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Chemotherapy, Total-Body Irradiation, and Peripheral Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Chemotherapy, Total-Body Irradiation, and Peripheral Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Chemotherapy, Total-Body Irradiation, and Peripheral Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia Clinical research trials and Chemotherapy, Total-Body Irradiation, and Peripheral Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Chemotherapy, Total-Body Irradiation, and Peripheral Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia. Chemotherapy, Total-Body Irradiation, and Peripheral Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Chemotherapy, Total-Body Irradiation, and Peripheral Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia clinical trial. Participants frequently obtain the most expert healthcare available for their Chemotherapy, Total-Body Irradiation, and Peripheral Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Chemotherapy, Total-Body Irradiation, and Peripheral Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia  Chemotherapy, Total-Body Irradiation, and Peripheral Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia
Chemotherapy, Total-Body Irradiation, and Peripheral Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia
For Condition: adult acute myeloid leukemia in remission
Status: Recruiting
Sponsor(s): Southwest Oncology Group , National Cancer Institute (NCI)
Synopsis: 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.
Details: OBJECTIVES: - 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. - Determine the frequency and severity of toxic effects of this regimen in these patients. - 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 55 Years/69 Years
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PeterMcSweeney, Study Chair, University of Colorado Cancer Center
MBCCOP - Hawaii *Recruiting*
Honolulu, Hawaii, 96813
United States
Recruiting Brian Issell 808-586-3013
Cleveland Clinic Taussig Cancer Center *Recruiting*
Cleveland, Ohio, 44195-9001
United States
Recruiting George Budd 216-444-6480
Veterans Affairs Medical Center - Biloxi *Recruiting*
Biloxi, Mississippi, 39531-2410
United States
Recruiting Robert Veith 504-568-5151
Kansas Cancer Institute at the University of Kansas Medical Center *Recruiting*
Kansas City, Kansas, 66160-7353
United States
Recruiting Sarah Taylor 913-588-6029
University of Michigan Comprehensive Cancer Center *Recruiting*
Ann Arbor, Michigan, 48109-0912
United States
Recruiting Laurence Baker 734-936-3983
Barbara Ann Karmanos Cancer Institute *Recruiting*
Detroit, Michigan, 48201-1379
United States
Recruiting Lawrence Flaherty 313-745-9155
City of Hope Comprehensive Cancer Center *Recruiting*
Duarte, California, 91010-0269
United States
Recruiting Kim Margolin 626-359-8111
Cancer Research Center of Hawaii *Recruiting*
Honolulu, Hawaii, 96813
United States
Recruiting Brian Issell 808-586-3013
Cancer Institute at Oregon Health and Science University *Recruiting*
Portland, Oregon, 97201-3098
United States
Recruiting Craig Nichols 503-494-6346
St. Louis University Hospital Cancer Center *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting Paul Petruska 314-577-8854
CCOP - Wichita *Recruiting*
Wichita, Kansas, 67214-3882
United States
Recruiting Shaker Dakhil 316-268-5784
CCOP - Kansas City *Recruiting*
Kansas City, Missouri, 64131
United States
Recruiting Jorge Paradelo 816-823-0555
University of Texas Health Science Center at San Antonio *Recruiting*
San Antonio, Texas, 78229-3900
United States
Recruiting Geoffrey Weiss 210-617-5120
University of Arkansas for Medical Sciences *Recruiting*
Little Rock, Arkansas, 72205
United States
Recruiting Laura Hutchins 501-686-8511
Arizona Cancer Center at University of Arizona Health Sciences Center *Recruiting*
Tucson, Arizona, 85724
United States
Recruiting Thomas Miller 520-626-2667
Tulane University School of Medicine *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting Alan Miller 504-587-7566
University of Mississippi Medical Center *Recruiting*
Jackson, Mississippi, 39216-4505
United States
Recruiting James Thigpen 601-984-5590
MBCCOP - LSU Health Sciences Center *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting Jill Gilbert 504-568-5136
Brooke Army Medical Center *Recruiting*
Fort Sam Houston, Texas, 78234-6200
United States
Recruiting Mitchell Garrison 210-916-0504
Markey Cancer Center at University of Kentucky Chandler Medical Center *Recruiting*
Lexington, Kentucky, 40536-0084
United States
Recruiting Michael Doukas 859-257-4500
CCOP - Virginia Mason Research Center *Recruiting*
Seattle, Washington, 98101
United States
Recruiting Andrew Jacobs 206-341-0446
Oklahoma University Medical Center at University of Oklahoma Health Sciences Center *Recruiting*
Oklahoma City, Oklahoma, 73104
United States
Recruiting Howard Ozer 405-271-4022
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095-1781
United States
Recruiting John Barstis 310-825-5268
Louisiana State University Health Sciences Center - Shreveport *Recruiting*
Shreveport, Louisiana, 71130-3932
United States
Recruiting Glenn Mills 318-675-7639
Cardinal Bernardin Cancer Center at Loyola University Medical Center *Recruiting*
Maywood, Illinois, 60153-5500
United States
Recruiting Patrick Stiff 708-327-3148
Additional Information:
Study ID Numbers: CDR0000269049; SWOG-S0125
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00053014
Other Adult Acute Myeloid Leukemia In Remission Studies:
1. Total-Body Irradiation Plus Stem Cell Transplantation And White Blood Cell Infusion in Treating Older Patients With Acute Myeloid Leukemia
2. Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Acute Myeloid Leukemia in Second Remission
3. Bone Marrow Transplantation in Treating Patients With Acute Leukemia in First or Second Remission
4. Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation and Low-Dose Interleukin-2 in Treating Patients With Acute Myelogenous Leukemia
5. Chemotherapy Plus Monoclonal Antibody in Treating Patients With Acute Promyelocytic Leukemia
Related Studies:
Other adult acute myeloid leukemia in remission Clinical Trials
Other Oklahoma Clinical Trials
Other Oklahoma City Clinical Trials
Chemotherapy, Total-Body Irradiation, and Peripheral Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia
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