Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

S9920 Busulfan Compared With Cyclophosphamide in Patients Undergoing Total-Body Irradiation Plus Peripheral Stem Cell Transplantation for Advanced Myelodysplastic Syndrome or Related Acute Myeloid Leukemia

5. mars 2015 oppdatert av: Southwest Oncology Group

A Phase III Randomized Study Comparing Busulfan-Total Body Irradiation Versus Cyclophosphamide-Total Body Irradiation Preparative Regimen in Patients With Advanced Myelodysplastic Syndrome (MDS) or MDS-Related Acute Myeloid Leukemia (AML) Undergoing HLA-Identical Sibling Peripheral Blood Stem Cell Transplantation, (A BMT Study)

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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

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.

Studietype

Intervensjonell

Registrering (Forventet)

240

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital
  • Forente stater
    • Arizona
      • Phoenix, Arizona, Forente stater, 85062-2989
        • Good Samaritan Medical Center
      • Tucson, Arizona, Forente stater, 85724
        • Arizona Cancer Center
    • Arkansas
      • Little Rock, Arkansas, Forente stater, 72205
        • University of Arkansas for Medical Sciences
    • California
      • Berkeley, California, Forente stater, 94704
        • Alta Bates Comprehensive Cancer Center
      • Duarte, California, Forente stater, 91010-3000
        • Cancer Center and Beckman Research Institute, City of Hope
      • La Jolla, California, Forente stater, 92037
        • Scripps Clinic
      • Los Angeles, California, Forente stater, 90095-1781
        • Jonsson Comprehensive Cancer Center, UCLA
      • Los Angeles, California, Forente stater, 90033-0804
        • USC/Norris Comprehensive Cancer Center and Hospital
      • Orange, California, Forente stater, 92868
        • Chao Family Comprehensive Cancer Center
      • Orange, California, Forente stater, 92613-5600
        • St. Joseph Hospital - Orange
      • Sacramento, California, Forente stater, 95816
        • Sutter Cancer Center
      • Sacramento, California, Forente stater, 95817
        • University of California Davis Cancer Center
      • Stanford, California, Forente stater, 94305-5408
        • Stanford University Medical Center
      • Walnut Creek, California, Forente stater, 94598
        • Northern California Cancer Specialists Medical Clinic
    • Colorado
      • Denver, Colorado, Forente stater, 80010
        • University of Colorado Cancer Center
    • Hawaii
      • Honolulu, Hawaii, Forente stater, 96813
        • Queen's Medical Center
      • Honolulu, Hawaii, Forente stater, 96813
        • Cancer Research Center of Hawaii
      • Honolulu, Hawaii, Forente stater, 96817
        • St. Francis Medical Center
    • Idaho
      • Boise, Idaho, Forente stater, 83712
        • Mountain States Tumor Institute
    • Illinois
      • Maywood, Illinois, Forente stater, 60153
        • Loyola University Medical Center
    • Kansas
      • Kansas City, Kansas, Forente stater, 66160-7357
        • University of Kansas Medical Center
      • Wichita, Kansas, Forente stater, 67214
        • Cancer Center of Kansas - Wichita
      • Wichita, Kansas, Forente stater, 67214-3882
        • CCOP - Wichita
    • Kentucky
      • Lexington, Kentucky, Forente stater, 40536-0084
        • Albert B. Chandler Medical Center, University of Kentucky
      • Lexington, Kentucky, Forente stater, 40536-0093
        • Lucille Parker Markey Cancer Center, University of Kentucky
    • Louisiana
      • New Orleans, Louisiana, Forente stater, 70112
        • Tulane University School of Medicine
      • New Orleans, Louisiana, Forente stater, 70112
        • MBCCOP - LSU Health Sciences Center
      • New Orleans, Louisiana, Forente stater, 70112-2822
        • Louisiana State University School of Medicine
      • New Orleans, Louisiana, Forente stater, 70115
        • Memorial Medical Center
      • Shreveport, Louisiana, Forente stater, 71130-3932
        • Louisiana State University Health Sciences Center - Shreveport
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02118
        • Boston Medical Center
      • Boston, Massachusetts, Forente stater, 02118
        • Cancer Research Center
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48109-0752
        • University Of Michigan Comprehensive Cancer Center
      • Detroit, Michigan, Forente stater, 48202
        • Henry Ford Hospital
      • Detroit, Michigan, Forente stater, 48201-1379
        • Barbara Ann Karmanos Cancer Institute
    • Mississippi
      • Jackson, Mississippi, Forente stater, 39216-4505
        • University of Mississippi Medical Center
    • Missouri
      • Saint Louis, Missouri, Forente stater, 63110-0250
        • St. Louis University Health Sciences Center
      • Springfield, Missouri, Forente stater, 65807
        • CCOP - Cancer Research for the Ozarks
      • Springfield, Missouri, Forente stater, 65804
        • St. John's Health System
    • New York
      • New York, New York, Forente stater, 10032
        • Herbert Irving Comprehensive Cancer Center
    • Ohio
      • Cincinnati, Ohio, Forente stater, 45236
        • Jewish Hospital of Cincinnati, Inc.
      • Cleveland, Ohio, Forente stater, 44195
        • Cleveland Clinic Taussig Cancer Center
      • Dayton, Ohio, Forente stater, 45409
        • Miami Valley Hospital
      • Kettering, Ohio, Forente stater, 45429
        • CCOP - Dayton
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater, 73190
        • University of Oklahoma Health Sciences Center
    • Oregon
      • Portland, Oregon, Forente stater, 97213
        • CCOP - Columbia River Program
      • Portland, Oregon, Forente stater, 97201-3098
        • Oregon Cancer Center
      • Portland, Oregon, Forente stater, 97225
        • Providence St. Vincent Medical Center
      • Portland, Oregon, Forente stater, 97210
        • Legacy Cancer Services
    • Texas
      • Fort Sam Houston, Texas, Forente stater, 78234
        • Brooke Army Medical Center
      • Lackland Air Force Base, Texas, Forente stater, 78236-5300
        • Wilford Hall - 59th Medical Wing
      • Lubbock, Texas, Forente stater, 79423
        • Texas Tech University Health Science Center
      • Lubbock, Texas, Forente stater, 79430
        • Health Science Center
      • San Antonio, Texas, Forente stater, 78284-7811
        • University of Texas Health Science Center at San Antonio
      • San Antonio, Texas, Forente stater, 78229
        • Methodist Health Care System
      • Temple, Texas, Forente stater, 76508
        • Scott and White Clinic
      • Temple, Texas, Forente stater, 76508
        • CCOP - Scott and White Hospital
    • Utah
      • Salt Lake City, Utah, Forente stater, 84112
        • Huntsman Cancer Institute
      • Salt Lake City, Utah, Forente stater, 84143
        • LDS Hospital
    • Washington
      • Seattle, Washington, Forente stater, 98101
        • CCOP - Virginia Mason Research Center
      • Seattle, Washington, Forente stater, 98104
        • Swedish Cancer Institute
      • Seattle, Washington, Forente stater, 98109-1024
        • Fred Hutchinson Cancer Research Center
      • Seattle, Washington, Forente stater, 98195-6043
        • University of Washington Medical Center
      • Tacoma, Washington, Forente stater, 98405-0986
        • CCOP - Northwest
      • Tacoma, Washington, Forente stater, 98401-2197
        • Franciscan Health System

