- 观测模型：队列
- 时间观点：预期
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 Analyzed Participants Receiving Hematopoietic Stem Cell Transplantation (HCT)
大体时间：1 year after starting induction
|
Percentage analyzed participants receiving HCT
|
1 year after starting induction
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percentage Analyzed Participants Without HCT and Deceased
大体时间：1 year after starting induction
|
Percentage analyzed participants without HCT and Deceased
|
1 year after starting induction
|
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
- 首席研究员：Mohamed Sorror, MD, MSc、Associate Member, Fred Hutch; Associate Professor of Medicine, UW
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。
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 (实际的)
2013年7月19日
初级完成 (实际的)
2018年12月4日
研究完成 (实际的)
2018年12月4日
研究注册日期
首次提交
2013年8月14日
首先提交符合 QC 标准的
2013年8月21日
首次发布 (估计)
2013年8月28日
研究记录更新
最后更新发布 (实际的)
2019年11月15日
上次提交的符合 QC 标准的更新
2019年11月12日
最后验证
2019年11月1日
更多信息
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.