Trial record 1 of 1 for:    COG AALL0631
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Combination Chemotherapy With or Without Lestaurtinib in Treating Infants With Newly Diagnosed Acute Lymphoblastic Leukemia

This study is currently recruiting participants.
Verified February 2014 by Children's Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00557193
First received: November 9, 2007
Last updated: February 5, 2014
Last verified: February 2014
  Purpose

This phase III trial is studying giving lestaurtinib together with combination chemotherapy to see how well it works compared to combination chemotherapy alone in treating infants with newly diagnosed acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of stop cancer cells, either by killing the cells or by stopping them from dividing. Lestaurtinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving more than one drug (combination chemotherapy) together with lestaurtinib may kill more cancer cells.


Condition Intervention Phase
Acute Undifferentiated Leukemia
T-cell Childhood Acute Lymphoblastic Leukemia
Untreated Childhood Acute Lymphoblastic Leukemia
Drug: asparaginase
Drug: daunorubicin hydrochloride
Drug: lestaurtinib
Drug: cyclophosphamide
Drug: pegaspargase
Drug: prednisone
Drug: methylprednisolone
Drug: dexamethasone
Drug: cytarabine
Drug: methotrexate
Biological: filgrastim
Drug: leucovorin calcium
Drug: etoposide
Drug: mercaptopurine
Drug: vincristine sulfate
Drug: hydrocortisone sodium succinate
Other: laboratory biomarker analysis
Other: pharmacological study
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Study of Risk Directed Therapy for Infants With Acute Lymphoblastic Leukemia (ALL): Randomization of Highest Risk Infants to Intensive Chemotherapy +/- FLT3 Inhibition (CEP-701, Lestaurtinib; IND #76431; NSC#617807)

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Event-free survival of MLL-R infants randomized to a modified P9407 backbone with or without lestaurtinib [ Time Frame: At 3 years ] [ Designated as safety issue: No ]
    All randomized patients will be included in the intent-to-treat efficacy analyses. Event-free survival time will be calculated from the time of randomization, which is just prior to beginning Induction Intensification.


Secondary Outcome Measures:
  • Safe, tolerable, and biologically active dose of lestaurtinib as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 10 years ] [ Designated as safety issue: Yes ]
    Lestaurtinib-related dose limiting toxicity (DLT) is defined as any grade 4 non-hematologic (i.e., excluding blood/bone marrow) toxicity that occurs after the first dose of lestaurtinib and is at least possibly related to lestaurtinib. Any grade 3 non-hematologic (i.e., excluding blood/bone marrow) toxicity that occurs after the first dose of lestaurtinib, is at least possibly attributable to lestaurtinib and results in omission or delay of the beginning of the subsequent course of chemotherapy for greater than 7 days.

  • Pharmacokinetic profile of lestaurtinib by plasma inhibitory activity (PIA) assay [ Time Frame: At baseline and during weeks 6-9 and 10-12 of lestaurinib treatment ] [ Designated as safety issue: No ]
    Cells (FLT3/ITD) incubated with plasma are washed, lysed, and analyzed for FLT3 phosphorylation by FLT3 immunoprecipitation and sequential immunoblotting with 4G10 anti-phosphotyrosine antibody and anti-FLT3 antibody. Densitometric analysis will be used to calculate the PIA (the percent inhibition of FLT3 phosphorylation of each timepoint relative to the pre-treatment sample). These results will be used to determine whether a given dose of lestaurtinib is biologically active.


Estimated Enrollment: 315
Study Start Date: January 2008
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (Post-induction chemotherapy A)
Patients receive induction therapy (weeks 1-5) comprising vincristine sulfate (VCR) IV; daunorubicin hydrochloride (DNR) IV; cyclophosphamide (CPM) IV; pegaspargase (PEG) or asparaginase (ASP) IM; prednisone (PED) PO or methylprednisolone IV; dexamethasone (DEX) IV or PO; cytarabine (ARAC) IV; methotrexate (MTX), ARAC, and hydrocortisone sodium succinate (HC) IT [triple IT chemotherapy]; and filgrastim IV or SC. Patients then receive post-induction therapy A comprising high-dose (HD) MTX; triple IT chemotherapy; leucovorin calcium IV; CPM; etoposide IV, VCR; DNR; PEG and ASP; DEX; HD ARAC; mercaptopurine PO; and filgrastim IV or SC for up to 104 weeks.
Drug: asparaginase
Given IV, IM, or PO
Other Names:
  • ASNase
  • Colaspase
  • Crasnitin
  • Elspar
  • L-ASP
Drug: daunorubicin hydrochloride
Given IV
Other Names:
  • Cerubidin
  • Cerubidine
  • daunomycin hydrochloride
  • daunorubicin
  • RP-13057
Drug: cyclophosphamide
Given IV
Other Names:
  • CPM
  • CTX
  • Cytoxan
  • Endoxan
  • Endoxana
Drug: pegaspargase
Given IM
Other Names:
  • L-asparaginase with polyethylene glycol
  • Oncaspar
  • PEG-ASP
  • PEG-L-asparaginase
Drug: prednisone
Given PO
Other Names:
  • DeCortin
  • Deltra
Drug: methylprednisolone
Given IV
Other Names:
  • Depo-Medrol
  • Medrol
  • MePRDL
  • Solu-Medrol
  • Wyacort
Drug: dexamethasone
Given IV or PO
Other Names:
  • Aeroseb-Dex
  • Decaderm
  • Decadron
  • DM
  • DXM
Drug: cytarabine
Given IV or IT
Other Names:
  • ARA-C
  • arabinofuranosylcytosine
  • arabinosylcytosine
  • Cytosar-U
  • cytosine arabinoside
Drug: methotrexate
Given IV, IT, or PO
Other Names:
  • amethopterin
  • Folex
  • methylaminopterin
  • Mexate
  • MTX
Biological: filgrastim
Given IV or SC
Other Names:
  • G-CSF
  • Neupogen
Drug: leucovorin calcium
Given IV
Other Names:
  • CF
  • CFR
  • LV
Drug: etoposide
Given IV
Other Names:
  • EPEG
  • VP-16
  • VP-16-213
Drug: mercaptopurine
Given PO
Other Names:
  • 6-mercaptopurine
  • 6-MP
  • Leukerin
  • MP
Drug: vincristine sulfate
Given IV
Other Names:
  • leurocristine sulfate
  • VCR
  • Vincasar PFS
Drug: hydrocortisone sodium succinate
Given IT
Other Names:
  • Sodium hydrocortisone succinate
  • Solu-Cortef
  • Solu-Glyc
Other: laboratory biomarker analysis
Correlative studies
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Active Comparator: Treatment (Post-induction chemotherapy B)
Patients receive induction therapy (weeks 1-5) comprising vincristine sulfate (VCR) IV; daunorubicin hydrochloride (DNR) IV; cyclophosphamide (CPM) IV; pegaspargase (PEG) or asparaginase (ASP) IM; prednisone (PED) PO or methylprednisolone IV; dexamethasone (DEX) IV or PO; cytarabine (ARAC) IV; methotrexate (MTX), ARAC, and hydrocortisone sodium succinate (HC) IT [triple IT chemotherapy]; and filgrastim IV or SC. Patients then receive post-induction therapy B comprising high-dose (HD) MTX; triple IT chemotherapy; leucovorin calcium IV; CPM; etoposide IV, VCR; DNR; PEG and ASP; DEX; HD ARAC; mercaptopurine PO; and filgrastim IV or SC for up to 104 weeks.
Drug: asparaginase
Given IV, IM, or PO
Other Names:
  • ASNase
  • Colaspase
  • Crasnitin
  • Elspar
  • L-ASP
Drug: daunorubicin hydrochloride
Given IV
Other Names:
  • Cerubidin
  • Cerubidine
  • daunomycin hydrochloride
  • daunorubicin
  • RP-13057
Drug: cyclophosphamide
Given IV
Other Names:
  • CPM
  • CTX
  • Cytoxan
  • Endoxan
  • Endoxana
Drug: pegaspargase
Given IM
Other Names:
  • L-asparaginase with polyethylene glycol
  • Oncaspar
  • PEG-ASP
  • PEG-L-asparaginase
Drug: prednisone
Given PO
Other Names:
  • DeCortin
  • Deltra
Drug: methylprednisolone
Given IV
Other Names:
  • Depo-Medrol
  • Medrol
  • MePRDL
  • Solu-Medrol
  • Wyacort
Drug: dexamethasone
Given IV or PO
Other Names:
  • Aeroseb-Dex
  • Decaderm
  • Decadron
  • DM
  • DXM
Drug: cytarabine
Given IV or IT
Other Names:
  • ARA-C
  • arabinofuranosylcytosine
  • arabinosylcytosine
  • Cytosar-U
  • cytosine arabinoside
Drug: methotrexate
Given IV, IT, or PO
Other Names:
  • amethopterin
  • Folex
  • methylaminopterin
  • Mexate
  • MTX
Biological: filgrastim
Given IV or SC
Other Names:
  • G-CSF
  • Neupogen
Drug: leucovorin calcium
Given IV
Other Names:
  • CF
  • CFR
  • LV
Drug: etoposide
Given IV
Other Names:
  • EPEG
  • VP-16
  • VP-16-213
Drug: mercaptopurine
Given PO
Other Names:
  • 6-mercaptopurine
  • 6-MP
  • Leukerin
  • MP
Drug: vincristine sulfate
Given IV
Other Names:
  • leurocristine sulfate
  • VCR
  • Vincasar PFS
Drug: hydrocortisone sodium succinate
Given IT
Other Names:
  • Sodium hydrocortisone succinate
  • Solu-Cortef
  • Solu-Glyc
Other: laboratory biomarker analysis
Correlative studies
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Experimental: Treatment (Post-induction chemotherapy C)
Patients receive induction therapy (weeks 1-5) comprising vincristine sulfate (VCR) IV; daunorubicin hydrochloride (DNR) IV; cyclophosphamide (CPM) IV; pegaspargase (PEG) or asparaginase (ASP) IM; prednisone (PED) PO or methylprednisolone IV; dexamethasone (DEX) IV or PO; cytarabine (ARAC) IV; methotrexate (MTX), ARAC, and hydrocortisone sodium succinate (HC) IT [triple IT chemotherapy]; and filgrastim IV or SC. Patients then receive post-induction therapy C comprising high-dose (HD) MTX; lestaurtinib PO; triple IT chemotherapy; leucovorin calcium IV; CPM; etoposide IV, VCR; DNR; PEG and ASP; DEX; HD ARAC; mercaptopurine PO; and filgrastim IV or SC for up to 104 weeks.
Drug: asparaginase
Given IV, IM, or PO
Other Names:
  • ASNase
  • Colaspase
  • Crasnitin
  • Elspar
  • L-ASP
Drug: daunorubicin hydrochloride
Given IV
Other Names:
  • Cerubidin
  • Cerubidine
  • daunomycin hydrochloride
  • daunorubicin
  • RP-13057
Drug: lestaurtinib
Given PO
Other Names:
  • CEP 701
  • CEP-701
  • KT-5555
Drug: cyclophosphamide
Given IV
Other Names:
  • CPM
  • CTX
  • Cytoxan
  • Endoxan
  • Endoxana
Drug: pegaspargase
Given IM
Other Names:
  • L-asparaginase with polyethylene glycol
  • Oncaspar
  • PEG-ASP
  • PEG-L-asparaginase
Drug: prednisone
Given PO
Other Names:
  • DeCortin
  • Deltra
Drug: methylprednisolone
Given IV
Other Names:
  • Depo-Medrol
  • Medrol
  • MePRDL
  • Solu-Medrol
  • Wyacort
Drug: dexamethasone
Given IV or PO
Other Names:
  • Aeroseb-Dex
  • Decaderm
  • Decadron
  • DM
  • DXM
Drug: cytarabine
Given IV or IT
Other Names:
  • ARA-C
  • arabinofuranosylcytosine
  • arabinosylcytosine
  • Cytosar-U
  • cytosine arabinoside
Drug: methotrexate
Given IV, IT, or PO
Other Names:
  • amethopterin
  • Folex
  • methylaminopterin
  • Mexate
  • MTX
Biological: filgrastim
Given IV or SC
Other Names:
  • G-CSF
  • Neupogen
Drug: leucovorin calcium
Given IV
Other Names:
  • CF
  • CFR
  • LV
Drug: etoposide
Given IV
Other Names:
  • EPEG
  • VP-16
  • VP-16-213
Drug: mercaptopurine
Given PO
Other Names:
  • 6-mercaptopurine
  • 6-MP
  • Leukerin
  • MP
Drug: vincristine sulfate
Given IV
Other Names:
  • leurocristine sulfate
  • VCR
  • Vincasar PFS
Drug: hydrocortisone sodium succinate
Given IT
Other Names:
  • Sodium hydrocortisone succinate
  • Solu-Cortef
  • Solu-Glyc
Other: laboratory biomarker analysis
Correlative studies
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must be enrolled on a COG ALL Classification Study (AALL08B1) prior to enrollment on AALL0631
  • Patients must be newly diagnosed with acute lymphoblastic leukemia (ALL) or acute undifferentiated leukemia (AUL); patients with T-cell ALL are eligible; patients with bilineage or biphenotypic acute leukemia are eligible, provided the morphology and immunophenotype are predominately lymphoid
  • Patients with mature B-cell ALL or acute myelogenous leukemia (AML) are NOT eligible
  • Patients with Down syndrome are NOT eligible
  • Patients receiving prior steroid therapy are eligible for study; any amount of steroid pretreatment will not affect initial Induction assignment as long as the patient meets all other eligibility criteria; IT chemotherapy per protocol is allowed for patient convenience at the time of the diagnostic bone marrow or venous line placement to avoid second lumbar puncture; (Note: the CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment); systemic chemotherapy must begin within 72 hours of this IT therapy
  • All patients and/or their parents or legal guardians must sign a written informed consent
  • All institutional, FDA, and NCI requirements for human studies must be met
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00557193

  Hide Study Locations
Locations
United States, Alabama
Children's Hospital of Alabama Recruiting
Birmingham, Alabama, United States, 35233
Contact: Alyssa T. Reddy    205-934-0309      
Principal Investigator: Alyssa T. Reddy         
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Alyssa T. Reddy    205-934-0309      
Principal Investigator: Alyssa T. Reddy         
United States, Arizona
Phoenix Childrens Hospital Recruiting
Phoenix, Arizona, United States, 85016
Contact: Jessica Boklan    602-546-0920      
Principal Investigator: Jessica Boklan         
United States, Arkansas
University of Arkansas for Medical Sciences Active, not recruiting
Little Rock, Arkansas, United States, 72205
United States, California
Children's Oncology Group Recruiting
Arcadia, California, United States, 91006-3776
Contact: Joanne M. Hilden    720-777-6538    Joanne.Hilden@childrenscolorado.org   
Principal Investigator: Joanne M. Hilden         
Southern California Permanente Medical Group Recruiting
Downey, California, United States, 90242
Contact: Robert M. Cooper    626-564-3455      
Principal Investigator: Robert M. Cooper         
Loma Linda University Medical Center Recruiting
Loma Linda, California, United States, 92354
Contact: Antranik A. Bedros    909-558-3375      
Principal Investigator: Antranik A. Bedros         
Miller Children's Hospital Active, not recruiting
Long Beach, California, United States, 90806
Cedars-Sinai Medical Center Active, not recruiting
Los Angeles, California, United States, 90048
Children's Hospital Central California Recruiting
Madera, California, United States, 93636-8762
Contact: Vonda L. Crouse    866-353-5437      
Principal Investigator: Vonda L. Crouse         
Kaiser Permanente-Oakland Recruiting
Oakland, California, United States, 94611
Contact: Steven K. Bergstrom    626-564-3455      
Principal Investigator: Steven K. Bergstrom         
Children's Hospital and Research Center at Oakland Recruiting
Oakland, California, United States, 94609-1809
Contact: Carla B. Golden    510-450-7600      
Principal Investigator: Carla B. Golden         
Childrens Hospital of Orange County Recruiting
Orange, California, United States, 92868-3874
Contact: Violet Shen    714-997-3000      
Principal Investigator: Violet Shen         
Lucile Packard Children's Hospital Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Neyssa M. Marina    650-498-7061    clinicaltrials@med.stanford.edu   
Principal Investigator: Neyssa M. Marina         
UC Davis Comprehensive Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Jay Michael S. Balagtas    916-734-3089      
Principal Investigator: Jay Michael S. Balagtas         
Rady Children's Hospital - San Diego Recruiting
San Diego, California, United States, 92123
Contact: William D. Roberts    858-966-5934      
Principal Investigator: William D. Roberts         
University of California San Francisco Medical Center-Parnassus Recruiting
San Francisco, California, United States, 94143
Contact: Mignon L. Loh    877-827-3222      
Principal Investigator: Mignon L. Loh         
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Kelly W. Maloney    720-777-6672      
Principal Investigator: Kelly W. Maloney         
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Recruiting
Denver, Colorado, United States, 80218
Contact: Jennifer J. Clark    866-775-6246      
Principal Investigator: Jennifer J. Clark         
United States, Connecticut
Connecticut Children's Medical Center Recruiting
Hartford, Connecticut, United States, 06106
Contact: Michael S. Isakoff    860-545-9981      
Principal Investigator: Michael S. Isakoff         
Yale University Recruiting
New Haven, Connecticut, United States, 06520-8032
Contact: Nina S. Kadan-Lottick    203-785-5702      
Principal Investigator: Nina S. Kadan-Lottick         
United States, Delaware
Alfred I duPont Hospital for Children Recruiting
Wilmington, Delaware, United States, 19803
Contact: Christopher N. Frantz    302-651-5755      
Principal Investigator: Christopher N. Frantz         
United States, District of Columbia
Children's National Medical Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Jeffrey S. Dome    202-884-2549      
Principal Investigator: Jeffrey S. Dome         
Lombardi Comprehensive Cancer Center at Georgetown University Active, not recruiting
Washington, District of Columbia, United States, 20057
United States, Florida
Lee Memorial Health System Recruiting
Fort Myers, Florida, United States, 33901
Contact: Emad K. Salman    239-343-5333      
Principal Investigator: Emad K. Salman         
University of Florida Active, not recruiting
Gainesville, Florida, United States, 32610
Nemours Children's Clinic - Jacksonville Recruiting
Jacksonville, Florida, United States, 32207-8426
Contact: Eric S. Sandler    904-697-3529      
Principal Investigator: Eric S. Sandler         
University of Miami Miller School of Medicine-Sylvester Cancer Center Active, not recruiting
Miami, Florida, United States, 33136
Baptist Hospital of Miami Active, not recruiting
Miami, Florida, United States, 33176
M D Anderson Cancer Center- Orlando Recruiting
Orlando, Florida, United States, 32806
Contact: Vincent F. Giusti    321-841-7246      
Principal Investigator: Vincent F. Giusti         
Florida Hospital Recruiting
Orlando, Florida, United States, 32803
Contact: Clifford A. Selsky    407-303-5623      
Principal Investigator: Clifford A. Selsky         
Nemours Childrens Clinic - Orlando Recruiting
Orlando, Florida, United States, 32806
Contact: Ramamoorthy Nagasubramanian    407-650-7150      
Principal Investigator: Ramamoorthy Nagasubramanian         
Nemours Children's Clinic - Pensacola Recruiting
Pensacola, Florida, United States, 32504
Contact: Jeffrey H. Schwartz    904-697-3529      
Principal Investigator: Jeffrey H. Schwartz         
All Children's Hospital Recruiting
Saint Petersburg, Florida, United States, 33701
Contact: Gregory A. Hale    727-767-2423    HamblinF@allkids.org   
Principal Investigator: Gregory A. Hale         
Saint Joseph Children's Hospital of Tampa Recruiting
Tampa, Florida, United States, 33607
Contact: Hardeo K. Panchoosingh    800-882-4123      
Principal Investigator: Hardeo K. Panchoosingh         
Saint Mary's Hospital Recruiting
West Palm Beach, Florida, United States, 33407
Contact: Narayana Gowda    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Narayana Gowda         
United States, Georgia
Children's Healthcare of Atlanta - Egleston Recruiting
Atlanta, Georgia, United States, 30322
Contact: Howard M. Katzenstein    888-785-1112      
Principal Investigator: Howard M. Katzenstein         
Memorial Health University Medical Center Recruiting
Savannah, Georgia, United States, 31403
Contact: J. Martin Johnston    912-350-8568      
Principal Investigator: J. Martin Johnston         
United States, Hawaii
University of Hawaii Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Robert W. Wilkinson    808-983-6090      
Principal Investigator: Robert W. Wilkinson         
United States, Idaho
Saint Luke's Mountain States Tumor Institute Recruiting
Boise, Idaho, United States, 83712
Contact: Eugenia Chang    800-845-4624      
Principal Investigator: Eugenia Chang         
United States, Illinois
University of Illinois Recruiting
Chicago, Illinois, United States, 60612
Contact: Mary L. Schmidt    312-355-3046      
Principal Investigator: Mary L. Schmidt         
University of Chicago Comprehensive Cancer Center Active, not recruiting
Chicago, Illinois, United States, 60637-1470
Childrens Memorial Hospital Recruiting
Chicago, Illinois, United States, 60614
Contact: David O. Walterhouse    773-880-4562      
Principal Investigator: David O. Walterhouse         
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Ricarchito B. Manera    708-226-4357      
Principal Investigator: Ricarchito B. Manera         
Advocate Hope Children's Hospital Active, not recruiting
Oak Lawn, Illinois, United States, 60453
Advocate Lutheran General Hospital Active, not recruiting
Park Ridge, Illinois, United States, 60068
United States, Indiana
Riley Hospital for Children Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Robert J. Fallon    317-274-2552      
Principal Investigator: Robert J. Fallon         
Saint Vincent Hospital and Health Services Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Bassem I. Razzouk    317-338-2194      
Principal Investigator: Bassem I. Razzouk         
United States, Iowa
Raymond Blank Children's Hospital Recruiting
Des Moines, Iowa, United States, 50309
Contact: Wendy L. Woods-Swafford    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Wendy L. Woods-Swafford         
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Contact: Martha F. Greenwood    859-257-3379      
Principal Investigator: Martha F. Greenwood         
Kosair Children's Hospital Recruiting
Louisville, Kentucky, United States, 40202
Contact: Salvatore J. Bertolone    866-530-5516      
Principal Investigator: Salvatore J. Bertolone         
United States, Louisiana
Children's Hospital-Main Campus Active, not recruiting
New Orleans, Louisiana, United States, 70118
Tulane University Health Sciences Center Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Tammuella C. Singleton    504-988-6121      
Principal Investigator: Tammuella C. Singleton         
United States, Maine
Eastern Maine Medical Center Recruiting
Bangor, Maine, United States, 04401
Contact: Sarah J. Fryberger    207-973-4274      
Principal Investigator: Sarah J. Fryberger         
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287-8936
Contact: Patrick A. Brown    410-955-8804    jhcccro@jhmi.edu   
Principal Investigator: Patrick A. Brown         
Sinai Hospital of Baltimore Recruiting
Baltimore, Maryland, United States, 21215
Contact: Joseph M. Wiley    410-601-6120    pridgely@lifebridgehealth.org   
Principal Investigator: Joseph M. Wiley         
University of Maryland Greenebaum Cancer Center Recruiting
Baltimore, Maryland, United States, 21201-1595
Contact: Teresa A. York    800-888-8823      
Principal Investigator: Teresa A. York         
United States, Massachusetts
Floating Hospital for Children at Tufts Medical Center Active, not recruiting
Boston, Massachusetts, United States, 02111
United States, Michigan
C S Mott Children's Hospital Active, not recruiting
Ann Arbor, Michigan, United States, 48109
Wayne State University Recruiting
Detroit, Michigan, United States, 48202
Contact: Jeffrey W. Taub    313-576-9363      
Principal Investigator: Jeffrey W. Taub         
Hurley Medical Center Recruiting
Flint, Michigan, United States, 48502
Contact: Susumu Inoue    888-606-6556      
Principal Investigator: Susumu Inoue         
Helen DeVos Children's Hospital at Spectrum Health Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: David S. Dickens    616-267-1925      
Principal Investigator: David S. Dickens         
Bronson Methodist Hospital Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Jeffrey S. Lobel    800-227-2345      
Principal Investigator: Jeffrey S. Lobel         
Kalamazoo Center for Medical Studies Recruiting
Kalamazoo, Michigan, United States, 49008
Contact: Jeffrey S. Lobel    800-227-2345      
Principal Investigator: Jeffrey S. Lobel         
Michigan State University - Breslin Cancer Center Recruiting
Lansing, Michigan, United States, 48910
Contact: Renuka Gera    517-334-2765      
Principal Investigator: Renuka Gera         
United States, Minnesota
Children's Hospitals and Clinics of Minnesota - Minneapolis Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Bruce C. Bostrom    612-813-5193      
Principal Investigator: Bruce C. Bostrom         
University of Minnesota Medical Center-Fairview Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Michael J. Burke    612-624-2620      
Principal Investigator: Michael J. Burke         
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Vilmarie Rodriguez    507-538-7623      
Principal Investigator: Vilmarie Rodriguez         
United States, Mississippi
University of Mississippi Medical Center Active, not recruiting
Jackson, Mississippi, United States, 39216
United States, Missouri
University of Missouri-Columbia Recruiting
Columbia, Missouri, United States, 65212
Contact: Thomas W. Loew    573-882-7440      
Principal Investigator: Thomas W. Loew         
The Childrens Mercy Hospital Active, not recruiting
Kansas City, Missouri, United States, 64108
Saint John's Mercy Medical Center Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Bethany G. Sleckman    913-948-5588      
Principal Investigator: Bethany G. Sleckman         
United States, Nevada
Nevada Cancer Research Foundation CCOP Recruiting
Las Vegas, Nevada, United States, 89106
Contact: Jonathan Bernstein    702-384-0013      
Principal Investigator: Jonathan Bernstein         
United States, New Hampshire
Dartmouth Hitchcock Medical Center Active, not recruiting
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Burton E. Appel    201-996-2879      
Principal Investigator: Burton E. Appel         
Saint Barnabas Medical Center Active, not recruiting
Livingston, New Jersey, United States, 07039
Morristown Memorial Hospital Recruiting
Morristown, New Jersey, United States, 07962
Contact: Steven L. Halpern    973-971-5900      
Principal Investigator: Steven L. Halpern         
UMDNJ - Robert Wood Johnson University Hospital Active, not recruiting
New Brunswick, New Jersey, United States, 08903
Saint Peter's University Hospital Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Stanley Calderwood    732-745-8600 ext 6163    kcovert@saintpetersuh.com   
Principal Investigator: Stanley Calderwood         
Newark Beth Israel Medical Center Active, not recruiting
Newark, New Jersey, United States, 07112
Saint Joseph's Regional Medical Center Recruiting
Paterson, New Jersey, United States, 07503
Contact: Mary A. Bonilla    973-754-2909      
Principal Investigator: Mary A. Bonilla         
Overlook Hospital Recruiting
Summit, New Jersey, United States, 07902
Contact: Steven L. Halpern    973-971-5900      
Principal Investigator: Steven L. Halpern         
United States, New Mexico
University of New Mexico Cancer Center Active, not recruiting
Albuquerque, New Mexico, United States, 87106
United States, New York
Albany Medical Center Recruiting
Albany, New York, United States, 12208
Contact: Vikramjit S. Kanwar    518-262-3368      
Principal Investigator: Vikramjit S. Kanwar         
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467-2490
Contact: Peter D. Cole    718-904-2730    aecc@aecom.yu.edu   
Principal Investigator: Peter D. Cole         
Roswell Park Cancer Institute Active, not recruiting
Buffalo, New York, United States, 14263
Winthrop University Hospital Active, not recruiting
Mineola, New York, United States, 11501
The Steven and Alexandra Cohen Children's Medical Center of New York Recruiting
New Hyde Park, New York, United States, 11040
Contact: Arlene S. Redner    718-470-3470      
Principal Investigator: Arlene S. Redner         
New York University Langone Medical Center Recruiting
New York, New York, United States, 10016
Contact: Elizabeth A. Raetz    212-263-4434    prmc.coordinator@nyumc.org   
Principal Investigator: Elizabeth A. Raetz         
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Jeffrey R. Andolina    585-275-5830      
Principal Investigator: Jeffrey R. Andolina         
State University of New York Upstate Medical University Recruiting
Syracuse, New York, United States, 13210
Contact: Karol H. Kerr    315-464-5476      
Principal Investigator: Karol H. Kerr         
New York Medical College Active, not recruiting
Valhalla, New York, United States, 10595
United States, North Carolina
Mission Hospitals Inc Recruiting
Asheville, North Carolina, United States, 28801
Contact: Krystal S. Bottom    828-213-4150      
Principal Investigator: Krystal S. Bottom         
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Stuart H. Gold    877-668-0683      
Principal Investigator: Stuart H. Gold         
Presbyterian Hospital Active, not recruiting
Charlotte, North Carolina, United States, 28204
Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Joel A. Kaplan    704-355-2884      
Principal Investigator: Joel A. Kaplan         
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Susan G. Kreissman    888-275-3853      
Principal Investigator: Susan G. Kreissman         
East Carolina University Recruiting
Greenville, North Carolina, United States, 27858
Contact: Mauro Grossi    252-744-2161      
Principal Investigator: Mauro Grossi         
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Thomas W. McLean    336-713-6771      
Principal Investigator: Thomas W. McLean         
United States, North Dakota
Sanford Medical Center-Fargo Recruiting
Fargo, North Dakota, United States, 58122
Contact: Nathan L. Kobrinsky    701-234-6161      
Principal Investigator: Nathan L. Kobrinsky         
United States, Ohio
Children's Hospital Medical Center of Akron Recruiting
Akron, Ohio, United States, 44308
Contact: Steven J. Kuerbitz    330-543-3193      
Principal Investigator: Steven J. Kuerbitz         
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: John P. Perentesis    513-636-2799      
Principal Investigator: John P. Perentesis         
Cleveland Clinic Foundation Active, not recruiting
Cleveland, Ohio, United States, 44195
Rainbow Babies and Childrens Hospital Recruiting
Cleveland, Ohio, United States, 44106
Contact: Yousif (Joe) H. Matloub    216-844-5437      
Principal Investigator: Yousif (Joe) H. Matloub         
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Mark A. Ranalli    614-722-2708      
Principal Investigator: Mark A. Ranalli         
The Children's Medical Center of Dayton Recruiting
Dayton, Ohio, United States, 45404
Contact: Emmett H. Broxson    800-228-4055      
Principal Investigator: Emmett H. Broxson         
The Toledo Hospital/Toledo Children's Hospital Recruiting
Toledo, Ohio, United States, 43606
Contact: Dagmar T. Stein    419-824-1842      
Principal Investigator: Dagmar T. Stein         
Mercy Children's Hospital Recruiting
Toledo, Ohio, United States, 43608
Contact: Rama Jasty    419-251-8210      
Principal Investigator: Rama Jasty         
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Rene Y. McNall-Knapp    405-271-4272    julie-traylor@ouhsc.edu   
Principal Investigator: Rene Y. McNall-Knapp         
United States, Oregon
Legacy Emanuel Children's Hospital Recruiting
Portland, Oregon, United States, 97227
Contact: Janice F. Olson    503-413-2560      
Principal Investigator: Janice F. Olson         
Legacy Emanuel Hospital and Health Center Recruiting
Portland, Oregon, United States, 97227
Contact: Janice F. Olson    503-413-2560      
Principal Investigator: Janice F. Olson         
United States, Pennsylvania
Geisinger Medical Center Active, not recruiting
Danville, Pennsylvania, United States, 17822-2001
Penn State Hershey Children's Hospital Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Lisa M. McGregor    717-531-6012      
Principal Investigator: Lisa M. McGregor         
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Frank M. Balis    215-590-2810      
Principal Investigator: Frank M. Balis         
Saint Christopher's Hospital for Children Recruiting
Philadelphia, Pennsylvania, United States, 19134
Contact: Gregory E. Halligan    215-427-8991      
Principal Investigator: Gregory E. Halligan         
Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Arthur K. Ritchey    412-692-5573      
Principal Investigator: Arthur K. Ritchey         
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Cindy L. Schwartz    401-444-1488      
Principal Investigator: Cindy L. Schwartz         
United States, South Carolina
Palmetto Health Richland Recruiting
Columbia, South Carolina, United States, 29203
Contact: Ronnie W. Neuberg    803-434-3680      
Principal Investigator: Ronnie W. Neuberg         
BI-LO Charities Children's Cancer Center Recruiting
Greenville, South Carolina, United States, 29605
Contact: Nichole L. Bryant    864-241-6251      
Principal Investigator: Nichole L. Bryant         
Greenville Cancer Treatment Center Recruiting
Greenville, South Carolina, United States, 29605
Contact: Cary E. Stroud    864-241-6251      
Principal Investigator: Cary E. Stroud         
United States, South Dakota
Sanford USD Medical Center - Sioux Falls Recruiting
Sioux Falls, South Dakota, United States, 57117-5134
Contact: Kayelyn J. Wagner    605-328-1367      
Principal Investigator: Kayelyn J. Wagner         
United States, Tennessee
East Tennessee Childrens Hospital Active, not recruiting
Knoxville, Tennessee, United States, 37916
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Haydar A. Frangoul    800-811-8480      
Principal Investigator: Haydar A. Frangoul         
United States, Texas
Texas Tech University Health Science Center-Amarillo Recruiting
Amarillo, Texas, United States, 79106
Contact: Osvaldo Regueira    806-354-5411      
Principal Investigator: Osvaldo Regueira         
Dell Children's Medical Center of Central Texas Recruiting
Austin, Texas, United States, 78723
Contact: Sharon K. Lockhart    512-324-8022      
Principal Investigator: Sharon K. Lockhart         
Driscoll Children's Hospital Recruiting
Corpus Christi, Texas, United States, 78411
Contact: M. C. Johnson    361-694-5311      
Principal Investigator: M. C. Johnson         
Medical City Dallas Hospital Recruiting
Dallas, Texas, United States, 75230
Contact: Carl Lenarsky    972-566-5588      
Principal Investigator: Carl Lenarsky         
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Naomi J. Winick    214-648-7097      
Principal Investigator: Naomi J. Winick         
Cook Children's Medical Center Recruiting
Fort Worth, Texas, United States, 76104
Contact: Mary Meaghan P. Granger    682-885-2103      
Principal Investigator: Mary Meaghan P. Granger         
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Lisa R. Bomgaars    713-798-1354    burton@bcm.edu   
Principal Investigator: Lisa R. Bomgaars         
Covenant Children's Hospital Active, not recruiting
Lubbock, Texas, United States, 79410
Methodist Children's Hospital of South Texas Active, not recruiting
San Antonio, Texas, United States, 78229
University of Texas Health Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78229-3900
Contact: Anne-Marie R. Langevin    210-567-0653    che@uthscsa.edu   
Principal Investigator: Anne-Marie R. Langevin         
Scott and White Memorial Hospital Recruiting
Temple, Texas, United States, 76508
Contact: Guy H. Grayson    254-724-5407      
Principal Investigator: Guy H. Grayson         
United States, Utah
Primary Children's Medical Center Recruiting
Salt Lake City, Utah, United States, 84113
Contact: Phillip E. Barnette    801-585-5270      
Principal Investigator: Phillip E. Barnette         
United States, Vermont
University of Vermont Recruiting
Burlington, Vermont, United States, 05401
Contact: Alan C. Homans    802-656-8990      
Principal Investigator: Alan C. Homans         
United States, Virginia
Inova Fairfax Hospital Recruiting
Falls Church, Virginia, United States, 22042
Contact: Marshall A. Schorin    703-208-6650      
Principal Investigator: Marshall A. Schorin         
Childrens Hospital-King's Daughters Recruiting
Norfolk, Virginia, United States, 23507
Contact: Eric J. Lowe    757-668-7243      
Principal Investigator: Eric J. Lowe         
United States, Washington
Providence Sacred Heart Medical Center and Children's Hospital Active, not recruiting
Spokane, Washington, United States, 99204
Mary Bridge Children's Hospital and Health Center Recruiting
Tacoma, Washington, United States, 98405
Contact: Robert G. Irwin    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Robert G. Irwin         
Madigan Army Medical Center Recruiting
Tacoma, Washington, United States, 98431
Contact: Melissa A. Forouhar    253-968-0129    mamcdci@amedd.army.mil   
Principal Investigator: Melissa A. Forouhar         
United States, West Virginia
West Virginia University Charleston Recruiting
Charleston, West Virginia, United States, 25304
Contact: Allen R. Chauvenet    304-388-9944      
Principal Investigator: Allen R. Chauvenet         
United States, Wisconsin
Saint Vincent Hospital Recruiting
Green Bay, Wisconsin, United States, 54301
Contact: John R. Hill    920-433-8889      
Principal Investigator: John R. Hill         
University of Wisconsin Hospital and Clinics Active, not recruiting
Madison, Wisconsin, United States, 53792
Marshfield Clinic Recruiting
Marshfield, Wisconsin, United States, 54449
Contact: Michael J. McManus    715-389-4457      
Principal Investigator: Michael J. McManus         
Midwest Children's Cancer Center Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Michael E. Kelly    414-805-4380      
Principal Investigator: Michael E. Kelly         
Australia, Western Australia
Princess Margaret Hospital for Children Recruiting
Perth, Western Australia, Australia, 6008
Contact: Catherine H. Cole    (08) 9340 8330    admin@childcancerresearch.com.au   
Principal Investigator: Catherine H. Cole         
Canada, Alberta
Alberta Children's Hospital Active, not recruiting
Calgary, Alberta, Canada, T3B 6A8
University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Sunil Jayantilal` S. Desai    780-407-6615    val.taylor@albertahealthservices.ca   
Principal Investigator: Sunil Jayantilal` S. Desai         
Canada, British Columbia
British Columbia Children's Hospital Active, not recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Canada, Manitoba
CancerCare Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Contact: Rochelle A. Yanofsky    866-561-1026    CIO_Web@cancercare.mb.ca   
Principal Investigator: Rochelle A. Yanofsky         
Canada, Newfoundland and Labrador
Janeway Child Health Centre Active, not recruiting
Saint John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
IWK Health Centre Recruiting
Halifax, Nova Scotia, Canada, B3J 3G9
Contact: Margaret C. Yhap    902-470-8394      
Principal Investigator: Margaret C. Yhap         
Canada, Ontario
Children's Hospital Active, not recruiting
London, Ontario, Canada, N6A 5W9
Children's Hospital of Eastern Ontario Active, not recruiting
Ottawa, Ontario, Canada, K1H 8L1
Hospital for Sick Children Active, not recruiting
Toronto, Ontario, Canada, M5G 1X8
Canada, Quebec
The Montreal Children's Hospital of the MUHC Recruiting
Montreal, Quebec, Canada, H3H 1P3
Contact: Sharon B. Abish    514-412-4445    info@thechildren.com   
Principal Investigator: Sharon B. Abish         
Canada, Saskatchewan
Saskatoon Cancer Centre Active, not recruiting
Saskatoon, Saskatchewan, Canada, S7N 4H4
New Zealand
Starship Children's Hospital Recruiting
Grafton, Auckland, New Zealand, 1145
Contact: Nyree O. Cole    0800 728 436      
Principal Investigator: Nyree O. Cole         
Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Joanne Hilden, MD Children's Oncology Group
  More Information

No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00557193     History of Changes
Other Study ID Numbers: AALL0631, NCI-2009-00313, COG-AALL0631, CDR0000573996, U10CA098543
Study First Received: November 9, 2007
Last Updated: February 5, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, Myeloid
6-Mercaptopurine
Cytarabine
Methotrexate
Cyclophosphamide
Etoposide phosphate
Pegaspargase
Asparaginase
Daunorubicin
Dexamethasone
Etoposide
Methylprednisolone Hemisuccinate
Prednisolone
Prednisone
Vincristine
BB 1101
Lenograstim
Dexamethasone acetate
Cortisol succinate
Hydrocortisone acetate

ClinicalTrials.gov processed this record on April 23, 2014