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Busulfan Compared With Cyclophosphamide in Patients Undergoing Total-Body Irradiation Plus Peripheral Stem Cell Transplantation for Advanced Myelodysplastic Syndrome or Related Acute Myeloid Leukemia Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Busulfan Compared With Cyclophosphamide in Patients Undergoing Total-Body Irradiation Plus Peripheral Stem Cell Transplantation for Advanced Myelodysplastic Syndrome or Related Acute Myeloid Leukemia conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Busulfan Compared With Cyclophosphamide in Patients Undergoing Total-Body Irradiation Plus Peripheral Stem Cell Transplantation for Advanced Myelodysplastic Syndrome or Related Acute Myeloid Leukemia Clinical research trials and Busulfan Compared With Cyclophosphamide in Patients Undergoing Total-Body Irradiation Plus Peripheral Stem Cell Transplantation for Advanced Myelodysplastic Syndrome or Related Acute Myeloid Leukemia health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Busulfan Compared With Cyclophosphamide in Patients Undergoing Total-Body Irradiation Plus Peripheral Stem Cell Transplantation for Advanced Myelodysplastic Syndrome or Related Acute Myeloid Leukemia. Busulfan Compared With Cyclophosphamide in Patients Undergoing Total-Body Irradiation Plus Peripheral Stem Cell Transplantation for Advanced Myelodysplastic Syndrome or Related Acute Myeloid Leukemia Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Busulfan Compared With Cyclophosphamide in Patients Undergoing Total-Body Irradiation Plus Peripheral Stem Cell Transplantation for Advanced Myelodysplastic Syndrome or Related Acute Myeloid Leukemia clinical trial. Human subjects frequently get the finest healthcare available for their Busulfan Compared With Cyclophosphamide in Patients Undergoing Total-Body Irradiation Plus Peripheral Stem Cell Transplantation for Advanced Myelodysplastic Syndrome or Related Acute Myeloid Leukemia condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "B" Clinical Trials Conditions > Busulfan Compared With Cyclophosphamide in Patients Undergoing Total-Body Irradiation Plus Peripheral Stem Cell Transplantation for Advanced Myelodysplastic Syndrome or Related Acute Myeloid Leukemia  Busulfan Compared With Cyclophosphamide in Patients Undergoing Total-Body Irradiation Plus Peripheral Stem Cell Transplantation for Advanced Myelodysplastic Syndrome or Related Acute Myeloid Leukemia
Busulfan Compared With Cyclophosphamide in Patients Undergoing Total-Body Irradiation Plus Peripheral Stem Cell Transplantation for Advanced Myelodysplastic Syndrome or Related Acute Myeloid Leukemia
For Condition: untreated adult acute myeloid leukemia,Chronic Myelomonocytic Leukemia,de novo myelodysplastic syndrome,secondary myelodysplastic syndrome,refractory anemia with excess blasts,refractory anemia with excess blasts in transformation,secondary acute myeloid leukemia
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Southwest Oncology Group
Synopsis: RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells. It is not yet known if total-body irradiation plus peripheral stem cell transplantation is more effective with busulfan or with cyclophosphamide for myelodysplastic syndrome or acute myeloid leukemia. PURPOSE: Randomized phase III trial to compare the effectiveness of busulfan with that of cyclophosphamide in patients undergoing total-body irradiation plus peripheral stem cell transplantation for advanced myelodysplastic syndrome or related acute myeloid leukemia.
Details: OBJECTIVES: I. Compare event free survival after total body irradiation (TBI) plus busulfan versus TBI plus cyclophosphamide followed by allogeneic peripheral blood stem cell transplantation in patients with advanced myelodysplastic syndrome (MDS) or MDS related acute myeloid leukemia. II. Determine the distribution of pharmacokinetic parameters for busulfan in those patients randomized to the busulfan treatment arm. III. Investigate the prognostic significance for event free survival of prior history of red cell transfusions, cytogenetic pattern, and of functional drug resistance at diagnosis in these patients. IV. Estimate the frequencies of cytogenetic and genetic changes during disease progression in these patients. PROTOCOL OUTLINE: This a randomized, multicenter study. Patients are stratified according to age (40 and under vs 41-55) and diagnosis and International Prognostic Scoring System (IPSS) risk group (myelodysplastic syndrome (MDS)/IPSS - intermediate 1 vs MDS/IPSS - intermediate 2 vs MDS/IPSS high risk vs MDS related acute myeloid leukemia). Patients are randomized to one of two treatment arms. Arm I: Patients receive busulfan IV over 2 hours every 6 hours on days -7 to -4 for a total of 16 doses. Arm II: Patients receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients receive total body irradiation (TBI) twice a day on days -3 to -1; peripheral blood stem cell transplantation from genotypically HLA identical sibling on day 0; cyclosporine IV every 12 hours on days -1 to 60, and then tapering in the absence of graft versus host disease; and methotrexate IV on days 1, 3, 6, and 11. Patients are followed every 6 months for 5 years. PROJECTED ACCRUAL: A total of 240 patients (120 per treatment arm) will be accrued for this study over 5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/55 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Cytologically confirmed myelodysplastic syndrome (MDS); Increased blasts (i.e., greater than 1 to 30% peripheral blood blasts and/or 5 to 30% bone marrow blasts) AND International Prognostic Score intermediate 1, intermediate 2, or high risk - Refractory anemia with excess blasts OR Refractory anemia with excess blasts in transformation (no presence of auer rods as sole criteria) OR Chronic myelomonocytic leukemia; Greater than 1% blasts in the peripheral blood and/or at least 5% blasts in the bone marrow OR MDS related acute myeloid leukemia; Arising after documented MDS of at least 60 days; Absolute peripheral blast count no greater than 5,000/mm3 - Must have genotypically HLA identical sibling donor - Must also be enrolled on SWOG-S9910 and SWOG-9007 --Prior/Concurrent Therapy-- - Biologic therapy: No autologous peripheral stem cell transplantation prior to diagnosis of myelodysplastic syndrome (MDS) or MDS related acute myeloid leukemia - Chemotherapy: No prior chemotherapy for MDS or MDS related acute myeloid leukemia except oral chemotherapy to control leukocytosis or thrombocytosis (e.g., hydroxyurea or etoposide) - Endocrine therapy: Not specified - Radiotherapy: No radiotherapy prior to diagnosis of MDS or MDS related acute myeloid leukemia - Surgery: Not specified --Patient Characteristics-- - Age: 16 to 55 - Performance status: Zubrod 0-2 - Life expectancy: Not specified - Hematopoietic: See Disease Characteristics - Hepatic: Not specified - Renal: Not specified - Other: No prior malignancy within past 5 years except: 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; HIV negative; Not pregnant or nursing; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JeanneAnderson, Study Chair, Southwest Oncology Group
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, 71130-3932
United States
Northern California Cancer Specialists Medical Clinic
Walnut Creek, California, 94598
United States
Tulane University School of Medicine
New Orleans, Louisiana, 70112
United States
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, 91010-3000
United States
Cancer Center of Kansas - Wichita
Wichita, Kansas, 67214
United States
Loyola University Medical Center
Maywood, Illinois, 60153
United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
St. Joseph Hospital - Orange
Orange, California, 92613-5600
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
Franciscan Health System
Tacoma, Washington, 98401-2197
United States
Herbert Irving Comprehensive Cancer Center
New York City, New York, 10032
United States
Memorial Medical Center
New Orleans, Louisiana, 70115
United States
Wilford Hall - 59th Medical Wing
Lackland Air Force Base, Texas, 78236-5300
United States
Mountain States Tumor Institute
Boise, Idaho, 83712
United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
United States
Boston Medical Center
Boston, Massachusetts, 02118
United States
Scripps Clinic
La Jolla, California, 92037
United States
Providence St. Vincent Medical Center
Portland, Oregon, 97225
United States
St. Francis Medical Center
Honolulu, Hawaii, 96817
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0752
United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813
United States
Scott and White Clinic
Temple, Texas, 76508
United States
Stanford University Medical Center
Stanford, California, 94305-5408
United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73190
United States
Good Samaritan Medical Center
Phoenix, Arizona, 85062-2989
United States
Arizona Cancer Center
Tucson, Arizona, 85724
United States
University of California Davis Cancer Center
Sacramento, California, 95817
United States
Health Science Center
Lubbock, Texas, 79430
United States
Jewish Hospital of Cincinnati, Inc.
Cincinnati, Ohio, 45236
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65807
United States
Texas Tech University Health Science Center
Lubbock, Texas, 79423
United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112
United States
Miami Valley Hospital
Dayton, Ohio, 45409
United States
Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
CCOP - Dayton
Kettering, Ohio, 45429
United States
Queen's Medical Center
Honolulu, Hawaii, 96813
United States
St. Louis University Health Sciences Center
St. Louis, Missouri, 63110-0250
United States
Methodist Health Care System
San Antonio, Texas, 78229
United States
Louisiana State University School of Medicine
New Orleans, Louisiana, 70112-2822
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
United States
Sutter Cancer Center
Sacramento, California, 95816
United States
Cancer Research Center
Boston, Massachusetts, 02118
United States
Legacy Cancer Services
Portland, Oregon, 97210
United States
St. John's Health System
Springfield, Missouri, 65804
United States
CCOP - Northwest
Tacoma, Washington, 98405-0986
United States
CCOP - Columbia River Program
Portland, Oregon, 97213
United States
University of Washington Medical Center
Seattle, Washington, 98195-6043
United States
University of Colorado Cancer Center
Denver, Colorado, 80010
United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084
United States
Lucille Parker Markey Cancer Center, University of Kentucky
Lexington, Kentucky, 40536-0093
United States
LDS Hospital
Salt Lake City, Utah, 84143
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7811
United States
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Canada
Alta Bates Comprehensive Cancer Center
Berkeley, California, 94704
United States
CCOP - Scott and White Hospital
Temple, Texas, 76508
United States
Oregon Cancer Center
Portland, Oregon, 97201-3098
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160-7357
United States
Swedish Cancer Institute
Seattle, Washington, 98104
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
CCOP - Virginia Mason Research Center
Seattle, Washington, 98101
United States
Additional Information:
Study ID Numbers: CDR0000067898; SWOG-S9920
Study Start Date: June 2000
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005866
Other Refractory Anemia With Excess Blasts In Transformation Studies:
1. Chemotherapy in Treating Patients With Newly Diagnosed Acute or Chronic Myelogenous Leukemia or Myelodysplastic Syndrome
2. Monoclonal Antibody Therapy in Treating Patients With Primary Myelodysplastic Syndrome
3. Combination Chemotherapy Followed By Peripheral Stem Cell Transplantation or Isotretinoin in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Acute Lymphocytic Leukemia
4. Donor Bone Marrow Transplantation in Treating Patients With Hematologic Cancer
5. Dolastatin 10 in Treating Patients With Refractory or Relapsed Acute Leukemia, Myelodysplastic Syndrome, or Chronic Myelogenous Leukemia
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Busulfan Compared With Cyclophosphamide in Patients Undergoing Total-Body Irradiation Plus Peripheral Stem Cell Transplantation for Advanced Myelodysplastic Syndrome or Related Acute Myeloid Leukemia
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