Induction Intensification in Treating Infants With Newly Diagnosed Acute Lymphoblastic Leukemia
NCT ID: NCT00002756
Last Updated: 2014-02-14
Study Results
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Basic Information
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COMPLETED
PHASE2
221 participants
INTERVENTIONAL
1996-06-30
2012-03-31
Brief Summary
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PURPOSE: This phase II trial is studying how well induction intensification works in treating infants with newly diagnosed acute lymphocytic leukemia.
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Detailed Description
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Primary
* Assess the feasibility of intensification with two courses of high-dose methotrexate followed by one course of cyclophosphamide/etoposide during induction and later as consolidation in infants with newly diagnosed acute lymphoblastic leukemia.
* Determine event-free survival after shortened, intensive therapy in these patients.
* Compare event-free survival rates of infants receiving this regimen whose leukemic blasts have or do not have translocations involving the 11q23 gene MLL.
Secondary
* Correlate the presence of minimal residual disease at completion of induction, beginning of continuation, and at completion of therapy with patient outcome.
* Investigate the clinical prognostic features that may be associated with outcome in infants, such as bone marrow blast content at day 8, white blood cell count, and age.
* Correlate biologic characteristics of the leukemia cells at diagnosis (protocol POG-9900) with outcome in patients treated with this regimen.
* Characterize patterns of gene expression associated with host and disease characteristics and treatment response in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients are stratified according to participating center and presence of CNS disease (yes vs no).
Patients receive induction chemotherapy comprising vincristine IV on days 1, 8, and 15; oral prednisone three times a day on days 1-21; daunorubicin IV over 30 minutes on days 1-2; cyclophosphamide IV over 30 minutes every 12 hours on days 3-4; and asparaginase intramuscularly (IM) on days 4, 6, 8, 10, 12, 15, 17, and 19. Patients also receive triple intrathecal therapy comprising methotrexate, hydrocortisone, and cytarabine on days 1, 8, and 15 and filgrastim (G-CSF) subcutaneously (SC) or IV beginning on day 5 and continuing until day 20, regardless of blood counts.
Patients receive induction intensification chemotherapy comprising high-dose methotrexate IV over 24 hours; triple intrathecal therapy as per induction therapy on days 22 and 29; and leucovorin calcium IV every 6 hours for 2 doses beginning 42 hours after start of high-dose methotrexate and then orally every 6 hours for 3 doses. Patients also receive etoposide IV over 2 hours and cyclophosphamide IV over 30 minutes on days 36-40. Patients receive G-CSF SC or IV beginning on day 41 and continuing until blood counts recover.
Patients achieving morphologic remission and recovery of blood counts while off G-CSF for 48 hours receive reinduction chemotherapy comprising the same regimen as in induction therapy with the exception of asparaginase IM beginning on day 1 (week 8) and continuing every Monday, Wednesday, and Friday for a total of 8 doses and triple intrathecal therapy on days 1 and 15 only (weeks 8 and 10). Patients receive G-CSF SC or IV beginning on day 5 and continuing until blood counts recover.
After blood count recovery, patients receive consolidation chemotherapy comprising triple intrathecal therapy as per induction therapy on day 1 (week 11); high-dose methotrexate IV over 24 hours on weeks 8 and 12; and leucovorin calcium IV every 6 hours for 2 doses beginning 42 hours after start of high-dose methotrexate and then orally every 6 hours for 3 doses. Patients also receive etoposide IV over 2 hours followed by cyclophosphamide IV over 30 minutes on days 15-19 (week 13). Patients receive G-CSF SC or IV beginning on day 20 and continuing until blood counts recover. On days 29-31 (week 15), patients receive high-dose cytarabine IV over 3 hours every 12 hours for 4 doses and asparaginase IM 6 hours after completion of high-dose cytarabine. Patients receive G-CSF beginning 24 hours after completion of asparaginase and continuing until blood counts recover.
Patients achieving morphologic remission and blood count recovery while off G-CSF for 48 hours receive continuation therapy comprising vincristine IV on day 1; oral prednisone three times a day on days 1-5; and triple intrathecal therapy on day 1 (weeks 18 and 22). Patients also receive methotrexate IM once a week and oral mercaptopurine daily on weeks 19-21, 23, and 24. On week 25, patients receive etoposide IV over 2 hours daily followed by cyclophosphamide IV over 30 minutes daily on days 1-5 and G-CSF SC or IV beginning on day 6 and continuing until blood counts recover. Patients receive an additional course of continuation therapy on weeks 28-35. On weeks 38-48, patients receive another identical course of continuation therapy with the exclusion of the etoposide and cyclophosphamide combination regimen.
Patients are followed monthly for 1 year, every 2 months for 1 year, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 58-104 patients will be accrued for this study within 2.1 years.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Chemo (Reduced Induction) No BMT (Open February 2004)
filgrastim
asparaginase
cyclophosphamide
cytarabine
daunorubicin hydrochloride
etoposide
leucovorin calcium
mercaptopurine
methotrexate
prednisone
therapeutic hydrocortisone
vincristine sulfate
Interventions
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filgrastim
asparaginase
cyclophosphamide
cytarabine
daunorubicin hydrochloride
etoposide
leucovorin calcium
mercaptopurine
methotrexate
prednisone
therapeutic hydrocortisone
vincristine sulfate
Eligibility Criteria
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Inclusion Criteria
Age:
* Under 1 at diagnosis
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Not specified
Renal:
* Not specified
Other:
* No uncontrolled infection
* Adequate major organ function
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* Not specified
Endocrine therapy:
* See Disease Characteristics
* No concurrent chronic steroid treatment
Radiotherapy:
* Not specified
Surgery:
* Not specified
Other:
* No other concurrent anticancer therapy
1 Year
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Zoann E. Dreyer, MD
Role: STUDY_CHAIR
Texas Children's Cancer Center
Locations
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Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, Alabama, United States
Phoenix Children's Hospital
Phoenix, Arizona, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Southern California Permanente Medical Group
Downey, California, United States
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, United States
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
Long Beach, California, United States
Children's Hospital Central California
Madera, California, United States
Children's Hospital and Research Center - Oakland
Oakland, California, United States
Children's Hospital of Orange County
Orange, California, United States
Sutter Cancer Center
Sacramento, California, United States
Kaiser Permanente Medical Center - Oakland
Sacramento, California, United States
Children's Hospital and Health Center - San Diego
San Diego, California, United States
UCSF Comprehensive Cancer Center
San Francisco, California, United States
Santa Barbara Cottage Children's Hospital
Santa Barbara, California, United States
Stanford Cancer Center at Stanford University Medical Center
Stanford, California, United States
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
Farmington, Connecticut, United States
Yale Cancer Center
New Haven, Connecticut, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Broward General Medical Center Cancer Center
Fort Lauderdale, Florida, United States
Lee Cancer Care of Lee Memorial Health System
Fort Myers, Florida, United States
University of Florida Shands Cancer Center
Gainesville, Florida, United States
Nemours Children's Clinic
Jacksonville, Florida, United States
Baptist-South Miami Regional Cancer Program
Miami, Florida, United States
Florida Hospital Cancer Institute at Florida Hospital Orlando
Orlando, Florida, United States
Nemours Children's Clinic - Orlando
Orlando, Florida, United States
Sacred Heart Cancer Center at Sacred Heart Hospital
Pensacola, Florida, United States
St. Joseph's Cancer Institute at St. Joseph's Hospital
Tampa, Florida, United States
Kaplan Cancer Center at St. Mary's Medical Center
West Palm Beach, Florida, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States
St. Luke's Mountain States Tumor Institute - Boise