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

16 år til 55 år (Barn, Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

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

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: behandling
Fremgangsmåte: allogen benmargstransplantasjon
dag 0
Legemiddel: busulfan
arm 1: 0.44 mg/kg every 6 hours, IV over 2 hours, day -7 to -4
Legemiddel: cyclophosphamide
arm 2: 60 mg/kg every 24 hrs for 2 doses, IV over 2 hrs, days -5 and -4
Legemiddel: cyclosporine
both arms per published schedule
Legemiddel: methotrexate
GVHD: 15 mg/m2 day 1, 10 mg/m2 day 3, 6 and 11 by IV
Stråling: radiation therapy
both arms: 1200 cGy total dose (6 x 200 fractions)

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Event-free survival
Tidsramme: every 6 months after stem cell infusion until death or 5 years
every 6 months after stem cell infusion until death or 5 years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Southwest Oncology Group

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

  • Studiestol: Jeanne E. Anderson, MD, Katmai Oncology Group

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. februar 2000

Primær fullføring (Faktiske)

1. mars 2004

Studiet fullført (Faktiske)

1. mars 2006

Datoer for studieregistrering

Først innsendt

2. juni 2000

Først innsendt som oppfylte QC-kriteriene

15. mars 2004

Først lagt ut (Anslag)

16. mars 2004

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

6. mars 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. mars 2015

Sist bekreftet

1. mars 2015

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • S9920 (Annen identifikator: SWOG)
  • U10CA032102 (U.S. NIH-stipend/kontrakt)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere