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Tipifarnib til behandling af patienter med akut myeloid leukæmi i remission

18. marts 2024 opdateret af: National Cancer Institute (NCI)

En fase III randomiseret undersøgelse af Farnesyl Transferase-hæmmer R115777 hos patienter med akut myeloid leukæmi (AML) i anden eller efterfølgende remission eller i remission efter primær induktionssvigt eller patienter over 60 år i første remission

Dette randomiserede fase III-studie undersøger tipifarnib til behandling af patienter med akut myeloid leukæmi (AML) i remission. Tipifarnib kan stoppe væksten af ​​kræftceller ved at blokere de enzymer, der er nødvendige for deres vækst. Det vides endnu ikke, om tipifarnib er mere effektivt end observation alene til at forhindre tilbagefald af AML.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

PRIMÆRE MÅL:

I. At sammenligne R115777 (tipifarnib) vedligeholdelsesterapi med kun observation med hensyn til sygdomsfri overlevelse (DFS) hos patienter med AML i anden eller efterfølgende fuldstændig remission eller i komplet respons (CR) efter primær induktionssvigt.

SEKUNDÆRE MÅL:

I. At sammenligne den samlede overlevelse af patienter i begge arme. II. At evaluere den langsigtede sikkerhed og toksicitet af forlænget administration af R115777 hos AML-patienter i remission.

OVERSIGT: Patienterne randomiseres til 1 ud af 2 behandlingsarme.

ARM A: Patienterne får tipifarnib oralt (PO) to gange dagligt (BID) på dag 1-21. Kurser gentages hver 28. dag i fravær af sygdomsprogression eller uacceptabel toksicitet.

ARM B: Patienter gennemgår kun observation.

Efter afsluttet studiebehandling følges patienterne op i 5 år.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

