S0125, Chemotherapy, Total-Body Irradiation, and Peripheral Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia
NCT ID: NCT00053014
Last Updated: 2015-03-25
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
5 participants
INTERVENTIONAL
2003-04-30
2006-06-30
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
therapeutic allogeneic lymphocytes
cyclosporine
fludarabine
mycophenolate mofetil
peripheral blood stem cell transplantation
radiation therapy
Interventions
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therapeutic allogeneic lymphocytes
cyclosporine
fludarabine
mycophenolate mofetil
peripheral blood stem cell transplantation
radiation therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
55 Years
69 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
SWOG Cancer Research Network
NETWORK
Responsible Party
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Principal Investigators
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Peter McSweeney, MD
Role: STUDY_CHAIR
Rocky Mountain Cancer Centers - Denver Midtown
Locations
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Banner Good Samaritan Medical Center
Phoenix, Arizona, United States
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, United States
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Veterans Affairs Medical Center - Little Rock
Little Rock, Arkansas, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Scripps Cancer Center at Scripps Clinic
La Jolla, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Orange, California, United States
Sutter Cancer Center
Sacramento, California, United States
University of California Davis Cancer Center
Sacramento, California, United States
Stanford Cancer Center at Stanford University Medical Center
Stanford, California, United States
General Robert Huyser Cancer Center at David Grant Medical Center
Travis Air Force Base, California, United States
John Muir/Mt. Diablo Comprehensive Cancer Center
Walnut Creek, California, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, Colorado, United States
Veterans Affairs Medical Center - Denver
Denver, Colorado, United States
Veterans Affairs Medical Center - Tampa (Haley)
Tampa, Florida, United States
CCOP - Atlanta Regional
Atlanta, Georgia, United States
Charles B. Eberhart Cancer Center at DeKalb Medical Center
Decatur, Georgia, United States
Dwight David Eisenhower Army Medical Center
Fort Gordon, Georgia, United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States
MBCCOP - Hawaii
Honolulu, Hawaii, United States
Mountain States Tumor Institute - Boise
Boise, Idaho, United States
Veterans Affairs Medical Center - Chicago Westside Hospital
Chicago, Illinois, United States
Veterans Affairs Medical Center - Hines
Hines, Illinois, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States
Indiana Blood and Marrow Transplantation
Beech Grove, Indiana, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States
CCOP - Wichita
Wichita, Kansas, United States
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, United States
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States
Tulane Cancer Center at Tulane University Hospital and Clinic
New Orleans, Louisiana, United States
Veterans Affairs Medical Center - New Orleans
New Orleans, Louisiana, United States
New Orleans Cancer Institute at Memorial Medical Center
New Orleans, Louisiana, United States
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, United States
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
Shreveport, Louisiana, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Cancer Research Center at Boston Medical Center
Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, United States
Josephine Ford Cancer Center at Henry Ford Health System
Detroit, Michigan, United States
Providence Cancer Institute at Providence Hospital - Southfield Campus
Southfield, Michigan, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Veterans Affairs Medical Center - Jackson
Jackson, Mississippi, United States
CCOP - Kansas City
Kansas City, Missouri, United States
Saint Louis University Cancer Center
St Louis, Missouri, United States
CCOP - Montana Cancer Consortium
Billings, Montana, United States
Veterans Affairs Medical Center - Albuquerque
Albuquerque, New Mexico, United States
Veterans Affairs Medical Center - Albany
Albany, New York, United States
NYU Cancer Institute at New York University Medical Center
New York, New York, United States
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States
Veterans Affairs Medical Center - Cincinnati
Cincinnati, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States
CCOP - Dayton
Dayton, Ohio, United States
Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States
Veterans Affairs Medical Center - Oklahoma City
Oklahoma City, Oklahoma, United States
Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States
CCOP - Columbia River Oncology Program
Portland, Oregon, United States
Veterans Affairs Medical Center - Charleston
Charleston, South Carolina, United States
CCOP - Greenville
Greenville, South Carolina, United States
University of Tennessee Cancer Institute at Methodist Central Hospital
Memphis, Tennessee, United States
Veterans Affairs Medical Center - Amarillo
Amarillo, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Wilford Hall Medical Center
Lackland Air Force Base, Texas, United States
UMC Southwest Cancer and Research Center
Lubbock, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, United States
Veterans Affairs Medical Center - Temple
Temple, Texas, United States
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City, Utah, United States
CCOP - Virginia Mason Research Center
Seattle, Washington, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States
Veterans Affairs Medical Center - Seattle
Seattle, Washington, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
CCOP - Northwest
Tacoma, Washington, United States
Madigan Army Medical Center
Tacoma, Washington, United States
Countries
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Other Identifiers
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S0125
Identifier Type: OTHER
Identifier Source: secondary_id
S0125
Identifier Type: -
Identifier Source: org_study_id
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