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S0125, Chemotherapy, Total-Body Irradiation, and Peripheral Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia

5. marts 2015 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

5

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85006
        • Banner Good Samaritan Medical Center
      • Tucson, Arizona, Forenede Stater, 85723
        • Veterans Affairs Medical Center - Tucson
      • Tucson, Arizona, Forenede Stater, 85724
        • Arizona Cancer Center at University of Arizona Health Sciences Center
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater, 72205
        • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
      • Little Rock, Arkansas, Forenede Stater, 72205
        • Veterans Affairs Medical Center - Little Rock
    • California
      • Duarte, California, Forenede Stater, 91010-3000
        • City of Hope Comprehensive Cancer Center
      • La Jolla, California, Forenede Stater, 92037-1027
        • Scripps Cancer Center at Scripps Clinic
      • Los Angeles, California, Forenede Stater, 90033
        • USC/Norris Comprehensive Cancer Center and Hospital
      • Los Angeles, California, Forenede Stater, 90095-1678
        • Jonsson Comprehensive Cancer Center at UCLA
      • Martinez, California, Forenede Stater, 94553
        • Veterans Affairs Outpatient Clinic - Martinez
      • Orange, California, Forenede Stater, 92868
        • Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
      • Sacramento, California, Forenede Stater, 95816
        • Sutter Cancer center
      • Sacramento, California, Forenede Stater, 95817
        • University of California Davis Cancer Center
      • Stanford, California, Forenede Stater, 94305-5408
        • Stanford Cancer Center at Stanford University Medical Center
      • Travis Air Force Base, California, Forenede Stater, 94535
        • General Robert Huyser Cancer Center at David Grant Medical Center
      • Walnut Creek, California, Forenede Stater, 94598
        • John Muir/Mt. Diablo Comprehensive Cancer Center
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80010
        • University of Colorado Cancer Center at University of Colorado Health Sciences Center
      • Denver, Colorado, Forenede Stater, 80220
        • Veterans Affairs Medical Center - Denver
    • Florida
      • Tampa, Florida, Forenede Stater, 33612
        • Veterans Affairs Medical Center - Tampa (Haley)
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30342-1701
        • CCOP - Atlanta Regional
      • Decatur, Georgia, Forenede Stater, 30033
        • Charles B. Eberhart Cancer Center at DeKalb Medical Center
      • Fort Gordon, Georgia, Forenede Stater, 30905-5650
        • Dwight David Eisenhower Army Medical Center
    • Hawaii
      • Honolulu, Hawaii, Forenede Stater, 96813
        • Cancer Research Center of Hawaii
      • Honolulu, Hawaii, Forenede Stater, 96813
        • MBCCOP - Hawaii
    • Idaho
      • Boise, Idaho, Forenede Stater, 83712
        • Mountain States Tumor Institute - Boise
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • Veterans Affairs Medical Center - Chicago Westside Hospital
      • Hines, Illinois, Forenede Stater, 60141
        • Veterans Affairs Medical Center - Hines
      • Maywood, Illinois, Forenede Stater, 60153-5500
        • Cardinal Bernardin Cancer Center at Loyola University Medical Center
    • Indiana
      • Beech Grove, Indiana, Forenede Stater, 46107
        • Indiana Blood and Marrow Transplantation
    • Kansas
      • Kansas City, Kansas, Forenede Stater, 66160-7353
        • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
      • Wichita, Kansas, Forenede Stater, 67214-3882
        • CCOP - Wichita
      • Wichita, Kansas, Forenede Stater, 67218
        • Veterans Affairs Medical Center - Wichita
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40502-2236
        • Veterans Affairs Medical Center - Lexington
      • Lexington, Kentucky, Forenede Stater, 40536-0084
        • Markey Cancer Center at University of Kentucky Chandler Medical Center
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70112
        • Veterans Affairs Medical Center - New Orleans
      • New Orleans, Louisiana, Forenede Stater, 70112
        • MBCCOP - LSU Health Sciences Center
      • New Orleans, Louisiana, Forenede Stater, 70115
        • New Orleans Cancer Institute at Memorial Medical Center
      • New Orleans, Louisiana, Forenede Stater, 70112
        • Tulane Cancer Center at Tulane University Hospital and Clinic
      • Shreveport, Louisiana, Forenede Stater, 71130-3932
        • Feist-Weiller Cancer Center at Louisiana State University Health Sciences
      • Shreveport, Louisiana, Forenede Stater, 71101-4295
        • Veterans Affairs Medical Center - Shreveport
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02114
        • Massachusetts General Hospital Cancer Center
      • Boston, Massachusetts, Forenede Stater, 02118
        • Cancer Research Center at Boston Medical Center
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109-0948
        • University of Michigan Comprehensive Cancer Center
      • Detroit, Michigan, Forenede Stater, 48201-1379
        • Barbara Ann Karmanos Cancer Institute
      • Detroit, Michigan, Forenede Stater, 48201-1932
        • Veterans Affairs Medical Center - Detroit
      • Detroit, Michigan, Forenede Stater, 48202
        • Josephine Ford Cancer Center at Henry Ford Health System
      • Southfield, Michigan, Forenede Stater, 48075
        • Providence Cancer Institute at Providence Hospital - Southfield Campus
    • Mississippi
      • Jackson, Mississippi, Forenede Stater, 39216-4505
        • University of Mississippi Medical Center
      • Jackson, Mississippi, Forenede Stater, 39216
        • Veterans Affairs Medical Center - Jackson
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64131
        • CCOP - Kansas City
      • Saint Louis, Missouri, Forenede Stater, 63110
        • Saint Louis University Cancer Center
    • Montana
      • Billings, Montana, Forenede Stater, 59101
        • CCOP - Montana Cancer Consortium
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87108-5138
        • Veterans Affairs Medical Center - Albuquerque
    • New York
      • Albany, New York, Forenede Stater, 12208
        • Veterans Affairs Medical Center - Albany
      • New York, New York, Forenede Stater, 10016
        • NYU Cancer Institute at New York University Medical Center
      • New York, New York, Forenede Stater, 10032
        • Herbert Irving Comprehensive Cancer Center at Columbia University
      • Rochester, New York, Forenede Stater, 14642
        • James P. Wilmot Cancer Center at University of Rochester Medical Center
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45220-2288
        • Veterans Affairs Medical Center - Cincinnati
      • Cleveland, Ohio, Forenede Stater, 44195-9001
        • Cleveland Clinic Taussig Cancer Center
      • Dayton, Ohio, Forenede Stater, 45429
        • CCOP - Dayton
      • Dayton, Ohio, Forenede Stater, 45428-1002
        • Veterans Affairs Medical Center - Dayton
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
        • Veterans Affairs Medical Center - Oklahoma City
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
        • Oklahoma University Medical center
    • Oregon
      • Portland, Oregon, Forenede Stater, 97225
        • CCOP - Columbia River Oncology Program
      • Portland, Oregon, Forenede Stater, 97201-3098
        • Cancer Institute at Oregon Health and Science University
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29401-5799
        • Veterans Affairs Medical Center - Charleston
      • Greenville, South Carolina, Forenede Stater, 29615
        • CCOP - Greenville
    • Tennessee
      • Memphis, Tennessee, Forenede Stater, 38104
        • University of Tennessee Cancer Institute at Methodist Central Hospital
    • Texas
      • Amarillo, Texas, Forenede Stater, 79106
        • Veterans Affairs Medical Center - Amarillo
      • Houston, Texas, Forenede Stater, 77030
        • Baylor College of Medicine
      • Lackland Air Force Base, Texas, Forenede Stater, 78236-5300
        • Wilford Hall Medical Center
      • Lubbock, Texas, Forenede Stater, 79415-3364
        • UMC Southwest Cancer and Research Center
      • San Antonio, Texas, Forenede Stater, 78229-3900
        • University of Texas Health Science Center at San Antonio
      • San Antonio, Texas, Forenede Stater, 78229
        • Veterans Affairs Medical Center - San Antonio (Murphy)
      • Temple, Texas, Forenede Stater, 76504
        • Veterans Affairs Medical Center - Temple
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84148
        • Veterans Affairs Medical Center - Salt Lake City
      • Salt Lake City, Utah, Forenede Stater, 84132
        • Huntsman Cancer Institute at University of Utah
    • Washington
      • Seattle, Washington, Forenede Stater, 98101
        • CCOP - Virginia Mason Research Center
      • Seattle, Washington, Forenede Stater, 98108
        • Veterans Affairs Medical Center - Seattle
      • Seattle, Washington, Forenede Stater, 98109-1024
        • Fred Hutchinson Cancer Research Center
      • Seattle, Washington, Forenede Stater, 98104
        • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
      • Tacoma, Washington, Forenede Stater, 98431-5000
        • Madigan Army Medical Center
      • Tacoma, Washington, Forenede Stater, 98405-0986
        • CCOP - Northwest

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

55 år til 69 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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
Stråling: strålebehandling
Biologisk: terapeutiske allogene lymfocytter
Procedure: perifer blodstamcelletransplantation
Medicin: cyclosporin
Medicin: mycophenolatmofetil
Andre navne:
  • MMF
Medicin: fludarabin

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Survival
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Serious Adverse Events
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Southwest Oncology Group

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Studiestol: Peter McSweeney, MD, Rocky Mountain Cancer Centers - Denver Midtown

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2003

Primær færdiggørelse (Faktiske)

1. juni 2005

Studieafslutning (Faktiske)

1. juni 2006

Datoer for studieregistrering

Først indsendt

27. januar 2003

Først indsendt, der opfyldte QC-kriterier

27. januar 2003

Først opslået (Skøn)

28. januar 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

25. marts 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. marts 2015

Sidst verificeret

1. marts 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • S0125 (Anden identifikator: SWOG)
  • U10CA032102 (U.S. NIH-bevilling/kontrakt)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med strålebehandling

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Sponsorer og samarbejdspartnere

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Narkotikainterventioner

CROs by country

CROs in Suriname

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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