144

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35233
        • University of Alabama at Birmingham Cancer Center
    • Alaska
      • Anchorage, Alaska, Forenede Stater, 99508
        • Providence Alaska Medical Center
    • Arizona
      • Scottsdale, Arizona, Forenede Stater, 85259
        • Mayo Clinic in Arizona
    • California
      • San Diego, California, Forenede Stater, 92108
        • Kaiser Permanente-San Diego Mission
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80012
        • The Medical Center of Aurora
      • Boulder, Colorado, Forenede Stater, 80301
        • Boulder Community Hospital
      • Colorado Springs, Colorado, Forenede Stater, 80907
        • Penrose-Saint Francis Healthcare
      • Denver, Colorado, Forenede Stater, 80210
        • Porter Adventist Hospital
      • Denver, Colorado, Forenede Stater, 80218
        • Presbyterian - Saint Lukes Medical Center - Health One
      • Denver, Colorado, Forenede Stater, 80218
        • SCL Health Saint Joseph Hospital
      • Denver, Colorado, Forenede Stater, 80220
        • Rose Medical Center
      • Denver, Colorado, Forenede Stater, 80222
        • Colorado Cancer Research Program NCORP
      • Englewood, Colorado, Forenede Stater, 80113
        • Swedish Medical Center
      • Fort Collins, Colorado, Forenede Stater, 80524
        • Poudre Valley Hospital
      • Grand Junction, Colorado, Forenede Stater, 81501
        • Saint Mary's Hospital and Regional Medical Center
      • Greeley, Colorado, Forenede Stater, 80631
        • North Colorado Medical Center
      • Lakewood, Colorado, Forenede Stater, 80228
        • Saint Anthony Hospital
      • Lone Tree, Colorado, Forenede Stater, 80124
        • Sky Ridge Medical Center
      • Longmont, Colorado, Forenede Stater, 80501
        • Longmont United Hospital
      • Loveland, Colorado, Forenede Stater, 80539
        • McKee Medical Center
      • Pueblo, Colorado, Forenede Stater, 81004
        • Saint Mary Corwin Medical Center
      • Thornton, Colorado, Forenede Stater, 80229
        • North Suburban Medical Center
      • Wheat Ridge, Colorado, Forenede Stater, 80033
        • SCL Health Lutheran Medical Center
    • Connecticut
      • Torrington, Connecticut, Forenede Stater, 06790
        • Smilow Cancer Hospital-Torrington Care Center
    • Delaware
      • Lewes, Delaware, Forenede Stater, 19958
        • Beebe Medical Center
      • Newark, Delaware, Forenede Stater, 19718
        • Christiana Care Health System-Christiana Hospital
      • Wilmington, Delaware, Forenede Stater, 19805
        • Saint Francis Hospital - Wilmington
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20010
        • Medstar Washington Hospital Center
      • Washington, District of Columbia, Forenede Stater, 20007
        • MedStar Georgetown University Hospital
    • Florida
      • Boca Raton, Florida, Forenede Stater, 33486
        • Boca Raton Regional Hospital
      • Fort Lauderdale, Florida, Forenede Stater, 33316
        • Broward Health Medical Center
      • Fort Lauderdale, Florida, Forenede Stater, 33308
        • Holy Cross Hospital
      • Gainesville, Florida, Forenede Stater, 32610
        • University of Florida Health Science Center - Gainesville
      • Hollywood, Florida, Forenede Stater, 33021
        • Memorial Regional Hospital/Joe DiMaggio Children's Hospital
      • Jacksonville, Florida, Forenede Stater, 32207
        • Baptist MD Anderson Cancer Center
      • Jupiter, Florida, Forenede Stater, 33458
        • Jupiter Medical Center
      • Miami, Florida, Forenede Stater, 33136
        • University of Miami Miller School of Medicine-Sylvester Cancer Center
      • Miami Beach, Florida, Forenede Stater, 33140
        • Mount Sinai Medical Center
    • Georgia
      • Albany, Georgia, Forenede Stater, 31701
        • Phoebe Putney Memorial Hospital
      • Athens, Georgia, Forenede Stater, 30607
        • University Cancer and Blood Center LLC
      • Augusta, Georgia, Forenede Stater, 30912
        • Augusta University Medical Center
      • Savannah, Georgia, Forenede Stater, 31405
        • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
      • Savannah, Georgia, Forenede Stater, 31404
        • Memorial University Medical Center
    • Idaho
      • Idaho Falls, Idaho, Forenede Stater, 83404
        • Hematology Oncology Associates of Eastern Idaho
    • Illinois
      • Aurora, Illinois, Forenede Stater, 60504
        • Rush - Copley Medical Center
      • Bloomington, Illinois, Forenede Stater, 61701
        • Saint Joseph Medical Center
      • Canton, Illinois, Forenede Stater, 61520
        • Graham Hospital Association
      • Carthage, Illinois, Forenede Stater, 62321
        • Memorial Hospital
      • Chicago, Illinois, Forenede Stater, 60611
        • Northwestern University
      • Chicago, Illinois, Forenede Stater, 60612
        • Rush University Medical Center
      • Chicago, Illinois, Forenede Stater, 60637
        • University of Chicago Comprehensive Cancer Center
      • Chicago, Illinois, Forenede Stater, 60625
        • Swedish Covenant Hospital
      • Chicago, Illinois, Forenede Stater, 60611
        • Hematology and Oncology Associates
      • Chicago, Illinois, Forenede Stater, 60612
        • Jesse Brown Veterans Affairs Medical Center
      • Chicago, Illinois, Forenede Stater, 60616
        • Mercy Hospital and Medical Center
      • Decatur, Illinois, Forenede Stater, 62526
        • Decatur Memorial Hospital
      • Decatur, Illinois, Forenede Stater, 62526
        • Heartland Cancer Research NCORP
      • Eureka, Illinois, Forenede Stater, 61530
        • Eureka Hospital
      • Evanston, Illinois, Forenede Stater, 60201
        • NorthShore University HealthSystem-Evanston Hospital
      • Galesburg, Illinois, Forenede Stater, 61401
        • Western Illinois Cancer Treatment Center
      • Galesburg, Illinois, Forenede Stater, 61401
        • Illinois CancerCare-Galesburg
      • Galesburg, Illinois, Forenede Stater, 61401
        • Galesburg Cottage Hospital
      • Havana, Illinois, Forenede Stater, 62644
        • Mason District Hospital
      • Hinsdale, Illinois, Forenede Stater, 60521
        • Hinsdale Hematology Oncology Associates Incorporated
      • Hopedale, Illinois, Forenede Stater, 61747
        • Hopedale Medical Complex - Hospital
      • Joliet, Illinois, Forenede Stater, 60435
        • Joliet Oncology-Hematology Associates Limited
      • Joliet, Illinois, Forenede Stater, 60432
        • Midwest Center for Hematology Oncology
      • Kewanee, Illinois, Forenede Stater, 61443
        • Kewanee Hospital
      • Lake Forest, Illinois, Forenede Stater, 60045
        • Deerpath Medical Associates
      • Libertyville, Illinois, Forenede Stater, 60048
        • NorthShore Hematology Oncology-Libertyville
      • Macomb, Illinois, Forenede Stater, 61455
        • Mcdonough District Hospital
      • Maywood, Illinois, Forenede Stater, 60153
        • Loyola University Medical Center
      • Niles, Illinois, Forenede Stater, 60714
        • Illinois Cancer Specialists-Niles
      • Normal, Illinois, Forenede Stater, 61761
        • Community Cancer Center Foundation
      • Normal, Illinois, Forenede Stater, 61761
        • Bromenn Regional Medical Center
      • Olympia Fields, Illinois, Forenede Stater, 60461
        • Franciscan St. James Health-Olympia Fields Campus
      • Ottawa, Illinois, Forenede Stater, 61350
        • Illinois CancerCare-Ottawa Clinic
      • Ottawa, Illinois, Forenede Stater, 61350
        • Ottawa Regional Hospital and Healthcare Center
      • Pekin, Illinois, Forenede Stater, 61554
        • OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
      • Pekin, Illinois, Forenede Stater, 61554
        • Pekin Hospital
      • Peoria, Illinois, Forenede Stater, 61637
        • OSF Saint Francis Medical Center
      • Peoria, Illinois, Forenede Stater, 61615
        • Illinois CancerCare-Peoria
      • Peoria, Illinois, Forenede Stater, 61614
        • Proctor Hospital
      • Peoria, Illinois, Forenede Stater, 61603
        • Methodist Medical Center of Illinois
      • Peru, Illinois, Forenede Stater, 61354
        • Valley Radiation Oncology
      • Peru, Illinois, Forenede Stater, 61354
        • Illinois Valley Hospital
      • Princeton, Illinois, Forenede Stater, 61356
        • Perry Memorial Hospital
      • Rushville, Illinois, Forenede Stater, 62681
        • Sarah Culbertson Memorial Hospital
      • Skokie, Illinois, Forenede Stater, 60076
        • Hematology Oncology Associates of Illinois - Skokie
      • Skokie, Illinois, Forenede Stater, 60076
        • Edward H Kaplan MD and Associates
      • Skokie, Illinois, Forenede Stater, 60077
        • Midwest Cancer Research Group Incorporated
      • Spring Valley, Illinois, Forenede Stater, 61362
        • Saint Margaret's Hospital
      • Springfield, Illinois, Forenede Stater, 62781
        • Memorial Medical Center
      • Urbana, Illinois, Forenede Stater, 61801
        • Carle Cancer Center
    • Indiana
      • Beech Grove, Indiana, Forenede Stater, 46107
        • Franciscan Saint Francis Health-Beech Grove
      • Elkhart, Indiana, Forenede Stater, 46515
        • Elkhart General Hospital
      • Fort Wayne, Indiana, Forenede Stater, 46845
        • Fort Wayne Medical Oncology and Hematology Inc-Parkview
      • Kokomo, Indiana, Forenede Stater, 46904
        • Community Howard Regional Health
      • La Porte, Indiana, Forenede Stater, 46350
        • IU Health La Porte Hospital
      • Michigan City, Indiana, Forenede Stater, 46360
        • Franciscan Saint Anthony Health-Michigan City
      • Mishawaka, Indiana, Forenede Stater, 46545
        • Saint Joseph Regional Medical Center-Mishawaka
      • Munster, Indiana, Forenede Stater, 46321
        • The Community Hospital
      • South Bend, Indiana, Forenede Stater, 46601
        • Memorial Hospital of South Bend
      • South Bend, Indiana, Forenede Stater, 46628
        • Northern Indiana Cancer Research Consortium
    • Iowa
      • Ames, Iowa, Forenede Stater, 50010
        • McFarland Clinic PC-William R Bliss Cancer Center
      • Bettendorf, Iowa, Forenede Stater, 52722
        • University of Iowa Healthcare Cancer Services Quad Cities
      • Clive, Iowa, Forenede Stater, 50325
        • Medical Oncology and Hematology Associates-West Des Moines
      • Council Bluffs, Iowa, Forenede Stater, 51503
        • Heartland Oncology and Hematology LLP
      • Davenport, Iowa, Forenede Stater, 52803
        • Genesis Medical Center - East Campus
      • Davenport, Iowa, Forenede Stater, 52804
        • Genesis Medical Center - West Campus
      • Des Moines, Iowa, Forenede Stater, 50309
        • Iowa Methodist Medical Center
      • Des Moines, Iowa, Forenede Stater, 50314
        • Mercy Medical Center - Des Moines
      • Des Moines, Iowa, Forenede Stater, 50309
        • Medical Oncology and Hematology Associates-Des Moines
      • Des Moines, Iowa, Forenede Stater, 50316
        • Iowa Lutheran Hospital
      • Des Moines, Iowa, Forenede Stater, 50309
        • Iowa-Wide Oncology Research Coalition NCORP
      • Des Moines, Iowa, Forenede Stater, 50314
        • Medical Oncology and Hematology Associates-Laurel
      • Des Moines, Iowa, Forenede Stater, 50307
        • Mercy Capitol
      • Sioux City, Iowa, Forenede Stater, 51101
        • Siouxland Regional Cancer Center
      • Sioux City, Iowa, Forenede Stater, 51104
        • Saint Luke's Regional Medical Center
      • Sioux City, Iowa, Forenede Stater, 51104
        • Mercy Medical Center-Sioux City
    • Kansas
      • Anthony, Kansas, Forenede Stater, 67003
        • Hospital District Sixth of Harper County
      • Arkansas City, Kansas, Forenede Stater, 67005
        • Memorial Hospital of Arkansas City
      • Chanute, Kansas, Forenede Stater, 66720
        • Cancer Center of Kansas - Chanute
      • Dodge City, Kansas, Forenede Stater, 67801
        • Cancer Center of Kansas - Dodge City
      • El Dorado, Kansas, Forenede Stater, 67042
        • Cancer Center of Kansas - El Dorado
      • Fort Scott, Kansas, Forenede Stater, 66701
        • Cancer Center of Kansas - Fort Scott
      • Independence, Kansas, Forenede Stater, 67301
        • Cancer Center of Kansas-Independence
      • Kingman, Kansas, Forenede Stater, 67068
        • Cancer Center of Kansas-Kingman
      • Lawrence, Kansas, Forenede Stater, 66044
        • Lawrence Memorial Hospital
      • Liberal, Kansas, Forenede Stater, 67901
        • Southwest Medical Center
      • Newton, Kansas, Forenede Stater, 67114
        • Cancer Center of Kansas - Newton
      • Ottawa, Kansas, Forenede Stater, 66067
        • Cancer Center of Kansas - Ottawa
      • Overland Park, Kansas, Forenede Stater, 66209
        • Menorah Medical Center
      • Overland Park, Kansas, Forenede Stater, 66213
        • Saint Luke's South Hospital
      • Parsons, Kansas, Forenede Stater, 67357
        • Cancer Center of Kansas - Parsons
      • Prairie Village, Kansas, Forenede Stater, 66208
        • Kansas City NCI Community Oncology Research Program
      • Pratt, Kansas, Forenede Stater, 67124
        • Cancer Center of Kansas - Pratt
      • Salina, Kansas, Forenede Stater, 67401
        • Cancer Center of Kansas - Salina
      • Shawnee Mission, Kansas, Forenede Stater, 66204
        • Shawnee Mission Medical Center-KCCC
      • Topeka, Kansas, Forenede Stater, 66606
        • Cotton O'Neil Cancer Center / Stormont Vail Health
      • Topeka, Kansas, Forenede Stater, 66606
        • Saint Francis Hospital and Medical Center - Topeka
      • Wellington, Kansas, Forenede Stater, 67152
        • Cancer Center of Kansas - Wellington
      • Wichita, Kansas, Forenede Stater, 67208
        • Cancer Center of Kansas-Wichita Medical Arts Tower
      • Wichita, Kansas, Forenede Stater, 67214
        • Cancer Center of Kansas - Wichita
      • Wichita, Kansas, Forenede Stater, 67208
        • Associates In Womens Health
      • Wichita, Kansas, Forenede Stater, 67214
        • Wichita NCI Community Oncology Research Program
      • Wichita, Kansas, Forenede Stater, 67214
        • Via Christi Regional Medical Center
      • Winfield, Kansas, Forenede Stater, 67156
        • Cancer Center of Kansas - Winfield
    • Louisiana
      • Baton Rouge, Louisiana, Forenede Stater, 70809
        • Mary Bird Perkins Cancer Center
      • Baton Rouge, Louisiana, Forenede Stater, 70809
        • Ochsner Health Center-Summa
      • Baton Rouge, Louisiana, Forenede Stater, 70806
        • Baton Rouge General Medical Center
      • Houma, Louisiana, Forenede Stater, 70360
        • Mary Bird Perkins Cancer Center/Terrebonne General Medical Center
      • New Orleans, Louisiana, Forenede Stater, 70121
        • Ochsner Medical Center Jefferson
      • New Orleans, Louisiana, Forenede Stater, 70112
        • University Medical Center New Orleans
      • New Orleans, Louisiana, Forenede Stater, 70112
        • Louisiana State University Health Science Center
      • Shreveport, Louisiana, Forenede Stater, 71103
        • Louisiana State University Health Sciences Center Shreveport
      • Shreveport, Louisiana, Forenede Stater, 71101
        • Overton Brooks Veteran's Administration Medical Center
    • Maine
      • Bangor, Maine, Forenede Stater, 04401
        • Eastern Maine Medical Center
      • Waterville, Maine, Forenede Stater, 04901
        • Maine General Medical Center-Thayer
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21287
        • Johns Hopkins University/Sidney Kimmel Cancer Center
      • Elkton, Maryland, Forenede Stater, 21921
        • Union Hospital of Cecil County
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02111
        • Tufts Medical Center
      • Boston, Massachusetts, Forenede Stater, 02118
        • Boston Medical Center
      • Burlington, Massachusetts, Forenede Stater, 01805
        • Lahey Hospital and Medical Center
      • Greenfield, Massachusetts, Forenede Stater, 01301
        • Franklin Medical Center
      • Springfield, Massachusetts, Forenede Stater, 01199
        • Baystate Medical Center
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48202
        • Henry Ford Hospital
      • Kalamazoo, Michigan, Forenede Stater, 49007
        • West Michigan Cancer Center
      • Kalamazoo, Michigan, Forenede Stater, 49007
        • Bronson Methodist Hospital
      • Kalamazoo, Michigan, Forenede Stater, 49001
        • Borgess Medical Center
      • Kalamazoo, Michigan, Forenede Stater, 49008
        • Kalamazoo Center for Medical Studies
      • Royal Oak, Michigan, Forenede Stater, 48073
        • William Beaumont Hospital-Royal Oak
      • Saint Joseph, Michigan, Forenede Stater, 49085
        • Lakeland Hospital
      • Southfield, Michigan, Forenede Stater, 48075
        • Providence Hospital-Southfield Cancer Center
    • Minnesota
      • Alexandria, Minnesota, Forenede Stater, 56308
        • Medini, Eitan MD (UIA Investigator)
      • Burnsville, Minnesota, Forenede Stater, 55337
        • Fairview Ridges Hospital
      • Coon Rapids, Minnesota, Forenede Stater, 55433
        • Mercy Hospital
      • Duluth, Minnesota, Forenede Stater, 55805
        • Essentia Health Cancer Center
      • Duluth, Minnesota, Forenede Stater, 55805
        • Essentia Health Saint Mary's Medical Center
      • Duluth, Minnesota, Forenede Stater, 55805
        • Miller-Dwan Hospital
      • Edina, Minnesota, Forenede Stater, 55435
        • Fairview-Southdale Hospital
      • Fergus Falls, Minnesota, Forenede Stater, 56537
        • Etzell, Paul S MD (UIA Investigator)
      • Fergus Falls, Minnesota, Forenede Stater, 56537
        • Swenson, Wade II, MD (UIA Investigator)
      • Fridley, Minnesota, Forenede Stater, 55432
        • Unity Hospital
      • Maplewood, Minnesota, Forenede Stater, 55109
        • Minnesota Oncology Hematology PA-Maplewood
      • Minneapolis, Minnesota, Forenede Stater, 55407
        • Abbott-Northwestern Hospital
      • Robbinsdale, Minnesota, Forenede Stater, 55422
        • North Memorial Medical Health Center
      • Rochester, Minnesota, Forenede Stater, 55905
        • Mayo Clinic
      • Saint Cloud, Minnesota, Forenede Stater, 56303
        • Coborn Cancer Center at Saint Cloud Hospital
      • Saint Cloud, Minnesota, Forenede Stater, 56303
        • Saint Cloud Hospital
      • Saint Louis Park, Minnesota, Forenede Stater, 55416
        • Park Nicollet Clinic - Saint Louis Park
      • Saint Paul, Minnesota, Forenede Stater, 55102
        • United Hospital
      • Shakopee, Minnesota, Forenede Stater, 55379
        • Saint Francis Regional Medical Center
      • Waconia, Minnesota, Forenede Stater, 55387
        • Ridgeview Medical Center
      • Woodbury, Minnesota, Forenede Stater, 55125
        • Minnesota Oncology Hematology PA-Woodbury
    • Mississippi
      • Hattiesburg, Mississippi, Forenede Stater, 39401
        • Hattiesburg Clinic - Hematology/Oncology Clinic
      • Hattiesburg, Mississippi, Forenede Stater, 39402
        • Hematology and Oncology Clinic
    • Missouri
      • Independence, Missouri, Forenede Stater, 64057
        • Centerpoint Medical Center LLC
      • Kansas City, Missouri, Forenede Stater, 64116
        • North Kansas City Hospital
      • Kansas City, Missouri, Forenede Stater, 64111
        • Saint Luke's Hospital of Kansas City
      • Kansas City, Missouri, Forenede Stater, 64132
        • Research Medical Center
      • Kansas City, Missouri, Forenede Stater, 64108
        • Truman Medical Center
      • Kansas City, Missouri, Forenede Stater, 64114
        • Saint Joseph Health Center
      • Lee's Summit, Missouri, Forenede Stater, 64086
        • Saint Luke's East - Lee's Summit
      • Liberty, Missouri, Forenede Stater, 64068
        • Liberty Radiation Oncology Center
      • Saint Joseph, Missouri, Forenede Stater, 64507
        • Heartland Regional Medical Center
      • Saint Louis, Missouri, Forenede Stater, 63110
        • Washington University School of Medicine
    • Montana
      • Billings, Montana, Forenede Stater, 59101
        • Billings Clinic Cancer Center
      • Billings, Montana, Forenede Stater, 59101
        • Saint Vincent Healthcare
      • Billings, Montana, Forenede Stater, 59102
        • Montana Cancer Consortium NCORP
      • Billings, Montana, Forenede Stater, 59101
        • Northern Rockies Radiation Oncology Center
      • Billings, Montana, Forenede Stater, 59102
        • Saint Vincent Frontier Cancer Center
      • Billings, Montana, Forenede Stater, 59107
        • Deaconess Medical Center
      • Bozeman, Montana, Forenede Stater, 59715
        • Bozeman Deaconess Hospital
      • Bozeman, Montana, Forenede Stater, 59715
        • Internal Medicine of Bozeman
      • Butte, Montana, Forenede Stater, 59701
        • Saint James Community Hospital and Cancer Treatment Center
      • Great Falls, Montana, Forenede Stater, 59405
        • Great Falls Clinic
      • Great Falls, Montana, Forenede Stater, 59405
        • Benefis Healthcare- Sletten Cancer Institute
      • Great Falls, Montana, Forenede Stater, 59405
        • Berdeaux, Donald MD (UIA Investigator)
      • Helena, Montana, Forenede Stater, 59601
        • Saint Peter's Community Hospital
      • Kalispell, Montana, Forenede Stater, 59901
        • Kalispell Regional Medical Center
      • Kalispell, Montana, Forenede Stater, 59901
        • Glacier Oncology PLLC
      • Kalispell, Montana, Forenede Stater, 59901
        • Kalispell Medical Oncology
      • Miles City, Montana, Forenede Stater, 59301
        • Eastern Montana Cancer Center
      • Missoula, Montana, Forenede Stater, 59804
        • Community Medical Hospital
      • Missoula, Montana, Forenede Stater, 59802
        • Saint Patrick Hospital - Community Hospital
      • Missoula, Montana, Forenede Stater, 59804
        • Guardian Oncology and Center for Wellness
      • Missoula, Montana, Forenede Stater, 59802
        • Montana Cancer Specialists
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89102
        • University Medical Center of Southern Nevada
      • Las Vegas, Nevada, Forenede Stater, 89106
        • Nevada Cancer Research Foundation CCOP
    • New Jersey
      • Camden, New Jersey, Forenede Stater, 08103
        • Cooper Hospital University Medical Center
      • New Brunswick, New Jersey, Forenede Stater, 08903
        • Rutgers Cancer Institute of New Jersey
    • New York
      • Bronx, New York, Forenede Stater, 10467
        • Montefiore Medical Center - Moses Campus
      • Bronx, New York, Forenede Stater, 10461
        • Montefiore Medical Center-Weiler Hospital
      • Bronx, New York, Forenede Stater, 10466
        • Montefiore Medical Center-Wakefield Campus
      • Buffalo, New York, Forenede Stater, 14263
        • Roswell Park Cancer Institute
      • East Syracuse, New York, Forenede Stater, 13057
        • Hematology Oncology Associates of Central New York-East Syracuse
      • Middletown, New York, Forenede Stater, 10940
        • Orange Regional Medical Center
      • New York, New York, Forenede Stater, 10065
        • Weill Medical College of Cornell University
      • New York, New York, Forenede Stater, 10016
        • Laura and Isaac Perlmutter Cancer Center at NYU Langone
      • Stony Brook, New York, Forenede Stater, 11794
        • Stony Brook University Medical Center
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater, 28203
        • Carolinas Medical Center/Levine Cancer Institute
      • Goldsboro, North Carolina, Forenede Stater, 27534
        • Southeastern Medical Oncology Center-Goldsboro
      • Goldsboro, North Carolina, Forenede Stater, 27534
        • Wayne Memorial Hospital
      • Goldsboro, North Carolina, Forenede Stater, 27534
        • Wayne Radiation Oncology
      • Kinston, North Carolina, Forenede Stater, 28501
        • Kinston Medical Specialists PA
      • Rutherfordton, North Carolina, Forenede Stater, 28139
        • Rutherford Hospital
      • Wilson, North Carolina, Forenede Stater, 27893
        • Wilson Medical Center
    • Ohio
      • Akron, Ohio, Forenede Stater, 44304
        • Summa Akron City Hospital/Cooper Cancer Center
      • Akron, Ohio, Forenede Stater, 44307
        • Akron General Medical Center
      • Canton, Ohio, Forenede Stater, 44710
        • Aultman Health Foundation
      • Cincinnati, Ohio, Forenede Stater, 45236
        • The Jewish Hospital
      • Cleveland, Ohio, Forenede Stater, 44106
        • Case Western Reserve University
      • Cleveland, Ohio, Forenede Stater, 44109
        • MetroHealth Medical Center
      • Cleveland, Ohio, Forenede Stater, 44195
        • Cleveland Clinic Foundation
      • Columbus, Ohio, Forenede Stater, 43210
        • Ohio State University Comprehensive Cancer Center
      • Dayton, Ohio, Forenede Stater, 45415
        • Samaritan North Health Center
      • Independence, Ohio, Forenede Stater, 44131
        • Cleveland Clinic Cancer Center Independence
      • Lima, Ohio, Forenede Stater, 45801
        • Saint Rita's Medical Center
      • Wooster, Ohio, Forenede Stater, 44691
        • Cleveland Clinic Wooster Family Health and Surgery Center
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
        • University of Oklahoma Health Sciences Center
      • Oklahoma City, Oklahoma, Forenede Stater, 73120
        • Cancer Care Associates
      • Tulsa, Oklahoma, Forenede Stater, 74136
        • Natalie Warren Bryant Cancer Center at Saint Francis
    • Pennsylvania
      • Allentown, Pennsylvania, Forenede Stater, 18103
        • Lehigh Valley Hospital-Cedar Crest
      • Danville, Pennsylvania, Forenede Stater, 17822
        • Geisinger Medical Center
      • Hershey, Pennsylvania, Forenede Stater, 17033-0850
        • Penn State Milton S Hershey Medical Center
      • Lewistown, Pennsylvania, Forenede Stater, 17044
        • Lewistown Hospital
      • Philadelphia, Pennsylvania, Forenede Stater, 19111
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • University of Pennsylvania/Abramson Cancer Center
      • Philadelphia, Pennsylvania, Forenede Stater, 19107
        • Pennsylvania Hospital
      • Scranton, Pennsylvania, Forenede Stater, 18510
        • Scranton Hematology Oncology
      • Scranton, Pennsylvania, Forenede Stater, 18501
        • Mercy Hospital
      • State College, Pennsylvania, Forenede Stater, 16801
        • Geisinger Medical Group
      • State College, Pennsylvania, Forenede Stater, 16803
        • Mount Nittany Medical Center
      • Wilkes-Barre, Pennsylvania, Forenede Stater, 18711
        • Geisinger Wyoming Valley/Henry Cancer Center
      • York, Pennsylvania, Forenede Stater, 17403
        • WellSpan Health-York Hospital
    • South Carolina
      • Anderson, South Carolina, Forenede Stater, 29621
        • AnMed Health Hospital
      • Florence, South Carolina, Forenede Stater, 29506
        • McLeod Regional Medical Center
      • Spartanburg, South Carolina, Forenede Stater, 29303
        • Spartanburg Medical Center
    • South Dakota
      • Sioux Falls, South Dakota, Forenede Stater, 57105
        • Avera Cancer Institute
      • Sioux Falls, South Dakota, Forenede Stater, 57117-5134
        • Sanford USD Medical Center - Sioux Falls
      • Sioux Falls, South Dakota, Forenede Stater, 57104
        • Sanford Cancer Center Oncology Clinic
      • Sioux Falls, South Dakota, Forenede Stater, 57105
        • Medical X-Ray Center
      • Sioux Falls, South Dakota, Forenede Stater, 57105
        • Avera McKennan Hospital and University Health Center
    • Tennessee
      • Knoxville, Tennessee, Forenede Stater, 37920
        • University of Tennessee - Knoxville
    • Texas
      • Fort Sam Houston, Texas, Forenede Stater, 78234
        • Brooke Army Medical Center
      • Houston, Texas, Forenede Stater, 77030
        • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
      • Houston, Texas, Forenede Stater, 77030
        • Michael E DeBakey VA Medical Center
      • Houston, Texas, Forenede Stater, 77030
        • The Methodist Hospital System
      • Houston, Texas, Forenede Stater, 77030
        • Ben Taub General Hospital
      • Houston, Texas, Forenede Stater, 77030
        • Baylor Saint Luke's Medical Center
      • Lackland Air Force Base, Texas, Forenede Stater, 78236
        • Wilford Hall Medical Center
    • Utah
      • Cedar City, Utah, Forenede Stater, 84720
        • Sandra L Maxwell Cancer Center
      • Logan, Utah, Forenede Stater, 84321
        • Logan Regional Hospital
      • Murray, Utah, Forenede Stater, 84107
        • Intermountain Medical Center
      • Murray, Utah, Forenede Stater, 84107
        • Cottonwood Hospital Medical Center
      • Ogden, Utah, Forenede Stater, 84403
        • McKay-Dee Hospital Center
      • Provo, Utah, Forenede Stater, 84604
        • Utah Valley Regional Medical Center
      • Saint George, Utah, Forenede Stater, 84770
        • Dixie Medical Center Regional Cancer Center
      • Salt Lake City, Utah, Forenede Stater, 84112
        • Huntsman Cancer Institute/University of Utah
      • Salt Lake City, Utah, Forenede Stater, 84106
        • Utah Cancer Specialists-Salt Lake City
      • Salt Lake City, Utah, Forenede Stater, 84143
        • LDS Hospital
      • Salt Lake City, Utah, Forenede Stater, 84103
        • Intermountain Health Care
    • Vermont
      • Berlin, Vermont, Forenede Stater, 05602
        • Central Vermont Medical Center/National Life Cancer Treatment
      • Burlington, Vermont, Forenede Stater, 05405
        • University of Vermont College of Medicine
    • Washington
      • Bellingham, Washington, Forenede Stater, 98225
        • PeaceHealth Saint Joseph Medical Center
      • Bremerton, Washington, Forenede Stater, 98310
        • Harrison HealthPartners Hematology and Oncology-Bremerton
      • Kennewick, Washington, Forenede Stater, 99336
        • Kadlec Clinic Hematology and Oncology
      • Mount Vernon, Washington, Forenede Stater, 98274
        • Skagit Valley Hospital
      • Seattle, Washington, Forenede Stater, 98109
        • Fred Hutchinson Cancer Research Center
      • Seattle, Washington, Forenede Stater, 98195
        • University of Washington Medical Center
      • Seattle, Washington, Forenede Stater, 98104
        • Harborview Medical Center
      • Seattle, Washington, Forenede Stater, 98112
        • Kaiser Permanente Washington
      • Seattle, Washington, Forenede Stater, 98104
        • Minor and James Medical PLLC
      • Seattle, Washington, Forenede Stater, 98122-4307
        • Swedish Medical Center-First Hill
      • Sedro-Woolley, Washington, Forenede Stater, 98284
        • PeaceHealth United General Medical Center
      • Spokane, Washington, Forenede Stater, 99202
        • Cancer Care Northwest - Spokane South
      • Vancouver, Washington, Forenede Stater, 98664
        • PeaceHealth Southwest Medical Center
      • Wenatchee, Washington, Forenede Stater, 98801
        • Wenatchee Valley Hospital and Clinics
      • Wenatchee, Washington, Forenede Stater, 98801
        • Central Washington Hospital
    • West Virginia
      • Morgantown, West Virginia, Forenede Stater, 26506
        • West Virginia University Healthcare
    • Wisconsin
      • Chippewa Falls, Wisconsin, Forenede Stater, 54729
        • Marshfield Clinic-Chippewa Center
      • Eau Claire, Wisconsin, Forenede Stater, 54701
        • Marshfield Clinic Cancer Center at Sacred Heart
      • Eau Claire, Wisconsin, Forenede Stater, 54701
        • Sacred Heart Hospital
      • La Crosse, Wisconsin, Forenede Stater, 54601
        • Gundersen Lutheran Medical Center
      • Marshfield, Wisconsin, Forenede Stater, 54449
        • Marshfield Clinic
      • Marshfield, Wisconsin, Forenede Stater, 54449
        • Marshfield Medical Center
      • Milwaukee, Wisconsin, Forenede Stater, 53226
        • Froedtert and the Medical College of Wisconsin
      • Minocqua, Wisconsin, Forenede Stater, 54548
        • Marshfield Clinic-Minocqua Center
      • Oconomowoc, Wisconsin, Forenede Stater, 53066
        • ProHealth Oconomowoc Memorial Hospital
      • Rhinelander, Wisconsin, Forenede Stater, 54501
        • Ascension Saint Mary's Hospital
      • Rice Lake, Wisconsin, Forenede Stater, 54868
        • Marshfield Clinic-Rice Lake Center
      • Stevens Point, Wisconsin, Forenede Stater, 54481
        • Saint Michael's Hospital
      • Waukesha, Wisconsin, Forenede Stater, 53188
        • ProHealth Waukesha Memorial Hospital
      • Wausau, Wisconsin, Forenede Stater, 54401
        • Marshfield Clinic-Wausau Center
      • Weston, Wisconsin, Forenede Stater, 54476
        • Diagnostic and Treatment Center
      • Weston, Wisconsin, Forenede Stater, 54476
        • Marshfield Clinic - Weston Center
      • Wisconsin Rapids, Wisconsin, Forenede Stater, 54494
        • Marshfield Clinic - Wisconsin Rapids Center
    • Wyoming
      • Sheridan, Wyoming, Forenede Stater, 82801
        • Welch Cancer Center
  • Israel
      • Haifa, Israel, 31096
        • Rambam Medical Center
  • Peru
      • Lima, Peru, Lima 34
        • Instituto Nacional de Enfermedades Neoplasicas

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Patienter, der er kvalificerede til at deltage i denne undersøgelse, skal falde ind under en af ​​disse kategorier:

    • Patienter i første remission efter primær induktionssvigt
    • Patienter skal have modtaget mindst to kemoterapi-induktionsregimer
    • Patienter i anden eller efterfølgende remission
    • Patienter > 60 år i første remission

  • Patienter skal være i fuldstændig remission (CR) eller morfologisk remission (MR) ved blodtællinger og knoglemarvsundersøgelser for at deltage i undersøgelsen

    • Bekræftende knoglemarv skal udføres =< 2 uger før randomisering

  • Patienter skal have morfologisk bevis (fra knoglemarvsaspirat, udstrygninger eller berøringsforberedelser af marvbiopsi), at de havde AML af en af ​​følgende typer før opnåelse af CR/MR

    • Akut myeloblastisk leukæmi, minimal differentiering (fransk-amerikansk-britisk [FAB] M0)
    • Akut myeloblastisk leukæmi uden differentiering (FAB M1)
    • Akut myeloblastisk leukæmi med modning (FAB M2)
    • Akut myelomonocytisk leukæmi (FAB M4)
    • Akut monocytisk leukæmi (FAB M5)
    • Akut erythroleukæmi (FAB M6)
    • Akut megakaryocytisk leukæmi (FAB M7)
    • Refraktær anæmi med overskydende blaster i transformation (RAEB-T)
    • AML efter Verdenssundhedsorganisationens (WHO) kriterier
    • Akut myeloid leukæmi med multilineage dysplasi
  • Patienter med akut promyelocytisk leukæmi (FAB M3) er ikke kvalificerede

  • Patienter skal registreres inden for 60 dage efter afslutning af behandlingen for den aktuelle remission; patienter er kvalificerede, hvis de opfylder et af nedenstående kriterier:

    • Inden for 60 dage efter remission (CR eller MR) ved perifere blodtællinger efter induktionsbehandling eller
    • Inden for 60 dage efter udskrivelse fra hospitalet efter induktionsbehandling eller
    • Inden for 60 dage efter udskrivelse fra hospitalet efter behandling efter remission eller
    • Inden for 60 dage efter genopretning af blodtal efter sidste dosis kemoterapi

  • Alle nedenstående patienter er berettigede til studieoptagelse:

    • Patienter, der har modtaget konsolideringsterapi
    • Patienter, der ikke har modtaget konsoliderings- eller postremissionsbehandling
    • Patienter, der har fået en autolog stamcelletransplantation
  • Patienter, der har modtaget en allogen transplantation (knoglemarvstransplantation [BMT] eller perifer stamcelletransplantation [PSCT]) i deres nuværende remission, er ikke berettigede; patienter, der har fået en allogen transplantation i en tidligere remission og i øjeblikket er i remission efter efterfølgende tilbagefald, er berettigede
  • Patienter med en anamnese med ekstramedullær sygdom er berettigede, hvis de er i fuldstændig remission på tidspunktet for studiestart og ikke længere har behov for behandling for deres ekstramedullære sygdom
  • Patienter må ikke være gravide eller ammende; alle kvinder i den fødedygtige alder skal have en blodprøve eller urinundersøgelse < 2 uger før randomisering for at udelukke graviditet
  • Kvinder i den fødedygtige alder og seksuelt aktive mænd anbefales kraftigt at bruge en accepteret og effektiv præventionsmetode
  • Patienter må ikke være kendt for at have en allergi over for imidazolmedicin, såsom clotrimazol ketoconazol, miconazol, econazol eller terconazol; dette inkluderer ikke fluconazol, voriconazol eller itraconazol
  • Eastern Cooperative Oncology Group (ECOG) præstationsstatus på 0 - 2
  • Patienter må ikke have aktiv hjerte- eller lungesygdom; men patienten vil være berettiget, hvis sygdommen er medicinsk kontrolleret
  • Patienter må ikke have aktiv nyresygdom; kreatinin skal være =< 1,5 x øvre normalgrænse
  • Patienter må ikke have aktiv leversygdom; total eller direkte bilirubin skal være < 2 mg/dl
  • Serumglutamin-oxaloeddikesyretransaminase (SGOT) (aspartataminotransferase [AST]) og serumglutamatpyruvattransaminase (SGPT) (alaninaminotransferase [ALT]) skal være =< 2,5 gange den øvre grænse for normalen
  • Absolut neutrofiltal (ANC) >= 1000/mm^3
  • Blodpladetal >= 50.000/mm^3
  • Patienter må ikke tage et leverenzyminducerende antikonvulsivt middel; en patient vil ikke være berettiget til undersøgelsen, hvis patienten i øjeblikket tager et af disse midler og ikke kan skiftes til et ikke-hepatisk enzym-inducerende antikonvulsivt middel

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: Arm A (tipifarnib)
Patienterne modtager tipifarnib PO BID på dag 1-21. Kurser gentages hver 28. dag i fravær af sygdomsprogression eller uacceptabel toksicitet.
Medicin: Tipifarnib
Givet PO
Andre navne:
  • R115777
  • Zarnestra
Andet: Arm B (klinisk observation)
Patienter gennemgår kun observation.
Procedure: Klinisk observation
Gennemgå observation
Andre navne:
  • observation

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Sygdomsfri overlevelse
Tidsramme: Vurderet månedligt i de første 6 måneder og derefter hver 3. måned eller som klinisk indiceret, op til 5 år.
Sygdomsfri overlevelse (DFS) er defineret som tiden fra randomisering til tilbagefald eller død uden tilbagefald.
Vurderet månedligt i de første 6 måneder og derefter hver 3. måned eller som klinisk indiceret, op til 5 år.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Samlet overlevelse
Tidsramme: Vurderet månedligt i de første 6 måneder og derefter hver 3. måned eller som klinisk indiceret, op til 5 år.
Samlet overlevelse (OS) er defineret som tiden fra randomisering til død uanset årsag.
Vurderet månedligt i de første 6 måneder og derefter hver 3. måned eller som klinisk indiceret, op til 5 år.

Samarbejdspartnere og efterforskere

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

Sponsor

National Cancer Institute (NCI)

Efterforskere

  • Ledende efterforsker: Selina Luger, ECOG-ACRIN Cancer Research Group

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

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 (Faktiske)

18. august 2004

Primær færdiggørelse (Faktiske)

20. februar 2015

Datoer for studieregistrering

Først indsendt

6. oktober 2004

Først indsendt, der opfyldte QC-kriterier

7. oktober 2004

Først opslået (Anslået)

8. oktober 2004

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. marts 2024

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. marts 2024

Sidst verificeret

1. marts 2024

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NCI-2009-00535 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • U10CA180820 (U.S. NIH-bevilling/kontrakt)
  • U10CA021115 (U.S. NIH-bevilling/kontrakt)
  • E2902 (Anden identifikator: CTEP)

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 Tipifarnib

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Spain

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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