Combination Chemotx in Treating Children or Adolescents With Newly Diagnosed Stg III or Stg IV Lymphoblastic Lymphoma

July 24, 2019 updated by: Children's Oncology Group

Randomized Phase III Study for the Treatment of Newly Diagnosed Disseminated Lymphoblastic Lymphoma or Localized Lymphoblastic Lymphoma

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known which regimen of combination chemotherapy is most effective for lymphoblastic lymphoma.

PURPOSE: This randomized phase III trial is studying different regimens of combination chemotherapy to compare how well they work in treating children or adolescents with newly diagnosed stage III or stage IV lymphoblastic lymphoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Compare the event-free survival and overall survival of children or adolescents with newly diagnosed disseminated stage III or IV lymphoblastic lymphoma treated with 4 chemotherapy regimens*.
  • Determine whether treatment with a regimen without methotrexate maintains the same disease-free survival as NHL/BFM 90 in these patients.
  • Determine whether intensification with anthracycline and cyclophosphamide improves disease-free survival in these patients.
  • Collect outcome data on uniformly treated patients with localized disease or CNS-positive disease.
  • Determine whether rapid reduction in tumor volume by chest radiography and CT scan is predictive of improved outcome in patients treated with these regimens.
  • Determine the prevalence of bone marrow involvement at presentation in these patients.
  • Determine whether peripheral blood can replace bone marrow in the initial staging of these patients.
  • Determine the clinical significance of bone marrow and peripheral blood involvement in these patients.

NOTE: *All patients as of 4/2006 receive treatment on Arm III regimen only

OUTLINE: Patients are stratified by disease characteristics (disseminated lymphoblastic lymphoma vs localized lymphoblastic lymphoma [localized lymphoblastic lymphoma is closed to accrual as of 10/2005]) and age. Patients with CNS negative disseminated lymphoblastic lymphoma are randomized to 1 of 4 treatment arms*. Patients with testicular involvement at diagnosis are nonrandomly assigned to arm IV and do not receive testicular radiotherapy. Patients with localized lymphoblastic lymphoma (closed to accrual as of 10/2005) are not randomized.

NOTE: *All patients as of 4/2006 receive treatment on Arm III only

  • Localized lymphoblastic lymphoma (closed to accrual as of 10/2005):

    • Induction (5 weeks): Patients receive vincristine IV and daunorubicin IV over 15 minutes to 2 hours on days 0, 7, 14, and 21; oral prednisone on days 0-27; and asparaginase intramuscularly (IM) on days 3, 5, and 7 and then 3 times a week for 9 doses (during days 8-21). Patients also receive methotrexate intrathecally (IT) on days 7 and 28 and cytarabine IT on day 0.
    • Consolidation (5 weeks): Patients receive methotrexate IT on days 0, 7, 14, and 21 followed by cyclophosphamide IV over 1 hour on days 0 and 14; cytarabine IV on days 0-3, 7-10, 14-17, and 21-24; oral mercaptopurine on days 0-27; and oral prednisone over 10 days.
    • Interim maintenance (8 weeks): Patients receive methotrexate IT on days 0 and 28; oral mercaptopurine on days 0-41; and oral methotrexate on days 7, 14, 21, and 35.
    • Delayed intensification (7 weeks): Patients receive vincristine IV and doxorubicin IV over 15 minutes to 2 hours on days 0, 7, and 14; asparaginase IM on day 3 and then 3 times a week for 6 doses; oral dexamethasone on days 0-30; cyclophosphamide IV over 1 hour on day 28; and cytarabine IV or SC on days 28-31 and 35-38. Patients also receive oral thioguanine on days 28-41 and methotrexate IT on days 28 and 35.
    • Maintenance (84 day course): Patients receive vincristine IV on days 0, 28, and 56; oral prednisone on days 0-4, 28-32, and 56-60; oral methotrexate on days 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, and 77; oral mercaptopurine on days 0-83; and methotrexate IT on day 0.

  • Disseminated lymphoblastic lymphoma:

    • Arm I (closed to accrual as of 4/2006): Patients receive same induction, consolidation, and interim maintenance therapy schedule as localized lymphoblastic lymphoma patients.

      • Delayed intensification (7 weeks): Patients receive vincristine IV and doxorubicin IV over 15 minutes to 2 hours on days 0, 7, 14, and 21; asparaginase IM on day 3 and then 3 times a week for 6 doses; and oral dexamethasone on days 0-28. Patients also receive cyclophosphamide IV over 1 hour on day 35; cytarabine IV or SC on days 35-38 and 42-45; oral thioguanine on days 35-48; and methotrexate IT on days 35 and 42.
      • Maintenance (84 day course): Patients receive same therapy as localized lymphoblastic lymphoma patients, except methotrexate IT is administered on day 0 and 28 (for first 4 courses).

    • Arm II (closed to accrual as of 4/2006): Patients receive consolidation, interim maintenance, and maintenance therapy as in arm I.

      • Induction (5 weeks): Patients receive vincristine IV on days 0, 7, 14, and 21; daunorubicin IV over 48 hours on days 0-2; oral prednisone on days 0-27; and asparaginase IM on days 3, 5, and 7 and then 3 times a week for 9 doses (during days 8-21). Patients also receive methotrexate IT on days 7 and 28; cyclophosphamide IV over 1 hour on day 2; and cytarabine IT on day 0.
      • Delayed intensification (7 weeks): Patients receive vincristine IV on days 0, 7, 14, 21; daunorubicin IV over 48 hours on days 0-2; asparaginase IM on day 3 and then 3 times a week for 6 doses; and oral dexamethasone on days 0-28. Patients also receive cyclophosphamide IV over 1 hour on days 2 and 35; cytarabine IV or SC on days 35-38 and 42-45; oral thioguanine on days 35-48; and methotrexate IT on days 35 and 42.

    • Arm III:

      • Induction (5 weeks): Patients receive vincristine IV and daunorubicin IV over 1 hour on days 0, 7, 14, and 21 and oral prednisone on days 0-37. Patients also receive asparaginase IM on day 11 and then 3 times a week for 9 doses; methotrexate IT on days 7 and 28; and cytarabine IT on day 0.
      • Consolidation (5 weeks): Patients receive methotrexate IT and cyclophosphamide IV over 1 hour on days 0 and 14; cytarabine IV or SC on days 0-3, 7-10, 14-17, and 21-24; oral mercaptopurine on days 0-27; and oral prednisone over 10 days.
      • Interim maintenance (9 weeks): Patients receive methotrexate IT and IV on days 7, 21, 35, and 49; oral mercaptopurine on days 0-55; and leucovorin calcium IV at 42, 48, and 54 hours after methotrexate IV.
      • Delayed intensification (10 weeks): Patients receive vincristine IV and doxorubicin IV over 1 hour on days 0, 7, 14, and 21; asparaginase IM on day 3 and then 3 times a week for 6 doses; and oral dexamethasone on days 0-29. Patients also receive cyclophosphamide IV over 1 hour on day 35; cytarabine IV on days 35-38 and 42-45; oral thioguanine on days 35-48; and methotrexate IT on days 35 and 42.
      • Maintenance (84 day courses): Patients receive vincristine IV on days 0, 28, and 56; oral prednisone on days 0-4, 28-32, and 56-60; oral methotrexate on days 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, and 77; and oral mercaptopurine on days 0-83.

    • Arm IV (closed to accrual as of 4/2006): Patients receive consolidation and interim maintenance therapy as in arm III.

      • Induction: Patients receive vincristine IV on days 0, 7, 14, and 21; daunorubicin IV over 48 hours on days 0-2; oral prednisone on days 0-37; asparaginase IM on day 11 and then 3 times a week for 9 doses; methotrexate IT on days 7, 14, 21, and 28; cyclophosphamide IV on day 2; and cytarabine IT on day 0.
      • Delayed intensification (10 weeks): Patients receive vincristine IV on days 7, 14, 21, and 28; daunorubicin IV over 48 hours on days 0-2; asparaginase IM on day 3 and then 3 times a week for 6 doses; and oral dexamethasone on days 0-29. Patients also receive cyclophosphamide IV over 1 hour on days 2 and 35; cytarabine IV on days 35-38 and 42-45; oral thioguanine on days 35-48; and methotrexate IT on days 35 and 42.
      • Maintenance (84 day courses): Patients receive therapy as in arm III. Patients who are over 1 year of age and have CNS disease at diagnosis undergo cranial radiotherapy once daily 5 days a week beginning on day 0. Patients over 2 years of age undergo radiotherapy over 11-14 days (6-9 days for 1-2 years of age).

Patients are followed monthly for one year, every 3 months for 1 year, every 6 months for 1.5 years, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 250-400 patients will be accrued for this study within 5 years.

Study Type

Interventional

Enrollment (Actual)

393

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Randwick, New South Wales, Australia, 2031
        • Prince of Wales Private Hospital
    • Queensland
      • Herston, Brisbane, Queensland, Australia, 4029
        • Royal Children's Hospital
    • South Australia
      • North Adelaide, South Australia, Australia, 5006
        • Women's and Children's Hospital
    • Victoria
      • Parkville, Victoria, Australia, 3052
        • Royal Children's Hospital
    • Western Australia
      • Perth, Western Australia, Australia, 6001
        • Princess Margaret Hospital for Children
  • Canada
      • Quebec, Canada, G1V 4G2
        • Centre Hospitalier Universitaire de Quebec
    • Alberta
      • Calgary, Alberta, Canada, T3B 6A8
        • Alberta Children's Hospital
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3V4
        • Children's & Women's Hospital of British Columbia
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • CancerCare Manitoba
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
        • Janeway Children's Health and Rehabilitation Centre
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 6R8
        • IWK Health Centre
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • McMaster Children's Hospital at Hamilton Health Sciences
      • Kingston, Ontario, Canada, K7L 3N6
        • Cancer Centre of Southeastern Ontario at Kingston General Hospital
      • London, Ontario, Canada, N6A 4G5
        • Children's Hospital of Western Ontario
      • Ottawa, Ontario, Canada, K1H 8L1
        • Children's Hospital of Eastern Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Hospital for Sick Children
    • Quebec
      • Montreal, Quebec, Canada, H3H 1P3
        • Montreal Children's Hospital at McGill University Health Center
      • Montreal, Quebec, Canada, H3T 1C5
        • Hopital Sainte Justine
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Allan Blair Cancer Centre at Pasqua Hospital
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • Saskatoon Cancer Centre at the University of Saskatchewan
  • Puerto Rico
      • Santurce, Puerto Rico, 00912
        • San Jorge Children's Hospital
  • Switzerland
      • Bern, Switzerland, 3010
        • Swiss Pediatric Oncology Group Bern
      • Geneva, Switzerland, 1205
        • Swiss Pediatric Oncology Group Geneva
      • Lausanne, Switzerland, 1011
        • Swiss Pediatric Oncology Group Lausanne
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
    • Arizona
      • Phoenix, Arizona, United States, 85016-7710
        • Phoenix Children's Hospital
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
    • California
      • Downey, California, United States, 90242-2814
        • Southern California Permanente Medical Group
      • Duarte, California, United States, 91010-3000
        • City of Hope Comprehensive Cancer Center
      • Loma Linda, California, United States, 92354
        • Loma Linda University Cancer Institute at Loma Linda University Medical Center
      • Long Beach, California, United States, 90801
        • Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
      • Los Angeles, California, United States, 90095-1781
        • Jonsson Comprehensive Cancer Center at UCLA
      • Los Angeles, California, United States, 90027
        • Childrens Hospital Los Angeles
      • Madera, California, United States, 93638-8762
        • Children's Hospital Central California
      • Orange, California, United States, 92868
        • Children's Hospital of Orange County
      • Sacramento, California, United States, 95816
        • Sutter Cancer center
      • Sacramento, California, United States, 95817
        • University of California Davis Cancer Center
      • Sacramento, California, United States, 95825
        • Kaiser Permanente Medical Center - Oakland
      • San Diego, California, United States, 92123-4282
        • Children's Hospital and Health Center - San Diego
      • San Francisco, California, United States, 94115
        • UCSF Comprehensive Cancer Center
      • Stanford, California, United States, 94305
        • Stanford Comprehensive Cancer Center - Stanford
    • Colorado
      • Denver, Colorado, United States, 80218-1088
        • Children's Hospital Cancer Center
    • Connecticut
      • Farmington, Connecticut, United States, 06360-2875
        • Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20010-2970
        • Children's National Medical Center
    • Florida
      • Fort Lauderdale, Florida, United States, 33316
        • Broward General Medical Center Cancer Center
      • Fort Myers, Florida, United States, 33901
        • Lee Cancer Care of Lee Memorial Health System
      • Gainesville, Florida, United States, 32610-0232
        • University of Florida Shands Cancer Center
      • Hollywood, Florida, United States, 33021
        • Memorial Cancer Institute at Memorial Regional Hospital
      • Jacksonville, Florida, United States, 32207
        • Nemours Children's Clinic
      • Miami, Florida, United States, 33136
        • University of Miami Sylvester Comprehensive Cancer Center - Miami
      • Miami, Florida, United States, 33155
        • Miami Children's Hospital
      • Orlando, Florida, United States, 32803-1273
        • Florida Hospital Cancer Institute at Florida Hospital Orlando
      • Orlando, Florida, United States, 32806
        • Nemours Children's Clinic - Orlando
      • Orlando, Florida, United States, 32806
        • M.D. Anderson Cancer Center at Orlando
      • Pensacola, Florida, United States, 32504
        • Sacred Heart Cancer Center at Sacred Heart Hospital
      • Saint Petersburg, Florida, United States, 33701
        • All Children's Hospital
      • Tampa, Florida, United States, 33607
        • St. Joseph's Cancer Institute at St. Joseph's Hospital
      • West Palm Beach, Florida, United States, 33407
        • Kaplan Cancer Center at St. Mary's Medical Center
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Institute of Emory University
      • Augusta, Georgia, United States, 30912-3730
        • MBCCOP - Medical College of Georgia Cancer Center
      • Savannah, Georgia, United States, 31403-3089
        • Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
    • Idaho
      • Boise, Idaho, United States, 83712-6297
        • St. Luke's Mountain States Tumor Institute - Boise
    • Illinois
      • Chicago, Illinois, United States, 60612-7243
        • University of Illinois Cancer Center
      • Chicago, Illinois, United States, 60614
        • Children's Memorial Hospital - Chicago
      • Maywood, Illinois, United States, 60153
        • Cardinal Bernardin Cancer Center at Loyola University Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202-5289
        • Indiana University Melvin and Bren Simon Cancer Center
    • Iowa
      • Des Moines, Iowa, United States, 50309
        • Blank Children's Hospital
      • Iowa City, Iowa, United States, 52242-1002
        • Holden Comprehensive Cancer Center at University of Iowa
    • Kansas
      • Kansas City, Kansas, United States, 66160-7357
        • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0293
        • Markey Cancer Center at University of Kentucky Chandler Medical Center
      • Louisville, Kentucky, United States, 40232
        • Kosair Children's Hospital
    • Louisiana
      • Alexandria, Louisiana, United States, 71315-3198
        • Tulane Cancer Center
      • New Orleans, Louisiana, United States, 70118
        • Children's Hospital of New Orleans
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Cancer Institute at Ochsner Clinic Foundation
    • Maine
      • Bangor, Maine, United States, 04401
        • CancerCare of Maine at Eastern Maine Medial Center
      • Scarborough, Maine, United States, 04074-9308
        • Maine Children's Cancer Program at Barbara Bush Children's Hospital
    • Maryland
      • Baltimore, Maryland, United States, 21231-2410
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
      • Baltimore, Maryland, United States, 21215
        • Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Floating Hospital for Children at Tufts - New England Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0238
        • C.S. Mott Children's Hospital at University of Michigan Medical Center
      • Detroit, Michigan, United States, 48201-1379
        • Barbara Ann Karmanos Cancer Institute
      • Flint, Michigan, United States, 48503
        • Hurley Medical Center
      • Grand Rapids, Michigan, United States, 49503-2560
        • Spectrum Health Hospital - Butterworth Campus
      • Grosse Pointe Woods, Michigan, United States, 48236
        • Van Elslander Cancer Center at St. John Hospital and Medical Center
      • Kalamazoo, Michigan, United States, 49007-5341
        • CCOP - Kalamazoo
      • Lansing, Michigan, United States, 48910
        • Breslin Cancer Center at Ingham Regional Medical Center
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital - Royal Oak Campus
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Children's Hospitals and Clinics of Minnesota - Minneapolis
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Children's Hospital - Fairview
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Cancer Center
    • Mississippi
      • Jackson, Mississippi, United States, 39216-4505
        • University of Mississippi Cancer Clinic
    • Missouri
      • Columbia, Missouri, United States, 65203
        • Ellis Fischel Cancer Center at University of Missouri - Columbia
      • Kansas City, Missouri, United States, 64108
        • Children's Mercy Hospital
      • Saint Louis, Missouri, United States, 63104
        • Cardinal Glennon Children's Hospital
      • Saint Louis, Missouri, United States, 63110
        • Siteman Cancer Center at Barnes-Jewish Hospital
    • Nebraska
      • Omaha, Nebraska, United States, 68114-4113
        • Children's Hospital
      • Omaha, Nebraska, United States, 68198-6805
        • UNMC Eppley Cancer Center at the University of Nebraska Medical Center
    • Nevada
      • Las Vegas, Nevada, United States, 89109-2306
        • Sunrise Hospital and Medical Center
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756-0002
        • Norris Cotton Cancer Center at Dartmouth - Hitchcock Medical Center
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center Cancer Center
      • Livingston, New Jersey, United States, 07039
        • St. Barnabas Medical Center Cancer Center
      • Morristown, New Jersey, United States, 07962
        • Overlook Hospital
      • New Brunswick, New Jersey, United States, 08903
        • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
      • Newark, New Jersey, United States, 07112
        • Newark Beth Israel Medical Center
      • Paterson, New Jersey, United States, 07503
        • St. Joseph's Hospital and Medical Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131-5636
        • University of New Mexico Cancer Research and Treatment Center
    • New York
      • Brooklyn, New York, United States, 11201-5493
        • Brooklyn Hospital Center
      • Buffalo, New York, United States, 14263-0001
        • Roswell Park Cancer Institute
      • Mineola, New York, United States, 11501
        • Winthrop University Hospital
      • New Hyde Park, New York, United States, 11040
        • Schneider Children's Hospital
      • New York, New York, United States, 10016
        • NYU Cancer Institute at New York University Medical Center
      • New York, New York, United States, 10029
        • Mount Sinai Medical Center
      • New York, New York, United States, 10032
        • Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
      • Rochester, New York, United States, 14642
        • James P. Wilmot Cancer Center at University of Rochester Medical Center
      • Stony Brook, New York, United States, 11794-8174
        • Stony Brook University Cancer Center
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University Hospital
      • Valhalla, New York, United States, 10595
        • New York Medical College
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7295
        • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
      • Charlotte, North Carolina, United States, 28232-2861
        • Blumenthal Cancer Center at Carolinas Medical Center
      • Charlotte, North Carolina, United States, 28233-3549
        • Presbyterian Cancer Center at Presbyterian Hospital
      • Durham, North Carolina, United States, 27710
        • Duke Comprehensive Cancer Center
      • Greenville, North Carolina, United States, 27835-6028
        • Leo W. Jenkins Cancer Center at ECU Medical School
      • Winston-Salem, North Carolina, United States, 27157-1096
        • Wake Forest University Comprehensive Cancer Center
    • North Dakota
      • Fargo, North Dakota, United States, 58122
        • CCOP - MeritCare Hospital
    • Ohio
      • Akron, Ohio, United States, 44308-1062
        • Children's Hospital Medical Center of Akron
      • Cincinnati, Ohio, United States, 45229-3039
        • Cincinnati Children's Hospital Medical Center
      • Cleveland, Ohio, United States, 44106-5000
        • Rainbow Babies and Children's Hospital
      • Cleveland, Ohio, United States, 44195-5217
        • Cleveland Clinic Taussig Cancer Center
      • Columbus, Ohio, United States, 43205-2696
        • Columbus Children's Hospital
      • Dayton, Ohio, United States, 45404-1815
        • Children's Medical Center - Dayton
      • Toledo, Ohio, United States, 43606
        • Toledo Hospital
      • Toledo, Ohio, United States, 43614
        • Medical University of Ohio Cancer Center
      • Youngstown, Ohio, United States, 44501
        • Tod Children's Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma University Cancer Institute
    • Oregon
      • Portland, Oregon, United States, 97227
        • Legacy Emanuel Hospital and Health Center & Children's Hospital
      • Portland, Oregon, United States, 97239-3098
        • Oregon Health & Science University Cancer Institute
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822-0001
        • Geisinger Medical Center
      • Hershey, Pennsylvania, United States, 17033-0850
        • Penn State Cancer Institute at Milton S. Hershey Medical Center
      • Philadelphia, Pennsylvania, United States, 19104-9786
        • Children's Hospital of Philadelphia
      • Pittsburgh, Pennsylvania, United States, 15213
        • Children's Hospital of Pittsburgh
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital Comprehensive Cancer Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Hollings Cancer Center at Medical University of South Carolina
      • Greenville, South Carolina, United States, 29605
        • Greenville Hospital System Cancer Center
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57117-5039
        • Sanford Cancer Center at Sanford USD Medical Center
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • T.C. Thompson Children's Hospital
      • Knoxville, Tennessee, United States, 37901
        • East Tennessee Children's Hospital
      • Memphis, Tennessee, United States, 38105
        • St. Jude Children's Research Hospital
      • Nashville, Tennessee, United States, 37232-6838
        • Vanderbilt-Ingram Cancer Center
    • Texas
      • Amarillo, Texas, United States, 79106
        • Texas Tech University Health Sciences Center School of Medicine - Amarillo
      • Austin, Texas, United States, 78701
        • Children's Hospital of Austin
      • Corpus Christi, Texas, United States, 78411
        • Driscoll Children's Hospital
      • Dallas, Texas, United States, 75230
        • Medical City Dallas Hospital
      • Dallas, Texas, United States, 75390
        • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
      • Fort Worth, Texas, United States, 76104-9958
        • Cook Children's Medical Center - Fort Worth
      • Houston, Texas, United States, 77030-4009
        • M. D. Anderson Cancer Center at University of Texas
      • Houston, Texas, United States, 77030-2399
        • Baylor University Medical Center - Houston
      • Lubbock, Texas, United States, 79410
        • Covenant Children's Hospital
      • San Antonio, Texas, United States, 78229-3993
        • Methodist Children's Hospital of South Texas
      • San Antonio, Texas, United States, 78207
        • University of Texas Health Science Center at San Antonio
      • Temple, Texas, United States, 76508
        • CCOP - Scott and White Hospital
    • Utah
      • Salt Lake City, Utah, United States, 84113-1100
        • Primary Children's Medical Center
    • Vermont
      • Burlington, Vermont, United States, 05405
        • Fletcher Allen Health Care - University Health Center Campus
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Cancer Center
      • Fairfax, Virginia, United States, 22031
        • Inova Fairfax Hospital
      • Norfolk, Virginia, United States, 23507-1971
        • Children's Hospital of The King's Daughters
      • Richmond, Virginia, United States, 23298-0037
        • Virginia Commonwealth University Massey Cancer Center
      • Roanoke, Virginia, United States, 24029
        • Carilion Cancer Center of Western Virginia
    • Washington
      • Seattle, Washington, United States, 98105
        • Children's Hospital and Regional Medical Center - Seattle
      • Spokane, Washington, United States, 99220-2555
        • Providence Cancer Center at Sacred Heart Medical Center
      • Tacoma, Washington, United States, 98405
        • Mary Bridge Children's Hospital and Health Center - Tacoma
      • Tacoma, Washington, United States, 98431
        • Madigan Army Medical Center - Tacoma
    • West Virginia
      • Huntington, West Virginia, United States, 25701
        • Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
      • Morgantown, West Virginia, United States, 26506
        • Mary Babb Randolph Cancer Center at West Virginia University Hospitals
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54307-3508
        • St. Vincent Hospital Regional Cancer Center
      • Madison, Wisconsin, United States, 53792-6164
        • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Clinic - Marshfield Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Newly diagnosed disseminated lymphoblastic lymphoma or localized lymphoblastic lymphoma*

    • Less than 25% tumor cells in the bone marrow
    • Previously untreated (prior intrathecal cytarabine allowed if protocol therapy begins within 72 hours)
    • Stage III or IV disease
  • NOTE: *Localized lymphoblastic lymphoma is closed to accrual as of 10/2005

PATIENT CHARACTERISTICS:

Age:

  • 1 to 30

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Cardiovascular:

  • Adequate cardiac function

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics

Endocrine therapy:

  • Emergency steroid therapy (if required) must be started within 72 hours prior to protocol therapy

Radiotherapy:

  • Emergency radiotherapy (if required) must be started within 72 hours prior to protocol therapy

Surgery:

  • Not specified

Other:

  • No other prior therapy except for emergency treatment of airway obstruction and/or superior vena cava syndrome

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A0 (localized disease Stg I/II) Modified CCG BFM
Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Doxorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Methotrexate, Intrathecal Methotrexate)
Drug: cyclophosphamide
Given IV
Other Names:
  • Cytoxan
  • NSC #26271
Drug: methotrexate
Given IV
Other Names:
  • amethopterin
  • MTX
  • NSC #000740
  • Trexall
Drug: cytarabine
Given IV
Other Names:
  • Ara-C
  • Cytosar
  • cytosine arabinoside
  • NSC #63878
Drug: doxorubicin hydrochloride
Given IV
Other Names:
  • Adriamycin
  • NSC #123127
Drug: vincristine sulfate
Given IV
Other Names:
  • VCR
  • Oncovin
  • LCR
  • NSC #67574
Drug: daunorubicin hydrochloride
Given IV
Other Names:
  • Cerubidine
  • daunomycin
  • NSC #82151
  • rubidomycin
Drug: dexamethasone
Given IV
Other Names:
  • Decadron
  • Dexameth
  • Dexone
  • Hexadrol
  • NSC #34521
Drug: asparaginase
Given IV
Other Names:
  • Elspar
  • Kidrolase
  • Leunase
  • Crasnitin
  • E.coli L-asparaginase
  • EC 3.5.2.2
  • colaspase
  • L-asnase
  • NSC#109229
Drug: prednisone
Given IV
Other Names:
  • Deltasone
  • Orasone
  • Meticorten
  • Liquid Pred
  • Sterapred
  • Pediapred
  • NSC #010023
Drug: thioguanine
Given PO
Other Names:
  • 6-thioguanine
  • Lanvis
  • Tabloid
  • WR-1141
  • 2-amino-1,7-dihydro-6H-purine-6-thione
  • NSC # 751
Drug: mercaptopurine
Given IV
Other Names:
  • 6-MP
  • Purinethol
  • NSC #000755
  • 6-mercaptopurine
Experimental: A1 (Disseminated, No CNS - CCG mod BFM w/out intens
Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, prednisone, Methotrexate, Intrathecal Methotrexate)
Drug: cyclophosphamide
Given IV
Other Names:
  • Cytoxan
  • NSC #26271
Drug: methotrexate
Given IV
Other Names:
  • amethopterin
  • MTX
  • NSC #000740
  • Trexall
Drug: cytarabine
Given IV
Other Names:
  • Ara-C
  • Cytosar
  • cytosine arabinoside
  • NSC #63878
Drug: doxorubicin hydrochloride
Given IV
Other Names:
  • Adriamycin
  • NSC #123127
Drug: vincristine sulfate
Given IV
Other Names:
  • VCR
  • Oncovin
  • LCR
  • NSC #67574
Drug: daunorubicin hydrochloride
Given IV
Other Names:
  • Cerubidine
  • daunomycin
  • NSC #82151
  • rubidomycin
Drug: dexamethasone
Given IV
Other Names:
  • Decadron
  • Dexameth
  • Dexone
  • Hexadrol
  • NSC #34521
Drug: asparaginase
Given IV
Other Names:
  • Elspar
  • Kidrolase
  • Leunase
  • Crasnitin
  • E.coli L-asparaginase
  • EC 3.5.2.2
  • colaspase
  • L-asnase
  • NSC#109229
Drug: prednisone
Given IV
Other Names:
  • Deltasone
  • Orasone
  • Meticorten
  • Liquid Pred
  • Sterapred
  • Pediapred
  • NSC #010023
Drug: thioguanine
Given PO
Other Names:
  • 6-thioguanine
  • Lanvis
  • Tabloid
  • WR-1141
  • 2-amino-1,7-dihydro-6H-purine-6-thione
  • NSC # 751
Drug: mercaptopurine
Given IV
Other Names:
  • 6-MP
  • Purinethol
  • NSC #000755
  • 6-mercaptopurine
Experimental: A2 (Disseminated, No CNS - CCG mod BFM w/ intens
Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
Drug: cyclophosphamide
Given IV
Other Names:
  • Cytoxan
  • NSC #26271
Drug: methotrexate
Given IV
Other Names:
  • amethopterin
  • MTX
  • NSC #000740
  • Trexall
Drug: cytarabine
Given IV
Other Names:
  • Ara-C
  • Cytosar
  • cytosine arabinoside
  • NSC #63878
Drug: doxorubicin hydrochloride
Given IV
Other Names:
  • Adriamycin
  • NSC #123127
Drug: vincristine sulfate
Given IV
Other Names:
  • VCR
  • Oncovin
  • LCR
  • NSC #67574
Drug: daunorubicin hydrochloride
Given IV
Other Names:
  • Cerubidine
  • daunomycin
  • NSC #82151
  • rubidomycin
Drug: dexamethasone
Given IV
Other Names:
  • Decadron
  • Dexameth
  • Dexone
  • Hexadrol
  • NSC #34521
Drug: asparaginase
Given IV
Other Names:
  • Elspar
  • Kidrolase
  • Leunase
  • Crasnitin
  • E.coli L-asparaginase
  • EC 3.5.2.2
  • colaspase
  • L-asnase
  • NSC#109229
Drug: prednisone
Given IV
Other Names:
  • Deltasone
  • Orasone
  • Meticorten
  • Liquid Pred
  • Sterapred
  • Pediapred
  • NSC #010023
Drug: thioguanine
Given PO
Other Names:
  • 6-thioguanine
  • Lanvis
  • Tabloid
  • WR-1141
  • 2-amino-1,7-dihydro-6H-purine-6-thione
  • NSC # 751
Drug: mercaptopurine
Given IV
Other Names:
  • 6-MP
  • Purinethol
  • NSC #000755
  • 6-mercaptopurine
Experimental: B2 (CNS+) NHL/BFM-95 w/intens delayed radiation therapy
Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
Radiation: radiation therapy
Drug: leucovorin calcium
Given IV
Other Names:
  • LCV
  • Wellcovorin
  • citrovorum factor
  • folinic acid
  • NSC #003590
Drug: cyclophosphamide
Given IV
Other Names:
  • Cytoxan
  • NSC #26271
Drug: methotrexate
Given IV
Other Names:
  • amethopterin
  • MTX
  • NSC #000740
  • Trexall
Drug: cytarabine
Given IV
Other Names:
  • Ara-C
  • Cytosar
  • cytosine arabinoside
  • NSC #63878
Drug: doxorubicin hydrochloride
Given IV
Other Names:
  • Adriamycin
  • NSC #123127
Drug: vincristine sulfate
Given IV
Other Names:
  • VCR
  • Oncovin
  • LCR
  • NSC #67574
Drug: daunorubicin hydrochloride
Given IV
Other Names:
  • Cerubidine
  • daunomycin
  • NSC #82151
  • rubidomycin
Drug: dexamethasone
Given IV
Other Names:
  • Decadron
  • Dexameth
  • Dexone
  • Hexadrol
  • NSC #34521
Drug: asparaginase
Given IV
Other Names:
  • Elspar
  • Kidrolase
  • Leunase
  • Crasnitin
  • E.coli L-asparaginase
  • EC 3.5.2.2
  • colaspase
  • L-asnase
  • NSC#109229
Drug: prednisone
Given IV
Other Names:
  • Deltasone
  • Orasone
  • Meticorten
  • Liquid Pred
  • Sterapred
  • Pediapred
  • NSC #010023
Drug: thioguanine
Given PO
Other Names:
  • 6-thioguanine
  • Lanvis
  • Tabloid
  • WR-1141
  • 2-amino-1,7-dihydro-6H-purine-6-thione
  • NSC # 751
Drug: mercaptopurine
Given IV
Other Names:
  • 6-MP
  • Purinethol
  • NSC #000755
  • 6-mercaptopurine
Experimental: B1 (Disseminated CNS- <Amend 7B) NHL/BFM-95 w/out intens
Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
Drug: leucovorin calcium
Given IV
Other Names:
  • LCV
  • Wellcovorin
  • citrovorum factor
  • folinic acid
  • NSC #003590
Drug: cyclophosphamide
Given IV
Other Names:
  • Cytoxan
  • NSC #26271
Drug: methotrexate
Given IV
Other Names:
  • amethopterin
  • MTX
  • NSC #000740
  • Trexall
Drug: cytarabine
Given IV
Other Names:
  • Ara-C
  • Cytosar
  • cytosine arabinoside
  • NSC #63878
Drug: doxorubicin hydrochloride
Given IV
Other Names:
  • Adriamycin
  • NSC #123127
Drug: vincristine sulfate
Given IV
Other Names:
  • VCR
  • Oncovin
  • LCR
  • NSC #67574
Drug: daunorubicin hydrochloride
Given IV
Other Names:
  • Cerubidine
  • daunomycin
  • NSC #82151
  • rubidomycin
Drug: dexamethasone
Given IV
Other Names:
  • Decadron
  • Dexameth
  • Dexone
  • Hexadrol
  • NSC #34521
Drug: asparaginase
Given IV
Other Names:
  • Elspar
  • Kidrolase
  • Leunase
  • Crasnitin
  • E.coli L-asparaginase
  • EC 3.5.2.2
  • colaspase
  • L-asnase
  • NSC#109229
Drug: prednisone
Given IV
Other Names:
  • Deltasone
  • Orasone
  • Meticorten
  • Liquid Pred
  • Sterapred
  • Pediapred
  • NSC #010023
Drug: thioguanine
Given PO
Other Names:
  • 6-thioguanine
  • Lanvis
  • Tabloid
  • WR-1141
  • 2-amino-1,7-dihydro-6H-purine-6-thione
  • NSC # 751
Drug: mercaptopurine
Given IV
Other Names:
  • 6-MP
  • Purinethol
  • NSC #000755
  • 6-mercaptopurine
Experimental: B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/intens
Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
Drug: leucovorin calcium
Given IV
Other Names:
  • LCV
  • Wellcovorin
  • citrovorum factor
  • folinic acid
  • NSC #003590
Drug: cyclophosphamide
Given IV
Other Names:
  • Cytoxan
  • NSC #26271
Drug: methotrexate
Given IV
Other Names:
  • amethopterin
  • MTX
  • NSC #000740
  • Trexall
Drug: cytarabine
Given IV
Other Names:
  • Ara-C
  • Cytosar
  • cytosine arabinoside
  • NSC #63878
Drug: doxorubicin hydrochloride
Given IV
Other Names:
  • Adriamycin
  • NSC #123127
Drug: vincristine sulfate
Given IV
Other Names:
  • VCR
  • Oncovin
  • LCR
  • NSC #67574
Drug: daunorubicin hydrochloride
Given IV
Other Names:
  • Cerubidine
  • daunomycin
  • NSC #82151
  • rubidomycin
Drug: dexamethasone
Given IV
Other Names:
  • Decadron
  • Dexameth
  • Dexone
  • Hexadrol
  • NSC #34521
Drug: asparaginase
Given IV
Other Names:
  • Elspar
  • Kidrolase
  • Leunase
  • Crasnitin
  • E.coli L-asparaginase
  • EC 3.5.2.2
  • colaspase
  • L-asnase
  • NSC#109229
Drug: prednisone
Given IV
Other Names:
  • Deltasone
  • Orasone
  • Meticorten
  • Liquid Pred
  • Sterapred
  • Pediapred
  • NSC #010023
Drug: thioguanine
Given PO
Other Names:
  • 6-thioguanine
  • Lanvis
  • Tabloid
  • WR-1141
  • 2-amino-1,7-dihydro-6H-purine-6-thione
  • NSC # 751
Drug: mercaptopurine
Given IV
Other Names:
  • 6-MP
  • Purinethol
  • NSC #000755
  • 6-mercaptopurine
Experimental: B1 (Disseminated CNS-) NHL/BFM-95 w/out intens
Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
Drug: leucovorin calcium
Given IV
Other Names:
  • LCV
  • Wellcovorin
  • citrovorum factor
  • folinic acid
  • NSC #003590
Drug: cyclophosphamide
Given IV
Other Names:
  • Cytoxan
  • NSC #26271
Drug: methotrexate
Given IV
Other Names:
  • amethopterin
  • MTX
  • NSC #000740
  • Trexall
Drug: cytarabine
Given IV
Other Names:
  • Ara-C
  • Cytosar
  • cytosine arabinoside
  • NSC #63878
Drug: doxorubicin hydrochloride
Given IV
Other Names:
  • Adriamycin
  • NSC #123127
Drug: vincristine sulfate
Given IV
Other Names:
  • VCR
  • Oncovin
  • LCR
  • NSC #67574
Drug: daunorubicin hydrochloride
Given IV
Other Names:
  • Cerubidine
  • daunomycin
  • NSC #82151
  • rubidomycin
Drug: dexamethasone
Given IV
Other Names:
  • Decadron
  • Dexameth
  • Dexone
  • Hexadrol
  • NSC #34521
Drug: asparaginase
Given IV
Other Names:
  • Elspar
  • Kidrolase
  • Leunase
  • Crasnitin
  • E.coli L-asparaginase
  • EC 3.5.2.2
  • colaspase
  • L-asnase
  • NSC#109229
Drug: prednisone
Given IV
Other Names:
  • Deltasone
  • Orasone
  • Meticorten
  • Liquid Pred
  • Sterapred
  • Pediapred
  • NSC #010023
Drug: thioguanine
Given PO
Other Names:
  • 6-thioguanine
  • Lanvis
  • Tabloid
  • WR-1141
  • 2-amino-1,7-dihydro-6H-purine-6-thione
  • NSC # 751
Drug: mercaptopurine
Given IV
Other Names:
  • 6-MP
  • Purinethol
  • NSC #000755
  • 6-mercaptopurine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event-free Survival
Time Frame: 5 years
Assessed by time to treatment failure, occurrence of second malignant neoplasm, or death from any cause. Statistical analysis will be to estimate the difference in the proportion of patients treated with each therapy who are long-term event-free survivors due either to the difference between the backbone therapy regimens (CCG BFM vs NHL/BFM-95), or due to the intensification.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients With Overall Survival as Assessed by Time to Death
Time Frame: 5 years
Overall survival will be computed by measuring the rate of deaths during induction due primarily to treatment toxicity and cumulative incidence of toxic deaths in induction or deaths in remission overall and separately for treatment groups defined by the two design factors.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Minnie Abromowitch, MD, Children's Hospital Medical Center, Cincinnati

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2000

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

March 31, 2015

Study Registration Dates

First Submitted

January 28, 2000

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Actual)

August 6, 2019

Last Update Submitted That Met QC Criteria

July 24, 2019

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A5971
  • CCG-59701 (Other Identifier: Children's Cancer Group)
  • CCG-59701C (Other Identifier: Children's Cancer Group)
  • CCG-A5971 (Other Identifier: Children's Cancer Group)
  • POG-A5971 (Other Identifier: Pediatric Oncology Group)
  • CDR0000067470 (Other Identifier: Clinical Trials.gov)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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