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Fludarabine and Busulfan Followed by Allogeneic Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia in First Complete Remission Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Fludarabine and Busulfan Followed by Allogeneic Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia in First Complete Remission conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Fludarabine and Busulfan Followed by Allogeneic Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia in First Complete Remission Clinical research trials and Fludarabine and Busulfan Followed by Allogeneic Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia in First Complete Remission healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Fludarabine and Busulfan Followed by Allogeneic Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia in First Complete Remission. Fludarabine and Busulfan Followed by Allogeneic Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia in First Complete Remission Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Fludarabine and Busulfan Followed by Allogeneic Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia in First Complete Remission clinical trial. Human subjects often obtain the finest healthcare possible for their Fludarabine and Busulfan Followed by Allogeneic Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia in First Complete Remission condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "F" Clinical Trials Conditions > Fludarabine and Busulfan Followed by Allogeneic Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia in First Complete Remission  Fludarabine and Busulfan Followed by Allogeneic Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia in First Complete Remission
Fludarabine and Busulfan Followed by Allogeneic Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia in First Complete Remission
For Condition: secondary acute myeloid leukemia,adult acute myeloid leukemia,adult acute monocytic leukemia
Status: Recruiting
Sponsor(s): Cancer and Leukemia Group B , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy, such as fludarabine and busulfan, use different ways to stop cancer cells from dividing so they stop growing or die. Allogeneic stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy. PURPOSE: Phase II trial to study the effectiveness of combining fludarabine with busulfan before allogeneic stem cell transplantation in treating older patients who have acute myeloid leukemia that is in the first complete remission.
Details: OBJECTIVES: Primary - Determine whether allogeneic stem cell transplantation from a matched sibling donor using a nonmyeloablative preparative regimen comprising fludarabine and busulfan results in a 2-year disease-free survival that is better than historical results using standard chemotherapy in older patients with acute myeloid leukemia in first complete remission. Secondary - Determine the 2-year actuarial risks of transplant-related mortality, acute and chronic graft-versus-host disease, and relapse in patients treated with this regimen. - Determine the recovery of T- and B-cell number and function and the time course of T, B, and myeloid progenitor chimerism in patients treated with this regimen. OUTLINE: This is a multicenter study. - Preparative regimen: Patients receive fludarabine IV over 30 minutes on days -7 to -3 and busulfan IV over 2 hours 4 times per day (every 6 hours) on days -4 and -3. - Graft-versus-host disease (GVHD) prophylaxis: Patients receive oral tacrolimus twice daily on days -2 to 150, with tapering beginning on day 90. Patients also receive methotrexate IV on days 1, 3, and 6. - Allogeneic peripheral blood stem cell transplantation (PBSC): Patients undergo allogeneic PBSC transplantation on day 0. Patients then receive filgrastim (G-CSF) subcutaneously daily beginning on day 7 and continuing until blood counts recover. - Donor lymphocyte infusion (DLI): Patients who relapse and show no signs of active GVHD may receive DLI every 8 weeks for up to 3 infusions. Patients are followed monthly for 1 year, every 3 months for 1 year, and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 60 Years/74 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of acute myeloid leukemia (AML) in first complete remission - No FAB M3 disease - Preceding myelodysplastic syndromes and treatment-related AML allowed - Complete remission achieved within the past 6 months and after no more than 2 courses of induction chemotherapy - Complete remission is defined by all of the following criteria: - Normal bone marrow morphology with less than 5% blasts - Absolute neutrophil count greater than 1,500/mm^3* - Platelet count greater than 100,000/mm^3* - No extramedullary leukemia - No blasts in peripheral blood NOTE: *Must be sustained for at least 30 days - No more than 1 course of prior consolidation therapy - Any consolidation regimen that does not require transplantation allowed - No acute leukemia after blast transformation of prior chronic myelogenous leukemia or other myeloproliferative disease - Prior CNS involvement allowed provided the disease is in remission at time of transplantation - Available HLA-identical (6/6) sibling donor by serological typing (A, B, DR) - No syngeneic donors PATIENT CHARACTERISTICS: Age - 60 to 74 Performance status - 0-2 Life expectancy - Not specified Hematopoietic - See Disease Characteristics Hepatic - Bilirubin less than 2 mg/dL* - Bilirubin 2-3 mg/dL with normal direct bilirubin allowed - AST less than 3 times upper limit of normal* NOTE: *Unless attributable to disease Renal - Creatinine clearance at least 40 mL/min (unless attributable to disease) Cardiovascular - LVEF at least 30% by MUGA Pulmonary - DLCO greater than 40% - No symptomatic pulmonary disease Other - Not pregnant - Fertile patients must use effective contraception - HIV negative - No uncontrolled diabetes mellitus - No active serious infection requiring antibiotics - No known hypersensitivity to E. coli-derived products PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics Chemotherapy - See Disease Characteristics - At least 4 weeks since prior chemotherapy Endocrine therapy - Not specified Radiotherapy - At least 4 weeks since prior radiotherapy Surgery - At least 4 weeks since prior surgery
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StevenDevine, Study Chair, Washington University Siteman Cancer Center
Oncology and Hematology Associates of Southwest Virginia, Inc. *Recruiting*
Roanoke, Virginia, 24014
United States
Recruiting Paul Richards 540-982-0237
Veterans Affairs Medical Center - Washington, DC *Recruiting*
Washington D.C., District of Columbia, 20422
United States
Recruiting Steven Krasnow 202-745-8178
University of Minnesota Cancer Center *Recruiting*
Minneapolis, Minnesota, 55455
United States
Recruiting Linda Burns 612-626-8484
Massey Cancer Center at Virginia Commonwealth University *Recruiting*
Richmond, Virginia, 23298-0037
United States
Recruiting John McCarty 804-828-4360
Florida Hospital Cancer Institute *Recruiting*
Orlando, Florida, 32804
United States
Recruiting Jane Crofton 407-303-2090
New York Weill Cornell Cancer Center at Cornell University *Recruiting*
New York City, New York, 10021
United States
Recruiting Tsiporah Shore 212-746-2646
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Craig Moskowitz 212-639-2696
Vermont Cancer Center at University of Vermont *Recruiting*
Burlington, Vermont, 05401-3498
United States
Recruiting Barbara Grant 802-847-8400
Veterans Affairs Medical Center - Syracuse *Recruiting*
Syracuse, New York, 13210
United States
Recruiting Stephen Graziano 315-476-7461
Walter Reed Army Medical Center *Recruiting*
Washington D.C., District of Columbia, 20307-5000
United States
Recruiting Joseph Drabick 202-782-6751
CCOP - Christiana Care Health Services *Recruiting*
Newark, Delaware, 19713
United States
Recruiting Robert Slease 302-623-4550
Fort Wayne Medical Oncology and Hematology, Incorporated *Recruiting*
Ft. Wayne, Indiana, 46885-5099
United States
Recruiting Sreenivasa Nattam 219-484-8830
Veterans Affairs Medical Center - Buffalo *Recruiting*
Buffalo, New York, 14215
United States
Recruiting Lynn Steinbrenner 716-862-3191
Veterans Affairs Medical Center - Columbia (Truman Memorial) *Recruiting*
Columbia, Missouri, 65201
United States
Recruiting William Patterson 573-882-6163
Baptist Cancer Institute - Memphis at Baptist Memorial Hospital - Memphis *Recruiting*
Memphis, Tennessee, 38120
United States
Recruiting Lee Schwartzberg 901-227-0036
Barnes-Jewish Hospital *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting Nancy Bartlett 314-747-3000
CCOP - Southern Nevada Cancer Research Foundation *Recruiting*
Las Vegas, Nevada, 89106
United States
Recruiting John Ellerton 702-384-0013
Lombardi Cancer Center at Georgetown University Medical Center *Recruiting*
Washington D.C., District of Columbia, 20007
United States
Recruiting Saul Yanovich 202-444-7253
Oncology/Hematology Associates of Central Illinois, P.C. *Recruiting*
Peoria, Illinois, 61602
United States
Recruiting John Kugler 309-636-3605
Veterans Affairs Medical Center - Asheville *Recruiting*
Asheville, North Carolina, 28805
United States
Recruiting John Lucke 828-299-2540
University of Chicago Cancer Research Center *Recruiting*
Chicago, Illinois, 60637-1470
United States
Recruiting Koen Besien 773-702-6696
St. Mary's Medical Center *Recruiting*
Huntington, West Virginia, 25701
United States
Recruiting Gerrit Kimmey 304-528-4645
University of Massachusetts Memorial Medical Center - University Campus *Recruiting*
Worcester, Massachusetts, 01655
United States
Recruiting Karen Ballen 508-856-1518
Veterans Affairs Medical Center - Dallas *Recruiting*
Dallas, Texas, 75216
United States
Recruiting Barry Levinson 214-648-4193
Martha Jefferson Hospital *Recruiting*
Charlottesville, Virginia, 22902
United States
Recruiting Stefan Gorsch 434-982-8410
Lahey Clinic Medical Center - Burlington *Recruiting*
Burlington, Massachusetts, 01805
United States
Recruiting Arthur Rabinowitz 781-744-8400
Maine Medical Center *Recruiting*
Scarborough, Maine, 04074
United States
Recruiting Thomas Ervin 207-885-7600
Rebecca and John Moores UCSD Cancer Center *Recruiting*
La Jolla, California, 92037-0960
United States
Recruiting Edward Ball 858-657-7053
Lutheran General Cancer Care Center *Recruiting*
Park Ridge, Illinois, 60068-1270
United States
Recruiting Jacob Bitran 847-268-8200
Duke Comprehensive Cancer Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting Nelson Chao 919-684-3377
Queens Cancer Center of Queens Hospital *Recruiting*
Jamaica, New York, 11432
United States
Recruiting Hans Grunwald 718-883-4118
Virginia Oncology Associates - Norfolk *Recruiting*
Norfolk, Virginia, 23502
United States
Recruiting Paul Conkling 757-466-8683
Northeast Alabama Regional Medical Center *Recruiting*
Anniston, Alabama, 36207
United States
Recruiting Thomas Twele 256-236-2549
CCOP - Southeast Cancer Control Consortium *Recruiting*
Winston Salem, North Carolina, 27104-4241
United States
Recruiting James Atkins 336-777-3036
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill *Recruiting*
Chapel Hill, North Carolina, 27599-7295
United States
Recruiting Thomas Shea 919-966-7746
New Hanover Regional Medical Center *Recruiting*
Wilmington, North Carolina, 28402-9025
United States
Recruiting Cyrus Kotwall 910-763-4630
MBCCOP - Massey Cancer Center *Recruiting*
Richmond, Virginia, 23298-0037
United States
Recruiting John Roberts 804-828-0450
Veterans Affairs Medical Center - White River Junction *Recruiting*
White River Junction, Vermont, 05009
United States
Recruiting Joseph O'Donnell 802-295-9363 ext. 5480
UNMC Eppley Cancer Center at the University of Nebraska Medical Center *Recruiting*
Omaha, Nebraska, 68198-7680
United States
Recruiting Margaret Kessinger 402-559-7511
CCOP - Mount Sinai Medical Center *Recruiting*
Miami, Florida, 33140
United States
Recruiting Rogerio Lilenbaum 305-674-2625
Louis A. Weiss Memorial Hospital *Recruiting*
Chicago, Illinois, 60640
United States
Recruiting Keith Shulman 773-564-5022
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Joseph Antin 617-632-2525
Arthur G. James Cancer Hospital - Ohio State University *Recruiting*
Columbus, Ohio, 43210-1240
United States
Recruiting Sherif Farag 614-293-7527
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center *Recruiting*
Los Angeles, California, 90048
United States
Recruiting Michael Lill 310-423-2997
UCSF Comprehensive Cancer Center *Recruiting*
San Francisco, California, 94115
United States
Recruiting Charles Linker 415-353-9510
Memorial Regional Hospital Comprehensive Cancer Center *Recruiting*
Hollywood, Florida, 33021
United States
Recruiting Atif Hussein 954-986-6363
Veterans Affairs Medical Center - Chicago (Westside Hospital) *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Thomas Lad 312-996-2046
FirstHealth Moore Regional Hospital *Recruiting*
Pinehurst, North Carolina, 28374
United States
Recruiting Ellen Willard 910-295-9205
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph *Recruiting*
Saint Joseph, Michigan, 49085
United States
Recruiting Eric Lester 269-982-4963
Cooper University Hospital *Recruiting*
Camden, New Jersey, 08103
United States
Recruiting Edison Catalano 856-342-2506
NorthEast Oncology Associates *Recruiting*
Concord, North Carolina, 28025
United States
Recruiting James Wall 704-783-1370
CCOP - Illinois Oncology Research Association *Recruiting*
Peoria, Illinois, 61602
United States
Recruiting John Kugler 309-636-3605
Lifespan: The Miriam Hospital *Recruiting*
Providence, Rhode Island, 02906
United States
Recruiting William Sikov 401-793-7151
Comprehensive Cancer Center at Wake Forest University *Recruiting*
Winston Salem, North Carolina, 27157-1082
United States
Recruiting David Hurd 336-716-2088
Veterans Affairs Medical Center - Minneapolis *Recruiting*
Minneapolis, Minnesota, 55417
United States
Recruiting Vicki Morrison 612-725-2000 ext. 4135
Veterans Affairs Medical Center - San Diego *Recruiting*
San Diego, California, 92161
United States
Recruiting Saeeda Kirmani 619-552-8585 ext. 3356
Massachusetts General Hospital Cancer Center *Recruiting*
Boston, Massachusetts, 02114-2698
United States
Recruiting Thomas Spitzer 617-724-1124
CCOP - North Shore University Hospital *Recruiting*
Manhasset, New York, 11030
United States
Recruiting Vincent Vinciguerra 516-562-8915
Holden Comprehensive Cancer Center at University of Iowa *Recruiting*
Iowa City, Iowa, 52242-1009
United States
Recruiting Roger Gingrich 312-356-3425
Saint Anthony Medical Center *Recruiting*
Rockford, Illinois, 61108
United States
Recruiting Richard Nora 815-227-2273
Blumenthal Cancer Center at Carolinas Medical Center *Recruiting*
Charlotte, North Carolina, 28232-2861
United States
Recruiting Gary Frenette 704-355-3789
CCOP - Northern Indiana CR Consortium *Recruiting*
South Bend, Indiana, 46601
United States
Recruiting Rafat Ansari 574-284-7977
Ellis Fischel Cancer Center at University of Missouri - Columbia *Recruiting*
Columbia, Missouri, 65203
United States
Recruiting Michael Perry 573-882-4979
Veterans Affairs Medical Center - San Francisco *Recruiting*
San Francisco, California, 94121
United States
Recruiting Patricia Cornett 415-221-4810 ext. 3423
Methodist Healthcare - University Hospital *Recruiting*
Memphis, Tennessee, 38104
United States
Recruiting Irvin Fleming 901-726-8080
Missouri Baptist Cancer Center *Recruiting*
St. Louis, Missouri, 63131
United States
Recruiting Alan Lyss 314-996-5514
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. *Recruiting*
Syracuse, New York, 13217
United States
Recruiting Jeffrey Kirshner 315-472-7504
Oncology Alliance, S.C. *Recruiting*
Milwaukee, Wisconsin, 53215
United States
Recruiting Robert Taylor 414-384-5111
Hollings Cancer Center at Medical University of South Carolina *Recruiting*
Charleston, South Carolina, 29425-0721
United States
Recruiting Debra Frei-Lahr 843-792-4271
St. Joseph's Hospital and Medical Center *Recruiting*
Paterson, New Jersey, 07503
United States
Recruiting Arnold Rubin 973-754-2432
Palm Beach Cancer Institute *Recruiting*
West Palm Beach, Florida, 33401
United States
Recruiting Robert Jacobson 561-366-4150
Marlene and Stewart Greenebaum Cancer Center, University of Maryland *Recruiting*
Baltimore, Maryland, 21201
United States
Recruiting Barry Meisenberg 410-328-6842
MBCCOP - University of Illinois at Chicago *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Lawrence Feldman 312-335-3614
Mount Sinai Medical Center, NY *Recruiting*
New York City, New York, 10029
United States
Recruiting Luis Isola 212-241-7529
West Suburban Center for Cancer Care *Recruiting*
River Forest, Illinois, 60305
United States
Recruiting John Showel 708-763-2700
University Hospital at State University of New York - Upstate Medical University *Recruiting*
Syracuse, New York, 13210
United States
Recruiting Teresa Gentile 315-464-8240
Baptist Hospital East - Louisville *Recruiting*
Louisville, Kentucky, 40207
United States
Recruiting Daniel Scullin 502-897-1166
New Hampshire Oncology-Hematology, PA - Hooksett *Recruiting*
Hooksett, New Hampshire, 03106
United States
Recruiting Douglas Weckstein 603-622-6484
North Shore University Hospital *Recruiting*
Manhasset, New York, 11030
United States
Recruiting Ruthee-Lu Bayer 516-562-8973
Norris Cotton Cancer Center at Dartmouth Medical School *Recruiting*
Lebanon, New Hampshire, 03756-0002
United States
Recruiting Kenneth Meehan 603-650-4628
Oklahoma University Medical Center at University of Oklahoma Health Sciences Center *Recruiting*
Oklahoma City, Oklahoma, 73104
United States
Recruiting Howard Ozer 405-271-4022
Cape Fear Valley Health System *Recruiting*
Fayetteville, North Carolina, 28302-2000
United States
Recruiting Kamal Bakri 910-609-6910
CCOP - Evanston *Recruiting*
Evanston, Illinois, 60201
United States
Recruiting Gershon Locker 847-570-2518
Western Pennsylvania Hospital *Recruiting*
Pittsburgh, Pennsylvania, 15224-1791
United States
Recruiting John Lister 412-578-4355
Veterans Affairs Medical Center - Las Vegas *Recruiting*
Las Vegas, Nevada, 89106
United States
Recruiting Chitha Hulugalle 702-696-3000
Veterans Affairs Medical Center - Durham *Recruiting*
Durham, North Carolina, 27705
United States
Recruiting Michael Kelley 919-286-0411
CCOP - Kansas City *Recruiting*
Kansas City, Missouri, 64131
United States
Recruiting Jorge Paradelo 816-823-0555
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas *Recruiting*
Dallas, Texas, 75390
United States
Recruiting Debasish Tripathy 214-648-5113
Broward General Medical Center *Recruiting*
Ft. Lauderdale, Florida, 33316
United States
Recruiting Luis Barreras 954-771-0692
Additional Information:
Study ID Numbers: CDR0000330001; CALGB-100103
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00070135
Other Adult Acute Myeloid Leukemia Studies:
1. Combination Chemotherapy With or Without Monoclonal Antibody Therapy Followed by Stem Cell Transplantation in Treating Patients With Acute Myeloid Leukemia
2. Cyclosporine, Daunorubicin, and Cytarabine in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia
3. Peripheral Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia
4. Chemotherapy With or Without Gemtuzumab Ozogamicin in Treating Older Patients With Acute Myeloid Leukemia
5. Combination Chemotherapy With or Without Filgrastim and/or Tretinoin in Treating Patients With Acute Myeloid Leukemia
Related Studies:
Other adult acute myeloid leukemia Clinical Trials
Other New Hampshire Clinical Trials
Other Hooksett Clinical Trials
Fludarabine and Busulfan Followed by Allogeneic Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia in First Complete Remission
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