Boise, Idaho, United States
Children's Memorial Hospital - Chicago
Chicago, Illinois, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
Lutheran General Cancer Care Center
Park Ridge, Illinois, United States
Southern Illinois University School of Medicine
Springfield, Illinois, United States
St. Vincent Indianapolis Hospital
Indianapolis, Indiana, United States
Blank Children's Hospital
Des Moines, Iowa, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States
Kosair Children's Hospital
Louisville, Kentucky, United States
Children's Hospital of New Orleans
New Orleans, Louisiana, United States
Ochsner Cancer Institute at Ochsner Clinic Foundation
New Orleans, Louisiana, United States
CancerCare of Maine at Eastern Maine Medial Center
Bangor, Maine, United States
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
Baltimore, Maryland, United States
Floating Hospital for Children at Tufts - New England Medical Center
Boston, Massachusetts, United States
C.S. Mott Children's Hospital at University of Michigan
Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
Spectrum Health Cancer Care - Butterworth Campus
Grand Rapids, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States
CCOP - Kalamazoo
Kalamazoo, Michigan, United States
Breslin Cancer Center at Ingham Regional Medical Center
Lansing, Michigan, United States
Children's Hospitals and Clinics of Minneapolis
Minneapolis, Minnesota, United States
University of Minnesota Medical Center - Fairview
Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Keesler Medical Center - Keesler Air Force Base
Keesler Air Force Base, Mississippi, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
Cardinal Glennon Children's Hospital
St Louis, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, United States
Sunrise Hospital and Medical Center
Las Vegas, Nevada, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Hackensack University Medical Center Cancer Center
Hackensack, New Jersey, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, United States
University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, United States
Maimonides Medical Center
Brooklyn, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Winthrop University Hospital
Mineola, New York, United States
Schneider Children's Hospital
New Hyde Park, New York, United States
NYU Cancer Institute at New York University Medical Center
New York, New York, United States
Mount Sinai Medical Center
New York, New York, United States
Stony Brook University Cancer Center
Stony Brook, New York, United States
SUNY Upstate Medical University Hospital
Syracuse, New York, United States
Albert Einstein Cancer Center at Albert Einstein College of Medicine
The Bronx, New York, United States
New York Medical College
Valhalla, New York, United States
Mission Hospitals - Memorial Campus
Asheville, North Carolina, United States
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, United States
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Children's Hospital Medical Center of Akron
Akron, Ohio, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Toledo Hospital
Toledo, Ohio, United States
Medical University of Ohio Cancer Center
Toledo, Ohio, United States
Tod Children's Hospital - Forum Health
Youngstown, Ohio, United States
Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, United States
Legacy Emanuel Hospital and Health Center & Children's Hospital
Portland, Oregon, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital Comprehensive Cancer Center
Providence, Rhode Island, United States
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States
Greenville Hospital System Cancer Center
Greenville, South Carolina, United States
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls, South Dakota, United States
East Tennessee Children's Hospital
Knoxville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Texas Tech University Health Sciences Center School of Medicine - Amarillo
Amarillo, Texas, United States
Medical City Dallas Hospital
Dallas, Texas, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States
Cook Children's Medical Center - Fort Worth
Fort Worth, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
Baylor University Medical Center - Houston
Houston, Texas, United States
Covenant Children's Hospital
Lubbock, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Methodist Children's Hospital of South Texas
San Antonio, Texas, United States
CCOP - Scott and White Hospital
Temple, Texas, United States
Primary Children's Medical Center
Salt Lake City, Utah, United States
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, United States
INOVA Fairfax Hospital
Fairfax, Virginia, United States
Children's Hospital of the King's Daughters
Norfolk, Virginia, United States
Naval Medical Center - Portsmouth
Portsmouth, Virginia, United States
Massey Cancer Center at Virginia Commonwealth University
Richmond, Virginia, United States
Carilion Cancer Center of Western Virginia
Roanoke, Virginia, United States
Providence Cancer Center at Sacred Heart Medical Center
Spokane, Washington, United States
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
Charleston, West Virginia, United States
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
Huntington, West Virginia, United States
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
Morgantown, West Virginia, United States
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, United States
Midwest Children's Cancer Center
Milwaukee, Wisconsin, United States
Princess Margaret Hospital for Children
Perth, Western Australia, Australia
Alberta Children's Hospital
Calgary, Alberta, Canada
Children's & Women's Hospital of British Columbia
Vancouver, British Columbia, Canada
CancerCare Manitoba
Winnipeg, Manitoba, Canada
IWK Health Centre
Halifax, Nova Scotia, Canada
Hospital for Sick Children
Toronto, Ontario, Canada
Montreal Children's Hospital at McGill University Health Center
Montreal, Quebec, Canada
Allan Blair Cancer Centre at Pasqua Hospital
Regina, Saskatchewan, Canada
Saskatoon Cancer Centre at the University of Saskatchewan
Saskatoon, Saskatchewan, Canada
Swiss Pediatric Oncology Group Bern
Bern, , Switzerland
Swiss Pediatric Oncology Group Geneva
Geneva, , Switzerland
Swiss Pediatric Oncology Group Lausanne
Lausanne, , Switzerland
Countries
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References
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Dreyer ZE, Dinndorf PA, Camitta B, Sather H, La MK, Devidas M, Hilden JM, Heerema NA, Sanders JE, McGlennen R, Willman CL, Carroll AJ, Behm F, Smith FO, Woods WG, Godder K, Reaman GH. Analysis of the role of hematopoietic stem-cell transplantation in infants with acute lymphoblastic leukemia in first remission and MLL gene rearrangements: a report from the Children's Oncology Group. J Clin Oncol. 2011 Jan 10;29(2):214-22. doi: 10.1200/JCO.2009.26.8938. Epub 2010 Dec 6.
Fernandez CV, Kodish E, Taweel S, Shurin S, Weijer C; Children's Oncology Group. Disclosure of the right of research participants to receive research results: an analysis of consent forms in the Children's Oncology Group. Cancer. 2003 Jun 1;97(11):2904-9. doi: 10.1002/cncr.11391.
Kang H, Wilson CS, Harvey RC, Chen IM, Murphy MH, Atlas SR, Bedrick EJ, Devidas M, Carroll AJ, Robinson BW, Stam RW, Valsecchi MG, Pieters R, Heerema NA, Hilden JM, Felix CA, Reaman GH, Camitta B, Winick N, Carroll WL, Dreyer ZE, Hunger SP, Willman CL. Gene expression profiles predictive of outcome and age in infant acute lymphoblastic leukemia: a Children's Oncology Group study. Blood. 2012 Feb 23;119(8):1872-81. doi: 10.1182/blood-2011-10-382861. Epub 2011 Dec 30.
Salzer WL, Jones TL, Devidas M, Hilden JM, Winick N, Hunger S, Carroll WL, Camitta B, Dreyer ZE. Modifications to induction therapy decrease risk of early death in infants with acute lymphoblastic leukemia treated on Children's Oncology Group P9407. Pediatr Blood Cancer. 2012 Nov;59(5):834-9. doi: 10.1002/pbc.24132. Epub 2012 Apr 5.
Robinson BW, Devidas M, Carroll AJ, et al.: Specific MLL partner genes in infant acute lymphoblastic leukemia (ALL) associated with outcome are linked to age and white blood cell count (WBC) at diagnosis: A report on the Children's Oncology Group (COG) P9407 trial. [Abstract] Blood 114 (22): A-907, 2009.
Thompson PA, Murry DJ, Rosner GL, Lunagomez S, Blaney SM, Berg SL, Camitta BM, Dreyer ZE, Bomgaars LR. Methotrexate pharmacokinetics in infants with acute lymphoblastic leukemia. Cancer Chemother Pharmacol. 2007 May;59(6):847-53. doi: 10.1007/s00280-006-0388-1. Epub 2006 Nov 29.
Other Identifiers
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COG-P9407
Identifier Type: OTHER
Identifier Source: secondary_id
POG-9407
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000064693
Identifier Type: OTHER
Identifier Source: secondary_id
P9407
Identifier Type: -
Identifier Source: org_study_id
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