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

19. února 2016 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

3054

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

1 rok až 9 let (Dítě)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Induction Not Randomized
Standard Induction (28 Days). M3 Marrow at Day 28 and Off Protocol Therapy.
Lék: cyklofosfamid
Vzhledem k tomu, IV
Ostatní jména:
  • Cytoxan
  • NSC-26271
Lék: vinkristin sulfát
Vzhledem k tomu, IV
Ostatní jména:
  • Videorekordér
  • Oncovin
  • NSC-67574
Lék: pegaspargase
Vzhledem k IM
Ostatní jména:
  • Oncaspar
  • L-asparagináza s polyethylenglykolem
  • PEG-asparagináza
Lék: dexamethason
Vzhledem k PO
Ostatní jména:
  • Decadron
  • DM
  • NSC-34521
Lék: methotrexate
Given PO and IT
Ostatní jména:
  • MTX
Experimentální: 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.
Lék: cyklofosfamid
Vzhledem k tomu, IV
Ostatní jména:
  • Cytoxan
  • NSC-26271
Lék: vinkristin sulfát
Vzhledem k tomu, IV
Ostatní jména:
  • Videorekordér
  • Oncovin
  • NSC-67574
Lék: cytarabin
Vzhledem k IT
Ostatní jména:
  • Cytosar-U
  • Cytosin arabinosid
  • NSC-63878
  • Ara_C
Lék: pegaspargase
Vzhledem k IM
Ostatní jména:
  • Oncaspar
  • L-asparagináza s polyethylenglykolem
  • PEG-asparagináza
Záření: radiační terapie
Podstoupit radiační terapii
Ostatní jména:
  • ozáření
  • záření
  • radioterapie
  • terapie
Lék: dexamethason
Vzhledem k PO
Ostatní jména:
  • Decadron
  • DM
  • NSC-34521
Lék: merkaptopurin
Vzhledem k PO
Ostatní jména:
  • 6-MP
Lék: thioguanin
Vzhledem k PO
Ostatní jména:
  • NSC-752
  • 6 TG
Lék: methotrexate
Given PO and IT
Ostatní jména:
  • MTX
Lék: doxorubicin hydrochloride
Dose 25 g/m² IV Days 0, 7, 14, given over a period of 15 minutes to 2 hours
Ostatní jména:
  • Adriamycin
  • NSC-123127
Experimentální: 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).
Lék: cyklofosfamid
Vzhledem k tomu, IV
Ostatní jména:
  • Cytoxan
  • NSC-26271
Lék: vinkristin sulfát
Vzhledem k tomu, IV
Ostatní jména:
  • Videorekordér
  • Oncovin
  • NSC-67574
Lék: cytarabin
Vzhledem k IT
Ostatní jména:
  • Cytosar-U
  • Cytosin arabinosid
  • NSC-63878
  • Ara_C
Lék: pegaspargase
Vzhledem k IM
Ostatní jména:
  • Oncaspar
  • L-asparagináza s polyethylenglykolem
  • PEG-asparagináza
Lék: daunorubicin hydrochlorid
Vzhledem k tomu, IV
Ostatní jména:
  • Cerubidin
  • NSC-82151
Záření: radiační terapie
Podstoupit radiační terapii
Ostatní jména:
  • ozáření
  • záření
  • radioterapie
  • terapie
Lék: dexamethason
Vzhledem k PO
Ostatní jména:
  • Decadron
  • DM
  • NSC-34521
Lék: merkaptopurin
Vzhledem k PO
Ostatní jména:
  • 6-MP
Lék: thioguanin
Vzhledem k PO
Ostatní jména:
  • NSC-752
  • 6 TG
Lék: methotrexate
Given PO and IT
Ostatní jména:
  • MTX
Lék: doxorubicin hydrochloride
Dose 25 g/m² IV Days 0, 7, 14, given over a period of 15 minutes to 2 hours
Ostatní jména:
  • Adriamycin
  • NSC-123127
Experimentální: 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.
Lék: cyklofosfamid
Vzhledem k tomu, IV
Ostatní jména:
  • Cytoxan
  • NSC-26271
Lék: vinkristin sulfát
Vzhledem k tomu, IV
Ostatní jména:
  • Videorekordér
  • Oncovin
  • NSC-67574
Lék: cytarabin
Vzhledem k IT
Ostatní jména:
  • Cytosar-U
  • Cytosin arabinosid
  • NSC-63878
  • Ara_C
Lék: pegaspargase
Vzhledem k IM
Ostatní jména:
  • Oncaspar
  • L-asparagináza s polyethylenglykolem
  • PEG-asparagináza
Záření: radiační terapie
Podstoupit radiační terapii
Ostatní jména:
  • ozáření
  • záření
  • radioterapie
  • terapie
Lék: dexamethason
Vzhledem k PO
Ostatní jména:
  • Decadron
  • DM
  • NSC-34521
Lék: merkaptopurin
Vzhledem k PO
Ostatní jména:
  • 6-MP
Lék: thioguanin
Vzhledem k PO
Ostatní jména:
  • NSC-752
  • 6 TG
Lék: methotrexate
Given PO and IT
Ostatní jména:
  • MTX
Lék: doxorubicin hydrochloride
Dose 25 g/m² IV Days 0, 7, 14, given over a period of 15 minutes to 2 hours
Ostatní jména:
  • Adriamycin
  • NSC-123127
Experimentální: 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.
Lék: cyklofosfamid
Vzhledem k tomu, IV
Ostatní jména:
  • Cytoxan
  • NSC-26271
Lék: vinkristin sulfát
Vzhledem k tomu, IV
Ostatní jména:
  • Videorekordér
  • Oncovin
  • NSC-67574
Lék: cytarabin
Vzhledem k IT
Ostatní jména:
  • Cytosar-U
  • Cytosin arabinosid
  • NSC-63878
  • Ara_C
Lék: pegaspargase
Vzhledem k IM
Ostatní jména:
  • Oncaspar
  • L-asparagináza s polyethylenglykolem
  • PEG-asparagináza
Záření: radiační terapie
Podstoupit radiační terapii
Ostatní jména:
  • ozáření
  • záření
  • radioterapie
  • terapie
Lék: dexamethason
Vzhledem k PO
Ostatní jména:
  • Decadron
  • DM
  • NSC-34521
Lék: merkaptopurin
Vzhledem k PO
Ostatní jména:
  • 6-MP
Lék: thioguanin
Vzhledem k PO
Ostatní jména:
  • NSC-752
  • 6 TG
Lék: methotrexate
Given PO and IT
Ostatní jména:
  • MTX
Lék: doxorubicin hydrochloride
Dose 25 g/m² IV Days 0, 7, 14, given over a period of 15 minutes to 2 hours
Ostatní jména:
  • Adriamycin
  • NSC-123127
Experimentální: 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.
Lék: cyklofosfamid
Vzhledem k tomu, IV
Ostatní jména:
  • Cytoxan
  • NSC-26271
Lék: vinkristin sulfát
Vzhledem k tomu, IV
Ostatní jména:
  • Videorekordér
  • Oncovin
  • NSC-67574
Lék: cytarabin
Vzhledem k IT
Ostatní jména:
  • Cytosar-U
  • Cytosin arabinosid
  • NSC-63878
  • Ara_C
Lék: pegaspargase
Vzhledem k IM
Ostatní jména:
  • Oncaspar
  • L-asparagináza s polyethylenglykolem
  • PEG-asparagináza
Záření: radiační terapie
Podstoupit radiační terapii
Ostatní jména:
  • ozáření
  • záření
  • radioterapie
  • terapie
Lék: dexamethason
Vzhledem k PO
Ostatní jména:
  • Decadron
  • DM
  • NSC-34521
Lék: merkaptopurin
Vzhledem k PO
Ostatní jména:
  • 6-MP
Lék: thioguanin
Vzhledem k PO
Ostatní jména:
  • NSC-752
  • 6 TG
Lék: methotrexate
Given PO and IT
Ostatní jména:
  • MTX
Lék: doxorubicin hydrochloride
Dose 25 g/m² IV Days 0, 7, 14, given over a period of 15 minutes to 2 hours
Ostatní jména:
  • Adriamycin
  • NSC-123127
Experimentální: 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.
Lék: cyklofosfamid
Vzhledem k tomu, IV
Ostatní jména:
  • Cytoxan
  • NSC-26271
Lék: vinkristin sulfát
Vzhledem k tomu, IV
Ostatní jména:
  • Videorekordér
  • Oncovin
  • NSC-67574
Lék: cytarabin
Vzhledem k IT
Ostatní jména:
  • Cytosar-U
  • Cytosin arabinosid
  • NSC-63878
  • Ara_C
Lék: pegaspargase
Vzhledem k IM
Ostatní jména:
  • Oncaspar
  • L-asparagináza s polyethylenglykolem
  • PEG-asparagináza
Záření: radiační terapie
Podstoupit radiační terapii
Ostatní jména:
  • ozáření
  • záření
  • radioterapie
  • terapie
Lék: dexamethason
Vzhledem k PO
Ostatní jména:
  • Decadron
  • DM
  • NSC-34521
Lék: merkaptopurin
Vzhledem k PO
Ostatní jména:
  • 6-MP
Lék: thioguanin
Vzhledem k PO
Ostatní jména:
  • NSC-752
  • 6 TG
Lék: methotrexate
Given PO and IT
Ostatní jména:
  • MTX
Lék: doxorubicin hydrochloride
Dose 25 g/m² IV Days 0, 7, 14, given over a period of 15 minutes to 2 hours
Ostatní jména:
  • Adriamycin
  • NSC-123127

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Event Free Survival
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Children's Oncology Group

Spolupracovníci

National Cancer Institute (NCI)

Vyšetřovatelé

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

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. června 2000

Primární dokončení (Aktuální)

1. listopadu 2007

Dokončení studie (Aktuální)

1. června 2008

Termíny zápisu do studia

První předloženo

5. července 2000

První předloženo, které splnilo kritéria kontroly kvality

26. ledna 2003

První zveřejněno (Odhad)

27. ledna 2003

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

23. února 2016

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

19. února 2016

Naposledy ověřeno

1. února 2016

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 1991
  • U10CA098543 (Grant/smlouva NIH USA)
  • CCG-1991 (Jiný identifikátor: Children's Cancer Group)
  • CDR0000067855 (Jiný identifikátor: Clinical Trials.gov)
  • NCT00005945 (Jiný identifikátor: NCI)
  • NCI-2012-02333 (Jiný identifikátor: NCI)

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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Zdravotní podmínky

Drogové intervence

CROs by country

CROs in Liberia

Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

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