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

2016년 2월 19일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

3054

단계

  • 3단계

연락처 및 위치

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연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

1년 (어린이)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Induction Not Randomized
Standard Induction (28 Days). M3 Marrow at Day 28 and Off Protocol Therapy.
의약품: 사이클로포스파마이드
주어진 IV
다른 이름들:
  • 사이톡산
  • NSC-26271
의약품: 빈크리스틴 설페이트
주어진 IV
다른 이름들:
  • VCR
  • 온코빈
  • NSC-67574
의약품: 페가스파가제
주어진 IM
다른 이름들:
  • 온카스파
  • 폴리에틸렌 글리콜을 함유한 L-아스파라기나제
  • PEG-아스파라기나아제
의약품: 덱사메타손
주어진 PO
다른 이름들:
  • 데카드론
  • DM
  • NSC-34521
의약품: methotrexate
Given PO and IT
다른 이름들:
  • MTX
실험적: 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.
의약품: 사이클로포스파마이드
주어진 IV
다른 이름들:
  • 사이톡산
  • NSC-26271
의약품: 빈크리스틴 설페이트
주어진 IV
다른 이름들:
  • VCR
  • 온코빈
  • NSC-67574
의약품: 시타라빈
주어진 IT
다른 이름들:
  • Cytosar-U
  • 시토신 아라비노사이드
  • NSC-63878
  • 아라_C
의약품: 페가스파가제
주어진 IM
다른 이름들:
  • 온카스파
  • 폴리에틸렌 글리콜을 함유한 L-아스파라기나제
  • PEG-아스파라기나아제
방사능: 방사선 요법
방사선 치료를 받다
다른 이름들:
  • 조사
  • 방사능
  • 방사선 요법
  • 요법
의약품: 덱사메타손
주어진 PO
다른 이름들:
  • 데카드론
  • DM
  • NSC-34521
의약품: 메르캅토퓨린
주어진 PO
다른 이름들:
  • 6MP
의약품: 티오구아닌
주어진 PO
다른 이름들:
  • NSC-752
  • 6 TG
의약품: methotrexate
Given PO and IT
다른 이름들:
  • MTX
의약품: doxorubicin hydrochloride
Dose 25 g/m² IV Days 0, 7, 14, given over a period of 15 minutes to 2 hours
다른 이름들:
  • 아드리아마이신
  • NSC-123127
실험적: 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).
의약품: 사이클로포스파마이드
주어진 IV
다른 이름들:
  • 사이톡산
  • NSC-26271
의약품: 빈크리스틴 설페이트
주어진 IV
다른 이름들:
  • VCR
  • 온코빈
  • NSC-67574
의약품: 시타라빈
주어진 IT
다른 이름들:
  • Cytosar-U
  • 시토신 아라비노사이드
  • NSC-63878
  • 아라_C
의약품: 페가스파가제
주어진 IM
다른 이름들:
  • 온카스파
  • 폴리에틸렌 글리콜을 함유한 L-아스파라기나제
  • PEG-아스파라기나아제
의약품: 다우노루비신염산염
주어진 IV
다른 이름들:
  • 세루비딘
  • NSC-82151
방사능: 방사선 요법
방사선 치료를 받다
다른 이름들:
  • 조사
  • 방사능
  • 방사선 요법
  • 요법
의약품: 덱사메타손
주어진 PO
다른 이름들:
  • 데카드론
  • DM
  • NSC-34521
의약품: 메르캅토퓨린
주어진 PO
다른 이름들:
  • 6MP
의약품: 티오구아닌
주어진 PO
다른 이름들:
  • NSC-752
  • 6 TG
의약품: methotrexate
Given PO and IT
다른 이름들:
  • MTX
의약품: doxorubicin hydrochloride
Dose 25 g/m² IV Days 0, 7, 14, given over a period of 15 minutes to 2 hours
다른 이름들:
  • 아드리아마이신
  • NSC-123127
실험적: 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.
의약품: 사이클로포스파마이드
주어진 IV
다른 이름들:
  • 사이톡산
  • NSC-26271
의약품: 빈크리스틴 설페이트
주어진 IV
다른 이름들:
  • VCR
  • 온코빈
  • NSC-67574
의약품: 시타라빈
주어진 IT
다른 이름들:
  • Cytosar-U
  • 시토신 아라비노사이드
  • NSC-63878
  • 아라_C
의약품: 페가스파가제
주어진 IM
다른 이름들:
  • 온카스파
  • 폴리에틸렌 글리콜을 함유한 L-아스파라기나제
  • PEG-아스파라기나아제
방사능: 방사선 요법
방사선 치료를 받다
다른 이름들:
  • 조사
  • 방사능
  • 방사선 요법
  • 요법
의약품: 덱사메타손
주어진 PO
다른 이름들:
  • 데카드론
  • DM
  • NSC-34521
의약품: 메르캅토퓨린
주어진 PO
다른 이름들:
  • 6MP
의약품: 티오구아닌
주어진 PO
다른 이름들:
  • NSC-752
  • 6 TG
의약품: methotrexate
Given PO and IT
다른 이름들:
  • MTX
의약품: doxorubicin hydrochloride
Dose 25 g/m² IV Days 0, 7, 14, given over a period of 15 minutes to 2 hours
다른 이름들:
  • 아드리아마이신
  • NSC-123127
실험적: 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.
의약품: 사이클로포스파마이드
주어진 IV
다른 이름들:
  • 사이톡산
  • NSC-26271
의약품: 빈크리스틴 설페이트
주어진 IV
다른 이름들:
  • VCR
  • 온코빈
  • NSC-67574
의약품: 시타라빈
주어진 IT
다른 이름들:
  • Cytosar-U
  • 시토신 아라비노사이드
  • NSC-63878
  • 아라_C
의약품: 페가스파가제
주어진 IM
다른 이름들:
  • 온카스파
  • 폴리에틸렌 글리콜을 함유한 L-아스파라기나제
  • PEG-아스파라기나아제
방사능: 방사선 요법
방사선 치료를 받다
다른 이름들:
  • 조사
  • 방사능
  • 방사선 요법
  • 요법
의약품: 덱사메타손
주어진 PO
다른 이름들:
  • 데카드론
  • DM
  • NSC-34521
의약품: 메르캅토퓨린
주어진 PO
다른 이름들:
  • 6MP
의약품: 티오구아닌
주어진 PO
다른 이름들:
  • NSC-752
  • 6 TG
의약품: methotrexate
Given PO and IT
다른 이름들:
  • MTX
의약품: doxorubicin hydrochloride
Dose 25 g/m² IV Days 0, 7, 14, given over a period of 15 minutes to 2 hours
다른 이름들:
  • 아드리아마이신
  • NSC-123127
실험적: 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.
의약품: 사이클로포스파마이드
주어진 IV
다른 이름들:
  • 사이톡산
  • NSC-26271
의약품: 빈크리스틴 설페이트
주어진 IV
다른 이름들:
  • VCR
  • 온코빈
  • NSC-67574
의약품: 시타라빈
주어진 IT
다른 이름들:
  • Cytosar-U
  • 시토신 아라비노사이드
  • NSC-63878
  • 아라_C
의약품: 페가스파가제
주어진 IM
다른 이름들:
  • 온카스파
  • 폴리에틸렌 글리콜을 함유한 L-아스파라기나제
  • PEG-아스파라기나아제
방사능: 방사선 요법
방사선 치료를 받다
다른 이름들:
  • 조사
  • 방사능
  • 방사선 요법
  • 요법
의약품: 덱사메타손
주어진 PO
다른 이름들:
  • 데카드론
  • DM
  • NSC-34521
의약품: 메르캅토퓨린
주어진 PO
다른 이름들:
  • 6MP
의약품: 티오구아닌
주어진 PO
다른 이름들:
  • NSC-752
  • 6 TG
의약품: methotrexate
Given PO and IT
다른 이름들:
  • MTX
의약품: doxorubicin hydrochloride
Dose 25 g/m² IV Days 0, 7, 14, given over a period of 15 minutes to 2 hours
다른 이름들:
  • 아드리아마이신
  • NSC-123127
실험적: 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.
의약품: 사이클로포스파마이드
주어진 IV
다른 이름들:
  • 사이톡산
  • NSC-26271
의약품: 빈크리스틴 설페이트
주어진 IV
다른 이름들:
  • VCR
  • 온코빈
  • NSC-67574
의약품: 시타라빈
주어진 IT
다른 이름들:
  • Cytosar-U
  • 시토신 아라비노사이드
  • NSC-63878
  • 아라_C
의약품: 페가스파가제
주어진 IM
다른 이름들:
  • 온카스파
  • 폴리에틸렌 글리콜을 함유한 L-아스파라기나제
  • PEG-아스파라기나아제
방사능: 방사선 요법
방사선 치료를 받다
다른 이름들:
  • 조사
  • 방사능
  • 방사선 요법
  • 요법
의약품: 덱사메타손
주어진 PO
다른 이름들:
  • 데카드론
  • DM
  • NSC-34521
의약품: 메르캅토퓨린
주어진 PO
다른 이름들:
  • 6MP
의약품: 티오구아닌
주어진 PO
다른 이름들:
  • NSC-752
  • 6 TG
의약품: methotrexate
Given PO and IT
다른 이름들:
  • MTX
의약품: doxorubicin hydrochloride
Dose 25 g/m² IV Days 0, 7, 14, given over a period of 15 minutes to 2 hours
다른 이름들:
  • 아드리아마이신
  • NSC-123127

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Event Free Survival
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Children's Oncology Group

협력자

National Cancer Institute (NCI)

수사관

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

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2000년 6월 1일

기본 완료 (실제)

2007년 11월 1일

연구 완료 (실제)

2008년 6월 1일

연구 등록 날짜

최초 제출

2000년 7월 5일

QC 기준을 충족하는 최초 제출

2003년 1월 26일

처음 게시됨 (추정)

2003년 1월 27일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2016년 2월 23일

QC 기준을 충족하는 마지막 업데이트 제출

2016년 2월 19일

마지막으로 확인됨

2016년 2월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 1991
  • U10CA098543 (미국 NIH 보조금/계약)
  • CCG-1991 (기타 식별자: Children's Cancer Group)
  • CDR0000067855 (기타 식별자: Clinical Trials.gov)
  • NCT00005945 (기타 식별자: NCI)
  • NCI-2012-02333 (기타 식별자: NCI)

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다