S0125, Chemotherapy, Total-Body Irradiation, and Peripheral Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia
5 mars 2015 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
5
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Arizona
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Phoenix, Arizona, Förenta staterna, 85006
- Banner Good Samaritan Medical Center
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Tucson, Arizona, Förenta staterna, 85723
- Veterans Affairs Medical Center - Tucson
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Tucson, Arizona, Förenta staterna, 85724
- Arizona Cancer Center at University of Arizona Health Sciences Center
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Arkansas
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Little Rock, Arkansas, Förenta staterna, 72205
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
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Little Rock, Arkansas, Förenta staterna, 72205
- Veterans Affairs Medical Center - Little Rock
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California
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Duarte, California, Förenta staterna, 91010-3000
- City of Hope Comprehensive Cancer Center
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La Jolla, California, Förenta staterna, 92037-1027
- Scripps Cancer Center at Scripps Clinic
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Los Angeles, California, Förenta staterna, 90033
- USC/Norris Comprehensive Cancer Center and Hospital
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Los Angeles, California, Förenta staterna, 90095-1678
- Jonsson Comprehensive Cancer Center at UCLA
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Martinez, California, Förenta staterna, 94553
- Veterans Affairs Outpatient Clinic - Martinez
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Orange, California, Förenta staterna, 92868
- Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
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Sacramento, California, Förenta staterna, 95816
- Sutter Cancer Center
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Sacramento, California, Förenta staterna, 95817
- University of California Davis Cancer Center
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Stanford, California, Förenta staterna, 94305-5408
- Stanford Cancer Center at Stanford University Medical Center
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Travis Air Force Base, California, Förenta staterna, 94535
- General Robert Huyser Cancer Center at David Grant Medical Center
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Walnut Creek, California, Förenta staterna, 94598
- John Muir/Mt. Diablo Comprehensive Cancer Center
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Colorado
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Aurora, Colorado, Förenta staterna, 80010
- University of Colorado Cancer Center at University of Colorado Health Sciences Center
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Denver, Colorado, Förenta staterna, 80220
- Veterans Affairs Medical Center - Denver
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Florida
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Tampa, Florida, Förenta staterna, 33612
- Veterans Affairs Medical Center - Tampa (Haley)
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Georgia
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Atlanta, Georgia, Förenta staterna, 30342-1701
- CCOP - Atlanta Regional
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Decatur, Georgia, Förenta staterna, 30033
- Charles B. Eberhart Cancer Center at DeKalb Medical Center
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Fort Gordon, Georgia, Förenta staterna, 30905-5650
- Dwight David Eisenhower Army Medical Center
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Hawaii
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Honolulu, Hawaii, Förenta staterna, 96813
- Cancer Research Center of Hawaii
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Honolulu, Hawaii, Förenta staterna, 96813
- MBCCOP - Hawaii
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Idaho
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Boise, Idaho, Förenta staterna, 83712
- Mountain States Tumor Institute - Boise
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Illinois
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Chicago, Illinois, Förenta staterna, 60612
- Veterans Affairs Medical Center - Chicago Westside Hospital
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Hines, Illinois, Förenta staterna, 60141
- Veterans Affairs Medical Center - Hines
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Maywood, Illinois, Förenta staterna, 60153-5500
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
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Indiana
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Beech Grove, Indiana, Förenta staterna, 46107
- Indiana Blood and Marrow Transplantation
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Kansas
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Kansas City, Kansas, Förenta staterna, 66160-7353
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
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Wichita, Kansas, Förenta staterna, 67214-3882
- CCOP - Wichita
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Wichita, Kansas, Förenta staterna, 67218
- Veterans Affairs Medical Center - Wichita
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Kentucky
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Lexington, Kentucky, Förenta staterna, 40502-2236
- Veterans Affairs Medical Center - Lexington
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Lexington, Kentucky, Förenta staterna, 40536-0084
- Markey Cancer Center at University of Kentucky Chandler Medical Center
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Louisiana
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New Orleans, Louisiana, Förenta staterna, 70112
- Veterans Affairs Medical Center - New Orleans
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New Orleans, Louisiana, Förenta staterna, 70112
- MBCCOP - LSU Health Sciences Center
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New Orleans, Louisiana, Förenta staterna, 70115
- New Orleans Cancer Institute at Memorial Medical Center
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New Orleans, Louisiana, Förenta staterna, 70112
- Tulane Cancer Center at Tulane University Hospital and Clinic
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Shreveport, Louisiana, Förenta staterna, 71130-3932
- Feist-Weiller Cancer Center at Louisiana State University Health Sciences
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Shreveport, Louisiana, Förenta staterna, 71101-4295
- Veterans Affairs Medical Center - Shreveport
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02114
- Massachusetts General Hospital Cancer Center
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Boston, Massachusetts, Förenta staterna, 02118
- Cancer Research Center at Boston Medical Center
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Michigan
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Ann Arbor, Michigan, Förenta staterna, 48109-0948
- University Of Michigan Comprehensive Cancer Center
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Detroit, Michigan, Förenta staterna, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Detroit, Michigan, Förenta staterna, 48201-1932
- Veterans Affairs Medical Center - Detroit
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Detroit, Michigan, Förenta staterna, 48202
- Josephine Ford Cancer Center at Henry Ford Health System
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Southfield, Michigan, Förenta staterna, 48075
- Providence Cancer Institute at Providence Hospital - Southfield Campus
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Mississippi
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Jackson, Mississippi, Förenta staterna, 39216-4505
- University of Mississippi Medical Center
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Jackson, Mississippi, Förenta staterna, 39216
- Veterans Affairs Medical Center - Jackson
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Missouri
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Kansas City, Missouri, Förenta staterna, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, Förenta staterna, 63110
- Saint Louis University Cancer Center
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Montana
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Billings, Montana, Förenta staterna, 59101
- CCOP - Montana Cancer Consortium
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New Mexico
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Albuquerque, New Mexico, Förenta staterna, 87108-5138
- Veterans Affairs Medical Center - Albuquerque
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New York
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Albany, New York, Förenta staterna, 12208
- Veterans Affairs Medical Center - Albany
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New York, New York, Förenta staterna, 10016
- NYU Cancer Institute at New York University Medical Center
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New York, New York, Förenta staterna, 10032
- Herbert Irving Comprehensive Cancer Center at Columbia University
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Rochester, New York, Förenta staterna, 14642
- James P. Wilmot Cancer Center at University of Rochester Medical Center
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Ohio
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Cincinnati, Ohio, Förenta staterna, 45220-2288
- Veterans Affairs Medical Center - Cincinnati
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Cleveland, Ohio, Förenta staterna, 44195-9001
- Cleveland Clinic Taussig Cancer Center
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Dayton, Ohio, Förenta staterna, 45429
- CCOP - Dayton
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Dayton, Ohio, Förenta staterna, 45428-1002
- Veterans Affairs Medical Center - Dayton
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Oklahoma
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Oklahoma City, Oklahoma, Förenta staterna, 73104
- Veterans Affairs Medical Center - Oklahoma City
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Oklahoma City, Oklahoma, Förenta staterna, 73104
- Oklahoma University Medical Center
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Oregon
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Portland, Oregon, Förenta staterna, 97225
- CCOP - Columbia River Oncology Program
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Portland, Oregon, Förenta staterna, 97201-3098
- Cancer Institute at Oregon Health and Science University
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South Carolina
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Charleston, South Carolina, Förenta staterna, 29401-5799
- Veterans Affairs Medical Center - Charleston
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Greenville, South Carolina, Förenta staterna, 29615
- CCOP - Greenville
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Tennessee
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Memphis, Tennessee, Förenta staterna, 38104
- University of Tennessee Cancer Institute at Methodist Central Hospital
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Texas
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Amarillo, Texas, Förenta staterna, 79106
- Veterans Affairs Medical Center - Amarillo
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Houston, Texas, Förenta staterna, 77030
- Baylor College of Medicine
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Lackland Air Force Base, Texas, Förenta staterna, 78236-5300
- Wilford Hall Medical Center
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Lubbock, Texas, Förenta staterna, 79415-3364
- UMC Southwest Cancer and Research Center
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San Antonio, Texas, Förenta staterna, 78229-3900
- University of Texas Health Science Center at San Antonio
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San Antonio, Texas, Förenta staterna, 78229
- Veterans Affairs Medical Center - San Antonio (Murphy)
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Temple, Texas, Förenta staterna, 76504
- Veterans Affairs Medical Center - Temple
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Utah
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Salt Lake City, Utah, Förenta staterna, 84148
- Veterans Affairs Medical Center - Salt Lake City
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Salt Lake City, Utah, Förenta staterna, 84132
- Huntsman Cancer Institute at University of Utah
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Washington
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Seattle, Washington, Förenta staterna, 98101
- CCOP - Virginia Mason Research Center
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Seattle, Washington, Förenta staterna, 98108
- Veterans Affairs Medical Center - Seattle
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Seattle, Washington, Förenta staterna, 98109-1024
- Fred Hutchinson Cancer Research Center
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Seattle, Washington, Förenta staterna, 98104
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
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Tacoma, Washington, Förenta staterna, 98431-5000
- Madigan Army Medical Center
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Tacoma, Washington, Förenta staterna, 98405-0986
- CCOP - Northwest
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
55 år till 69 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
|
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Overall Survival
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Serious Adverse Events
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Studiestol: Peter McSweeney, MD, Rocky Mountain Cancer Centers - Denver Midtown
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 april 2003
Primärt slutförande (Faktisk)
1 juni 2005
Avslutad studie (Faktisk)
1 juni 2006
Studieregistreringsdatum
Först inskickad
27 januari 2003
Först inskickad som uppfyllde QC-kriterierna
27 januari 2003
Första postat (Uppskatta)
28 januari 2003
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
25 mars 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
5 mars 2015
Senast verifierad
1 mars 2015
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Neoplasmer efter histologisk typ
- Neoplasmer
- Leukemi
- Leukemi, myeloid
- Leukemi, Myeloid, Akut
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Anti-infektionsmedel
- Enzyminhibitorer
- Antireumatiska medel
- Antineoplastiska medel
- Immunsuppressiva medel
- Immunologiska faktorer
- Dermatologiska medel
- Antibakteriella medel
- Antibiotika, antineoplastiska
- Antifungala medel
- Antituberkulära medel
- Antibiotika, Antituberkulära
- Calcineurin-hämmare
- Fludarabin
- Mykofenolsyra
- Cyklosporin
- Cyklosporiner
Andra studie-ID-nummer
- S0125 (Annan identifierare: SWOG)
- U10CA032102 (U.S.S. NIH-anslag/kontrakt)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .