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Fludarabin med eller uden cyclophosphamid til behandling af patienter med kronisk lymfatisk leukæmi

14. juni 2023 opdateret af: Eastern Cooperative Oncology Group

Fase III randomiseret forsøg med fludarabin og cyclophosphamid versus fludarabin til tidligere ubehandlet kronisk lymfatisk leukæmi

RATIONALE: Lægemidler, der bruges i kemoterapi, bruger forskellige måder til at stoppe kræftceller i at dele sig, så de holder op med at vokse eller dør. Kombination af mere end ét lægemiddel kan dræbe flere kræftceller. Det vides endnu ikke, om kombination af cyclophosphamid med fludarabin er mere effektiv end fludarabin alene til behandling af kronisk lymfatisk leukæmi.

FORMÅL: Randomiseret fase III-forsøg til undersøgelse af effektiviteten af fludarabin med eller uden cyclophosphamid til behandling af patienter, som har kronisk lymfatisk leukæmi, som ikke tidligere er blevet behandlet.

Studieoversigt

Status

Afsluttet

Betingelser

Leukæmi

Intervention / Behandling

Detaljeret beskrivelse

MÅL:

Sammenlign effekten af fludarabin med eller uden cyclophosphamid med hensyn til fuldstændig remissionsrate og samlet overlevelse hos patienter med tidligere ubehandlet B-celle kronisk lymfatisk leukæmi (CLL).
Sammenlign toksiciteten af disse 2 regimer i denne patientpopulation.
Bestem, om ekspressionen af proteiner specifikt impliceret i reguleringen af DNA-skade-induceret apoptose af lymfoide celler (dvs. p53; mdm2; GST; Bcl-2; Mcl-1; Bax; p27; og caspase-3) korrelerer med respons på kemoterapi hos disse patienter.
Bestem, om der er en sammenhæng mellem klinisk respons eller resistens og differentiel ekspression af gener i CLL-cellerne enten ved påbegyndelse af terapi eller efter tilbagefald og progression.
Korreler mutationer i immunoglobulin tung kæde variabel region gener med klinisk respons eller resistens i denne patientpopulation.

OVERSIGT: Dette er en randomiseret, multicenter undersøgelse. Patienterne er stratificeret efter sygdomsstadie (O-II vs III-IV). Patienterne randomiseres til en af to behandlingsarme.

Arm I: Patienterne får fludarabin IV over 30 minutter på dag 1-5.
Arm II: Patienterne får fludarabin som i arm I plus cyclophosphamid IV over 1 time på dag 1.

Behandlingen gentages hver 28. dag i op til 6 kure i fravær af sygdomsprogression eller uacceptabel toksicitet.

Patienterne følges hver 3. måned i 2 år og derefter hver 6. måned indtil sygdomsprogression.

PROJEKTERET TILSLUTNING: I alt 280 patienter vil blive akkumuleret til denne undersøgelse over 2 til 2,5 år.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

280

Fase

Fase 3

Kontakter og lokationer

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

Studiesteder

Canada
- Quebec
  - Montreal, Quebec, Canada, H2W 1S6
    - McGill University
Forenede Stater
- Alabama
  - Anniston, Alabama, Forenede Stater, 36207
    - Northeast Alabama Regional Medical Center
  - Birmingham, Alabama, Forenede Stater, 35294-3300
    - University of Alabama at Birmingham Comprehensive Cancer Center
  - Mobile, Alabama, Forenede Stater, 36688
    - MBCCOP - Gulf Coast
- Arizona
  - Phoenix, Arizona, Forenede Stater, 85006-2726
    - CCOP - Western Regional, Arizona
  - Phoenix, Arizona, Forenede Stater, 85012
    - Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
  - Tucson, Arizona, Forenede Stater, 85723
    - Veterans Affairs Medical Center - Tucson
  - Tucson, Arizona, Forenede Stater, 85724
    - Arizona Cancer Center at University of Arizona Health Sciences Center
- Arkansas
  - Little Rock, Arkansas, Forenede Stater, 72205
    - University of Arkansas for Medical Sciences
  - Little Rock, Arkansas, Forenede Stater, 72205
    - Veterans Affairs Medical Center - Little Rock (McClellan)
- California
  - Duarte, California, Forenede Stater, 91010-0269
    - City of Hope Comprehensive Cancer Center
  - La Jolla, California, Forenede Stater, 92093-0658
    - Rebecca and John Moores UCSD Cancer Center
  - Los Angeles, California, Forenede Stater, 90048
    - Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
  - Los Angeles, California, Forenede Stater, 90095-1781
    - Jonsson Comprehensive Cancer Center, UCLA
  - Los Angeles, California, Forenede Stater, 90033
    - USC/Norris Comprehensive Cancer Center and Hospital
  - Martinez, California, Forenede Stater, 94553
    - Veterans Affairs Outpatient Clinic - Martinez
  - Oakland, California, Forenede Stater, 94609-3305
    - CCOP - Bay Area Tumor Institute
  - Orange, California, Forenede Stater, 92868
    - Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
  - Sacramento, California, Forenede Stater, 95817
    - University of California Davis Cancer Center
  - San Diego, California, Forenede Stater, 92161
    - Veterans Affairs Medical Center - San Diego
  - San Francisco, California, Forenede Stater, 94121
    - Veterans Affairs Medical Center - San Francisco
  - Santa Rosa, California, Forenede Stater, 95403
    - CCOP - Santa Rosa Memorial Hospital
  - Travis Air Force Base, California, Forenede Stater, 94535
    - David Grant Medical Center
- Colorado
  - Aurora, Colorado, Forenede Stater, 80010
    - University of Colorado Cancer Center at University of Colorado Health Sciences Center
  - Aurora, Colorado, Forenede Stater, 80012-0000
    - Medical Center of Aurora - South Campus
  - Boulder, Colorado, Forenede Stater, 80301-9019
    - Boulder Community Hospital
  - Colorado Springs, Colorado, Forenede Stater, 80933
    - Penrose Cancer Center
  - Denver, Colorado, Forenede Stater, 80210
    - Porter Adventist Hospital
  - Denver, Colorado, Forenede Stater, 80218
    - Presbyterian-St Luke's Medical Center
  - Denver, Colorado, Forenede Stater, 80224
    - CCOP - Colorado Cancer Research Program, Incorporated
  - Denver, Colorado, Forenede Stater, 80218-1191
    - St. Joseph Hospital
  - Denver, Colorado, Forenede Stater, 80220
    - Rocky Mountain Cancer Centers - Rose
  - Englewood, Colorado, Forenede Stater, 80110
    - Swedish Medical Center
  - Lone Tree, Colorado, Forenede Stater, 80124
    - Sky Ridge Medical Center
  - Longmont, Colorado, Forenede Stater, 80501
    - Longmont United Hospital
  - Pueblo, Colorado, Forenede Stater, 81004
    - St. Mary-Corwin Regional Medical Center
  - Thornton, Colorado, Forenede Stater, 80260
    - Rocky Mountain Cancer Centers
- Delaware
  - Newark, Delaware, Forenede Stater, 19713
    - CCOP - Christiana Care Health Services
- District of Columbia
  - Washington, District of Columbia, Forenede Stater, 20307-5000
    - Walter Reed Army Medical Center
  - Washington, District of Columbia, Forenede Stater, 20422
    - Veterans Affairs Medical Center - Washington, DC
  - Washington, District of Columbia, Forenede Stater, 20007
    - Lombardi Cancer Center at Georgetown University Medical Center
  - Washington, District of Columbia, Forenede Stater, 20060
    - MBCCOP - Howard University Cancer Center
- Florida
  - Fort Lauderdale, Florida, Forenede Stater, 33316
    - Broward General Medical Center
  - Hollywood, Florida, Forenede Stater, 33021
    - Memorial Regional Hospital Comprehensive Cancer Center
  - Miami Beach, Florida, Forenede Stater, 33140
    - CCOP - Mount Sinai Medical Center
  - Orlando, Florida, Forenede Stater, 32804
    - Florida Hospital Cancer Institute
  - Tampa, Florida, Forenede Stater, 33612-9497
    - H. Lee Moffitt Cancer Center and Research Institute
  - West Palm Beach, Florida, Forenede Stater, 33401
    - Palm Beach Cancer Institute
- Georgia
  - Atlanta, Georgia, Forenede Stater, 30322
    - Winship Cancer Institute of Emory University
  - Atlanta, Georgia, Forenede Stater, 30342-1701
    - CCOP - Atlanta Regional
  - Decatur, Georgia, Forenede Stater, 30033
    - Veterans Affairs Medical Center - Atlanta (Decatur)
- Hawaii
  - Honolulu, Hawaii, Forenede Stater, 96813
    - MBCCOP - Hawaii
- Illinois
  - Chicago, Illinois, Forenede Stater, 60612
    - Veterans Affairs Medical Center - Chicago (Westside Hospital)
  - Chicago, Illinois, Forenede Stater, 60637-1470
    - University of Chicago Cancer Research Center
  - Chicago, Illinois, Forenede Stater, 60640
    - Louis A. Weiss Memorial Hospital
  - Chicago, Illinois, Forenede Stater, 60612
    - MBCCOP - University of Illinois at Chicago
  - Chicago, Illinois, Forenede Stater, 60611
    - Robert H. Lurie Comprehensive Cancer Center at Northwestern University
  - Chicago, Illinois, Forenede Stater, 60611-4494
    - Veterans Affairs Medical Center - Lakeside Chicago
  - Decatur, Illinois, Forenede Stater, 62526
    - CCOP - Central Illinois
  - Evanston, Illinois, Forenede Stater, 60201
    - CCOP - Evanston
  - Hines, Illinois, Forenede Stater, 60141
    - Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
  - Maywood, Illinois, Forenede Stater, 60153-5500
    - Cardinal Bernardin Cancer Center at Loyola University Medical Center
  - Peoria, Illinois, Forenede Stater, 61602
    - CCOP - Illinois Oncology Research Association
  - River Forest, Illinois, Forenede Stater, 60305
    - West Suburban Center for Cancer Care
  - Rockford, Illinois, Forenede Stater, 61108
    - Saint Anthony Medical Center
  - Urbana, Illinois, Forenede Stater, 61801
    - CCOP - Carle Cancer Center
- Indiana
  - Fort Wayne, Indiana, Forenede Stater, 46885-5099
    - Fort Wayne Medical Oncology and Hematology, Incorporated
  - South Bend, Indiana, Forenede Stater, 46601
    - CCOP - Northern Indiana CR Consortium
- Iowa
  - Bettendorf, Iowa, Forenede Stater, 52722
    - Hematology Oncology Associates of the Quad Cities
  - Cedar Rapids, Iowa, Forenede Stater, 52403-1206
    - CCOP - Cedar Rapids Oncology Project
  - Davenport, Iowa, Forenede Stater, 52804
    - Genesis Medical Center
  - Des Moines, Iowa, Forenede Stater, 50309-1016
    - CCOP - Iowa Oncology Research Association
  - Iowa City, Iowa, Forenede Stater, 52242-1009
    - Holden Comprehensive Cancer Center at University of Iowa
- Kansas
  - Kansas City, Kansas, Forenede Stater, 66160-7353
    - Kansas Cancer Institute at the University of Kansas Medical Center
  - Wichita, Kansas, Forenede Stater, 67214-3882
    - CCOP - Wichita
  - Wichita, Kansas, Forenede Stater, 67218
    - Veterans Affairs Medical Center - Wichita
- Kentucky
  - Lexington, Kentucky, Forenede Stater, 40502-2236
    - Veterans Affairs Medical Center - Lexington
  - Lexington, Kentucky, Forenede Stater, 40536-0084
    - Markey Cancer Center at University of Kentucky Chandler Medical Center
  - Louisville, Kentucky, Forenede Stater, 40207
    - Baptist Hospital East - Louisville
- Louisiana
  - New Orleans, Louisiana, Forenede Stater, 70112
    - Tulane University School of Medicine
  - New Orleans, Louisiana, Forenede Stater, 70112
    - Veterans Affairs Medical Center - New Orleans
  - New Orleans, Louisiana, Forenede Stater, 70121
    - CCOP - Ochsner
  - New Orleans, Louisiana, Forenede Stater, 70112
    - MBCCOP - LSU Health Sciences Center
  - Shreveport, Louisiana, Forenede Stater, 71130-3932
    - Louisiana State University Health Sciences Center - Shreveport
  - Shreveport, Louisiana, Forenede Stater, 71130
    - Veterans Affairs Medical Center - Shreveport
- Maryland
  - Baltimore, Maryland, Forenede Stater, 21201
    - Marlene and Stewart Greenebaum Cancer Center, University of Maryland
  - Baltimore, Maryland, Forenede Stater, 21201
    - Veterans Affairs Medical Center - Baltimore
  - Baltimore, Maryland, Forenede Stater, 21231
    - Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Massachusetts
  - Boston, Massachusetts, Forenede Stater, 02215
    - Beth Israel Deaconess Medical Center
  - Boston, Massachusetts, Forenede Stater, 02115
    - Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
  - Boston, Massachusetts, Forenede Stater, 02118
    - Cancer Research Center at Boston Medical Center
  - Boston, Massachusetts, Forenede Stater, 02111
    - TUFTS - New England Medical Center
  - Worcester, Massachusetts, Forenede Stater, 01655
    - University of Massachusetts Memorial Medical Center - University Campus
- Michigan
  - Ann Arbor, Michigan, Forenede Stater, 48105
    - Veterans Affairs Medical Center - Ann Arbor
  - Ann Arbor, Michigan, Forenede Stater, 48106
    - CCOP - Michigan Cancer Research Consortium
  - Ann Arbor, Michigan, Forenede Stater, 48109-0912
    - University of Michigan Comprehensive Cancer Center
  - Detroit, Michigan, Forenede Stater, 48202
    - Josephine Ford Cancer Center at Henry Ford Hospital
  - Detroit, Michigan, Forenede Stater, 48201-1379
    - Barbara Ann Karmanos Cancer Institute
  - Detroit, Michigan, Forenede Stater, 48201-1932
    - Veterans Affairs Medical Center - Detroit
  - Grand Rapids, Michigan, Forenede Stater, 49503
    - CCOP - Grand Rapids
  - Kalamazoo, Michigan, Forenede Stater, 49007-3731
    - CCOP - Kalamazoo
  - Royal Oak, Michigan, Forenede Stater, 48073-6769
    - CCOP - Beaumont
  - Saint Joseph, Michigan, Forenede Stater, 49085
    - Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
  - Southfield, Michigan, Forenede Stater, 48075
    - Providence Cancer Institute at Providence Hospital
- Minnesota
  - Minneapolis, Minnesota, Forenede Stater, 55417
    - Veterans Affairs Medical Center - Minneapolis
  - Minneapolis, Minnesota, Forenede Stater, 55455
    - University of Minnesota Cancer Center
  - Rochester, Minnesota, Forenede Stater, 55905
    - Mayo Clinic Cancer Center
  - Saint Louis Park, Minnesota, Forenede Stater, 55416
    - CCOP - Metro-Minnesota
- Mississippi
  - Biloxi, Mississippi, Forenede Stater, 39531-2410
    - Veterans Affairs Medical Center - Biloxi
  - Jackson, Mississippi, Forenede Stater, 39216-4505
    - University of Mississippi Medical Center
  - Jackson, Mississippi, Forenede Stater, 39216
    - Veterans Affairs Medical Center - Jackson
- Missouri
  - Columbia, Missouri, Forenede Stater, 65201
    - Veterans Affairs Medical Center - Columbia (Truman Memorial)
  - Columbia, Missouri, Forenede Stater, 65203
    - Ellis Fischel Cancer Center at University of Missouri - Columbia
  - Kansas City, Missouri, Forenede Stater, 64128
    - Veterans Affairs Medical Center - Kansas City
  - Kansas City, Missouri, Forenede Stater, 64131
    - CCOP - Kansas City
  - Saint Louis, Missouri, Forenede Stater, 63110
    - Barnes-Jewish Hospital
  - Saint Louis, Missouri, Forenede Stater, 63131
    - Missouri Baptist Cancer Center
  - Saint Louis, Missouri, Forenede Stater, 63141
    - CCOP - St. Louis-Cape Girardeau
  - Saint Louis, Missouri, Forenede Stater, 63110
    - St. Louis University Hospital Cancer Center
  - Springfield, Missouri, Forenede Stater, 65807
    - CCOP - Cancer Research for the Ozarks
- Montana
  - Billings, Montana, Forenede Stater, 59101
    - CCOP - Montana Cancer Consortium
- Nebraska
  - Omaha, Nebraska, Forenede Stater, 68198-7680
    - UNMC Eppley Cancer Center at the University of Nebraska Medical Center
- Nevada
  - Las Vegas, Nevada, Forenede Stater, 89106
    - CCOP - Southern Nevada Cancer Research Foundation
  - Las Vegas, Nevada, Forenede Stater, 89106
    - Veterans Affairs Medical Center - Las Vegas
- New Hampshire
  - Lebanon, New Hampshire, Forenede Stater, 03756-0002
    - Norris Cotton Cancer Center at Dartmouth Medical School
- New Jersey
  - Camden, New Jersey, Forenede Stater, 08103
    - Cooper University Hospital
  - East Orange, New Jersey, Forenede Stater, 07019
    - Veterans Affairs Medical Center - East Orange
  - New Brunswick, New Jersey, Forenede Stater, 08903
    - Cancer Institute Of New Jersey
- New Mexico
  - Albuquerque, New Mexico, Forenede Stater, 87108-5138
    - Veterans Affairs Medical Center - Albuquerque
  - Albuquerque, New Mexico, Forenede Stater, 87131
    - MBCCOP - University of New Mexico HSC
- New York
  - Albany, New York, Forenede Stater, 12208
    - Veterans Affairs Medical Center - Albany
  - Bronx, New York, Forenede Stater, 10461
    - Albert Einstein Clinical Cancer Center
  - Buffalo, New York, Forenede Stater, 14215
    - Veterans Affairs Medical Center - Buffalo
  - Elmhurst, New York, Forenede Stater, 11373
    - Elmhurst Hospital Center
  - Jamaica, New York, Forenede Stater, 11432
    - Queens Cancer Center of Queens Hospital
  - Manhasset, New York, Forenede Stater, 11030
    - CCOP - North Shore University Hospital
  - Manhasset, New York, Forenede Stater, 11030
    - North Shore University Hospital
  - New York, New York, Forenede Stater, 10021
    - Memorial Sloan-Kettering Cancer Center
  - New York, New York, Forenede Stater, 10029
    - Mount Sinai Medical Center, NY
  - New York, New York, Forenede Stater, 10021
    - New York Weill Cornell Cancer Center at Cornell University
  - New York, New York, Forenede Stater, 10032
    - Herbert Irving Comprehensive Cancer Center at Columbia University
  - Rochester, New York, Forenede Stater, 14642
    - James P. Wilmot Cancer Center at University of Rochester Medical Center
  - Syracuse, New York, Forenede Stater, 13210
    - Veterans Affairs Medical Center - Syracuse
  - Syracuse, New York, Forenede Stater, 13217
    - CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
  - Syracuse, New York, Forenede Stater, 13210
    - University Hospital at State University of New York - Upstate Medical University
- North Carolina
  - Asheville, North Carolina, Forenede Stater, 28805
    - Veterans Affairs Medical Center - Asheville
  - Chapel Hill, North Carolina, Forenede Stater, 27599-7295
    - Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
  - Concord, North Carolina, Forenede Stater, 28025
    - NorthEast Oncology Associates
  - Durham, North Carolina, Forenede Stater, 27705
    - Veterans Affairs Medical Center - Durham
  - Durham, North Carolina, Forenede Stater, 27710
    - Duke Comprehensive Cancer Center
  - Fayetteville, North Carolina, Forenede Stater, 28302-2000
    - Cape Fear Valley Health System
  - Kinston, North Carolina, Forenede Stater, 28503-1678
    - Lenoir Memorial Hospital Cancer Center
  - Pinehurst, North Carolina, Forenede Stater, 28374
    - Firsthealth Moore Regional Hospital
  - Wilmington, North Carolina, Forenede Stater, 28402-9025
    - New Hanover Regional Medical Center
  - Winston-Salem, North Carolina, Forenede Stater, 27104-4241
    - CCOP - Southeast Cancer Control Consortium
  - Winston-Salem, North Carolina, Forenede Stater, 27157-1082
    - Comprehensive Cancer Center at Wake Forest University
- North Dakota
  - Fargo, North Dakota, Forenede Stater, 58102
    - Veterans Affairs Medical Center - Fargo
  - Fargo, North Dakota, Forenede Stater, 58122
    - CCOP - Merit Care Hospital
- Ohio
  - Cincinnati, Ohio, Forenede Stater, 45220-2288
    - Veterans Affairs Medical Center - Cincinnati
  - Cincinnati, Ohio, Forenede Stater, 45267-0501
    - Charles M. Barrett Cancer Center at University Hospital
  - Cleveland, Ohio, Forenede Stater, 44109
    - MetroHealth Medical Center
  - Cleveland, Ohio, Forenede Stater, 44195-9001
    - Cleveland Clinic Taussig Cancer Center
  - Columbus, Ohio, Forenede Stater, 43210-1240
    - Arthur G. James Cancer Hospital - Ohio State University
  - Columbus, Ohio, Forenede Stater, 43206
    - CCOP - Columbus
  - Dayton, Ohio, Forenede Stater, 45429
    - CCOP - Dayton
  - Dayton, Ohio, Forenede Stater, 45428-1002
    - Veterans Affairs Medical Center - Dayton
- Oklahoma
  - Oklahoma City, Oklahoma, Forenede Stater, 73104
    - Veterans Affairs Medical Center - Oklahoma City
  - Oklahoma City, Oklahoma, Forenede Stater, 73104
    - Oklahoma University Medical Center at University of Oklahoma Health Sciences Center
- Oregon
  - Portland, Oregon, Forenede Stater, 97207
    - Veterans Affairs Medical Center - Portland
  - Portland, Oregon, Forenede Stater, 97225
    - CCOP - Columbia River Oncology Program
  - Portland, Oregon, Forenede Stater, 97201-3098
    - Cancer Institute at Oregon Health and Science University
- Pennsylvania
  - Danville, Pennsylvania, Forenede Stater, 17822-2001
    - CCOP - Geisinger Clinic and Medical Center
  - Hershey, Pennsylvania, Forenede Stater, 17033-0850
    - Penn State Cancer Institute at Milton S. Hershey Medical Center
  - Pittsburgh, Pennsylvania, Forenede Stater, 15224
    - Western Pennsylvania Hospital
  - Pittsburgh, Pennsylvania, Forenede Stater, 15236
    - Hillman Cancer Center at University of Pittsburgh Cancer Institute
  - Wynnewood, Pennsylvania, Forenede Stater, 19096
    - CCOP - MainLine Health
- Rhode Island
  - Providence, Rhode Island, Forenede Stater, 02906
    - Lifespan: The Miriam Hospital
- South Carolina
  - Charleston, South Carolina, Forenede Stater, 29425
    - Hollings Cancer Center at Medical University of South Carolina
  - Charleston, South Carolina, Forenede Stater, 29401-5799
    - Veterans Affairs Medical Center - Charleston
  - Greenville, South Carolina, Forenede Stater, 29615
    - CCOP - Greenville
  - Spartanburg, South Carolina, Forenede Stater, 29303
    - CCOP - Upstate Carolina
- South Dakota
  - Sioux Falls, South Dakota, Forenede Stater, 57104
    - CCOP - Sioux Community Cancer Consortium
- Tennessee
  - Memphis, Tennessee, Forenede Stater, 38103
    - University of Tennessee Cancer Institute
  - Memphis, Tennessee, Forenede Stater, 38104
    - Danville Radiation Therapy Center
- Texas
  - Amarillo, Texas, Forenede Stater, 79106
    - Harrington Cancer Center
  - Amarillo, Texas, Forenede Stater, 79106
    - Veterans Affairs Medical Center - Amarillo
  - Dallas, Texas, Forenede Stater, 75216
    - Veterans Affairs Medical Center - Dallas
  - Dallas, Texas, Forenede Stater, 75230
    - Medical City Dallas Hospital
  - Dallas, Texas, Forenede Stater, 75390
    - Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
  - Fort Sam Houston, Texas, Forenede Stater, 78234-6200
    - Brooke Army Medical Center
  - Galveston, Texas, Forenede Stater, 77555-0565
    - University of Texas Medical Branch
  - Houston, Texas, Forenede Stater, 77030
    - Veterans Affairs Medical Center - Houston
  - Houston, Texas, Forenede Stater, 77030-4095
    - University of Texas - MD Anderson Cancer Center
  - San Antonio, Texas, Forenede Stater, 78229-3900
    - University of Texas Health Science Center at San Antonio
  - San Antonio, Texas, Forenede Stater, 78229
    - Veterans Affairs Medical Center - San Antonio (Murphy)
  - Temple, Texas, Forenede Stater, 76504
    - Veterans Affairs Medical Center - Temple
  - Temple, Texas, Forenede Stater, 76508
    - CCOP - Scott and White Hospital
- Utah
  - Salt Lake City, Utah, Forenede Stater, 84148
    - Veterans Affairs Medical Center - Salt Lake City
  - Salt Lake City, Utah, Forenede Stater, 84112-5550
    - Huntsman Cancer Institute
- Vermont
  - Bennington, Vermont, Forenede Stater, 05201
    - Green Mountain Oncology Group
  - Burlington, Vermont, Forenede Stater, 05401-3498
    - Vermont Cancer Center at University of Vermont
  - White River Junction, Vermont, Forenede Stater, 05009
    - Veterans Affairs Medical Center - White River Junction
- Virginia
  - Charlottesville, Virginia, Forenede Stater, 22902
    - Martha Jefferson Hospital
  - Norfolk, Virginia, Forenede Stater, 23502
    - Virginia Oncology Associates - Norfolk
  - Richmond, Virginia, Forenede Stater, 23298-0037
    - MBCCOP - Massey Cancer Center
  - Roanoke, Virginia, Forenede Stater, 24014
    - Oncology and Hematology Associates of Southwest Virginia, Inc.
- Washington
  - Seattle, Washington, Forenede Stater, 98101
    - CCOP - Virginia Mason Research Center
  - Seattle, Washington, Forenede Stater, 98108
    - Veterans Affairs Medical Center - Seattle
  - Seattle, Washington, Forenede Stater, 98109
    - Puget Sound Oncology Consortium
  - Tacoma, Washington, Forenede Stater, 98431-5000
    - Madigan Army Medical Center
  - Tacoma, Washington, Forenede Stater, 98405-0986
    - CCOP - Northwest
- West Virginia
  - Huntington, West Virginia, Forenede Stater, 25701
    - St. Mary's Medical Center
- Wisconsin
  - Green Bay, Wisconsin, Forenede Stater, 54307-3453
    - CCOP - St. Vincent Hospital Cancer Center, Green Bay
  - Madison, Wisconsin, Forenede Stater, 53792-0001
    - University of Wisconsin Comprehensive Cancer Center
  - Marshfield, Wisconsin, Forenede Stater, 54449
    - CCOP - Marshfield Clinic Research Foundation
  - Rhinelander, Wisconsin, Forenede Stater, 54501
    - Ministry Medical Group - Northern Region
Puerto Rico
- - San Juan, Puerto Rico, 00936-5067
    - University of Puerto Rico School of Medicine Medical Sciences Campus
Sydafrika
- - Pretoria, Sydafrika, 0001
    - Pretoria Academic Hospital

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

SYGDOMS KARAKTERISTIKA:

Diagnose af kronisk lymfatisk leukæmi (CLL) i ethvert stadie som defineret af følgende:
- Perifert blod absolut lymfocyttal større end 5.000/mm^3 inden for 14 dage før undersøgelse
- Lymfocytter skal være små til moderate med ikke mere end 55 % prolymfocytter, atypiske lymfocytter eller lymfoblaster morfologisk
- Fænotypisk karakteriseret som B-CLL
Skal have en af følgende egenskaber, der indikerer behov for kemoterapi:
- Progressiv marvsvigt (hæmoglobin mindre end 10 g/dL og/eller blodpladetal mindre end 100.000/mm^3)
- Progressiv lymfocytose med en stigning på mere end 50 % over en 2 måneders periode eller forventet fordoblingstid på mindre end 6 måneder
- Massiv (dvs. større end 6 cm under venstre kystmargin) eller progressiv splenomegali
- Massive noder eller klynger (dvs. større end 10 cm i længste diameter) eller progressiv adenopati
- Mindst 10 % vægttab inden for 6 måneder efter studiet
- Ekstrem træthed
- Feber over 100,5 grader F i 2 uger uden tegn på infektion
- Nattesved uden tegn på infektion
Ingen autoimmun anæmi eller autoimmun trombocytopeni

PATIENT KARAKTERISTIKA:

Alder:

18 og derover

Ydeevnestatus:

ØKOG 0-2

Forventede levealder:

Ikke specificeret

Hæmatopoietisk:

Se Sygdomskarakteristika

Hepatisk:

Bilirubin ikke større end 2 mg/dL, medmindre det er sekundært til tumor

Nyre:

Kreatinin ikke større end 2,0 mg/dL
Kreatininclearance mindst 40 ml/min, hvis kreatinin er større end 1,5 mg/dL

Andet:

Ingen anden tidligere eller samtidig malignitet inden for de seneste 2 år undtagen basalcellekarcinom i huden eller carcinom in situ i livmoderhalsen
Ingen aktiv infektion, der kræver oral eller intravenøs antibiotika
Ikke gravid eller ammende
Fertile patienter skal bruge effektiv prævention

FORUDSÆTNING SAMTYDLIG TERAPI:

Biologisk terapi:

Ikke specificeret

Kemoterapi:

Ingen forudgående cytotoksisk kemoterapi

Endokrin terapi:

Ingen tidligere steroidbehandling for CLL

Strålebehandling:

Ikke specificeret

Kirurgi:

Ikke specificeret

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

Samarbejdspartnere og efterforskere

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

Sponsor

Eastern Cooperative Oncology Group

Samarbejdspartnere

National Cancer Institute (NCI)

Cancer and Leukemia Group B

SWOG Cancer Research Network

Efterforskere

Studiestol: Mohamad A. Hussein, MD, The Cleveland Clinic
Studiestol: Ian W. Flinn, MD, PhD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Studiestol: Michael R. Grever, MD, Ohio State University Comprehensive Cancer Center

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.

Generelle publikationer

Dewald GW, Paietta E, Goloubeva O, et al.: Correlation of interphase fluorescence in situ hybridization (FISH) anomalies with cell morphology and immunophenotyping in chronic lymphocytic leukemia (B-CLL). [Abstract] Blood 100 (11 pt 1): A-2334, 2002.
Flinn IW, Neuberg DS, Grever MR, Dewald GW, Bennett JM, Paietta EM, Hussein MA, Appelbaum FR, Larson RA, Moore DF Jr, Tallman MS. Phase III trial of fludarabine plus cyclophosphamide compared with fludarabine for patients with previously untreated chronic lymphocytic leukemia: US Intergroup Trial E2997. J Clin Oncol. 2007 Mar 1;25(7):793-8. doi: 10.1200/JCO.2006.08.0762. Epub 2007 Feb 5.
Grever MR, Lucas DM, Dewald GW, Neuberg DS, Reed JC, Kitada S, Flinn IW, Tallman MS, Appelbaum FR, Larson RA, Paietta E, Jelinek DF, Gribben JG, Byrd JC. Comprehensive assessment of genetic and molecular features predicting outcome in patients with chronic lymphocytic leukemia: results from the US Intergroup Phase III Trial E2997. J Clin Oncol. 2007 Mar 1;25(7):799-804. doi: 10.1200/JCO.2006.08.3089. Epub 2007 Feb 5.
Byrd JC, Gribben JG, Peterson BL, Grever MR, Lozanski G, Lucas DM, Lampson B, Larson RA, Caligiuri MA, Heerema NA. Select high-risk genetic features predict earlier progression following chemoimmunotherapy with fludarabine and rituximab in chronic lymphocytic leukemia: justification for risk-adapted therapy. J Clin Oncol. 2006 Jan 20;24(3):437-43. doi: 10.1200/JCO.2005.03.1021. Epub 2005 Dec 12.
Flinn IW, Kumm E, Grever MR, et al.: Fludarabine and cyclophosphamide produces a higher complete response rate and more durable remissions than fludarabine in patients with previously untreated CLL: Intergroup trial E2997. [Abstract] Blood 104 (11): A-475, 2004.
Grever MR, Lucas DM, Dewald GW, et al.: Outcome of treatment with fludarabine versus fludarabine and cyclophosphamide in chronic lymphocytic leukemia (CLL) is adversely impacted by high risk genetic features: results from ECOG 2997. [Abstract] Blood 104 (11 Pt 1): A-3487, 2004.
Lucas DM, Ruppert AS, Lozanski G, Dewald GW, Lozanski A, Claus R, Plass C, Flinn IW, Neuberg DS, Paietta EM, Bennett JM, Jelinek DF, Gribben JG, Hussein MA, Appelbaum FR, Larson RA, Moore DF Jr, Tallman MS, Byrd JC, Grever MR. Cytogenetic prioritization with inclusion of molecular markers predicts outcome in previously untreated patients with chronic lymphocytic leukemia treated with fludarabine or fludarabine plus cyclophosphamide: a long-term follow-up study of the US intergroup phase III trial E2997. Leuk Lymphoma. 2015;56(11):3031-7. doi: 10.3109/10428194.2015.1023800. Epub 2015 Mar 30.

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)

9. marts 2000

Primær færdiggørelse (Faktiske)

1. november 2005

Datoer for studieregistrering

Først indsendt

1. november 1999

Først indsendt, der opfyldte QC-kriterier

26. januar 2003

Først opslået (Anslået)

27. januar 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Anslået)

16. juni 2023

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. juni 2023

Sidst verificeret

1. juni 2023

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

CDR0000066890
E2997
CALGB-10103
SWOG-E2997

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 cyclophosphamid

University of Colorado, Denver

Afsluttet

Arsentrioxid med cyclophosphamid hos patienter med recidiverende/refraktær akut myeloid leukæmi

Akut myeloid leukæmi | Recidiverende/Refraktær Akut Myeloid Leukæmi

Forenede Stater
Children's Hospital Los Angeles
Lucile Packard Children's Hospital

Afsluttet

Relateret hæmatopoietisk stamcelletransplantation (HSCT) for genetiske sygdomme i blodceller

Metaboliske sygdomme | Stamcelletransplantation | Kronisk granulomatøs sygdom | Knoglemarvstransplantation | Thalassæmi | Wiskott-Aldrich syndrom | Genetiske sygdomme | Perifer blodstamcelletransplantation | Pædiatri | Diamond-Blackfan Anæmi | Allogen Transplantation | Kombineret immundefekt | X-bundet lymfoproliferativ...
TCRCure Biopharma Ltd.

Rekruttering

Funktionelt Forbedrede ALPP-målrettede Konstruerede T-celler i Avancerede Solide Tumorer

Solid tumor

Kina
Medical College of Wisconsin
National Cancer Institute (NCI); National Heart, Lung, and Blood Institute... og andre samarbejdspartnere

Afsluttet

Fludarabin-baseret konditionering til svær aplastisk anæmi (BMT CTN 0301)

Anæmi, aplastisk

Forenede Stater
Second Affiliated Hospital, School of Medicine,...

Ikke rekrutterer endnu

Benmelstobart i kombination med Anlotinib og oral metronomisk cyclophosphamid i behandlingen af recidiverende epitelial ovarie-, æggeleder- eller primær peritonealcancer (BACON)

Livmoderhalskræft | Primær peritoneal kræft | Æggelederkræft
European Organisation for Research and Treatment...
Pfizer; ETOP IBCSG Partners Foundation; UNICANCER; Breast International Group; SOLTI Breast Cancer Research Group og andre samarbejdspartnere

Aktiv, ikke rekrutterende

Adjuverende Palbociclib hos ældre patienter med brystkræft (Appalaches)

Brystkræft fase II | Brystkræft fase III

Spanien, Frankrig, Italien, Belgien, Jordan, Polen, Tyskland, Det Forenede Kongerige, Portugal
Mahidol University

Afsluttet

Lavdosis VS Højdosis IV cyclophosphamid til proliferativ LN hos børn (Low/highIVCY)

Nyreinsufficiens | Infektion

Thailand
Institut Bergonié
Merck Sharp & Dohme LLC; National Cancer Institute, France; Transgene; Fondation...

Rekruttering

En undersøgelse af metronomisk CP og JX-594 hos patienter med avanceret brystkræft og avanceret bløddelssarkom (METROmaJX) (METROmaJX)

Brystkræft | Blødt væv sarkom | Faste tumorer

Frankrig
Shandong Cancer Hospital and Institute

Ukendt

Undersøgelse af brystkræftsvindtilstande efter neoadjuverende kemoterapi med helmonterede seriesnit og tredimensionel patologisk og MR-rekonstruktion (BCSMANC)

Brystkræft

Kina
Merck KGaA, Darmstadt, Germany

Afsluttet

Undersøgelse af Tecemotide (L-BLP25) hos forsøgspersoner med langsomt progressivt myelomatose uden symptomer, og som ikke har fået kemoterapi

Myelomatose

Tyskland

Fludarabin med eller uden cyclophosphamid til behandling af patienter med kronisk lymfatisk leukæmi

Fase III randomiseret forsøg med fludarabin og cyclophosphamid versus fludarabin til tidligere ubehandlet kronisk lymfatisk leukæmi

Studieoversigt

Status

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Undersøgelsestype

Tilmelding (Anslået)

Fase

Kontakter og lokationer

Studiesteder

Deltagelseskriterier

Berettigelseskriterier

Aldre berettiget til at studere

Tager imod sunde frivillige

Beskrivelse

Studieplan

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Samarbejdspartnere og efterforskere

Sponsor

Samarbejdspartnere

Efterforskere

Publikationer og nyttige links

Generelle publikationer

Datoer for undersøgelser

Studer store datoer

Studiestart (Faktiske)

Primær færdiggørelse (Faktiske)

Datoer for studieregistrering

Først indsendt

Først indsendt, der opfyldte QC-kriterier

Først opslået (Anslået)

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Anslået)

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidst verificeret

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Kliniske forsøg med cyclophosphamid

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Georgia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer