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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. marts 2015 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

240

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

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

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

16 år til 55 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: behandling
Procedure: allogen knoglemarvstransplantation
dag 0
Medicin: busulfan
arm 1: 0.44 mg/kg every 6 hours, IV over 2 hours, day -7 to -4
Medicin: cyclophosphamide
arm 2: 60 mg/kg every 24 hrs for 2 doses, IV over 2 hrs, days -5 and -4
Medicin: cyclosporine
both arms per published schedule
Medicin: 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)

Hvad måler undersøgelsen?

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

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: Jeanne E. Anderson, MD, Katmai Oncology Group

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. februar 2000

Primær færdiggørelse (Faktiske)

1. marts 2004

Studieafslutning (Faktiske)

1. marts 2006

Datoer for studieregistrering

Først indsendt

2. juni 2000

Først indsendt, der opfyldte QC-kriterier

15. marts 2004

Først opslået (Skøn)

16. marts 2004

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. 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

  • S9920 (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 .

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