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

5 marzo 2015 aggiornato da: 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.

Panoramica dello studio

Stato

Terminato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

5

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 55 anni a 69 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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
Radiazione: radioterapia
Biologico: linfociti allogenici terapeutici
Procedura: trapianto di cellule staminali del sangue periferico
Droga: ciclosporina
Droga: micofenolato mofetile
Altri nomi:
  • MMF
Droga: fludarabina

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Overall Survival
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Serious Adverse Events
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Southwest Oncology Group

Collaboratori

National Cancer Institute (NCI)

Investigatori

  • Cattedra di studio: Peter McSweeney, MD, Rocky Mountain Cancer Centers - Denver Midtown

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 aprile 2003

Completamento primario (Effettivo)

1 giugno 2005

Completamento dello studio (Effettivo)

1 giugno 2006

Date di iscrizione allo studio

Primo inviato

27 gennaio 2003

Primo inviato che soddisfa i criteri di controllo qualità

27 gennaio 2003

Primo Inserito (Stima)

28 gennaio 2003

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

25 marzo 2015

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 marzo 2015

Ultimo verificato

1 marzo 2015

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • S0125 (Altro identificatore: SWOG)
  • U10CA032102 (Sovvenzione/contratto NIH degli Stati Uniti)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Condizioni

Malattie rare

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Sedi

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