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S0125, Chemotherapy, Total-Body Irradiation, and Peripheral Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia

2015年3月5日 更新者：Southwest Oncology Group

S0125, A Phase II Study Of Chimerism-Mediated Immunotherapy (CMI) Using Nonmyeloablative Allogeneic Peripheral Blood Stem Cell Transplantation In Older Patients With Acute Myeloid Leukemia (AML) In First Complete Remission (A BMT Study)

RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy. Sometimes the transplanted cells can make an immune response against the body's normal tissues. Cyclosporine and mycophenolate mofetil may prevent this from happening.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy and total-body irradiation followed by donor peripheral stem cell transplantation, cyclosporine, and mycophenolate mofetil in treating older patients who have acute myeloid leukemia.

研究概览

地位

终止

条件

干预/治疗

详细说明

Primary objective:

  • Determine whether allogeneic peripheral blood stem cell transplantation with pre-conditioning low dose total body irradiation and fludarabine followed by cyclosporine and mycophenolate mofetil, when given to elderly patients with acute myeloid leukemia in first complete remission, is sufficiently efficacious (in terms of survival 1 year after transplantation) to warrant a phase III investigation.

Secondary objective:

  • Determine the frequency and severity of toxic effects of this regimen in these patients.

Other objectives as funding permits:

  • Determine whether chimerism patterns in bone marrow and blood after transplantation are associated with relapse and/or graft-versus-host disease (GVHD) in these patients.
  • Determine whether cytogenic, immunophenotypic, and molecular biologic features detected in pre- and post-transplantation specimens are related to transplant outcomes and risk of relapse in these patients.

OUTLINE: This is an open-label study.

  • Conditioning regimen: Patients receive fludarabine IV over 1 hour on days -4 to -2. Patients also undergo total body irradiation on day 0.
  • Peripheral blood stem cell infusion (PBSC): Patients receive unmodified filgrastim transplantation (G-CSF)-mobilized donor PBSC on day 0.
  • Post-transplantation immunosuppression: Patients receive oral cyclosporine on days -3 to 35 followed by a taper until day 180. Patients also receive oral mycophenolate mofetil on day 0 to 27 without tapering.
  • Donor lymphocyte infusions (DLI): Patients with relapsed disease receive DLI IV over 30 minutes for up to 2 infusions.

Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for 3 years.

PROJECTED ACCRUAL: A total of 25-51 patients will be accrued for this study.

研究类型

介入性

注册 (实际的)

5

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

  • 美国
    • Arizona
      • Phoenix、Arizona、美国、85006
        • Banner Good Samaritan Medical Center
      • Tucson、Arizona、美国、85723
        • Veterans Affairs Medical Center - Tucson
      • Tucson、Arizona、美国、85724
        • Arizona Cancer Center at University of Arizona Health Sciences Center
    • Arkansas
      • Little Rock、Arkansas、美国、72205
        • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
      • Little Rock、Arkansas、美国、72205
        • Veterans Affairs Medical Center - Little Rock
    • California
      • Duarte、California、美国、91010-3000
        • City of Hope Comprehensive Cancer Center
      • La Jolla、California、美国、92037-1027
        • Scripps Cancer Center at Scripps Clinic
      • Los Angeles、California、美国、90033
        • USC/Norris Comprehensive Cancer Center and Hospital
      • Los Angeles、California、美国、90095-1678
        • Jonsson Comprehensive Cancer Center at UCLA
      • Martinez、California、美国、94553
        • Veterans Affairs Outpatient Clinic - Martinez
      • Orange、California、美国、92868
        • Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
      • Sacramento、California、美国、95816
        • Sutter Cancer Center
      • Sacramento、California、美国、95817
        • University of California Davis Cancer Center
      • Stanford、California、美国、94305-5408
        • Stanford Cancer Center at Stanford University Medical Center
      • Travis Air Force Base、California、美国、94535
        • General Robert Huyser Cancer Center at David Grant Medical Center
      • Walnut Creek、California、美国、94598
        • John Muir/Mt. Diablo Comprehensive Cancer Center
    • Colorado
      • Aurora、Colorado、美国、80010
        • University of Colorado Cancer Center at University of Colorado Health Sciences Center
      • Denver、Colorado、美国、80220
        • Veterans Affairs Medical Center - Denver
    • Florida
      • Tampa、Florida、美国、33612
        • Veterans Affairs Medical Center - Tampa (Haley)
    • Georgia
      • Atlanta、Georgia、美国、30342-1701
        • CCOP - Atlanta Regional
      • Decatur、Georgia、美国、30033
        • Charles B. Eberhart Cancer Center at DeKalb Medical Center
      • Fort Gordon、Georgia、美国、30905-5650
        • Dwight David Eisenhower Army Medical Center
    • Hawaii
      • Honolulu、Hawaii、美国、96813
        • Cancer Research Center of Hawaii
      • Honolulu、Hawaii、美国、96813
        • MBCCOP - Hawaii
    • Idaho
      • Boise、Idaho、美国、83712
        • Mountain States Tumor Institute - Boise
    • Illinois
      • Chicago、Illinois、美国、60612
        • Veterans Affairs Medical Center - Chicago Westside Hospital
      • Hines、Illinois、美国、60141
        • Veterans Affairs Medical Center - Hines
      • Maywood、Illinois、美国、60153-5500
        • Cardinal Bernardin Cancer Center at Loyola University Medical Center
    • Indiana
      • Beech Grove、Indiana、美国、46107
        • Indiana Blood and Marrow Transplantation
    • Kansas
      • Kansas City、Kansas、美国、66160-7353
        • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
      • Wichita、Kansas、美国、67214-3882
        • CCOP - Wichita
      • Wichita、Kansas、美国、67218
        • Veterans Affairs Medical Center - Wichita
    • Kentucky
      • Lexington、Kentucky、美国、40502-2236
        • Veterans Affairs Medical Center - Lexington
      • Lexington、Kentucky、美国、40536-0084
        • Markey Cancer Center at University of Kentucky Chandler Medical Center
    • Louisiana
      • New Orleans、Louisiana、美国、70112
        • Veterans Affairs Medical Center - New Orleans
      • New Orleans、Louisiana、美国、70112
        • MBCCOP - LSU Health Sciences Center
      • New Orleans、Louisiana、美国、70115
        • New Orleans Cancer Institute at Memorial Medical Center
      • New Orleans、Louisiana、美国、70112
        • Tulane Cancer Center at Tulane University Hospital and Clinic
      • Shreveport、Louisiana、美国、71130-3932
        • Feist-Weiller Cancer Center at Louisiana State University Health Sciences
      • Shreveport、Louisiana、美国、71101-4295
        • Veterans Affairs Medical Center - Shreveport
    • Massachusetts
      • Boston、Massachusetts、美国、02114
        • Massachusetts General Hospital Cancer Center
      • Boston、Massachusetts、美国、02118
        • Cancer Research Center at Boston Medical Center
    • Michigan
      • Ann Arbor、Michigan、美国、48109-0948
        • University Of Michigan Comprehensive Cancer Center
      • Detroit、Michigan、美国、48201-1379
        • Barbara Ann Karmanos Cancer Institute
      • Detroit、Michigan、美国、48201-1932
        • Veterans Affairs Medical Center - Detroit
      • Detroit、Michigan、美国、48202
        • Josephine Ford Cancer Center at Henry Ford Health System
      • Southfield、Michigan、美国、48075
        • Providence Cancer Institute at Providence Hospital - Southfield Campus
    • Mississippi
      • Jackson、Mississippi、美国、39216-4505
        • University of Mississippi Medical Center
      • Jackson、Mississippi、美国、39216
        • Veterans Affairs Medical Center - Jackson
    • Missouri
      • Kansas City、Missouri、美国、64131
        • CCOP - Kansas City
      • Saint Louis、Missouri、美国、63110
        • Saint Louis University Cancer Center
    • Montana
      • Billings、Montana、美国、59101
        • CCOP - Montana Cancer Consortium
    • New Mexico
      • Albuquerque、New Mexico、美国、87108-5138
        • Veterans Affairs Medical Center - Albuquerque
    • New York
      • Albany、New York、美国、12208
        • Veterans Affairs Medical Center - Albany
      • New York、New York、美国、10016
        • NYU Cancer Institute at New York University Medical Center
      • New York、New York、美国、10032
        • Herbert Irving Comprehensive Cancer Center at Columbia University
      • Rochester、New York、美国、14642
        • James P. Wilmot Cancer Center at University of Rochester Medical Center
    • Ohio
      • Cincinnati、Ohio、美国、45220-2288
        • Veterans Affairs Medical Center - Cincinnati
      • Cleveland、Ohio、美国、44195-9001
        • Cleveland Clinic Taussig Cancer Center
      • Dayton、Ohio、美国、45429
        • CCOP - Dayton
      • Dayton、Ohio、美国、45428-1002
        • Veterans Affairs Medical Center - Dayton
    • Oklahoma
      • Oklahoma City、Oklahoma、美国、73104
        • Veterans Affairs Medical Center - Oklahoma City
      • Oklahoma City、Oklahoma、美国、73104
        • Oklahoma University Medical Center
    • Oregon
      • Portland、Oregon、美国、97225
        • CCOP - Columbia River Oncology Program
      • Portland、Oregon、美国、97201-3098
        • Cancer Institute at Oregon Health and Science University
    • South Carolina
      • Charleston、South Carolina、美国、29401-5799
        • Veterans Affairs Medical Center - Charleston
      • Greenville、South Carolina、美国、29615
        • CCOP - Greenville
    • Tennessee
      • Memphis、Tennessee、美国、38104
        • University of Tennessee Cancer Institute at Methodist Central Hospital
    • Texas
      • Amarillo、Texas、美国、79106
        • Veterans Affairs Medical Center - Amarillo
      • Houston、Texas、美国、77030
        • Baylor College of Medicine
      • Lackland Air Force Base、Texas、美国、78236-5300
        • Wilford Hall Medical Center
      • Lubbock、Texas、美国、79415-3364
        • UMC Southwest Cancer and Research Center
      • San Antonio、Texas、美国、78229-3900
        • University of Texas Health Science Center at San Antonio
      • San Antonio、Texas、美国、78229
        • Veterans Affairs Medical Center - San Antonio (Murphy)
      • Temple、Texas、美国、76504
        • Veterans Affairs Medical Center - Temple
    • Utah
      • Salt Lake City、Utah、美国、84148
        • Veterans Affairs Medical Center - Salt Lake City
      • Salt Lake City、Utah、美国、84132
        • Huntsman Cancer Institute at University of Utah
    • Washington
      • Seattle、Washington、美国、98101
        • CCOP - Virginia Mason Research Center
      • Seattle、Washington、美国、98108
        • Veterans Affairs Medical Center - Seattle
      • Seattle、Washington、美国、98109-1024
        • Fred Hutchinson Cancer Research Center
      • Seattle、Washington、美国、98104
        • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
      • Tacoma、Washington、美国、98431-5000
        • Madigan Army Medical Center
      • Tacoma、Washington、美国、98405-0986
        • CCOP - Northwest

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

55年 至 69年 (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

DISEASE CHARACTERISTICS:

  • Morphologically confirmed acute myeloid leukemia (AML) (within 180 days of diagnosis) OR
  • Secondary AML (secondary to myelodysplastic syndromes (MDS) or to prior leukemogenic therapy)
  • Must have A1 marrow, B1 blood, and C1 extramedullary disease status
  • Must have received prior remission induction chemotherapy
  • Must have a genotypically HLA-identical sibling donor available that is not a monozygotic identical twin
  • No M3 AML or blastic transformation of chronic myelogenous leukemia
  • If history of CNS leukemia, no leukemia cells in CNS by lumbar puncture within past 7 days
  • Must be concurrently enrolled on protocols SWOG-9007 and SWOG-S9910

PATIENT CHARACTERISTICS:

Age

  • 55 to 69

Performance status

  • Zubrod 0-2

Life expectancy

  • Not specified

Hematopoietic

  • See Disease Characteristics

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative

  • No other malignancy within the past 2 years except for the following:

    • Adequately treated basal cell or squamous cell skin cancer
    • Carcinoma in situ of the cervix
    • Adequately treated stage I or II cancer in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior allogeneic hematopoietic stem cell transplantation

Chemotherapy

  • See Disease Characteristics
  • Prior consolidation therapy allowed

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Prior organ transplantation allowed provided not concurrently receiving immunosuppressive 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：treatment
patient conditioning - fludarabine 30 mg/m2 IV over 1 hour Days -4, -3, -2; TBI 6-7 cGy/min Day 0 post-transplant immunosuppression - cyclosporine 6.25 mg/kg bid PO D -3 to +180 (begin taper on D+35); mycophenolate mofetil 15mg/kg bid PO D0 to +27
辐射：放射治疗
生物：治疗性同种异体淋巴细胞
程序：外周血干细胞移植
药品：环孢菌素
药品：霉酚酸酯
其他名称：
  • MMF
药品：氟达拉滨

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
Overall Survival
大体时间：1 year
measured from date of registration to study until death from any cause with patients still alive censored at date of last contact
1 year

次要结果测量

结果测量
措施说明
大体时间
Serious Adverse Events
大体时间：9 months
Twice a week for the first two months, one time a week during month 3, one time every two weeks for months 4-9.
9 months

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

Southwest Oncology Group

合作者

National Cancer Institute (NCI)

调查人员

  • 学习椅：Peter McSweeney, MD、Rocky Mountain Cancer Centers - Denver Midtown

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

2003年4月1日

初级完成 (实际的)

2005年6月1日

研究完成 (实际的)

2006年6月1日

研究注册日期

首次提交

2003年1月27日

首先提交符合 QC 标准的

2003年1月27日

首次发布 (估计)

2003年1月28日

研究记录更新

最后更新发布 (估计)

2015年3月25日

上次提交的符合 QC 标准的更新

2015年3月5日

最后验证

2015年3月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • S0125 (其他标识符：SWOG)
  • U10CA032102 (美国 NIH 拨款/合同)

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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