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Comparison of Different Combination Chemotherapy Regimens in Treating Children With Acute Lymphoblastic Leukemia

19. Februar 2016 aktualisiert von: Children's Oncology Group

Escalating Dose Intravenous Methotrexate Without Leucovorin Rescue Versus Oral Methotrexate and Single Versus Double Delayed Intensification for Children With Standard Risk Acute Lymphoblastic Leukemia

RATIONALE: Drugs used in chemotherapy use 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 childhood acute lymphoblastic leukemia.

PURPOSE: This randomized phase III trial is comparing different combination chemotherapy regimens to see how well they work in treating children with acute lymphoblastic leukemia.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

OBJECTIVES:

  • Compare the event-free survival and overall survival of children with standard-risk acute lymphoblastic leukemia treated with escalating-dose IV methotrexate without leucovorin calcium versus oral methotrexate during the interim maintenance phase of therapy.
  • Compare the event-free survival and overall survival of these patients after receiving treatment in two delayed intensification phases versus one delayed intensification phase.
  • Compare the toxic effects of oral versus escalating-dose intravenous methotrexate in these patients.
  • Determine the prognostic significance of the rate of disappearance of peripheral lymphoblasts and lymphocytes during the first week of treatment in these patients.
  • Determine the prognostic significance of trisomies of chromosomes 4, 5, 10, and 17 and early treatment response in patients treated with these regimens.
  • Determine the prognostic significance of the TEL-AML1 fusion transcript and early treatment response in patients treated with these regimens.
  • Determine the minimal residual disease (MRD) by polymerase chain reaction in bone marrow and cerebrospinal fluid at various stages of therapy in these patients.
  • Determine the prognostic significance of MRD during various stages of therapy in these patients.
  • Determine whether a second delayed intensification therapy improves the prognosis of patients who have MRD at the end of induction therapy.

OUTLINE: This is a randomized, multicenter study. Patients without CNS disease at diagnosis, achieving a specified early marrow response profile and M1 marrow status of less than 5% blasts in the bone marrow (regardless of the proportion of mature lymphocytes) by day 28 of induction therapy, and remaining event free with favorable bone marrow status and cytogenetics between day 21 and 28 of consolidation therapy are randomized to one of four treatment arms. Patients with CNS disease at diagnosis are assigned to treatment arm II and undergo cranial irradiation. Patients with any of the following unfavorable bone marrow features and/or unfavorable cytogenetic features are assigned to the augmented treatment regimen by day 21 of induction chemotherapy or at the beginning of consolidation chemotherapy:

NOTE: All T-cell precursor patients that are not more than 4 months past completion of the delayed intensification phase of therapy should be switched to the augmented regimen as of 3/8/2004. These patients may be switched to the augmented regimen. The protocol gives specific instructions according to the phase of therapy the patients are actually in.

  • Unfavorable marrow status:

    • M2: 5-25% blasts in bone marrow at day 28 of induction chemotherapy (or at day 14 of induction chemotherapy if day 7 status is M3) OR
    • M3: More than 25% blast cell in bone marrow, regardless of the proportion of mature lymphocytes at day 14 of induction chemotherapy

  • Unfavorable cytogenetics: Must have 1 of the following:

    • t(9;22)(q34;q11)
    • t(4;11)(q21;q23)
    • Balanced t(1;19)(q23;p13)
    • Hypodiploidy with less than 45 chromosomes
    • Other 11q23 translocations involving MLL Patients receive standard induction chemotherapy comprising cytarabine (ARA-C) intrathecally (IT) on day 0 or up to 72 hours before day 0; oral dexamethasone (DM) twice daily on days 0-27; vincristine (VCR) IV on days 0, 7, 14, and 21; and pegaspargase (PEG-ASP) intramuscularly (IM) once between days 3-5. Patients without CNS disease at diagnosis receive methotrexate (MTX) IT on days 7 and 28. Patients with CNS disease at diagnosis receive MTX IT on days 7, 14, 21, and 28.

Patients who have achieved M1 marrow status by day 28 of induction therapy and have favorable early bone marrow response and cytogenetics proceed to standard consolidation therapy once blood counts have recovered. Patients with M3 bone marrow status at day 28 of induction therapy are taken off the protocol. All other patients are assigned to the augmented treatment regimen.

Beginning on day 28 of induction chemotherapy, patients receive standard consolidation chemotherapy comprising VCR IV on day 0 and oral mercaptopurine (MP) on days 0-27. Patients without CNS disease at diagnosis receive MTX IT on days 7, 14, 21, and 28. Patients with CNS disease at diagnosis receive MTX IT on day 7 and cranial irradiation 5 days a week for 2 weeks. Patients with testicular disease receive bilateral testicular radiotherapy 5 days a week for 1 week and then for 3 consecutive days during the next week.

NOTE: As of 3/8/2004, patients with T-cell disease who did not achieve M1 marrow status by day 14 of induction OR who did not receive augmented induction and/or consolidation (regardless of early marrow status) receive cranial irradiation.

  • Arm I: Beginning on day 28 of consolidation chemotherapy, patients receive interim maintenance I chemotherapy comprising oral DM twice daily on days 0-4 and 28-32; VCR IV on days 0 and 28; oral MTX on days 0, 7, 14, 21, 28, 35, 42, and 49; oral MP on days 0-49; and MTX IT on day 28.

Beginning on day 56 of interim maintenance I chemotherapy, patients receive delayed intensification chemotherapy comprising oral DM twice daily on days 0-6 and 14-20; VCR IV and doxorubicin (DOX) IV over 15 minutes to 2 hours on days 0, 7, and 14; PEG-ASP IM on day 3; cyclophosphamide (CTX) IV over 20-30 minutes on day 28; oral thioguanine (TG) on days 28-41; ARA-C IV or subcutaneously (SC) daily on days 28-31 and 35-38; and MTX IT on days 0 and 28.

Beginning on day 56 of delayed intensification chemotherapy, patients receive interim maintenance II chemotherapy identical to interim maintenance I chemotherapy except patients receive MTX IT on days 0 and 28.

Beginning on day 56 of interim maintenance II chemotherapy, patients receive maintenance chemotherapy comprising oral DM twice daily on days 0-4, 28-32, and 56-60; VCR IV on days 0, 28, and 56; oral MP on days 0-83; oral MTX on days 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, and 77; and MTX IT on day 0.

  • Arm II: Patients receive interim maintenance I chemotherapy, delayed intensification chemotherapy, and interim maintenance II chemotherapy as in arm I. Beginning on day 56 of interim maintenance II chemotherapy, patients then receive a second course of delayed intensification chemotherapy followed by maintenance chemotherapy as in arm I.
  • Arm III: Beginning on day 28 of consolidation chemotherapy, patients receive interim maintenance I chemotherapy comprising VCR IV; escalating doses of MTX IV on days 0, 10, 20, 30, and 40; and MTX IT on day 30. Patients then receive delayed intensification chemotherapy as in arm I. Patients receive interim maintenance II chemotherapy as in interim maintenance I chemotherapy, but with IV MTX starting at 2/3 of the maximum tolerated dose (MTD) attained in interim maintenance I chemotherapy. Patients then receive maintenance chemotherapy as in arm I.
  • Arm IV: Patients receive interim maintenance I chemotherapy as in arm III, delayed intensification chemotherapy as in arm I, interim maintenance II chemotherapy as in arm III, delayed intensification II chemotherapy as in arm II, and maintenance chemotherapy as in arm I.
  • Augmented Treatment: Patients receive induction chemotherapy comprising daunorubicin IV continuously for 48 hours beginning no later than day 21; oral DM twice daily on days 14-27; and VCR IV on days 14 and 21. Patients without CNS disease at diagnosis receive MTX IT on days 21 and 35. Patients with CNS disease at diagnosis receive MTX IT on days 21 and 28.

NOTE: Patients with T-cell disease should re-start with augmented consolidation and proceed as per the augmented regimen.

Beginning on day 35 of induction chemotherapy, patients receive consolidation therapy comprising CTX IV over 20-30 minutes on days 0 and 28; oral MP on days 0-13 and 28-41; ARA-C IV or SC daily on days 0-3, 7-10, 28-31, and 35-38; VCR IV on days 14, 21, 42, and 49; and PEG-ASP IM on days 14 and 42. Patients without CNS disease at diagnosis receive MTX IT on days 7, 14, and 21. Patients with CNS disease at diagnosis receive MTX IT on day 7 and cranial irradiation as in the randomized treatment section. Patients with testicular leukemia receive radiotherapy as in the randomized treatment section.

Beginning on day 63 of consolidation chemotherapy, patients receive interim maintenance I chemotherapy comprising VCR IV on days 0, 10, 20, 30, and 40; escalating doses of MTX IV on days 10, 20, 30, and 40; PEG-ASP IM on days 1 and 21; and MTX IT on days 0 and 30.

Beginning on day 56 of interim maintenance I chemotherapy, patients receive delayed intensification I chemotherapy comprising oral DM twice daily on days 0-6 and 14-20; VCR IV on days 0, 7, 14, 42, and 49; DOX IV over 15 minutes to 2 hours on days 0, 7, and 14; PEG-ASP IM on days 3 and 42; CTX IV over 20-30 minutes on day 28; oral TG on days 28-41; ARA-C IV or SC daily on days 28-31 and 35-38; and MTX IT on days 0 and 28.

NOTE: Patients with T-cell disease who are in interim maintenance I chemotherapy with escalating IV methotrexate should continue this phase and then proceed as per the augmented regimen. If these patients are receiving conventional interim maintenance chemotherapy with oral methotrexate, they should stop and restart the interim maintenance as per the augmented regimen. These patients receive cranial irradiation starting on day 28 of delayed intensification II chemotherapy.

Beginning on day 56 of delayed intensification I chemotherapy, patients receive interim maintenance II chemotherapy as in interim maintenance I chemotherapy, but with IV MTX starting at 2/3 of the MTD attained in interim maintenance I chemotherapy.

NOTE: Patients with T-cell disease who are in delayed intensification I chemotherapy proceed with this phase, with the addition of 2 vincristine doses on days 42 and 49 and PEG-ASP on day 42. These patients then proceed as per the augmented regimen with the addition of cranial irradiation starting on day 28 of delayed intensification II chemotherapy.

NOTE: Patients with T-cell disease who are within 4 months of completing delayed intensification I chemotherapy and have not received interim maintenance II chemotherapy with escalating IV methotrexate or delayed intensification II chemotherapy receive a course of interim maintenance chemotherapy and delayed intensification II chemotherapy according to the augmented regimen. If these patients have received interim maintenance II chemotherapy with escalating IV methotrexate, they receive delayed intensification II chemotherapy according to the augmented regimen. These patients also receive cranial irradiation starting on day 28 of delayed intensification II chemotherapy and then proceed to maintenance therapy.

Beginning on day 56 of interim maintenance II chemotherapy, patients receive delayed intensification II chemotherapy as in delayed intensification I chemotherapy.

Beginning on day 56 of delayed intensification II chemotherapy, patients receive maintenance chemotherapy comprising oral DM twice daily on days 0-4, 28-32, and 56-60; VCR IV on days 0, 28, and 56; oral MP on days 0-83; oral MTX on days 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, and 77; and MTX IT on day 0.

Patients are followed every 4-8 weeks for one year, every 3 months for one year, every 6 months for one year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 2,037 randomized patients will be accrued for this study within 3.75 years.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

3054

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Australien
    • New South Wales
      • Randwick, New South Wales, Australien, 2031
        • Sydney Children's Hospital
    • Queensland
      • Brisbane, Queensland, Australien, 4029
        • Royal Children's Hospital
    • Western Australia
      • Perth, Western Australia, Australien, 6001
        • Princess Margaret Hospital for Children
  • Kanada
    • British Columbia
      • Vancouver, British Columbia, Kanada, V6H 3V4
        • British Columbia Children's Hospital
    • Manitoba
      • Winnipeg, Manitoba, Kanada, R3E 0V9
        • CancerCare Manitoba
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Kanada, A1B 3V6
        • Janeway Children's Health and Rehabilitation Centre
    • Nova Scotia
      • Halifax, Nova Scotia, Kanada, B3J 3G9
        • IWK Health Centre
    • Ontario
      • London, Ontario, Kanada, N6C 2V5
        • Children's Hospital of Western Ontario
    • Saskatchewan
      • Regina, Saskatchewan, Kanada, S4T 7T1
        • Allan Blair Cancer Centre at Pasqua Hospital
      • Saskatoon, Saskatchewan, Kanada, S7N 4H4
        • Saskatoon Cancer Centre
  • Neuseeland
      • Auckland, Neuseeland
        • Starship Children's Health
  • Schweiz
      • Bern, Schweiz, CH 3010
        • Swiss Pediatric Oncology Group Bern
      • Geneva, Schweiz, CH 1211
        • Swiss Pediatric Oncology Group Geneva
      • Lausanne, Schweiz, CH 1011
        • Swiss Pediatric Oncology Group Lausanne
  • Vereinigte Staaten
    • Arizona
      • Phoenix, Arizona, Vereinigte Staaten, 85016
        • Phoenix Children's Hospital
    • California
      • Downey, California, Vereinigte Staaten, 90242
        • Southern California Permanente Medical Group
      • Duarte, California, Vereinigte Staaten, 91010-3000
        • City of Hope Comprehensive Cancer Center
      • Loma Linda, California, Vereinigte Staaten, 92354
        • Loma Linda University Cancer Institute at Loma Linda University Medical Center
      • Los Angeles, California, Vereinigte Staaten, 90095-1781
        • Jonsson Comprehensive Cancer Center, UCLA
      • Los Angeles, California, Vereinigte Staaten, 90027-0700
        • Children's Hospital Los Angeles
      • Los Angeles, California, Vereinigte Staaten, 90048
        • Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
      • Madera, California, Vereinigte Staaten, 93638-8762
        • Children's Hospital Central California
      • Oakland, California, Vereinigte Staaten, 94609-1809
        • Children's Hospital and Research Center at Oakland
      • Orange, California, Vereinigte Staaten, 92868
        • Children's Hospital of Orange County
      • Orange, California, Vereinigte Staaten, 92868
        • Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
      • Sacramento, California, Vereinigte Staaten, 95825
        • Kaiser Permanente Medical Center - Sacramento
      • San Diego, California, Vereinigte Staaten, 92120
        • Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
      • San Francisco, California, Vereinigte Staaten, 94143
        • UCSF Comprehensive Cancer Center
      • Santa Barbara, California, Vereinigte Staaten, 93102
        • Santa Barbara Cottage Hospital
      • Santa Clara, California, Vereinigte Staaten, 95051-5386
        • Kaiser Permanente Medical Center - Santa Clara
      • Travis Air Force Base, California, Vereinigte Staaten, 94535
        • General Robert Huyser Cancer Center at David Grant Medical Center
    • Colorado
      • Denver, Colorado, Vereinigte Staaten, 80218
        • Presbyterian - St. Luke's Medical Center
      • Denver, Colorado, Vereinigte Staaten, 80218
        • Children's Hospital Cancer Center
    • Connecticut
      • Farmington, Connecticut, Vereinigte Staaten, 06360-7106
        • Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
      • New Haven, Connecticut, Vereinigte Staaten, 06520-8064
        • Yale Comprehensive Cancer Center
    • Delaware
      • Wilmington, Delaware, Vereinigte Staaten, 19899
        • Alfred I. DuPont Hospital for Children
    • District of Columbia
      • Washington, District of Columbia, Vereinigte Staaten, 20007
        • Lombardi Cancer Center at Georgetown University Medical Center
      • Washington, District of Columbia, Vereinigte Staaten, 20010-2970
        • Children's National Medical Center
    • Georgia
      • Atlanta, Georgia, Vereinigte Staaten, 30342
        • AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus
      • Macon, Georgia, Vereinigte Staaten, 31201
        • Medical Center of Central Georgia
      • Savannah, Georgia, Vereinigte Staaten, 31405
        • Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
    • Idaho
      • Boise, Idaho, Vereinigte Staaten, 83712
        • Mountain States Tumor Institute - Boise
    • Illinois
      • Chicago, Illinois, Vereinigte Staaten, 60601
        • University of Chicago Cancer Research Center
      • Chicago, Illinois, Vereinigte Staaten, 60612
        • University of Illinois Medical Center
      • Park Ridge, Illinois, Vereinigte Staaten, 60068-1174
        • Lutheran General Cancer Care Center
      • Springfield, Illinois, Vereinigte Staaten, 62794-9658
        • Southern Illinois University School of Medicine
    • Indiana
      • Indianapolis, Indiana, Vereinigte Staaten, 46202-5225
        • Riley Children Cancer Center at Riley Hospital for Children
    • Iowa
      • Des Moines, Iowa, Vereinigte Staaten, 50308
        • Blank Children's Hospital
      • Iowa City, Iowa, Vereinigte Staaten, 52242-1009
        • Holden Comprehensive Cancer Center at University of Iowa
    • Kentucky
      • Lexington, Kentucky, Vereinigte Staaten, 40536-0284
        • Markey Cancer Center at University of Kentucky Chandler Medical Center
      • Louisville, Kentucky, Vereinigte Staaten, 40202-3830
        • Kosair Children's Hospital
    • Louisiana
      • New Orleans, Louisiana, Vereinigte Staaten, 70112
        • MBCCOP - LSU Health Sciences Center
    • Maryland
      • Baltimore, Maryland, Vereinigte Staaten, 21215
        • Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
    • Massachusetts
      • Springfield, Massachusetts, Vereinigte Staaten, 01107
        • Baystate Regional Cancer Program at D'Amour Center for Cancer Care
    • Michigan
      • Ann Arbor, Michigan, Vereinigte Staaten, 48109-0914
        • University of Michigan Comprehensive Cancer Center
      • Detroit, Michigan, Vereinigte Staaten, 48202
        • Josephine Ford Cancer Center at Henry Ford Health System
      • Grand Rapids, Michigan, Vereinigte Staaten, 49503
        • DeVos Children's Hospital
      • Kalamazoo, Michigan, Vereinigte Staaten, 49007-5364
        • Bronson Methodist Hospital
      • Lansing, Michigan, Vereinigte Staaten, 48910
        • Breslin Cancer Center at Ingham Regional Medical Center
      • Royal Oak, Michigan, Vereinigte Staaten, 48073-6769
        • CCOP - Beaumont
      • Royal Oak, Michigan, Vereinigte Staaten, 48073-6769
        • William Beaumont Hospital - Royal Oak
    • Minnesota
      • Duluth, Minnesota, Vereinigte Staaten, 55805
        • St. Mary's - Duluth Clinic Cancer Center
      • Minneapolis, Minnesota, Vereinigte Staaten, 55455
        • University of Minnesota Cancer Center
      • Minneapolis, Minnesota, Vereinigte Staaten, 55404
        • Children's Hospitals and Clinics - Minneapolis/St. Paul
      • Rochester, Minnesota, Vereinigte Staaten, 55905
        • Mayo Clinic Cancer Center
    • Missouri
      • Kansas City, Missouri, Vereinigte Staaten, 64108
        • Children's Mercy Hospital
    • Nebraska
      • Omaha, Nebraska, Vereinigte Staaten, 68114
        • Children's Hospital of Omaha
      • Omaha, Nebraska, Vereinigte Staaten, 68198-2168
        • UNMC Eppley Cancer Center at the University of Nebraska Medical Center
    • Nevada
      • Las Vegas, Nevada, Vereinigte Staaten, 89109
        • Sunrise Hospital and Medical Center
    • New Jersey
      • Livingston, New Jersey, Vereinigte Staaten, 07039
        • St. Barnabas Medical Center
      • New Brunswick, New Jersey, Vereinigte Staaten, 08903
        • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
      • Newark, New Jersey, Vereinigte Staaten, 07112-2094
        • Newark Beth Israel Medical Center
      • Paterson, New Jersey, Vereinigte Staaten, 07503
        • St. Joseph's Hospital and Medical Center
      • Summit, New Jersey, Vereinigte Staaten, 07901
        • Valerie Fund Children's Center at Atlantic Health
    • New York
      • Albany, New York, Vereinigte Staaten, 12208
        • Cancer Center of Albany Medical Center
      • Bronx, New York, Vereinigte Staaten, 10461
        • Albert Einstein Cancer Center at Albert Einstein College of Medicine
      • Brooklyn, New York, Vereinigte Staaten, 11203
        • SUNY Downstate Medical Center
      • Brooklyn, New York, Vereinigte Staaten, 11212
        • Brookdale University Hospital and Medical Center
      • Brooklyn, New York, Vereinigte Staaten, 11201-5493
        • Brooklyn Hospital Center
      • Brooklyn, New York, Vereinigte Staaten, 11219
        • Comprehensive Cancer Center at Maimonides Medical Center
      • New Hyde Park, New York, Vereinigte Staaten, 11042
        • Schneider Children's Hospital
      • New York, New York, Vereinigte Staaten, 10021
        • Memorial Sloan-Kettering Cancer Center
      • New York, New York, Vereinigte Staaten, 10021
        • New York Weill Cornell Cancer Center at Cornell University
      • New York, New York, Vereinigte Staaten, 10032
        • Herbert Irving Comprehensive Cancer Center at Columbia University
      • Stony Brook, New York, Vereinigte Staaten, 11794
        • Long Island Cancer Center at Stony Brook University Hospital
      • Syracuse, New York, Vereinigte Staaten, 13210
        • SUNY Upstate Medical University Hospital
      • Valhalla, New York, Vereinigte Staaten, 10595
        • New York Medical College
    • North Carolina
      • Chapel Hill, North Carolina, Vereinigte Staaten, 27599
        • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
      • Charlotte, North Carolina, Vereinigte Staaten, 28232-2861
        • Blumenthal Cancer Center at Carolinas Medical Center
      • Charlotte, North Carolina, Vereinigte Staaten, 28233
        • Presbyterian Cancer Center at Presbyterian Hospital
    • North Dakota
      • Fargo, North Dakota, Vereinigte Staaten, 58122
        • Meritcare Roger Maris Cancer Center
      • Fargo, North Dakota, Vereinigte Staaten, 58103-4940
        • Dakota Cancer Institute at Innovis Health - Dakota Clinic
    • Ohio
      • Akron, Ohio, Vereinigte Staaten, 44308-1062
        • Children's Hospital Medical Center of Akron
      • Cincinnati, Ohio, Vereinigte Staaten, 45229-3039
        • Cincinnati Children's Hospital Medical Center
      • Cleveland, Ohio, Vereinigte Staaten, 44106-5065
        • Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
      • Columbus, Ohio, Vereinigte Staaten, 43205-2696
        • Columbus Children's Hospital
      • Dayton, Ohio, Vereinigte Staaten, 45404
        • Children's Medical Center - Dayton
      • Toledo, Ohio, Vereinigte Staaten, 43601
        • Toledo Children's Hospital
      • Toledo, Ohio, Vereinigte Staaten, 43608
        • St. Vincent Mercy Medical Center
    • Oregon
      • Portland, Oregon, Vereinigte Staaten, 97225
        • CCOP - Columbia River Oncology Program
      • Portland, Oregon, Vereinigte Staaten, 97239-3098
        • Doernbecher Children's Hospital at Oregon Health & Science University
    • Pennsylvania
      • Danville, Pennsylvania, Vereinigte Staaten, 17822-1320
        • Geisinger Medical Center
      • Hershey, Pennsylvania, Vereinigte Staaten, 17033
        • Children's Hospital at Milton S. Hershey Medical Center
      • Philadelphia, Pennsylvania, Vereinigte Staaten, 19104
        • Children's Hospital of Philadelphia
      • Pittsburgh, Pennsylvania, Vereinigte Staaten, 15213
        • Children's Hospital of Pittsburgh
    • Rhode Island
      • Providence, Rhode Island, Vereinigte Staaten, 02903
        • Rhode Island Hospital
    • South Dakota
      • Sioux Falls, South Dakota, Vereinigte Staaten, 57117-5039
        • Sioux Valley Hospital and University of South Dakota Medical Center
    • Tennessee
      • Johnson City, Tennessee, Vereinigte Staaten, 37614-0622
        • East Tennessee State University Cancer Center at Johnson City Medical Center
      • Knoxville, Tennessee, Vereinigte Staaten, 37901
        • East Tennessee Children's Hospital
      • Nashville, Tennessee, Vereinigte Staaten, 37232-6310
        • Vanderbilt Children's Hospital
    • Texas
      • Amarillo, Texas, Vereinigte Staaten, 79106
        • Texas Tech University Health Sciences Center School of Medicine
      • Austin, Texas, Vereinigte Staaten, 78701
        • Children's Hospital of Austin
      • Dallas, Texas, Vereinigte Staaten, 75230
        • Medical City Dallas Hospital
      • Houston, Texas, Vereinigte Staaten, 77030-4009
        • MD Anderson Cancer Center at University of Texas
      • Lubbock, Texas, Vereinigte Staaten, 79410
        • Covenant Children's Hospital
      • San Antonio, Texas, Vereinigte Staaten, 78229-3900
        • MBCCOP - South Texas Pediatrics
      • San Antonio, Texas, Vereinigte Staaten, 78229-3902
        • Methodist Cancer Center at Methodist Specialty and Transplant Hospital
      • Temple, Texas, Vereinigte Staaten, 76508
        • CCOP - Scott and White Hospital
    • Virginia
      • Norfolk, Virginia, Vereinigte Staaten, 23507
        • Children's Hospital of The King's Daughters
    • Washington
      • Seattle, Washington, Vereinigte Staaten, 98105
        • Children's Hospital and Regional Medical Center - Seattle
      • Seattle, Washington, Vereinigte Staaten, 98112
        • Group Health Central Hospital
      • Spokane, Washington, Vereinigte Staaten, 99210-0248
        • Deaconess Medical Center
      • Tacoma, Washington, Vereinigte Staaten, 98415-0299
        • Mary Bridge Children's Hospital and Health Center
    • West Virginia
      • Charleston, West Virginia, Vereinigte Staaten, 25302
        • West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
      • Huntington, West Virginia, Vereinigte Staaten, 25701
        • Cabell Huntington Hospital
    • Wisconsin
      • Green Bay, Wisconsin, Vereinigte Staaten, 54301
        • Bellin Memorial Hospital
      • La Crosse, Wisconsin, Vereinigte Staaten, 54601
        • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
      • Madison, Wisconsin, Vereinigte Staaten, 53792-6164
        • University of Wisconsin Comprehensive Cancer Center
      • Marshfield, Wisconsin, Vereinigte Staaten, 54449
        • CCOP - Marshfield Clinic Research Foundation
      • Marshfield, Wisconsin, Vereinigte Staaten, 54449-5772
        • Marshfield Clinic - Marshfield Center

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

1 Jahr bis 9 Jahre (Kind)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

DISEASE CHARACTERISTICS:

  • Diagnosis of previously untreated B-cell precursor acute lymphoblastic leukemia

    • More than 25% L1 or L2 lymphoblasts
    • No more than 25% L3 lymphoblasts
    • WBC < 50,000/mm^3
  • No T-cell precursor acute lymphoblastic leukemia by immunophenotyping
  • Massive lymphadenopathy, massive splenomegaly, or large mediastinal mass allowed
  • CNS or testicular leukemia allowed
  • No patients found to have t(8;14)(q24;q32), t(8;22)(q24;q11), and t(2;8)(p11-p12;q24) (characteristic of Burkitt's lymphoma)

PATIENT CHARACTERISTICS:

Age:

  • 1 to 9

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • See Disease Characteristics

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • Not pregnant
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No more than 72 hours since prior intrathecal cytarabine

Endocrine therapy:

  • At least 30 days since prior systemic corticosteroids given for more than 48 hours
  • Prior corticosteroids for mediastinal mass causing superior mediastinal syndrome allowed
  • Prior or concurrent inhaled corticosteroids allowed

Radiotherapy:

  • Prior radiotherapy for mediastinal mass causing superior mediastinal syndrome allowed
  • No concurrent spinal radiotherapy

Surgery:

  • Not specified

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Induction Not Randomized
Standard Induction (28 Days). M3 Marrow at Day 28 and Off Protocol Therapy.
Arzneimittel: Cyclophosphamid
Gegeben IV
Andere Namen:
  • Cytoxan
  • NSC-26271
Arzneimittel: Vincristinsulfat
Gegeben IV
Andere Namen:
  • Videorecorder
  • Oncovin
  • NSC-67574
Arzneimittel: Pegaspargase
Gegeben IM
Andere Namen:
  • Onkaspar
  • L-Asparaginase mit Polyethylenglykol
  • PEG-Asparaginase
Arzneimittel: Dexamethason
PO gegeben
Andere Namen:
  • Dekadron
  • DM
  • NSC-34521
Arzneimittel: methotrexate
Given PO and IT
Andere Namen:
  • MTX
Experimental: Induction and Oral MTX, Double Delayed Intensification CNS
Patients with CNS disease at diagnosis, without other unfavorable characteristics. Standard Induction (28 Days). Consolidation (28 days) and in remission Day 21 and at time of randomization, Interim maintenance I (2 months), Delayed intensification I (2 months), Interim maintenance II (2 months), Delayed intensification II (2 months), then Maintenance (12 week cycles). Cranial radiation therapy during the Consolidation phase.
Arzneimittel: Cyclophosphamid
Gegeben IV
Andere Namen:
  • Cytoxan
  • NSC-26271
Arzneimittel: Vincristinsulfat
Gegeben IV
Andere Namen:
  • Videorecorder
  • Oncovin
  • NSC-67574
Arzneimittel: Cytarabin
Angesichts der IT
Andere Namen:
  • Cytosar-U
  • Cytosin Arabinosid
  • NSC-63878
  • Ara_C
Arzneimittel: Pegaspargase
Gegeben IM
Andere Namen:
  • Onkaspar
  • L-Asparaginase mit Polyethylenglykol
  • PEG-Asparaginase
Strahlung: Strahlentherapie
Unterziehe dich einer Strahlentherapie
Andere Namen:
  • Bestrahlung
  • Strahlung
  • Strahlentherapie
  • Therapie
Arzneimittel: Dexamethason
PO gegeben
Andere Namen:
  • Dekadron
  • DM
  • NSC-34521
Arzneimittel: Mercaptopurin
PO gegeben
Andere Namen:
  • 6 MP
Arzneimittel: Thioguanin
PO gegeben
Andere Namen:
  • NSC-752
  • 6 TG
Arzneimittel: methotrexate
Given PO and IT
Andere Namen:
  • MTX
Arzneimittel: doxorubicin hydrochloride
Dose 25 g/m² IV Days 0, 7, 14, given over a period of 15 minutes to 2 hours
Andere Namen:
  • Adriamycin
  • NSC-123127
Experimental: Induction and Augmented regimen (IV MTX, Double DI)
Patients with unfavorable characteristics. Standard Induction (14 Days), Augmented Induction (Days 14-35), Consolidation (9 weeks), Interim Maintenance I (56 Days), Delayed Intensification I (2 months), Interim Maintenance II (2 months), Delayed Intensification II (2 months), then Maintenance (84 day courses).
Arzneimittel: Cyclophosphamid
Gegeben IV
Andere Namen:
  • Cytoxan
  • NSC-26271
Arzneimittel: Vincristinsulfat
Gegeben IV
Andere Namen:
  • Videorecorder
  • Oncovin
  • NSC-67574
Arzneimittel: Cytarabin
Angesichts der IT
Andere Namen:
  • Cytosar-U
  • Cytosin Arabinosid
  • NSC-63878
  • Ara_C
Arzneimittel: Pegaspargase
Gegeben IM
Andere Namen:
  • Onkaspar
  • L-Asparaginase mit Polyethylenglykol
  • PEG-Asparaginase
Arzneimittel: Daunorubicinhydrochlorid
Gegeben IV
Andere Namen:
  • Cerubidin
  • NSC-82151
Strahlung: Strahlentherapie
Unterziehe dich einer Strahlentherapie
Andere Namen:
  • Bestrahlung
  • Strahlung
  • Strahlentherapie
  • Therapie
Arzneimittel: Dexamethason
PO gegeben
Andere Namen:
  • Dekadron
  • DM
  • NSC-34521
Arzneimittel: Mercaptopurin
PO gegeben
Andere Namen:
  • 6 MP
Arzneimittel: Thioguanin
PO gegeben
Andere Namen:
  • NSC-752
  • 6 TG
Arzneimittel: methotrexate
Given PO and IT
Andere Namen:
  • MTX
Arzneimittel: doxorubicin hydrochloride
Dose 25 g/m² IV Days 0, 7, 14, given over a period of 15 minutes to 2 hours
Andere Namen:
  • Adriamycin
  • NSC-123127
Experimental: Induction and Oral MTX, Single Delayed Intensification
Patients without CNS disease at diagnosis, with favorable cytogenetics. Standard Induction (28 Days). Consolidation (28 days) and in remission Day 21 and at time of randomization, Interim maintenance I (2 months), Delayed intensification I (2 months), Interim maintenance II (2 months) then Maintenance (12 week cycles). Biopsy-proven testicular leukemia pts at diagnosis will receive testicular radiation therapy during the consolidation phase.
Arzneimittel: Cyclophosphamid
Gegeben IV
Andere Namen:
  • Cytoxan
  • NSC-26271
Arzneimittel: Vincristinsulfat
Gegeben IV
Andere Namen:
  • Videorecorder
  • Oncovin
  • NSC-67574
Arzneimittel: Cytarabin
Angesichts der IT
Andere Namen:
  • Cytosar-U
  • Cytosin Arabinosid
  • NSC-63878
  • Ara_C
Arzneimittel: Pegaspargase
Gegeben IM
Andere Namen:
  • Onkaspar
  • L-Asparaginase mit Polyethylenglykol
  • PEG-Asparaginase
Strahlung: Strahlentherapie
Unterziehe dich einer Strahlentherapie
Andere Namen:
  • Bestrahlung
  • Strahlung
  • Strahlentherapie
  • Therapie
Arzneimittel: Dexamethason
PO gegeben
Andere Namen:
  • Dekadron
  • DM
  • NSC-34521
Arzneimittel: Mercaptopurin
PO gegeben
Andere Namen:
  • 6 MP
Arzneimittel: Thioguanin
PO gegeben
Andere Namen:
  • NSC-752
  • 6 TG
Arzneimittel: methotrexate
Given PO and IT
Andere Namen:
  • MTX
Arzneimittel: doxorubicin hydrochloride
Dose 25 g/m² IV Days 0, 7, 14, given over a period of 15 minutes to 2 hours
Andere Namen:
  • Adriamycin
  • NSC-123127
Experimental: Induction and Oral MTX, Double Delayed Intensification
Patients without CNS disease at diagnosis, with favorable cytogenetics. Standard Induction (28 Days). Consolidation (28 days) and in remission Day 21 and at time of randomization, Interim maintenance I (2 months), Delayed intensification I (2 months), Interim maintenance II (2 months), Delayed intensification II (2 months), then Maintenance (12 week cycles). Biopsy-proven testicular leukemia pts at diagnosis will receive testicular radiation therapy during the consolidation phase.
Arzneimittel: Cyclophosphamid
Gegeben IV
Andere Namen:
  • Cytoxan
  • NSC-26271
Arzneimittel: Vincristinsulfat
Gegeben IV
Andere Namen:
  • Videorecorder
  • Oncovin
  • NSC-67574
Arzneimittel: Cytarabin
Angesichts der IT
Andere Namen:
  • Cytosar-U
  • Cytosin Arabinosid
  • NSC-63878
  • Ara_C
Arzneimittel: Pegaspargase
Gegeben IM
Andere Namen:
  • Onkaspar
  • L-Asparaginase mit Polyethylenglykol
  • PEG-Asparaginase
Strahlung: Strahlentherapie
Unterziehe dich einer Strahlentherapie
Andere Namen:
  • Bestrahlung
  • Strahlung
  • Strahlentherapie
  • Therapie
Arzneimittel: Dexamethason
PO gegeben
Andere Namen:
  • Dekadron
  • DM
  • NSC-34521
Arzneimittel: Mercaptopurin
PO gegeben
Andere Namen:
  • 6 MP
Arzneimittel: Thioguanin
PO gegeben
Andere Namen:
  • NSC-752
  • 6 TG
Arzneimittel: methotrexate
Given PO and IT
Andere Namen:
  • MTX
Arzneimittel: doxorubicin hydrochloride
Dose 25 g/m² IV Days 0, 7, 14, given over a period of 15 minutes to 2 hours
Andere Namen:
  • Adriamycin
  • NSC-123127
Experimental: Induction and IV MTX, Single Delayed Intensification
Patients without CNS disease at diagnosis, with favorable cytogenetics. Standard Induction (28 Days). Consolidation (28 days) and in remission Day 21 and at time of randomization, Interim maintenance I (2 months), Delayed intensification I (2 months), Interim maintenance II (2 months) then Maintenance (12 week cycles). Biopsy-proven testicular leukemia pts at diagnosis will receive testicular radiation therapy during the consolidation phase.
Arzneimittel: Cyclophosphamid
Gegeben IV
Andere Namen:
  • Cytoxan
  • NSC-26271
Arzneimittel: Vincristinsulfat
Gegeben IV
Andere Namen:
  • Videorecorder
  • Oncovin
  • NSC-67574
Arzneimittel: Cytarabin
Angesichts der IT
Andere Namen:
  • Cytosar-U
  • Cytosin Arabinosid
  • NSC-63878
  • Ara_C
Arzneimittel: Pegaspargase
Gegeben IM
Andere Namen:
  • Onkaspar
  • L-Asparaginase mit Polyethylenglykol
  • PEG-Asparaginase
Strahlung: Strahlentherapie
Unterziehe dich einer Strahlentherapie
Andere Namen:
  • Bestrahlung
  • Strahlung
  • Strahlentherapie
  • Therapie
Arzneimittel: Dexamethason
PO gegeben
Andere Namen:
  • Dekadron
  • DM
  • NSC-34521
Arzneimittel: Mercaptopurin
PO gegeben
Andere Namen:
  • 6 MP
Arzneimittel: Thioguanin
PO gegeben
Andere Namen:
  • NSC-752
  • 6 TG
Arzneimittel: methotrexate
Given PO and IT
Andere Namen:
  • MTX
Arzneimittel: doxorubicin hydrochloride
Dose 25 g/m² IV Days 0, 7, 14, given over a period of 15 minutes to 2 hours
Andere Namen:
  • Adriamycin
  • NSC-123127
Experimental: Induction and IV MTX, Double Delayed Intensification
Patients without CNS disease at diagnosis, with favorable cytogenetics. Standard Induction (28 Days). Consolidation (28 days) and in event free remission Day 21 and at time of randomization, Interim maintenance I (2 months), Delayed intensification I (2 months), Interim maintenance II (2 months), Delayed intensification II (2 months), then Maintenance (12 week cycles). Biopsy-proven testicular leukemia pts at diagnosis will receive testicular radiation therapy during the consolidation phase.
Arzneimittel: Cyclophosphamid
Gegeben IV
Andere Namen:
  • Cytoxan
  • NSC-26271
Arzneimittel: Vincristinsulfat
Gegeben IV
Andere Namen:
  • Videorecorder
  • Oncovin
  • NSC-67574
Arzneimittel: Cytarabin
Angesichts der IT
Andere Namen:
  • Cytosar-U
  • Cytosin Arabinosid
  • NSC-63878
  • Ara_C
Arzneimittel: Pegaspargase
Gegeben IM
Andere Namen:
  • Onkaspar
  • L-Asparaginase mit Polyethylenglykol
  • PEG-Asparaginase
Strahlung: Strahlentherapie
Unterziehe dich einer Strahlentherapie
Andere Namen:
  • Bestrahlung
  • Strahlung
  • Strahlentherapie
  • Therapie
Arzneimittel: Dexamethason
PO gegeben
Andere Namen:
  • Dekadron
  • DM
  • NSC-34521
Arzneimittel: Mercaptopurin
PO gegeben
Andere Namen:
  • 6 MP
Arzneimittel: Thioguanin
PO gegeben
Andere Namen:
  • NSC-752
  • 6 TG
Arzneimittel: methotrexate
Given PO and IT
Andere Namen:
  • MTX
Arzneimittel: doxorubicin hydrochloride
Dose 25 g/m² IV Days 0, 7, 14, given over a period of 15 minutes to 2 hours
Andere Namen:
  • Adriamycin
  • NSC-123127

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Event Free Survival
Zeitfenster: Time of randomization
The primary outcome index used in examining the randomized treatment groups will be event free survival (EFS) from the time of randomization (i.e., end of Consolidation), where the life table events will consist of the first occurrence of leukemic relapse at any site, death, or occurrence of a second malignancy.
Time of randomization

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Children's Oncology Group

Mitarbeiter

National Cancer Institute (NCI)

Ermittler

  • Studienstuhl: Yousif H. Matloub, MD, University of Wisconsin, Madison

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Juni 2000

Primärer Abschluss (Tatsächlich)

1. November 2007

Studienabschluss (Tatsächlich)

1. Juni 2008

Studienanmeldedaten

Zuerst eingereicht

5. Juli 2000

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

26. Januar 2003

Zuerst gepostet (Schätzen)

27. Januar 2003

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

23. Februar 2016

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

19. Februar 2016

Zuletzt verifiziert

1. Februar 2016

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 1991
  • U10CA098543 (US NIH Stipendium/Vertrag)
  • CCG-1991 (Andere Kennung: Children's Cancer Group)
  • CDR0000067855 (Andere Kennung: Clinical Trials.gov)
  • NCT00005945 (Andere Kennung: NCI)
  • NCI-2012-02333 (Andere Kennung: NCI)

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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