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Trial record 11 of 67 for:    "Acute Lymphocytic Leukemia" | "Hydrocortisone"

Combination Chemotherapy and Radiation Therapy in Treating Patients With Acute Lymphoblastic Leukemia That Has Relapsed in the CNS or Testes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00096135
Recruitment Status : Completed
First Posted : November 9, 2004
Results First Posted : August 6, 2015
Last Update Posted : March 21, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Brief Summary:

RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Giving combination chemotherapy together with radiation therapy may kill more cancer cells.

PURPOSE: This clinical trial is studying how well giving chemotherapy together with radiation therapy works in treating patients with acute lymphoblastic leukemia that has relapsed in the CNS and/or testes.


Condition or disease Intervention/treatment Phase
Leukemia Biological: filgrastim Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: etoposide Drug: leucovorin calcium Drug: mercaptopurine Drug: methotrexate Drug: pegaspargase Drug: therapeutic hydrocortisone Drug: vincristine sulfate Radiation: radiation therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 168 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Late Isolated Extramedullary Relapse From Acute Lymphoblastic Leukemia (ALL) (Initial CR1≥ 18 Months)
Study Start Date : November 2004
Actual Primary Completion Date : September 2013


Arm Intervention/treatment
Experimental: CNS Patients-Treatment (combination chemotherapy)
All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: MTX, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (MTX, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.
Biological: filgrastim
given subcutaneously (SC)
Other Names:
  • Granulocyte Colony-Stimulating Factor
  • r-metHuG-CSF
  • G-CSF
  • Neupogen
  • NSC 614629

Drug: cyclophosphamide
IV over 15-30 minutes
Other Names:
  • CYTOXAN
  • NSC #26271

Drug: cytarabine
IV over 3 hours twice daily
Other Names:
  • Cytosine arabinoside
  • Ara-C
  • Cytosar
  • NSC #6387

Drug: daunorubicin hydrochloride
IV over 15 minutes
Other Names:
  • Daunomycin
  • rubidomycin
  • Cerubidine
  • NSC #82151

Drug: dexamethasone
oral twice daily
Other Names:
  • Decadron
  • Hexadrol
  • Dexone
  • Dexameth
  • NSC #34521

Drug: etoposide
IV over 1 hour
Other Names:
  • VePesid
  • Etopophos
  • VP-16
  • NSC #141540

Drug: leucovorin calcium
rescue IV over 24 hours
Other Names:
  • LCV
  • Wellcovorin
  • citrovorum factor
  • folinic acid
  • NSC 03590

Drug: mercaptopurine
oral
Other Names:
  • 6-MP
  • Purinethol
  • 6-mercaptopurine
  • NSC #000755

Drug: methotrexate
intramuscularly (IM)
Other Names:
  • MTX
  • amethopterin
  • Trexall
  • NSC #000740

Drug: pegaspargase
intramuscularly (IM)
Other Names:
  • PEG-asparaginase
  • PEGLA
  • PEG-L-asparaginase
  • polyethylene glycol-L-asparaginase
  • Oncaspar
  • NSC 624239

Drug: therapeutic hydrocortisone
Drug: vincristine sulfate
given IV
Other Names:
  • Oncovin
  • VCR
  • LCR
  • NSC #67574

Radiation: radiation therapy
Patients with isolated testicular relapse will start Induction with a single dose of high-dose methotrexate (HDMTX) and will not receive either testicular or cranial radiation. Patients with isolated CNS relapse will NOT receive the initial dose of HDMTX prior to Induction, but will receive 1200 cGy of cranial radiation after completing the initial 12 months of intensive systemic chemotherapy.

Experimental: Testicular Relapse Patients (Combination chemotherapy)
All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: MTX, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, testicular radiation therapy, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (MTX, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.
Biological: filgrastim
given subcutaneously (SC)
Other Names:
  • Granulocyte Colony-Stimulating Factor
  • r-metHuG-CSF
  • G-CSF
  • Neupogen
  • NSC 614629

Drug: cyclophosphamide
IV over 15-30 minutes
Other Names:
  • CYTOXAN
  • NSC #26271

Drug: cytarabine
IV over 3 hours twice daily
Other Names:
  • Cytosine arabinoside
  • Ara-C
  • Cytosar
  • NSC #6387

Drug: daunorubicin hydrochloride
IV over 15 minutes
Other Names:
  • Daunomycin
  • rubidomycin
  • Cerubidine
  • NSC #82151

Drug: dexamethasone
oral twice daily
Other Names:
  • Decadron
  • Hexadrol
  • Dexone
  • Dexameth
  • NSC #34521

Drug: etoposide
IV over 1 hour
Other Names:
  • VePesid
  • Etopophos
  • VP-16
  • NSC #141540

Drug: leucovorin calcium
rescue IV over 24 hours
Other Names:
  • LCV
  • Wellcovorin
  • citrovorum factor
  • folinic acid
  • NSC 03590

Drug: mercaptopurine
oral
Other Names:
  • 6-MP
  • Purinethol
  • 6-mercaptopurine
  • NSC #000755

Drug: methotrexate
intramuscularly (IM)
Other Names:
  • MTX
  • amethopterin
  • Trexall
  • NSC #000740

Drug: pegaspargase
intramuscularly (IM)
Other Names:
  • PEG-asparaginase
  • PEGLA
  • PEG-L-asparaginase
  • polyethylene glycol-L-asparaginase
  • Oncaspar
  • NSC 624239

Drug: therapeutic hydrocortisone
Drug: vincristine sulfate
given IV
Other Names:
  • Oncovin
  • VCR
  • LCR
  • NSC #67574

Radiation: radiation therapy
Patients with isolated testicular relapse will start Induction with a single dose of high-dose methotrexate (HDMTX) and will not receive either testicular or cranial radiation. Patients with isolated CNS relapse will NOT receive the initial dose of HDMTX prior to Induction, but will receive 1200 cGy of cranial radiation after completing the initial 12 months of intensive systemic chemotherapy.




Primary Outcome Measures :
  1. Event-free Survival [ Time Frame: 3 years ]
    Monitoring of efficacy results will be performed in comparison with historical results.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Months to 29 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of acute lymphoblastic leukemia (ALL)

    • B-precursor lineage (T-precursor lineage closed to accrual as of 05/20/10)
    • In first bone marrow remission (M1 by morphology) AND duration of first complete remission ≥ 18 months from time of initial diagnosis
  • First isolated CNS and/or testicular relapse

    • Isolated CNS relapse, as defined by 1 of the following:

      • WBC ≥ 5/mm^3 in cerebrospinal fluid (CSF) with blasts present on cytospin
      • Any number of WBC in CSF with immunophenotypic proof of leukemic relapse, defined by the following:

        • Identifiable blasts AND 1 of the following:

          • B-lineage (TdT OR CD-10-positive on 2 consecutive CSF samples obtained 4 weeks apart)
          • T-lineage (TdT AND CD-7 OR TdT positivity alone on 2 consecutive CSF samples obtained 4 weeks apart) (Closed to accrual as of 05/20/10)
    • Isolated testicular relapse, defined as biopsy proven testicular involvement
  • No Down syndrome
  • No T-cell ALL or T-cell non-Hodgkin lymphoma
  • No known optic nerve and/or retinal involvement

PATIENT CHARACTERISTICS:

Age

  • 18 months to 29 years at relapse

Performance status

  • Karnofsky 30-100% (for patients > 16 years of age) OR
  • Lansky 30-100% (for patients ≤ 16 years of age)

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Creatinine adjusted according to age as follows:

    • No greater than 0.4 mg/dL (≤ 5 months)
    • No greater than 0.5 mg/dL (6 months -11 months)
    • No greater than 0.6 mg/dL (1 year-23 months)
    • No greater than 0.8 mg/dL (2 years-5 years)
    • No greater than 1.0 mg/dL (6 years-9 years)
    • No greater than 1.2 mg/dL (10 years-12 years)
    • No greater than 1.4 mg/dL (13 years and over [female])
    • No greater than 1.5 mg/dL (13 years to 15 years [male])
    • No greater than 1.7 mg/dL (16 years and over [male]) OR
  • Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min

Cardiovascular

  • Shortening fraction ≥ 27% by echocardiogram OR
  • Ejection fraction ≥ 50% by MUGA

Other

  • Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior bone marrow transplantation

Chemotherapy

  • Prior total anthracycline dosage ≤ 360 mg/m^2

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • No prior systemic therapy for concurrent extramedullary relapse

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00096135


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Locations
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United States, Alabama
UAB Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
United States, Arizona
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016-7710
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724-5024
United States, Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Southern California Permanente Medical Group
Downey, California, United States, 90027
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
Long Beach, California, United States, 90801
Childrens Hospital Los Angeles
Los Angeles, California, United States, 90027
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
Children's Hospital Central California
Madera, California, United States, 93638-8762
Children's Hospital and Research Center Oakland
Oakland, California, United States, 94609
Children's Hospital of Orange County
Orange, California, United States, 92868
Lucile Packard Children's Hospital at Stanford University Medical Center
Palo Alto, California, United States, 95798
Sutter Cancer Center
Sacramento, California, United States, 95816
Kaiser Permanente Medical Center - Oakland
Sacramento, California, United States, 95825
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
United States, Colorado
Children's Hospital Center for Cancer and Blood Disorders
Aurora, Colorado, United States, 80045
Presbyterian - St. Luke's Medical Center
Denver, Colorado, United States, 80218
United States, Connecticut
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
United States, Delaware
Alfred I. duPont Hospital for Children
Wilmington, Delaware, United States, 19803
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010-2970
United States, Florida
Broward General Medical Center Cancer Center
Fort Lauderdale, Florida, United States, 33316
Lee Cancer Care of Lee Memorial Health System
Fort Myers, Florida, United States, 33901
University of Florida Shands Cancer Center
Gainesville, Florida, United States, 32610-0232
Memorial Cancer Institute at Memorial Regional Hospital
Hollywood, Florida, United States, 33021
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136
Miami Children's Hospital
Miami, Florida, United States, 33155
Baptist-South Miami Regional Cancer Program
Miami, Florida, United States, 33176
Florida Hospital Cancer Institute at Florida Hospital Orlando
Orlando, Florida, United States, 32803-1273
M.D. Anderson Cancer Center at Orlando
Orlando, Florida, United States, 32806
Nemours Children's Clinic - Orlando
Orlando, Florida, United States, 32806
Sacred Heart Cancer Center at Sacred Heart Hospital
Pensacola, Florida, United States, 32504
All Children's Hospital
Saint Petersburg, Florida, United States, 33701
St. Joseph's Cancer Institute at St. Joseph's Hospital
Tampa, Florida, United States, 33607
Kaplan Cancer Center at St. Mary's Medical Center
West Palm Beach, Florida, United States, 33407
United States, Georgia
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
Atlanta, Georgia, United States, 30322
United States, Hawaii
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States, 96813
United States, Idaho
Mountain States Tumor Institute at St. Luke's Regional Medical Center
Boise, Idaho, United States, 83712-6297
United States, Illinois
University of Illinois Cancer Center
Chicago, Illinois, United States, 60612-7243
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153
Keyser Family Cancer Center at Advocate Hope Children's Hospital
Oak Lawn, Illinois, United States, 60453
Advocate Lutheran General Cancer Care Center
Park Ridge, Illinois, United States, 60068-1174
Simmons Cooper Cancer Institute
Springfield, Illinois, United States, 62794-9677
United States, Indiana
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202-5289
St. Vincent Indianapolis Hospital
Indianapolis, Indiana, United States, 46260
United States, Iowa
Blank Children's Hospital
Des Moines, Iowa, United States, 50309
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242-1002
United States, Kansas
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7357
United States, Kentucky
Lucille P. Markey Cancer Center at University of Kentucky
Lexington, Kentucky, United States, 40536-0093
Kosair Children's Hospital
Louisville, Kentucky, United States, 40232
United States, Maine
CancerCare of Maine at Eastern Maine Medical Center
Bangor, Maine, United States, 04401
United States, Maryland
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
Baltimore, Maryland, United States, 21215
United States, Massachusetts
Floating Hospital for Children at Tufts - New England Medical Center
Boston, Massachusetts, United States, 02111
United States, Michigan
C.S. Mott Children's Hospital at University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109-0286
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Hurley Medical Center
Flint, Michigan, United States, 48503
Butterworth Hospital at Spectrum Health
Grand Rapids, Michigan, United States, 49503-2560
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States, 48236
CCOP - Kalamazoo
Kalamazoo, Michigan, United States, 49007-5381
Breslin Cancer Center at Ingham Regional Medical Center
Lansing, Michigan, United States, 48910
United States, Minnesota
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, United States, 55404
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Mississippi
University of Mississippi Cancer Clinic
Jackson, Mississippi, United States, 39216-4505
United States, Missouri
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States, 65203
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
United States, Nevada
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89109-2306
United States, New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002
United States, New Jersey
Hackensack University Medical Center Cancer Center
Hackensack, New Jersey, United States, 07601
Overlook Hospital
Morristown, New Jersey, United States, 07962
Saint Peter's University Hospital
New Brunswick, New Jersey, United States, 08901
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, United States, 07503
United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87131-5636
United States, New York
Albert Einstein Cancer Center at Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Brooklyn Hospital Center
Brooklyn, New York, United States, 11201-5493
Maimonides Cancer Center at Maimonides Medical Center
Brooklyn, New York, United States, 11219
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Winthrop University Hospital
Mineola, New York, United States, 11501
Schneider Children's Hospital
New Hyde Park, New York, United States, 11040
NYU Cancer Institute at New York University Medical Center
New York, New York, United States, 10016
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
New York, New York, United States, 10032
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
Stony Brook University Cancer Center
Stony Brook, New York, United States, 11794-9446
SUNY Upstate Medical University Hospital
Syracuse, New York, United States, 13210
New York Medical College
Valhalla, New York, United States, 10595
United States, North Carolina
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, United States, 28233-3549
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
United States, North Dakota
CCOP - MeritCare Hospital
Fargo, North Dakota, United States, 58122
United States, Ohio
Akron Children's Hospital
Akron, Ohio, United States, 44308-1062
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106-5000
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205-2696
Dayton Children's - Dayton
Dayton, Ohio, United States, 45404-1815
Medical University of Ohio Cancer Center
Toledo, Ohio, United States, 43614
Tod Children's Hospital
Youngstown, Ohio, United States, 44501
United States, Oklahoma
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Legacy Emanuel Hospital and Health Center and Children's Hospital
Portland, Oregon, United States, 97227
Knight Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States, 97239-3098
United States, Pennsylvania
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, United States, 18017
Geisinger Cancer Institute at Geisinger Health
Danville, Pennsylvania, United States, 17822-0001
Penn State Children's Hospital
Hershey, Pennsylvania, United States, 17033-0850
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104-9786
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States, 19134-1095
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Rhode Island Hospital Comprehensive Cancer Center
Providence, Rhode Island, United States, 02903
United States, South Carolina
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Greenville Hospital Cancer Center
Greenville, South Carolina, United States, 29605
United States, South Dakota
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, United States, 57117-5039
United States, Tennessee
T.C. Thompson Children's Hospital
Chattanooga, Tennessee, United States, 37403
East Tennessee Children's Hospital
Knoxville, Tennessee, United States, 37901
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
United States, Texas
Texas Tech University Health Sciences Center School of Medicine - Amarillo
Amarillo, Texas, United States, 79106
Driscoll Children's Hospital
Corpus Christi, Texas, United States, 78411
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390
Cook Children's Medical Center - Fort Worth
Fort Worth, Texas, United States, 76104
Baylor University Medical Center - Houston
Houston, Texas, United States, 77030-2399
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78207
Methodist Children's Hospital of South Texas
San Antonio, Texas, United States, 78229-3993
United States, Utah
Primary Children's Medical Center
Salt Lake City, Utah, United States, 84113-1100
United States, Vermont
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, United States, 05401
United States, Virginia
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042-3300
Carilion Medical Center for Children at Roanoke Community Hospital
Roanoke, Virginia, United States, 24014
United States, Washington
Providence Cancer Center at Sacred Heart Medical Center
Spokane, Washington, United States, 99220-2555
United States, West Virginia
West Virginia University Health Sciences Center - Charleston
Charleston, West Virginia, United States, 25302
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54307-3508
Gundersen Lutheran Center for Cancer and Blood
La Crosse, Wisconsin, United States, 54601
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, United States, 54449
Midwest Children's Cancer Center at Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Australia, Western Australia
Princess Margaret Hospital for Children
Perth, Western Australia, Australia, 6001
Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Children's & Women's Hospital of British Columbia
Vancouver, British Columbia, Canada, V6H 3V4
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Newfoundland and Labrador
Janeway Children's Health and Rehabilitation Centre
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada, B3J 3G9
Canada, Ontario
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario, Canada, L8N 3Z5
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
Canada, Quebec
Hopital Sainte Justine
Montreal, Quebec, Canada, H3T 1C5
Canada, Saskatchewan
Allan Blair Cancer Centre at Pasqua Hospital
Regina, Saskatchewan, Canada, S4T 7T1
Saskatoon Cancer Centre at the University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 4H4
Canada
Centre Hospitalier Universitaire de Quebec
Quebec, Canada, G1V 4G2
New Zealand
Starship Children's Health
Auckland, New Zealand, 1
Christchurch Hospital
Christchurch, New Zealand, 8140
Switzerland
Swiss Pediatric Oncology Group Bern
Bern, Switzerland, 3010
Swiss Pediatric Oncology Group Geneva
Geneva, Switzerland, 1205
Swiss Pediatric Oncology Group Lausanne
Lausanne, Switzerland, 1011
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
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Study Chair: Julio C. Barredo, MD University of Miami Miller School of Medicine-Sylvester Cancer Center
Study Chair: Caroline A. Hastings, MD UCSF Benioff Children’s Hospital Oakland

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Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00096135     History of Changes
Other Study ID Numbers: AALL02P2
COG-AALL02P2 ( Other Identifier: Children's Oncology Group )
NCI-2011-01623 ( Other Identifier: NCI Trial Identifier )
First Posted: November 9, 2004    Key Record Dates
Results First Posted: August 6, 2015
Last Update Posted: March 21, 2017
Last Verified: February 2017
Keywords provided by Children's Oncology Group:
recurrent childhood acute lymphoblastic leukemia
B-cell childhood acute lymphoblastic leukemia
T-cell childhood acute lymphoblastic leukemia
TdT positive childhood acute lymphoblastic leukemia
Additional relevant MeSH terms:
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Precursor Cell Lymphoblastic Leukemia-Lymphoma
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Leukemia
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Calcium, Dietary
Cytarabine
Dexamethasone
Dexamethasone acetate
Cyclophosphamide
Methotrexate
Etoposide
Etoposide phosphate
Vincristine
Daunorubicin
Asparaginase
Mercaptopurine
Pegaspargase
BB 1101
Lenograstim
Calcium
Levoleucovorin