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Dexamethasone Compared With Prednisone During Induction Therapy and Methotrexate With or Without Leucovorin During Maintenance Therapy in Treating Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia

2. april 2021 opdateret af: Children's Oncology Group

High Risk B-Precursor Acute Lymphoblastic Leukemia (ALL)

This randomized phase III trial is studying dexamethasone to see how well it works compared to prednisone during induction therapy. This trial is also studying methotrexate and leucovorin calcium to see how well they work compared to methotrexate alone during maintenance therapy in treating patients with newly diagnosed acute lymphoblastic leukemia (ALL). Drugs used in chemotherapy, such as dexamethasone, prednisone, methotrexate, and leucovorin calcium, work in different ways to stop cancer cells from dividing so they stop growing or die. Giving more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating acute lymphoblastic leukemia.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

I. Improve the outcome of children with high-risk acute lymphoblastic leukemia treated with 2 different chemotherapy regimens.

II. Determine the relative safety and efficacy of dexamethasone given for 14 days vs prednisone given for 28 days during induction.

III. Determine the relative safety and efficacy of high-dose methotrexate (5gm/m^2) with leucovorin rescue compared to escalating methotrexate without leucovorin rescue (Capizzi I) during interim maintenance I.

IV. Correlate Day 29 minimal residual disease (MRD) with event-free survival (EFS) and overall survival (OS).

V. Correlate early marrow response status with day-29 MRD status. VI. Improve outcome by identifying additional high risk patients by Day 29 MRD for treatment with fully augmented Berlin-Frankfurt-Munster (BFM).

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to early response (slow early response [SER] vs rapid early response [RER]). Induction therapy: Patients are randomized to 1 of 4 treatment arms.

ARM I: Patients receive cytarabine intrathecally (IT) on day 1, vincristine intravenously (IV) and daunorubicin IV on days 1, 8, 15, and 22, dexamethasone orally (PO) or IV twice daily (BID) on days 1-14, methotrexate (MTX) IT on days 8 and 29* and pegaspargase intramuscularly (IM) once on day 4, 5, or 6.

NOTE: *Patients with CNS3 disease (WBC > 5/mL in cerebrospinal fluid and positive for blasts on cytospin) also receive MTX IT on days 15 and 22.

ARM II: Patients receive induction therapy as in Arm I.

ARM III: Patients receive cytarabine, vincristine, daunorubicin, and pegaspargase as in Arm I. Patients also receive prednisone PO or IV BID on days 1-28 and MTX IT on days 8 and 29.

ARM IV: Patients receive induction therapy as in Arm III.

Patients in all arms are evaluated at day 29 of induction therapy. Patients with M3 disease are removed from study. Patients with M1 disease and less than 1% minimal residual disease (MRD) proceed to consolidation therapy beginning on day 36. Patients with M2 disease OR with MI disease and at least 1% MRD receive extended induction therapy for 2 additional weeks. Patients with SER disease and MLL rearrangements are removed from the study but may be eligible for treatment on protocol COG-AALL0031.

Extended induction therapy: Patients continue to receive therapy on the arm to which they were originally randomized.

ARMS I and II: Patients receive dexamethasone PO or IV BID on days 1-14, vincristine IV on days 1 and 8, daunorubicin IV on day 1 and pegaspargase IM on day 4, 5, or 6 and are then reevaluated.

ARMS III and IV: Patients receive prednisone PO or IV BID on days 1-14, and vincristine, daunorubicin, and pegaspargase as in Arms I and II and are then reevaluated.

Patients on all arms who have M1 disease and less than 1% MRD after extended induction proceed to consolidation therapy and continue as SER patients. All other patients are removed from study.

Consolidation therapy: All patients receive cyclophosphamide IV over 30 minutes on days 1 and 29, cytarabine IV or subcutaneously (SC) on days 1-4, 8-11, 29-32, and 36-39, mercaptopurine (MP) PO on days 1-14 and 29-42, vincristine IV on days 15, 22, 43, and 50; pegaspargase IM on days 15 and 43 and MTX* IT on days 1, 8, 15, and 22. Patients with testicular disease also receive radiotherapy to the testes.

NOTE: *Patients with CNS3 disease receive MTX on days 1 and 8 only.

Interim maintenance therapy I: Patients continue to receive treatment on the arm to which they were originally randomized.

ARM I: (escalating-dose MTX) Patients receive vincristine IV and escalating-dose MTX IV on days 1, 11, 21, 31, and 41, pegaspargase IM on days 2 and 22 and MTX IT on days 1 and 21.

ARM II: (high-dose MTX) Patients receive vincristine IV and high-dose methotrexate IV over 24 hours on days 1, 15, 29, and 43, MP PO on days 1-56 and IT MTX on days 1 and 29. Patients also receive leucovorin calcium IV every 6 hours for at least 3 doses, beginning 42 hours after start of each MTX infusion.

ARM III: (escalating-dose MTX) Patients receive interim maintenance I therapy as in Arm I.

ARM IV: (high-dose MTX) Patients receive interim maintenance I therapy as in Arm II.

DELAYED INTENSIFICATION THERAPY I: All patients receive vincristine IV on days 1, 8, 15, 43, and 50, dexamethasone PO or IV BID on days 1 to 21 for patients age 1 to 12 OR on days 1-7 and 15-21 for patients age 13 and over, doxorubicin IV on days 1, 8, and 15, pegaspargase IM on day 4, 5, or 6 AND day 43, cyclophosphamide IV over 30 minutes on day 29, cytarabine IV or SC on days 30-33 and 37-40, thioguanine PO on days 29-42 and MTX IT on days 1, 29, and 36.After delayed intensification I, SER patients proceed to interim maintenance II and delayed intensification II. RER patients proceed directly to maintenance.

INTERIM MAINTENANCE THERAPY II: All patients receive vincristine IV and MTX IV on days 1, 11, 21, 31, and 41, pegaspargase IM on days 2 and 22; and MTX IT on days 1 and 21. Patients then proceed to delayed intensification II.

DELAYED INTENSIFICATION THERAPY II: All patients receive therapy as in delayed intensification I, arm I. CNS3 patients also receive radiotherapy for 3-10 days, beginning on day 29. All other SER patients, patients with MLL rearrangements, and some patients pretreated with steroids (> 48 hours within the week prior to diagnosis) receive prophylactic cranial radiotherapy (CRT) for 8 days, beginning on day 29. Patients then proceed to maintenance therapy.

MAINTENANCE THERAPY: All patients receive vincristine IV on days 1, 29, and 57, dexamethasone PO BID on days 1-5, 29-33, and 57-61, MP PO on days 1-84, MTX IT on day 1*; and MTX PO on days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.

NOTE: *RER (who did not undergo CRT) patients also receive MTX IT on day 29 for maintenance courses 1-4.

In all arms, maintenance therapy repeats every 12 weeks until total duration of therapy is 2 years from the start of interim maintenance I for female patients and 3 years from the start of interim maintenance I for male patients. Patients with testicular disease may receive testicular radiotherapy for 8 days during one of the first 3 courses of maintenance therapy. Patients are followed monthly for 1 year, every 2 months for 1 year, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

3154

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Australien
    • Queensland
      • Herston, Queensland, Australien, 4029
        • Royal Brisbane and Women's Hospital
      • Herston, Queensland, Australien, 4029
        • Royal Children's Hospital-Brisbane
    • South Australia
      • North Adelaide, South Australia, Australien, 5006
        • Women's and Children's Hospital-Adelaide
    • Victoria
      • Parkville, Victoria, Australien, 3052
        • Royal Children's Hospital
    • Western Australia
      • Perth, Western Australia, Australien, 6008
        • Princess Margaret Hospital for Children
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3B 6A8
        • Alberta Children's Hospital
      • Edmonton, Alberta, Canada, T6G 2B7
        • University of Alberta Hospital
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3V4
        • British Columbia Children's Hospital
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • CancerCare Manitoba
    • Newfoundland and Labrador
      • Saint John's, Newfoundland and Labrador, Canada, A1B 3V6
        • Janeway Child Health Centre
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 6R8
        • IWK Health Centre
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7
        • Kingston Health Sciences Centre
      • London, Ontario, Canada, N6A 5W9
        • Children's Hospital
      • London, Ontario, Canada, N6K 1C2
        • Victoria Hospital
      • Ottawa, Ontario, Canada, K1H 8L1
        • Children's Hospital of Eastern Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Hospital for Sick Children
    • Quebec
      • Montreal, Quebec, Canada, H3H 1P3
        • The Montreal Children's Hospital of the MUHC
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Allan Blair Cancer Centre
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • Saskatoon Cancer Centre
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35233
        • University of Alabama at Birmingham Cancer Center
      • Birmingham, Alabama, Forenede Stater, 35233
        • Children's Hospital of Alabama
      • Mobile, Alabama, Forenede Stater, 36604
        • USA Health Strada Patient Care Center
    • Arizona
      • Mesa, Arizona, Forenede Stater, 85202
        • Banner Children's at Desert
      • Phoenix, Arizona, Forenede Stater, 85016
        • Phoenix Childrens Hospital
      • Tucson, Arizona, Forenede Stater, 85719
        • Banner University Medical Center - Tucson
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater, 72205
        • University of Arkansas for Medical Sciences
      • Little Rock, Arkansas, Forenede Stater, 72202-3591
        • Arkansas Children's Hospital
    • California
      • Downey, California, Forenede Stater, 90242
        • Kaiser Permanente Downey Medical Center
      • Duarte, California, Forenede Stater, 91010
        • City of Hope Comprehensive Cancer Center
      • Loma Linda, California, Forenede Stater, 92354
        • Loma Linda University Medical Center
      • Long Beach, California, Forenede Stater, 90806
        • Miller Children's and Women's Hospital Long Beach
      • Los Angeles, California, Forenede Stater, 90027
        • Children's Hospital Los Angeles
      • Los Angeles, California, Forenede Stater, 90095
        • UCLA / Jonsson Comprehensive Cancer Center
      • Los Angeles, California, Forenede Stater, 90048
        • Cedars Sinai Medical Center
      • Los Angeles, California, Forenede Stater, 90095
        • Mattel Children's Hospital UCLA
      • Madera, California, Forenede Stater, 93636
        • Valley Children's Hospital
      • Oakland, California, Forenede Stater, 94609
        • UCSF Benioff Children's Hospital Oakland
      • Oakland, California, Forenede Stater, 94611
        • Kaiser Permanente-Oakland
      • Orange, California, Forenede Stater, 92868
        • Children's Hospital of Orange County
      • Palo Alto, California, Forenede Stater, 94304
        • Lucile Packard Children's Hospital Stanford University
      • Sacramento, California, Forenede Stater, 95816
        • Sutter Medical Center Sacramento
      • Sacramento, California, Forenede Stater, 95817
        • University of California Davis Comprehensive Cancer Center
      • San Diego, California, Forenede Stater, 92123
        • Rady Children's Hospital - San Diego
      • San Francisco, California, Forenede Stater, 94143
        • UCSF Medical Center-Parnassus
      • Santa Barbara, California, Forenede Stater, 93102
        • Santa Barbara Cottage Hospital
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80045
        • Children's Hospital Colorado
      • Denver, Colorado, Forenede Stater, 80218
        • Presbyterian - Saint Lukes Medical Center - Health One
      • Denver, Colorado, Forenede Stater, 80218
        • Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
    • Connecticut
      • Farmington, Connecticut, Forenede Stater, 06030
        • University of Connecticut
      • Hartford, Connecticut, Forenede Stater, 06106
        • Connecticut Children's Medical Center
      • New Haven, Connecticut, Forenede Stater, 06520
        • Yale University
    • Delaware
      • Wilmington, Delaware, Forenede Stater, 19803
        • Alfred I duPont Hospital for Children
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20010
        • Children's National Medical Center
      • Washington, District of Columbia, Forenede Stater, 20007
        • MedStar Georgetown University Hospital
    • Florida
      • Fort Lauderdale, Florida, Forenede Stater, 33316
        • Broward Health Medical Center
      • Fort Myers, Florida, Forenede Stater, 33908
        • Golisano Children's Hospital of Southwest Florida
      • Fort Myers, Florida, Forenede Stater, 33901
        • Lee Memorial Health System
      • 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
        • Nemours Children's Clinic-Jacksonville
      • Miami, Florida, Forenede Stater, 33155
        • Nicklaus Children's Hospital
      • Miami, Florida, Forenede Stater, 33136
        • University of Miami Miller School of Medicine-Sylvester Cancer Center
      • Miami, Florida, Forenede Stater, 33176
        • Miami Cancer Institute
      • Orlando, Florida, Forenede Stater, 32806
        • Orlando Health Cancer Institute
      • Orlando, Florida, Forenede Stater, 32806
        • Nemours Children's Clinic - Orlando
      • Orlando, Florida, Forenede Stater, 32827
        • Nemours Children's Hospital
      • Orlando, Florida, Forenede Stater, 32803
        • AdventHealth Orlando
      • Pensacola, Florida, Forenede Stater, 32504
        • Sacred Heart Hospital
      • Pensacola, Florida, Forenede Stater, 32504
        • Nemours Children's Clinic - Pensacola
      • Saint Petersburg, Florida, Forenede Stater, 33701
        • Johns Hopkins All Children's Hospital
      • Tampa, Florida, Forenede Stater, 33607
        • Saint Joseph's Hospital/Children's Hospital-Tampa
      • West Palm Beach, Florida, Forenede Stater, 33407
        • Saint Mary's Hospital
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30322
        • Emory University Hospital/Winship Cancer Institute
      • Atlanta, Georgia, Forenede Stater, 30322
        • Children's Healthcare of Atlanta - Egleston
      • Augusta, Georgia, Forenede Stater, 30912
        • Augusta University Medical Center
      • Savannah, Georgia, Forenede Stater, 31404
        • Memorial Health University Medical Center
    • Hawaii
      • Honolulu, Hawaii, Forenede Stater, 96813
        • University of Hawaii Cancer Center
      • Honolulu, Hawaii, Forenede Stater, 96859
        • Tripler Army Medical Center
    • Idaho
      • Boise, Idaho, Forenede Stater, 83712
        • Saint Luke's Cancer Institute - Boise
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • Rush University Medical Center
      • Chicago, Illinois, Forenede Stater, 60637
        • University of Chicago Comprehensive Cancer Center
      • Chicago, Illinois, Forenede Stater, 60612
        • University of Illinois
      • Chicago, Illinois, Forenede Stater, 60611
        • Lurie Children's Hospital-Chicago
      • Maywood, Illinois, Forenede Stater, 60153
        • Loyola University Medical Center
      • Oak Lawn, Illinois, Forenede Stater, 60453
        • Advocate Children's Hospital-Oak Lawn
      • Park Ridge, Illinois, Forenede Stater, 60068
        • Advocate Lutheran General Hospital
      • Springfield, Illinois, Forenede Stater, 62702
        • Southern Illinois University School of Medicine
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46202
        • Indiana University/Melvin and Bren Simon Cancer Center
      • Indianapolis, Indiana, Forenede Stater, 46202
        • Riley Hospital for Children
      • Indianapolis, Indiana, Forenede Stater, 46260
        • Saint Vincent Hospital and Health Care Center
    • Iowa
      • Des Moines, Iowa, Forenede Stater, 50309
        • Blank Children's Hospital
      • Iowa City, Iowa, Forenede Stater, 52242
        • University of Iowa/Holden Comprehensive Cancer Center
    • Kansas
      • Kansas City, Kansas, Forenede Stater, 66160
        • University of Kansas Cancer Center
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40536
        • University of Kentucky/Markey Cancer Center
      • Louisville, Kentucky, Forenede Stater, 40202
        • Norton Children's Hospital
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70112
        • Tulane University Health Sciences Center
      • New Orleans, Louisiana, Forenede Stater, 70118
        • Children's Hospital New Orleans
    • Maine
      • Bangor, Maine, Forenede Stater, 04401
        • Eastern Maine Medical Center
      • Scarborough, Maine, Forenede Stater, 04074
        • Maine Children's Cancer Program
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21287
        • Johns Hopkins University/Sidney Kimmel Cancer Center
      • Baltimore, Maryland, Forenede Stater, 21215
        • Sinai Hospital of Baltimore
      • Baltimore, Maryland, Forenede Stater, 21201
        • University of Maryland/Greenebaum Cancer Center
      • Bethesda, Maryland, Forenede Stater, 20889-5600
        • Walter Reed National Military Medical Center
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02114
        • Massachusetts General Hospital Cancer Center
      • Boston, Massachusetts, Forenede Stater, 02111
        • Tufts Children's Hospital
      • Springfield, Massachusetts, Forenede Stater, 01199
        • Baystate Medical Center
      • Worcester, Massachusetts, Forenede Stater, 01655
        • UMass Memorial Medical Center - University Campus
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109
        • C S Mott Children's Hospital
      • Detroit, Michigan, Forenede Stater, 48201
        • Wayne State University/Karmanos Cancer Institute
      • Detroit, Michigan, Forenede Stater, 48236
        • Ascension Saint John Hospital
      • East Lansing, Michigan, Forenede Stater, 48824-7016
        • Michigan State University Clinical Center
      • Flint, Michigan, Forenede Stater, 48503
        • Hurley Medical Center
      • Grand Rapids, Michigan, Forenede Stater, 49503
        • Spectrum Health at Butterworth Campus
      • Grand Rapids, Michigan, Forenede Stater, 49503
        • Helen DeVos Children's Hospital at Spectrum Health
      • Kalamazoo, Michigan, Forenede Stater, 49007
        • Bronson Methodist Hospital
      • Kalamazoo, Michigan, Forenede Stater, 49008
        • Kalamazoo Center for Medical Studies
      • Royal Oak, Michigan, Forenede Stater, 48073
        • William Beaumont Hospital-Royal Oak
      • Royal Oak, Michigan, Forenede Stater, 48073
        • Beaumont Children's Hospital-Royal Oak
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55404
        • Children's Hospitals and Clinics of Minnesota - Minneapolis
      • Minneapolis, Minnesota, Forenede Stater, 55455
        • University of Minnesota/Masonic Cancer Center
      • Rochester, Minnesota, Forenede Stater, 55905
        • Mayo Clinic in Rochester
      • Saint Paul, Minnesota, Forenede Stater, 55102
        • Children's Hospital and Clinic-Saint Paul
    • Mississippi
      • Jackson, Mississippi, Forenede Stater, 39216
        • University of Mississippi Medical Center
    • Missouri
      • Columbia, Missouri, Forenede Stater, 65201
        • Columbia Regional
      • Columbia, Missouri, Forenede Stater, 65212
        • University of Missouri - Ellis Fischel
      • Kansas City, Missouri, Forenede Stater, 64108
        • Children's Mercy Hospitals and Clinics
      • Saint Louis, Missouri, Forenede Stater, 63110
        • Washington University School of Medicine
      • Saint Louis, Missouri, Forenede Stater, 63104
        • Cardinal Glennon Children's Medical Center
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68198
        • University of Nebraska Medical Center
      • Omaha, Nebraska, Forenede Stater, 68114
        • Children's Hospital and Medical Center of Omaha
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89169
        • Nevada Cancer Research Foundation NCORP
    • New Hampshire
      • Lebanon, New Hampshire, Forenede Stater, 03756
        • Dartmouth Hitchcock Medical Center
    • New Jersey
      • Hackensack, New Jersey, Forenede Stater, 07601
        • Hackensack University Medical Center
      • Livingston, New Jersey, Forenede Stater, 07039
        • Saint Barnabas Medical Center
      • Morristown, New Jersey, Forenede Stater, 07960
        • Morristown Medical Center
      • New Brunswick, New Jersey, Forenede Stater, 08901
        • Saint Peter's University Hospital
      • New Brunswick, New Jersey, Forenede Stater, 08903
        • Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
      • Newark, New Jersey, Forenede Stater, 07112
        • Newark Beth Israel Medical Center
      • Paterson, New Jersey, Forenede Stater, 07503
        • Saint Joseph's Regional Medical Center
      • Summit, New Jersey, Forenede Stater, 07902
        • Overlook Hospital
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87102
        • University of New Mexico Cancer Center
    • New York
      • Albany, New York, Forenede Stater, 12208
        • Albany Medical Center
      • Bronx, New York, Forenede Stater, 10467
        • Montefiore Medical Center - Moses Campus
      • Brooklyn, New York, Forenede Stater, 11219
        • Maimonides Medical Center
      • Brooklyn, New York, Forenede Stater, 11201
        • Brooklyn Hospital Center
      • Brooklyn, New York, Forenede Stater, 11212
        • Brookdale Hospital Medical Center
      • Buffalo, New York, Forenede Stater, 14263
        • Roswell Park Cancer Institute
      • Mineola, New York, Forenede Stater, 11501
        • NYU Winthrop Hospital
      • New Hyde Park, New York, Forenede Stater, 11040
        • The Steven and Alexandra Cohen Children's Medical Center of New York
      • New York, New York, Forenede Stater, 10029
        • Mount Sinai Hospital
      • New York, New York, Forenede Stater, 10065
        • NYP/Weill Cornell Medical Center
      • 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
      • Syracuse, New York, Forenede Stater, 13210
        • State University of New York Upstate Medical University
      • Valhalla, New York, Forenede Stater, 10595
        • New York Medical College
    • North Carolina
      • Asheville, North Carolina, Forenede Stater, 28801
        • Mission Hospital
      • Chapel Hill, North Carolina, Forenede Stater, 27599
        • UNC Lineberger Comprehensive Cancer Center
      • Charlotte, North Carolina, Forenede Stater, 28203
        • Carolinas Medical Center/Levine Cancer Institute
      • Charlotte, North Carolina, Forenede Stater, 28204
        • Novant Health Presbyterian Medical Center
      • Durham, North Carolina, Forenede Stater, 27710
        • Duke University Medical Center
      • Greenville, North Carolina, Forenede Stater, 27834
        • East Carolina University
      • Winston-Salem, North Carolina, Forenede Stater, 27157
        • Wake Forest University Health Sciences
    • North Dakota
      • Fargo, North Dakota, Forenede Stater, 58122
        • Sanford Broadway Medical Center
    • Ohio
      • Akron, Ohio, Forenede Stater, 44308
        • Children's Hospital Medical Center of Akron
      • Cincinnati, Ohio, Forenede Stater, 45229
        • Cincinnati Children's Hospital Medical Center
      • Cleveland, Ohio, Forenede Stater, 44195
        • Cleveland Clinic Foundation
      • Cleveland, Ohio, Forenede Stater, 44106
        • Rainbow Babies and Childrens Hospital
      • Columbus, Ohio, Forenede Stater, 43205
        • Nationwide Children's Hospital
      • Dayton, Ohio, Forenede Stater, 45404
        • Dayton Children's Hospital
      • Toledo, Ohio, Forenede Stater, 43606
        • ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
      • Toledo, Ohio, Forenede Stater, 43614
        • University of Toledo
      • Toledo, Ohio, Forenede Stater, 43608
        • Mercy Children's Hospital
      • Youngstown, Ohio, Forenede Stater, 44501
        • Tod Children's Hospital - Forum Health
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
        • University of Oklahoma Health Sciences Center
      • Tulsa, Oklahoma, Forenede Stater, 74136
        • Natalie Warren Bryant Cancer Center at Saint Francis
    • Oregon
      • Portland, Oregon, Forenede Stater, 97239
        • Oregon Health and Science University
      • Portland, Oregon, Forenede Stater, 97227
        • Legacy Emanuel Children's Hospital
      • Portland, Oregon, Forenede Stater, 97227
        • Legacy Emanuel Hospital and Health Center
    • Pennsylvania
      • Bethlehem, Pennsylvania, Forenede Stater, 18017
        • Lehigh Valley Hospital - Muhlenberg
      • Danville, Pennsylvania, Forenede Stater, 17822
        • Geisinger Medical Center
      • Hershey, Pennsylvania, Forenede Stater, 17033-0850
        • Penn State Milton S Hershey Medical Center
      • Hershey, Pennsylvania, Forenede Stater, 17033
        • Penn State Children's Hospital
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Children's Hospital of Philadelphia
      • Philadelphia, Pennsylvania, Forenede Stater, 19134
        • Saint Christopher's Hospital for Children
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Children's Oncology Group
      • Pittsburgh, Pennsylvania, Forenede Stater, 15224
        • Children's Hospital of Pittsburgh of UPMC
    • Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02903
        • Rhode Island Hospital
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29425
        • Medical University of South Carolina
      • Columbia, South Carolina, Forenede Stater, 29203
        • Prisma Health Richland Hospital
      • Greenville, South Carolina, Forenede Stater, 29605
        • BI-LO Charities Children's Cancer Center
      • Greenville, South Carolina, Forenede Stater, 29605
        • Greenville Cancer Treatment Center
    • South Dakota
      • Sioux Falls, South Dakota, Forenede Stater, 57117-5134
        • Sanford USD Medical Center - Sioux Falls
    • Tennessee
      • Chattanooga, Tennessee, Forenede Stater, 37403
        • T C Thompson Children's Hospital
      • Knoxville, Tennessee, Forenede Stater, 37916
        • East Tennessee Childrens Hospital
      • Nashville, Tennessee, Forenede Stater, 37232
        • Vanderbilt University/Ingram Cancer Center
    • Texas
      • Amarillo, Texas, Forenede Stater, 79106
        • Texas Tech University Health Sciences Center-Amarillo
      • Austin, Texas, Forenede Stater, 78723
        • Dell Children's Medical Center of Central Texas
      • Corpus Christi, Texas, Forenede Stater, 78411
        • Driscoll Children's Hospital
      • Dallas, Texas, Forenede Stater, 75390
        • UT Southwestern/Simmons Cancer Center-Dallas
      • Dallas, Texas, Forenede Stater, 75230
        • Medical City Dallas Hospital
      • Fort Worth, Texas, Forenede Stater, 76104
        • Cook Children's Medical Center
      • Galveston, Texas, Forenede Stater, 77555-0565
        • University of Texas Medical Branch
      • Houston, Texas, Forenede Stater, 77030
        • M D Anderson Cancer Center
      • Houston, Texas, Forenede Stater, 77030
        • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
      • Lubbock, Texas, Forenede Stater, 79410
        • Covenant Children's Hospital
      • San Antonio, Texas, Forenede Stater, 78229
        • University of Texas Health Science Center at San Antonio
      • San Antonio, Texas, Forenede Stater, 78229
        • Methodist Children's Hospital of South Texas
      • Temple, Texas, Forenede Stater, 76508
        • Scott and White Memorial Hospital
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84113
        • Primary Children's Hospital
    • Vermont
      • Burlington, Vermont, Forenede Stater, 05405
        • University of Vermont and State Agricultural College
    • Virginia
      • Charlottesville, Virginia, Forenede Stater, 22908
        • University of Virginia Cancer Center
      • Falls Church, Virginia, Forenede Stater, 22042
        • Inova Fairfax Hospital
      • Norfolk, Virginia, Forenede Stater, 23507
        • Children's Hospital of The King's Daughters
      • Portsmouth, Virginia, Forenede Stater, 23708-2197
        • Naval Medical Center - Portsmouth
      • Richmond, Virginia, Forenede Stater, 23298
        • Virginia Commonwealth University/Massey Cancer Center
      • Roanoke, Virginia, Forenede Stater, 24014
        • Carilion Children's
    • Washington
      • Seattle, Washington, Forenede Stater, 98105
        • Seattle Children's Hospital
      • Spokane, Washington, Forenede Stater, 99204
        • Providence Sacred Heart Medical Center and Children's Hospital
      • Tacoma, Washington, Forenede Stater, 98405
        • Mary Bridge Children's Hospital and Health Center
      • Tacoma, Washington, Forenede Stater, 98431
        • Madigan Army Medical Center
    • West Virginia
      • Charleston, West Virginia, Forenede Stater, 25304
        • West Virginia University Charleston Division
      • Morgantown, West Virginia, Forenede Stater, 26506
        • West Virginia University Healthcare
    • Wisconsin
      • Green Bay, Wisconsin, Forenede Stater, 54301
        • Saint Vincent Hospital Cancer Center Green Bay
      • La Crosse, Wisconsin, Forenede Stater, 54601
        • Gundersen Lutheran Medical Center
      • Madison, Wisconsin, Forenede Stater, 53792
        • University of Wisconsin Hospital and Clinics
      • Marshfield, Wisconsin, Forenede Stater, 54449
        • Marshfield Medical Center-Marshfield
      • Milwaukee, Wisconsin, Forenede Stater, 53226
        • Children's Hospital of Wisconsin
  • New Zealand
      • Christchurch, New Zealand, 8011
        • Christchurch Hospital
      • Wellington, New Zealand, 6002
        • Wellington Children's Hospital
    • Auckland
      • Grafton, Auckland, New Zealand, 1145
        • Starship Children's Hospital
  • Schweiz
      • Bern, Schweiz, 3010
        • Swiss Pediatric Oncology Group - Bern
      • Geneva, Schweiz, 1205
        • Swiss Pediatric Oncology Group - Geneva
      • Lausanne, Schweiz, 1011
        • Swiss Pediatric Oncology Group - Lausanne

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

1 år til 30 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Must be eligible for and enrolled on classification study COG-AALL03B1

  • Newly diagnosed B-precursor acute lymphoblastic leukemia

    • WBC > 50,000/mm^3 for patients age 1 to 9
    • Any WBC for patients age 10 to 30 OR patients who have received prior steroid therapy OR patients with testicular disease

  • Whit blood cell (WBC) criteria:

    • Age 1 - 9 years: WBC >= 50,000/uL
    • Age 10 - 30 years: any WBC
    • Prior steroid therapy: any WBC
    • Testicular disease: any WBC
  • Patients shall have had no other prior cytotoxic chemotherapy with the exception of steroids and intrathecal cytarabine
  • Patients receiving prior steroid therapy (as described in AALL03B1) are eligible for study; the dose and duration of previous steroid therapy should be carefully documented
  • All patients and/or their parents or legal guardians must sign a written informed consent
  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Exclusion Criteria:

  • Patients with Down syndrome are ineligible to enroll onto this study

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: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Arm I
Patients in arm I receive intrathecal cytarabine in week 1; infusions of vincristine and daunorubicin once a week in weeks 1-4; dexamethasone by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate in weeks 2 and 5 or 2-5; and an injection of pegaspargase in week 1.
Medicin: Daunorubicin Hydrochlorid
Givet IV
Andre navne:
  • Cerubidin
  • Cloridrato de Daunorubicina
  • Daunoblastin
  • Daunoblastina
  • Daunomycin hydrochlorid
  • Daunomycin, hydrochlorid
  • Daunorubicin.HCl
  • Daunorubicini Hydrochloridum
  • FI-6339
  • Ondena
  • RP-13057
  • Rubidomycin hydrochlorid
  • Rubilem
Medicin: Cyclofosfamid
Givet IV
Andre navne:
  • Cytoxan
  • CTX
  • (-)-Cyclophosphamid
  • 2H-1,3,2-Oxazaphosphorin, 2-[bis(2-chlorethyl)amino]tetrahydro-, 2-oxid, monohydrat
  • Carloxan
  • Ciclofosfamida
  • Ciclofosfamid
  • Cicloxal
  • Clafen
  • Claphene
  • CP monohydrat
  • CYCLO-celle
  • Cykloblastin
  • Cycloblastin
  • Cyclofosfam
  • Cyclophosphamid monohydrat
  • Cyclophosphamid Monohydrat
  • Cyclophospamidum
  • Cyclofosfan
  • Cyclophosphanum
  • Cyclostin
  • Cytophosphan
  • Cytofosfan
  • Fosfaseron
  • Genoxal
  • Genuxal
  • Ledoxina
  • Mitoxan
  • Neosar
  • Revimune
  • Syklofosfamid
  • WR- 138719
Medicin: Mercaptopurin
Givet PO
Andre navne:
  • 6 MP
  • Purinethol
  • 3H-Purin-6-thiol
  • 6 Thiohypoxanthin
  • 6 Thiopurin
  • 6-Mercaptopurin
  • 6-Mercaptopurin monohydrat
  • 6-Purinethiol
  • 6-thiopurin
  • 6-thioxopurin
  • 6H-Purin-6-thion, 1,7-dihydro- (9Cl)
  • 7-Mercapto-1,3,4,6-tetrazainden
  • Alti-Mercaptopurin
  • Azathiopurin
  • Bw 57-323H
  • Flocofil
  • Ismipur
  • Leukerin
  • Leupurin
  • Mercaleukim
  • Mercaleukin
  • Mercaptina
  • Mercaptopurinum
  • Mercapurin
  • Mern
  • NCI-C04886
  • Puri-Nethol
  • Purimethol
  • Purin, 6-mercapto-
  • Purin-6-thiol (8CI)
  • Purin-6-thiol, monohydrat
  • Purinethiol
  • U-4748
  • WR-2785
Medicin: Vincristinsulfat
Givet IV
Andre navne:
  • Oncovin
  • Kyocristine
  • Leurocristinsulfat
  • Leurocristin, sulfat
  • Vincasar
  • Vincosid
  • Vincrex
  • Vincristin, sulfat
Medicin: Doxorubicin Hydrochlorid
Givet IV
Andre navne:
  • Adriamycin
  • 5,12-naphthacendion, 10-[(3-amino-2,3,6-trideoxy-alfa-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy -8-(hydroxyacetyl)-1-methoxy-, hydrochlorid, (8S-cis)- (9Cl)
  • ADM
  • Adriacin
  • Adriamycin hydrochlorid
  • Adriamycin PFS
  • Adriamycin RDF
  • ADRIAMYCIN, HYDROCHLORID
  • Adriblastina
  • Adriblastin
  • Adrimedac
  • Chloridrato de Doxorrubicina
  • DOX
  • DOXO-CELL
  • Doxolem
  • Doxorubicin HCl
  • Doxorubicin.HCl
  • Doxorubin
  • Farmiblastina
  • FI 106
  • FI-106
  • hydroxydaunorubicin
  • Rubex
Medicin: Dexamethason
Givet PO eller IV
Andre navne:
  • Dekadron
  • Aacideksamen
  • Adexone
  • Aknichthol Dexa
  • Alba-Dex
  • Alin
  • Alin Depot
  • Alin Oftalmico
  • Amplidermis
  • Anemul mono
  • Auricularum
  • Auxiloson
  • Baycadron
  • Baycuten
  • Baycuten N
  • Cortidexason
  • Cortisumman
  • Decacort
  • Decadrol
  • Decadron DP
  • Decalix
  • Decameth
  • Decason R.p.
  • Dectancyl
  • Dekacort
  • Deltafluoren
  • Deronil
  • Desamethason
  • Desameton
  • Dexa-Mamallet
  • Dexa-næsehorn
  • Dexa-Scheroson
  • Dexa-sinus
  • Dexacortal
  • Dexacortin
  • Dexafarma
  • Dexafluoren
  • Dexalocal
  • Dexamecortin
  • Dexameth
  • Dexamethason Intensol
  • Dexamethasonum
  • Dexamonozon
  • Dexapos
  • Dexinoral
  • Dexone
  • Dinormon
  • Dxevo
  • Fluorodelta
  • Fortecortin
  • Gammacorten
  • Hexadecadrol
  • Hexadrol
  • Lokalison-F
  • Loverine
  • Methylfluorprednisolon
  • Millicorten
  • Mymethason
  • Orgadrone
  • Spersadex
  • TaperDex
  • Visumetazon
  • ZoDex
Medicin: Thioguanin
Givet PO
Andre navne:
  • 6-TG
  • 2-amino 6MP
  • 2-amino-1,7-dihydro-6H-purin-6-thion
  • 2-amino-6-mercaptopurin
  • 2-amino-6-purinethiol
  • 2-aminopurin-6-thiol
  • 2-aminopurin-6(1H)-thion
  • 2-aminopurin-6-thiol hemihydrat
  • 2-Mercapto-6-aminopurin
  • 6-amino-2-mercaptopurin
  • 6-Mercapto-2-aminopurin
  • 6-Mercaptoguanin
  • 6H-Purin-6-thion, 2-amino-1,7-dihydro- (9Cl)
  • BW 5071
  • Lanvis
  • Tabloid
  • Thioguanin hemihydrat
  • Thioguanin Hydrat
  • Tioguanin
  • Tioguanine
  • Velkommen U3B
  • WR-1141
  • X 27
Stråling: Stråleterapi
Gennemgå strålebehandling
Andre navne:
  • Kræftstrålebehandling
  • ENERGY_TYPE
  • Bestråle
  • Bestrålet
  • Bestråling
  • Stråling
  • Stråleterapi, NOS
  • Radioterapeutika
  • Strålebehandling
  • RT
  • Terapi, Stråling
Medicin: Pegaspargase
Givet IM
Andre navne:
  • L-asparaginase med polyethylenglycol
  • Oncaspar
  • Oncaspar-IV
  • PEG-asparaginase
  • PEG-L-asparaginase
  • PEG-L-Asparaginase (Enzon - Kyowa Hakko)
  • PEGLA
  • Polyethylenglycol L-Asparaginase
  • Polyethylenglycol-L-Asparaginase
Medicin: Methotrexat
Givet IT eller IV
Andre navne:
  • Abitrexat
  • Folex
  • Mexate
  • MTX
  • Alpha-Methopterin
  • Amethopterin
  • Brimexat
  • CL 14377
  • CL-14377
  • Emtexat
  • Emthexat
  • Farmitrexat
  • Fauldexato
  • Folex PFS
  • Lantarel
  • Ledertrexat
  • Lumexon
  • Maxtrex
  • Medsatrexat
  • Metex
  • Methoblastin
  • Methotrexat LPF
  • Methotrexat Methylaminopterin
  • Methotrexatum
  • Metotrexato
  • Metrotex
  • Mexate-AQ
  • Novatrex
  • Rheumatrex
  • Texate
  • Tremetex
  • Trexeron
  • Trixilem
  • WR-19039
Medicin: Cytarabine
Given IT, SC, or IV
Andre navne:
  • Β-Cytosin arabinosid
  • 1-β-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinon
  • 1-β-D-Arabinofuranosylcytosin
  • 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinon
  • 1-Beta-D-arabinofuranosylcytosin
  • 1β-D-Arabinofuranosylcytosin
  • 2(1H)-pyrimidinon, 4-amino-1-beta-D-arabinofuranosyl-
  • 2(1H)-pyrimidinon, 4-amino-1P-D-arabinofuranosyl-
  • Alexan
  • Ara-C
  • ARA-celle
  • Arabine
  • Arabinofuranosylcytosin
  • Arabinosylcytosin
  • Aracytidin
  • Aracytin
  • Beta-Cytosin Arabinoside
  • CHX-3311
  • Cytarabinum
  • Cytarbel
  • Cytosar
  • Cytosin Arabinoside
  • Cytosin-β-arabinosid
  • Cytosin-beta-arabinosid
  • Erpalfa
  • Starasid
  • Tarabin PFS
  • U 19920
  • U-19920
  • Udicil
  • WR-28453
Aktiv komparator: Arm II
Patients in arm II will receive intrathecal cytarabine in week 1; infusions of vincristine and daunorubicin once a week in weeks 1-4; dexamethasone by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate in weeks 2 and 5 or 2-5; and an injection of pegaspargase in week 1.
Medicin: Daunorubicin Hydrochlorid
Givet IV
Andre navne:
  • Cerubidin
  • Cloridrato de Daunorubicina
  • Daunoblastin
  • Daunoblastina
  • Daunomycin hydrochlorid
  • Daunomycin, hydrochlorid
  • Daunorubicin.HCl
  • Daunorubicini Hydrochloridum
  • FI-6339
  • Ondena
  • RP-13057
  • Rubidomycin hydrochlorid
  • Rubilem
Medicin: Cyclofosfamid
Givet IV
Andre navne:
  • Cytoxan
  • CTX
  • (-)-Cyclophosphamid
  • 2H-1,3,2-Oxazaphosphorin, 2-[bis(2-chlorethyl)amino]tetrahydro-, 2-oxid, monohydrat
  • Carloxan
  • Ciclofosfamida
  • Ciclofosfamid
  • Cicloxal
  • Clafen
  • Claphene
  • CP monohydrat
  • CYCLO-celle
  • Cykloblastin
  • Cycloblastin
  • Cyclofosfam
  • Cyclophosphamid monohydrat
  • Cyclophosphamid Monohydrat
  • Cyclophospamidum
  • Cyclofosfan
  • Cyclophosphanum
  • Cyclostin
  • Cytophosphan
  • Cytofosfan
  • Fosfaseron
  • Genoxal
  • Genuxal
  • Ledoxina
  • Mitoxan
  • Neosar
  • Revimune
  • Syklofosfamid
  • WR- 138719
Medicin: Mercaptopurin
Givet PO
Andre navne:
  • 6 MP
  • Purinethol
  • 3H-Purin-6-thiol
  • 6 Thiohypoxanthin
  • 6 Thiopurin
  • 6-Mercaptopurin
  • 6-Mercaptopurin monohydrat
  • 6-Purinethiol
  • 6-thiopurin
  • 6-thioxopurin
  • 6H-Purin-6-thion, 1,7-dihydro- (9Cl)
  • 7-Mercapto-1,3,4,6-tetrazainden
  • Alti-Mercaptopurin
  • Azathiopurin
  • Bw 57-323H
  • Flocofil
  • Ismipur
  • Leukerin
  • Leupurin
  • Mercaleukim
  • Mercaleukin
  • Mercaptina
  • Mercaptopurinum
  • Mercapurin
  • Mern
  • NCI-C04886
  • Puri-Nethol
  • Purimethol
  • Purin, 6-mercapto-
  • Purin-6-thiol (8CI)
  • Purin-6-thiol, monohydrat
  • Purinethiol
  • U-4748
  • WR-2785
Medicin: Vincristinsulfat
Givet IV
Andre navne:
  • Oncovin
  • Kyocristine
  • Leurocristinsulfat
  • Leurocristin, sulfat
  • Vincasar
  • Vincosid
  • Vincrex
  • Vincristin, sulfat
Medicin: Doxorubicin Hydrochlorid
Givet IV
Andre navne:
  • Adriamycin
  • 5,12-naphthacendion, 10-[(3-amino-2,3,6-trideoxy-alfa-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy -8-(hydroxyacetyl)-1-methoxy-, hydrochlorid, (8S-cis)- (9Cl)
  • ADM
  • Adriacin
  • Adriamycin hydrochlorid
  • Adriamycin PFS
  • Adriamycin RDF
  • ADRIAMYCIN, HYDROCHLORID
  • Adriblastina
  • Adriblastin
  • Adrimedac
  • Chloridrato de Doxorrubicina
  • DOX
  • DOXO-CELL
  • Doxolem
  • Doxorubicin HCl
  • Doxorubicin.HCl
  • Doxorubin
  • Farmiblastina
  • FI 106
  • FI-106
  • hydroxydaunorubicin
  • Rubex
Medicin: Dexamethason
Givet PO eller IV
Andre navne:
  • Dekadron
  • Aacideksamen
  • Adexone
  • Aknichthol Dexa
  • Alba-Dex
  • Alin
  • Alin Depot
  • Alin Oftalmico
  • Amplidermis
  • Anemul mono
  • Auricularum
  • Auxiloson
  • Baycadron
  • Baycuten
  • Baycuten N
  • Cortidexason
  • Cortisumman
  • Decacort
  • Decadrol
  • Decadron DP
  • Decalix
  • Decameth
  • Decason R.p.
  • Dectancyl
  • Dekacort
  • Deltafluoren
  • Deronil
  • Desamethason
  • Desameton
  • Dexa-Mamallet
  • Dexa-næsehorn
  • Dexa-Scheroson
  • Dexa-sinus
  • Dexacortal
  • Dexacortin
  • Dexafarma
  • Dexafluoren
  • Dexalocal
  • Dexamecortin
  • Dexameth
  • Dexamethason Intensol
  • Dexamethasonum
  • Dexamonozon
  • Dexapos
  • Dexinoral
  • Dexone
  • Dinormon
  • Dxevo
  • Fluorodelta
  • Fortecortin
  • Gammacorten
  • Hexadecadrol
  • Hexadrol
  • Lokalison-F
  • Loverine
  • Methylfluorprednisolon
  • Millicorten
  • Mymethason
  • Orgadrone
  • Spersadex
  • TaperDex
  • Visumetazon
  • ZoDex
Medicin: Thioguanin
Givet PO
Andre navne:
  • 6-TG
  • 2-amino 6MP
  • 2-amino-1,7-dihydro-6H-purin-6-thion
  • 2-amino-6-mercaptopurin
  • 2-amino-6-purinethiol
  • 2-aminopurin-6-thiol
  • 2-aminopurin-6(1H)-thion
  • 2-aminopurin-6-thiol hemihydrat
  • 2-Mercapto-6-aminopurin
  • 6-amino-2-mercaptopurin
  • 6-Mercapto-2-aminopurin
  • 6-Mercaptoguanin
  • 6H-Purin-6-thion, 2-amino-1,7-dihydro- (9Cl)
  • BW 5071
  • Lanvis
  • Tabloid
  • Thioguanin hemihydrat
  • Thioguanin Hydrat
  • Tioguanin
  • Tioguanine
  • Velkommen U3B
  • WR-1141
  • X 27
Stråling: Stråleterapi
Gennemgå strålebehandling
Andre navne:
  • Kræftstrålebehandling
  • ENERGY_TYPE
  • Bestråle
  • Bestrålet
  • Bestråling
  • Stråling
  • Stråleterapi, NOS
  • Radioterapeutika
  • Strålebehandling
  • RT
  • Terapi, Stråling
Medicin: Leucovorin Calcium
Givet IV
Andre navne:
  • Wellcovorin
  • folinsyre
  • Adinepar
  • Calcifolin
  • Calcium (6S)-folinat
  • Calciumfolinat
  • Calcium Leucovorin
  • Calfolex
  • Calinat
  • Cehafolin
  • Citofolin
  • Citrec
  • Citrovorum faktor
  • Cromatonbic Folinico
  • Dalisol
  • Disintox
  • Divical
  • Ecofol
  • Emovis
  • Faktor, Citrovorum
  • Flynoken A
  • Folaren
  • Folaxin
  • FOLI-celle
  • Foliben
  • Folidan
  • Folidar
  • Folinac
  • Folinat Calcium
  • Folinsyre Calcium Salt Pentahydrat
  • Folinoral
  • Folinvit
  • Foliplus
  • Folix
  • Imo
  • Lederfolat
  • Lederfolin
  • Leucosar
  • leukovorin
  • Rescufolin
  • Rescuvolin
  • Tonofolin
Medicin: Pegaspargase
Givet IM
Andre navne:
  • L-asparaginase med polyethylenglycol
  • Oncaspar
  • Oncaspar-IV
  • PEG-asparaginase
  • PEG-L-asparaginase
  • PEG-L-Asparaginase (Enzon - Kyowa Hakko)
  • PEGLA
  • Polyethylenglycol L-Asparaginase
  • Polyethylenglycol-L-Asparaginase
Medicin: Methotrexat
Givet IT eller IV
Andre navne:
  • Abitrexat
  • Folex
  • Mexate
  • MTX
  • Alpha-Methopterin
  • Amethopterin
  • Brimexat
  • CL 14377
  • CL-14377
  • Emtexat
  • Emthexat
  • Farmitrexat
  • Fauldexato
  • Folex PFS
  • Lantarel
  • Ledertrexat
  • Lumexon
  • Maxtrex
  • Medsatrexat
  • Metex
  • Methoblastin
  • Methotrexat LPF
  • Methotrexat Methylaminopterin
  • Methotrexatum
  • Metotrexato
  • Metrotex
  • Mexate-AQ
  • Novatrex
  • Rheumatrex
  • Texate
  • Tremetex
  • Trexeron
  • Trixilem
  • WR-19039
Medicin: Cytarabine
Given IT, SC, or IV
Andre navne:
  • Β-Cytosin arabinosid
  • 1-β-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinon
  • 1-β-D-Arabinofuranosylcytosin
  • 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinon
  • 1-Beta-D-arabinofuranosylcytosin
  • 1β-D-Arabinofuranosylcytosin
  • 2(1H)-pyrimidinon, 4-amino-1-beta-D-arabinofuranosyl-
  • 2(1H)-pyrimidinon, 4-amino-1P-D-arabinofuranosyl-
  • Alexan
  • Ara-C
  • ARA-celle
  • Arabine
  • Arabinofuranosylcytosin
  • Arabinosylcytosin
  • Aracytidin
  • Aracytin
  • Beta-Cytosin Arabinoside
  • CHX-3311
  • Cytarabinum
  • Cytarbel
  • Cytosar
  • Cytosin Arabinoside
  • Cytosin-β-arabinosid
  • Cytosin-beta-arabinosid
  • Erpalfa
  • Starasid
  • Tarabin PFS
  • U 19920
  • U-19920
  • Udicil
  • WR-28453
Eksperimentel: Arm III

Patients in arm III will receive cytarabine, vincristine, daunorubicin, and pegaspargase as in groups one and two. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5.

Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
Medicin: Daunorubicin Hydrochlorid
Givet IV
Andre navne:
  • Cerubidin
  • Cloridrato de Daunorubicina
  • Daunoblastin
  • Daunoblastina
  • Daunomycin hydrochlorid
  • Daunomycin, hydrochlorid
  • Daunorubicin.HCl
  • Daunorubicini Hydrochloridum
  • FI-6339
  • Ondena
  • RP-13057
  • Rubidomycin hydrochlorid
  • Rubilem
Medicin: Cyclofosfamid
Givet IV
Andre navne:
  • Cytoxan
  • CTX
  • (-)-Cyclophosphamid
  • 2H-1,3,2-Oxazaphosphorin, 2-[bis(2-chlorethyl)amino]tetrahydro-, 2-oxid, monohydrat
  • Carloxan
  • Ciclofosfamida
  • Ciclofosfamid
  • Cicloxal
  • Clafen
  • Claphene
  • CP monohydrat
  • CYCLO-celle
  • Cykloblastin
  • Cycloblastin
  • Cyclofosfam
  • Cyclophosphamid monohydrat
  • Cyclophosphamid Monohydrat
  • Cyclophospamidum
  • Cyclofosfan
  • Cyclophosphanum
  • Cyclostin
  • Cytophosphan
  • Cytofosfan
  • Fosfaseron
  • Genoxal
  • Genuxal
  • Ledoxina
  • Mitoxan
  • Neosar
  • Revimune
  • Syklofosfamid
  • WR- 138719
Medicin: Mercaptopurin
Givet PO
Andre navne:
  • 6 MP
  • Purinethol
  • 3H-Purin-6-thiol
  • 6 Thiohypoxanthin
  • 6 Thiopurin
  • 6-Mercaptopurin
  • 6-Mercaptopurin monohydrat
  • 6-Purinethiol
  • 6-thiopurin
  • 6-thioxopurin
  • 6H-Purin-6-thion, 1,7-dihydro- (9Cl)
  • 7-Mercapto-1,3,4,6-tetrazainden
  • Alti-Mercaptopurin
  • Azathiopurin
  • Bw 57-323H
  • Flocofil
  • Ismipur
  • Leukerin
  • Leupurin
  • Mercaleukim
  • Mercaleukin
  • Mercaptina
  • Mercaptopurinum
  • Mercapurin
  • Mern
  • NCI-C04886
  • Puri-Nethol
  • Purimethol
  • Purin, 6-mercapto-
  • Purin-6-thiol (8CI)
  • Purin-6-thiol, monohydrat
  • Purinethiol
  • U-4748
  • WR-2785
Medicin: Vincristinsulfat
Givet IV
Andre navne:
  • Oncovin
  • Kyocristine
  • Leurocristinsulfat
  • Leurocristin, sulfat
  • Vincasar
  • Vincosid
  • Vincrex
  • Vincristin, sulfat
Medicin: Doxorubicin Hydrochlorid
Givet IV
Andre navne:
  • Adriamycin
  • 5,12-naphthacendion, 10-[(3-amino-2,3,6-trideoxy-alfa-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy -8-(hydroxyacetyl)-1-methoxy-, hydrochlorid, (8S-cis)- (9Cl)
  • ADM
  • Adriacin
  • Adriamycin hydrochlorid
  • Adriamycin PFS
  • Adriamycin RDF
  • ADRIAMYCIN, HYDROCHLORID
  • Adriblastina
  • Adriblastin
  • Adrimedac
  • Chloridrato de Doxorrubicina
  • DOX
  • DOXO-CELL
  • Doxolem
  • Doxorubicin HCl
  • Doxorubicin.HCl
  • Doxorubin
  • Farmiblastina
  • FI 106
  • FI-106
  • hydroxydaunorubicin
  • Rubex
Medicin: Dexamethason
Givet PO eller IV
Andre navne:
  • Dekadron
  • Aacideksamen
  • Adexone
  • Aknichthol Dexa
  • Alba-Dex
  • Alin
  • Alin Depot
  • Alin Oftalmico
  • Amplidermis
  • Anemul mono
  • Auricularum
  • Auxiloson
  • Baycadron
  • Baycuten
  • Baycuten N
  • Cortidexason
  • Cortisumman
  • Decacort
  • Decadrol
  • Decadron DP
  • Decalix
  • Decameth
  • Decason R.p.
  • Dectancyl
  • Dekacort
  • Deltafluoren
  • Deronil
  • Desamethason
  • Desameton
  • Dexa-Mamallet
  • Dexa-næsehorn
  • Dexa-Scheroson
  • Dexa-sinus
  • Dexacortal
  • Dexacortin
  • Dexafarma
  • Dexafluoren
  • Dexalocal
  • Dexamecortin
  • Dexameth
  • Dexamethason Intensol
  • Dexamethasonum
  • Dexamonozon
  • Dexapos
  • Dexinoral
  • Dexone
  • Dinormon
  • Dxevo
  • Fluorodelta
  • Fortecortin
  • Gammacorten
  • Hexadecadrol
  • Hexadrol
  • Lokalison-F
  • Loverine
  • Methylfluorprednisolon
  • Millicorten
  • Mymethason
  • Orgadrone
  • Spersadex
  • TaperDex
  • Visumetazon
  • ZoDex
Medicin: Thioguanin
Givet PO
Andre navne:
  • 6-TG
  • 2-amino 6MP
  • 2-amino-1,7-dihydro-6H-purin-6-thion
  • 2-amino-6-mercaptopurin
  • 2-amino-6-purinethiol
  • 2-aminopurin-6-thiol
  • 2-aminopurin-6(1H)-thion
  • 2-aminopurin-6-thiol hemihydrat
  • 2-Mercapto-6-aminopurin
  • 6-amino-2-mercaptopurin
  • 6-Mercapto-2-aminopurin
  • 6-Mercaptoguanin
  • 6H-Purin-6-thion, 2-amino-1,7-dihydro- (9Cl)
  • BW 5071
  • Lanvis
  • Tabloid
  • Thioguanin hemihydrat
  • Thioguanin Hydrat
  • Tioguanin
  • Tioguanine
  • Velkommen U3B
  • WR-1141
  • X 27
Stråling: Stråleterapi
Gennemgå strålebehandling
Andre navne:
  • Kræftstrålebehandling
  • ENERGY_TYPE
  • Bestråle
  • Bestrålet
  • Bestråling
  • Stråling
  • Stråleterapi, NOS
  • Radioterapeutika
  • Strålebehandling
  • RT
  • Terapi, Stråling
Medicin: Prednison
Givet PO eller IV
Andre navne:
  • Deltasone
  • Orasone
  • 81-kortison
  • 1,2-dehydrocortison
  • Adasone
  • Cortancyl
  • Dacortin
  • DeCortin
  • Decortisyl
  • Decorton
  • Delta 1-kortison
  • Delta-Dome
  • Deltacortene
  • Deltacortison
  • Deltadehydrocortison
  • Deltison
  • Delta
  • Econosone
  • Lisacort
  • Meprosona-F
  • Metacortandracin
  • Meticorten
  • Ofisolona
  • Panafcort
  • Panasol-S
  • Paracort
  • Perrigo Prednison
  • PRED
  • Predicor
  • Predicorten
  • Prednicen-M
  • Prednicort
  • Prednidib
  • Prednilonga
  • Predniment
  • Prednison Intensol
  • Prednisonum
  • Predniton
  • Promifen
  • Rayos
  • Servisone
  • SK-Prednison
Medicin: Pegaspargase
Givet IM
Andre navne:
  • L-asparaginase med polyethylenglycol
  • Oncaspar
  • Oncaspar-IV
  • PEG-asparaginase
  • PEG-L-asparaginase
  • PEG-L-Asparaginase (Enzon - Kyowa Hakko)
  • PEGLA
  • Polyethylenglycol L-Asparaginase
  • Polyethylenglycol-L-Asparaginase
Medicin: Methotrexat
Givet IT eller IV
Andre navne:
  • Abitrexat
  • Folex
  • Mexate
  • MTX
  • Alpha-Methopterin
  • Amethopterin
  • Brimexat
  • CL 14377
  • CL-14377
  • Emtexat
  • Emthexat
  • Farmitrexat
  • Fauldexato
  • Folex PFS
  • Lantarel
  • Ledertrexat
  • Lumexon
  • Maxtrex
  • Medsatrexat
  • Metex
  • Methoblastin
  • Methotrexat LPF
  • Methotrexat Methylaminopterin
  • Methotrexatum
  • Metotrexato
  • Metrotex
  • Mexate-AQ
  • Novatrex
  • Rheumatrex
  • Texate
  • Tremetex
  • Trexeron
  • Trixilem
  • WR-19039
Medicin: Cytarabine
Given IT, SC, or IV
Andre navne:
  • Β-Cytosin arabinosid
  • 1-β-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinon
  • 1-β-D-Arabinofuranosylcytosin
  • 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinon
  • 1-Beta-D-arabinofuranosylcytosin
  • 1β-D-Arabinofuranosylcytosin
  • 2(1H)-pyrimidinon, 4-amino-1-beta-D-arabinofuranosyl-
  • 2(1H)-pyrimidinon, 4-amino-1P-D-arabinofuranosyl-
  • Alexan
  • Ara-C
  • ARA-celle
  • Arabine
  • Arabinofuranosylcytosin
  • Arabinosylcytosin
  • Aracytidin
  • Aracytin
  • Beta-Cytosin Arabinoside
  • CHX-3311
  • Cytarabinum
  • Cytarbel
  • Cytosar
  • Cytosin Arabinoside
  • Cytosin-β-arabinosid
  • Cytosin-beta-arabinosid
  • Erpalfa
  • Starasid
  • Tarabin PFS
  • U 19920
  • U-19920
  • Udicil
  • WR-28453
Eksperimentel: Arm IV

Patients in arm IV will receive cytarabine, vincristine, daunorubicin, and pegaspargase as in groups one and two. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5.

Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
Medicin: Daunorubicin Hydrochlorid
Givet IV
Andre navne:
  • Cerubidin
  • Cloridrato de Daunorubicina
  • Daunoblastin
  • Daunoblastina
  • Daunomycin hydrochlorid
  • Daunomycin, hydrochlorid
  • Daunorubicin.HCl
  • Daunorubicini Hydrochloridum
  • FI-6339
  • Ondena
  • RP-13057
  • Rubidomycin hydrochlorid
  • Rubilem
Medicin: Cyclofosfamid
Givet IV
Andre navne:
  • Cytoxan
  • CTX
  • (-)-Cyclophosphamid
  • 2H-1,3,2-Oxazaphosphorin, 2-[bis(2-chlorethyl)amino]tetrahydro-, 2-oxid, monohydrat
  • Carloxan
  • Ciclofosfamida
  • Ciclofosfamid
  • Cicloxal
  • Clafen
  • Claphene
  • CP monohydrat
  • CYCLO-celle
  • Cykloblastin
  • Cycloblastin
  • Cyclofosfam
  • Cyclophosphamid monohydrat
  • Cyclophosphamid Monohydrat
  • Cyclophospamidum
  • Cyclofosfan
  • Cyclophosphanum
  • Cyclostin
  • Cytophosphan
  • Cytofosfan
  • Fosfaseron
  • Genoxal
  • Genuxal
  • Ledoxina
  • Mitoxan
  • Neosar
  • Revimune
  • Syklofosfamid
  • WR- 138719
Medicin: Mercaptopurin
Givet PO
Andre navne:
  • 6 MP
  • Purinethol
  • 3H-Purin-6-thiol
  • 6 Thiohypoxanthin
  • 6 Thiopurin
  • 6-Mercaptopurin
  • 6-Mercaptopurin monohydrat
  • 6-Purinethiol
  • 6-thiopurin
  • 6-thioxopurin
  • 6H-Purin-6-thion, 1,7-dihydro- (9Cl)
  • 7-Mercapto-1,3,4,6-tetrazainden
  • Alti-Mercaptopurin
  • Azathiopurin
  • Bw 57-323H
  • Flocofil
  • Ismipur
  • Leukerin
  • Leupurin
  • Mercaleukim
  • Mercaleukin
  • Mercaptina
  • Mercaptopurinum
  • Mercapurin
  • Mern
  • NCI-C04886
  • Puri-Nethol
  • Purimethol
  • Purin, 6-mercapto-
  • Purin-6-thiol (8CI)
  • Purin-6-thiol, monohydrat
  • Purinethiol
  • U-4748
  • WR-2785
Medicin: Vincristinsulfat
Givet IV
Andre navne:
  • Oncovin
  • Kyocristine
  • Leurocristinsulfat
  • Leurocristin, sulfat
  • Vincasar
  • Vincosid
  • Vincrex
  • Vincristin, sulfat
Medicin: Doxorubicin Hydrochlorid
Givet IV
Andre navne:
  • Adriamycin
  • 5,12-naphthacendion, 10-[(3-amino-2,3,6-trideoxy-alfa-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy -8-(hydroxyacetyl)-1-methoxy-, hydrochlorid, (8S-cis)- (9Cl)
  • ADM
  • Adriacin
  • Adriamycin hydrochlorid
  • Adriamycin PFS
  • Adriamycin RDF
  • ADRIAMYCIN, HYDROCHLORID
  • Adriblastina
  • Adriblastin
  • Adrimedac
  • Chloridrato de Doxorrubicina
  • DOX
  • DOXO-CELL
  • Doxolem
  • Doxorubicin HCl
  • Doxorubicin.HCl
  • Doxorubin
  • Farmiblastina
  • FI 106
  • FI-106
  • hydroxydaunorubicin
  • Rubex
Medicin: Dexamethason
Givet PO eller IV
Andre navne:
  • Dekadron
  • Aacideksamen
  • Adexone
  • Aknichthol Dexa
  • Alba-Dex
  • Alin
  • Alin Depot
  • Alin Oftalmico
  • Amplidermis
  • Anemul mono
  • Auricularum
  • Auxiloson
  • Baycadron
  • Baycuten
  • Baycuten N
  • Cortidexason
  • Cortisumman
  • Decacort
  • Decadrol
  • Decadron DP
  • Decalix
  • Decameth
  • Decason R.p.
  • Dectancyl
  • Dekacort
  • Deltafluoren
  • Deronil
  • Desamethason
  • Desameton
  • Dexa-Mamallet
  • Dexa-næsehorn
  • Dexa-Scheroson
  • Dexa-sinus
  • Dexacortal
  • Dexacortin
  • Dexafarma
  • Dexafluoren
  • Dexalocal
  • Dexamecortin
  • Dexameth
  • Dexamethason Intensol
  • Dexamethasonum
  • Dexamonozon
  • Dexapos
  • Dexinoral
  • Dexone
  • Dinormon
  • Dxevo
  • Fluorodelta
  • Fortecortin
  • Gammacorten
  • Hexadecadrol
  • Hexadrol
  • Lokalison-F
  • Loverine
  • Methylfluorprednisolon
  • Millicorten
  • Mymethason
  • Orgadrone
  • Spersadex
  • TaperDex
  • Visumetazon
  • ZoDex
Medicin: Thioguanin
Givet PO
Andre navne:
  • 6-TG
  • 2-amino 6MP
  • 2-amino-1,7-dihydro-6H-purin-6-thion
  • 2-amino-6-mercaptopurin
  • 2-amino-6-purinethiol
  • 2-aminopurin-6-thiol
  • 2-aminopurin-6(1H)-thion
  • 2-aminopurin-6-thiol hemihydrat
  • 2-Mercapto-6-aminopurin
  • 6-amino-2-mercaptopurin
  • 6-Mercapto-2-aminopurin
  • 6-Mercaptoguanin
  • 6H-Purin-6-thion, 2-amino-1,7-dihydro- (9Cl)
  • BW 5071
  • Lanvis
  • Tabloid
  • Thioguanin hemihydrat
  • Thioguanin Hydrat
  • Tioguanin
  • Tioguanine
  • Velkommen U3B
  • WR-1141
  • X 27
Stråling: Stråleterapi
Gennemgå strålebehandling
Andre navne:
  • Kræftstrålebehandling
  • ENERGY_TYPE
  • Bestråle
  • Bestrålet
  • Bestråling
  • Stråling
  • Stråleterapi, NOS
  • Radioterapeutika
  • Strålebehandling
  • RT
  • Terapi, Stråling
Medicin: Prednison
Givet PO eller IV
Andre navne:
  • Deltasone
  • Orasone
  • 81-kortison
  • 1,2-dehydrocortison
  • Adasone
  • Cortancyl
  • Dacortin
  • DeCortin
  • Decortisyl
  • Decorton
  • Delta 1-kortison
  • Delta-Dome
  • Deltacortene
  • Deltacortison
  • Deltadehydrocortison
  • Deltison
  • Delta
  • Econosone
  • Lisacort
  • Meprosona-F
  • Metacortandracin
  • Meticorten
  • Ofisolona
  • Panafcort
  • Panasol-S
  • Paracort
  • Perrigo Prednison
  • PRED
  • Predicor
  • Predicorten
  • Prednicen-M
  • Prednicort
  • Prednidib
  • Prednilonga
  • Predniment
  • Prednison Intensol
  • Prednisonum
  • Predniton
  • Promifen
  • Rayos
  • Servisone
  • SK-Prednison
Medicin: Leucovorin Calcium
Givet IV
Andre navne:
  • Wellcovorin
  • folinsyre
  • Adinepar
  • Calcifolin
  • Calcium (6S)-folinat
  • Calciumfolinat
  • Calcium Leucovorin
  • Calfolex
  • Calinat
  • Cehafolin
  • Citofolin
  • Citrec
  • Citrovorum faktor
  • Cromatonbic Folinico
  • Dalisol
  • Disintox
  • Divical
  • Ecofol
  • Emovis
  • Faktor, Citrovorum
  • Flynoken A
  • Folaren
  • Folaxin
  • FOLI-celle
  • Foliben
  • Folidan
  • Folidar
  • Folinac
  • Folinat Calcium
  • Folinsyre Calcium Salt Pentahydrat
  • Folinoral
  • Folinvit
  • Foliplus
  • Folix
  • Imo
  • Lederfolat
  • Lederfolin
  • Leucosar
  • leukovorin
  • Rescufolin
  • Rescuvolin
  • Tonofolin
Medicin: Pegaspargase
Givet IM
Andre navne:
  • L-asparaginase med polyethylenglycol
  • Oncaspar
  • Oncaspar-IV
  • PEG-asparaginase
  • PEG-L-asparaginase
  • PEG-L-Asparaginase (Enzon - Kyowa Hakko)
  • PEGLA
  • Polyethylenglycol L-Asparaginase
  • Polyethylenglycol-L-Asparaginase
Medicin: Methotrexat
Givet IT eller IV
Andre navne:
  • Abitrexat
  • Folex
  • Mexate
  • MTX
  • Alpha-Methopterin
  • Amethopterin
  • Brimexat
  • CL 14377
  • CL-14377
  • Emtexat
  • Emthexat
  • Farmitrexat
  • Fauldexato
  • Folex PFS
  • Lantarel
  • Ledertrexat
  • Lumexon
  • Maxtrex
  • Medsatrexat
  • Metex
  • Methoblastin
  • Methotrexat LPF
  • Methotrexat Methylaminopterin
  • Methotrexatum
  • Metotrexato
  • Metrotex
  • Mexate-AQ
  • Novatrex
  • Rheumatrex
  • Texate
  • Tremetex
  • Trexeron
  • Trixilem
  • WR-19039
Medicin: Cytarabine
Given IT, SC, or IV
Andre navne:
  • Β-Cytosin arabinosid
  • 1-β-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinon
  • 1-β-D-Arabinofuranosylcytosin
  • 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinon
  • 1-Beta-D-arabinofuranosylcytosin
  • 1β-D-Arabinofuranosylcytosin
  • 2(1H)-pyrimidinon, 4-amino-1-beta-D-arabinofuranosyl-
  • 2(1H)-pyrimidinon, 4-amino-1P-D-arabinofuranosyl-
  • Alexan
  • Ara-C
  • ARA-celle
  • Arabine
  • Arabinofuranosylcytosin
  • Arabinosylcytosin
  • Aracytidin
  • Aracytin
  • Beta-Cytosin Arabinoside
  • CHX-3311
  • Cytarabinum
  • Cytarbel
  • Cytosar
  • Cytosin Arabinoside
  • Cytosin-β-arabinosid
  • Cytosin-beta-arabinosid
  • Erpalfa
  • Starasid
  • Tarabin PFS
  • U 19920
  • U-19920
  • Udicil
  • WR-28453

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Comparison of the Increase in Cure Rate of High Risk ALL Without Causing More Serious Side Effects Between Interventions
Tidsramme: 5 years
Event Free Probability.
5 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Correlation of Minimal Residual Disease (MRD) Positive With Overall Survival (OS)
Tidsramme: 5 Years
Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells, and negative with < 0.1 detectable leukemia cells.
5 Years
Correlation of Minimal Residual Disease (MRD) Negative With Overall Survival (OS).
Tidsramme: 5 years
Bone marrow MRD status is defined as negative with < .01 detectable leukemia cells.
5 years
Correlation of Early Marrow Response Status With MRD Positive.
Tidsramme: Day 29
Bone marrow status is defined as: M1: < 5% lymphoblasts; M2: 5-25% lymphoblasts; M3: > 25% lymphoblasts. Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells, and negative with < 0.1 detectable leukemia cells.
Day 29
Correlation of Early Marrow Response Status With MRD Negative.
Tidsramme: Day 29
Bone marrow status is defined as: M1: < 5% lymphoblasts; M2: 5-25% lymphoblasts; M3: > 25% lymphoblasts. Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells, and negative with < 0.1 detectable leukemia cells.
Day 29
Correlation of Minimal Residual Disease (MRD) Positive With Event Free Survival (EFS)
Tidsramme: 5 years
Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells.
5 years
Correlation of Minimal Residual Disease (MRD) Negative With Event Free Survival (EFS).
Tidsramme: 5 years
Bone marrow MRD status is defined as negative with < 0.1 detectable leukemia cells.
5 years

Samarbejdspartnere og efterforskere

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

Sponsor

Children's Oncology Group

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Ledende efterforsker: Eric C Larsen, Children's Oncology 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.

Generelle publikationer

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)

29. december 2003

Primær færdiggørelse (Faktiske)

31. december 2010

Studieafslutning (Faktiske)

31. marts 2021

Datoer for studieregistrering

Først indsendt

9. januar 2004

Først indsendt, der opfyldte QC-kriterier

12. januar 2004

Først opslået (Skøn)

13. januar 2004

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. april 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. april 2021

Sidst verificeret

1. april 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AALL0232 (Anden identifikator: CTEP)
  • U10CA098543 (U.S. NIH-bevilling/kontrakt)
  • 11723 (DAIDS ES Registry Number)
  • NCI-2009-00301 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • COG-AALL0232
  • CDR0000349182

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