Risk-Adapted Chemotherapy in Treating Younger Patients With Newly Diagnosed Standard-Risk Acute Lymphoblastic Leukemia or Localized B-Lineage Lymphoblastic Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2015 by Children's Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01190930
First received: August 27, 2010
Last updated: August 6, 2015
Last verified: August 2015
  Purpose

This partially randomized phase III trial studies different combinations of risk-adapted chemotherapy regimens and their side effects and comparing how well they work in treating younger patients with newly diagnosed standard-risk acute lymphoblastic leukemia or B-lineage lymphoblastic lymphoma that is found only in the tissue or organ where it began (localized). Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy), giving the drugs in different doses, and giving the drugs in different combinations may kill more cancer cells.


Condition Intervention Phase
Adult B Lymphoblastic Lymphoma
Childhood B Acute Lymphoblastic Leukemia
Childhood B Acute Lymphoblastic Leukemia With t(9;22)(q34;q11.2); BCR-ABL1
Childhood B Lymphoblastic Lymphoma
Down Syndrome
Stage I B Lymphoblastic Lymphoma
Stage II B Lymphoblastic Lymphoma
Untreated Adult Acute Lymphoblastic Leukemia
Untreated Childhood Acute Lymphoblastic Leukemia
Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Dexamethasone
Drug: Doxorubicin Hydrochloride
Other: Laboratory Biomarker Analysis
Drug: Leucovorin Calcium
Drug: Mercaptopurine
Drug: Methotrexate
Drug: Pegaspargase
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
Drug: Thioguanine
Drug: Vincristine Sulfate
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: Treatment of Patients With Newly Diagnosed Standard Risk B-Lymphoblastic Leukemia (B-ALL) or Localized B-Lineage Lymphoblastic Lymphoma (B-LLy)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Determination of whether less intensive therapy will maintain DFS >= 95% for LR patients randomized to 1 of 2 low-intensity regimens [ Time Frame: Time from end of Induction to first event (relapse, second malignancy, remission death) or date of last contact, assessed up to 5 years ] [ Designated as safety issue: No ]
    The 5-year DFS for these patients will be estimated on the 2 low intensity regimens. Interim analysis based on the estimated hazard rate will also be conducted, for each of the 2 low intensity regimens to protect against lower DFS for the LR patients.

  • Determination of whether the 5-year DFS in AR patients is adversely affected by the reduced pulses in maintenance [ Time Frame: Every 4 weeks versus every 8 weeks from the start of reduced pulse maintenance, assessed up to 5 years ] [ Designated as safety issue: No ]
    If it is found that there is a decrease in DFS due to the reduced pulses, comparison of outcomes between the two MTX regimens will be restricted to the every 4 week pulses arms. A Cox proportional hazards model will be used to test for quantitative interaction in this 2x2 factorial design.

  • DFS for B-LLy patients [ Time Frame: Time from end of Induction to first event (relapse, second malignancy, remission death) or date of last contact, assessed up to 5 years ] [ Designated as safety issue: No ]
    EFS rate will be estimated for this group of patients. The 95% confidence interval will be computed for the same. Biology data captured for these patients will be summarized.

  • DFS for Down syndrome patients [ Time Frame: Time from end of Induction to first event (relapse, second malignancy, remission death) or date of last contact, assessed up to 5 years ] [ Designated as safety issue: No ]
    The 5-year DFS for these patients will be estimated on modified therapy.

  • Improvement in DFS from 93% to 96% in AR patients based on the methotrexate randomization [ Time Frame: Time from randomization at the end of interim maintenance II to first event (relapse, second malignancy, remission death) or date of last contact, assessed up to 5 years ] [ Designated as safety issue: No ]
    All power calculations are based on the assumption of proportional hazards, and using the log rank test (alpha = 5%) with 5 planned analyses of the data for interim monitoring purposes (MTX question for AR patients). The study will also be monitored for futility.


Secondary Outcome Measures:
  • Burden of therapy in AR patients overall at different time points during and at the end of therapy [ Time Frame: Up to 30 months after beginning of maintenance (off-therapy time point for boys) ] [ Designated as safety issue: No ]
    Assessed by the Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), the Child Vulnerability Scale, and by the Behavior Assessment Scales of Children-Second Edition, Parent Rating Scale (BASC-2 PRS). Standardized scores for the sub-scales of the PedsQL 4.0 will be calculated using age and gender specific normative data.

  • Burden of therapy in AR patients randomized to every 4-week vs every 12-week pulses during maintenance therapy [ Time Frame: Up to 30 months after beginning of Maintenance (off-therapy time point for boys) ] [ Designated as safety issue: No ]
    Assessed by the Pediatric Quality of Life Instrument scores, the Child Vulnerability Scale, and emotional symptoms (measured by the BASC-2 PRS), adjusting for age, gender, and family income. Comparison of differences in means (of the continuous measures) between the 2 randomization groups with 2-sample t-tests will be done. If the continuous data are not normally distributed, a non-parametric statistical measure will be used.


Estimated Enrollment: 9022
Study Start Date: August 2010
Estimated Primary Completion Date: March 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A (risk-adapted chemotherapy)
Patients receive vincristine sulfate IV on days 1, 29, and 57; dexamethasone PO BID on days 1-5, 29-33, and 57-61; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.
Drug: Dexamethasone
Given orally (PO) or IV
Other Names:
  • Aacidexam
  • Adexone
  • Aknichthol Dexa
  • Alba-Dex
  • Alin
  • Alin Depot
  • Alin Oftalmico
  • Amplidermis
  • Anemul mono
  • Auricularum
  • Auxiloson
  • Baycuten
  • Baycuten N
  • Cortidexason
  • Cortisumman
  • Decacort
  • Decadrol
  • Decadron
  • Decalix
  • Decameth
  • Decasone R.p.
  • Dectancyl
  • Dekacort
  • Deltafluorene
  • Deronil
  • Desamethasone
  • Desameton
  • Dexa-Mamallet
  • Dexa-Rhinosan
  • Dexa-Scheroson
  • Dexa-sine
  • Dexacortal
  • Dexacortin
  • Dexafarma
  • Dexafluorene
  • Dexalocal
  • Dexamecortin
  • Dexameth
  • DEXAMETHASONE
  • Dexamethasonum
  • Dexamonozon
  • Dexapos
  • Dexinoral
  • Dexone
  • Dinormon
  • Fluorodelta
  • Fortecortin
  • Gammacorten
  • Hexadecadrol
  • Hexadrol
  • Lokalison-F
  • Loverine
  • Methylfluorprednisolone
  • Millicorten
  • Mymethasone
  • Orgadrone
  • Spersadex
  • Visumetazone
Other: Laboratory Biomarker Analysis
Correlative studies
Drug: Mercaptopurine
Given PO
Other Names:
  • 3H-Purine-6-thiol
  • 6 MP
  • 6 Thiohypoxanthine
  • 6 Thiopurine
  • 6-Mercaptopurine
  • 6-Mercaptopurine Monohydrate
  • 6-MP
  • 6-Purinethiol
  • 6-Thiopurine
  • 6-Thioxopurine
  • 6H-Purine-6-thione, 1,7-dihydro- (9CI)
  • 7-Mercapto-1,3,4,6-tetrazaindene
  • Alti-Mercaptopurine
  • Azathiopurine
  • BW 57-323H
  • Flocofil
  • Ismipur
  • Leukerin
  • Leupurin
  • Mercaleukim
  • Mercaleukin
  • Mercaptina
  • MERCAPTOPURINE
  • Mercaptopurinum
  • Mercapurin
  • Mern
  • NCI-C04886
  • Puri-Nethol
  • Purimethol
  • Purine, 6-mercapto-
  • Purine-6-thiol (8CI)
  • Purine-6-thiol, monohydrate
  • Purinethiol
  • Purinethol
  • U-4748
  • WR-2785
Drug: Methotrexate
Given IT, PO, or IV
Other Names:
  • Abitrexate
  • Alpha-Methopterin
  • Amethopterin
  • Brimexate
  • CL 14377
  • CL-14377
  • Emtexate
  • Emthexat
  • Emthexate
  • Farmitrexat
  • Fauldexato
  • Folex
  • Folex PFS
  • Lantarel
  • Ledertrexate
  • Lumexon
  • Maxtrex
  • Medsatrexate
  • Metex
  • Methoblastin
  • METHOTREXATE
  • Methotrexate LPF
  • Methotrexate Methylaminopterin
  • Methotrexatum
  • Metotrexato
  • Metrotex
  • Mexate
  • Mexate-AQ
  • MTX
  • Novatrex
  • Rheumatrex
  • Texate
  • Tremetex
  • Trexeron
  • Trixilem
  • WR-19039
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Drug: Vincristine Sulfate
Given IV
Other Names:
  • Kyocristine
  • Leurocristine Sulfate
  • Leurocristine, sulfate
  • Oncovin
  • Vincasar
  • Vincosid
  • Vincrex
  • VINCRISTINE SULFATE
  • Vincristine, sulfate
Experimental: Arm B (risk-adapted chemotherapy)
Patients receive vincristine sulfate IV on days 1, 29, and 57; dexamethasone PO BID on days 1-5, 29-33, and 57-61; higher-dose methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.
Drug: Dexamethasone
Given orally (PO) or IV
Other Names:
  • Aacidexam
  • Adexone
  • Aknichthol Dexa
  • Alba-Dex
  • Alin
  • Alin Depot
  • Alin Oftalmico
  • Amplidermis
  • Anemul mono
  • Auricularum
  • Auxiloson
  • Baycuten
  • Baycuten N
  • Cortidexason
  • Cortisumman
  • Decacort
  • Decadrol
  • Decadron
  • Decalix
  • Decameth
  • Decasone R.p.
  • Dectancyl
  • Dekacort
  • Deltafluorene
  • Deronil
  • Desamethasone
  • Desameton
  • Dexa-Mamallet
  • Dexa-Rhinosan
  • Dexa-Scheroson
  • Dexa-sine
  • Dexacortal
  • Dexacortin
  • Dexafarma
  • Dexafluorene
  • Dexalocal
  • Dexamecortin
  • Dexameth
  • DEXAMETHASONE
  • Dexamethasonum
  • Dexamonozon
  • Dexapos
  • Dexinoral
  • Dexone
  • Dinormon
  • Fluorodelta
  • Fortecortin
  • Gammacorten
  • Hexadecadrol
  • Hexadrol
  • Lokalison-F
  • Loverine
  • Methylfluorprednisolone
  • Millicorten
  • Mymethasone
  • Orgadrone
  • Spersadex
  • Visumetazone
Other: Laboratory Biomarker Analysis
Correlative studies
Drug: Mercaptopurine
Given PO
Other Names:
  • 3H-Purine-6-thiol
  • 6 MP
  • 6 Thiohypoxanthine
  • 6 Thiopurine
  • 6-Mercaptopurine
  • 6-Mercaptopurine Monohydrate
  • 6-MP
  • 6-Purinethiol
  • 6-Thiopurine
  • 6-Thioxopurine
  • 6H-Purine-6-thione, 1,7-dihydro- (9CI)
  • 7-Mercapto-1,3,4,6-tetrazaindene
  • Alti-Mercaptopurine
  • Azathiopurine
  • BW 57-323H
  • Flocofil
  • Ismipur
  • Leukerin
  • Leupurin
  • Mercaleukim
  • Mercaleukin
  • Mercaptina
  • MERCAPTOPURINE
  • Mercaptopurinum
  • Mercapurin
  • Mern
  • NCI-C04886
  • Puri-Nethol
  • Purimethol
  • Purine, 6-mercapto-
  • Purine-6-thiol (8CI)
  • Purine-6-thiol, monohydrate
  • Purinethiol
  • Purinethol
  • U-4748
  • WR-2785
Drug: Methotrexate
Given IT, PO, or IV
Other Names:
  • Abitrexate
  • Alpha-Methopterin
  • Amethopterin
  • Brimexate
  • CL 14377
  • CL-14377
  • Emtexate
  • Emthexat
  • Emthexate
  • Farmitrexat
  • Fauldexato
  • Folex
  • Folex PFS
  • Lantarel
  • Ledertrexate
  • Lumexon
  • Maxtrex
  • Medsatrexate
  • Metex
  • Methoblastin
  • METHOTREXATE
  • Methotrexate LPF
  • Methotrexate Methylaminopterin
  • Methotrexatum
  • Metotrexato
  • Metrotex
  • Mexate
  • Mexate-AQ
  • MTX
  • Novatrex
  • Rheumatrex
  • Texate
  • Tremetex
  • Trexeron
  • Trixilem
  • WR-19039
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Drug: Vincristine Sulfate
Given IV
Other Names:
  • Kyocristine
  • Leurocristine Sulfate
  • Leurocristine, sulfate
  • Oncovin
  • Vincasar
  • Vincosid
  • Vincrex
  • VINCRISTINE SULFATE
  • Vincristine, sulfate
Experimental: Arm C (risk-adapted chemotherapy)
Patients receive vincristine sulfate IV on day 1; dexamethasone PO BID on days 1-5; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.
Drug: Dexamethasone
Given orally (PO) or IV
Other Names:
  • Aacidexam
  • Adexone
  • Aknichthol Dexa
  • Alba-Dex
  • Alin
  • Alin Depot
  • Alin Oftalmico
  • Amplidermis
  • Anemul mono
  • Auricularum
  • Auxiloson
  • Baycuten
  • Baycuten N
  • Cortidexason
  • Cortisumman
  • Decacort
  • Decadrol
  • Decadron
  • Decalix
  • Decameth
  • Decasone R.p.
  • Dectancyl
  • Dekacort
  • Deltafluorene
  • Deronil
  • Desamethasone
  • Desameton
  • Dexa-Mamallet
  • Dexa-Rhinosan
  • Dexa-Scheroson
  • Dexa-sine
  • Dexacortal
  • Dexacortin
  • Dexafarma
  • Dexafluorene
  • Dexalocal
  • Dexamecortin
  • Dexameth
  • DEXAMETHASONE
  • Dexamethasonum
  • Dexamonozon
  • Dexapos
  • Dexinoral
  • Dexone
  • Dinormon
  • Fluorodelta
  • Fortecortin
  • Gammacorten
  • Hexadecadrol
  • Hexadrol
  • Lokalison-F
  • Loverine
  • Methylfluorprednisolone
  • Millicorten
  • Mymethasone
  • Orgadrone
  • Spersadex
  • Visumetazone
Other: Laboratory Biomarker Analysis
Correlative studies
Drug: Mercaptopurine
Given PO
Other Names:
  • 3H-Purine-6-thiol
  • 6 MP
  • 6 Thiohypoxanthine
  • 6 Thiopurine
  • 6-Mercaptopurine
  • 6-Mercaptopurine Monohydrate
  • 6-MP
  • 6-Purinethiol
  • 6-Thiopurine
  • 6-Thioxopurine
  • 6H-Purine-6-thione, 1,7-dihydro- (9CI)
  • 7-Mercapto-1,3,4,6-tetrazaindene
  • Alti-Mercaptopurine
  • Azathiopurine
  • BW 57-323H
  • Flocofil
  • Ismipur
  • Leukerin
  • Leupurin
  • Mercaleukim
  • Mercaleukin
  • Mercaptina
  • MERCAPTOPURINE
  • Mercaptopurinum
  • Mercapurin
  • Mern
  • NCI-C04886
  • Puri-Nethol
  • Purimethol
  • Purine, 6-mercapto-
  • Purine-6-thiol (8CI)
  • Purine-6-thiol, monohydrate
  • Purinethiol
  • Purinethol
  • U-4748
  • WR-2785
Drug: Methotrexate
Given IT, PO, or IV
Other Names:
  • Abitrexate
  • Alpha-Methopterin
  • Amethopterin
  • Brimexate
  • CL 14377
  • CL-14377
  • Emtexate
  • Emthexat
  • Emthexate
  • Farmitrexat
  • Fauldexato
  • Folex
  • Folex PFS
  • Lantarel
  • Ledertrexate
  • Lumexon
  • Maxtrex
  • Medsatrexate
  • Metex
  • Methoblastin
  • METHOTREXATE
  • Methotrexate LPF
  • Methotrexate Methylaminopterin
  • Methotrexatum
  • Metotrexato
  • Metrotex
  • Mexate
  • Mexate-AQ
  • MTX
  • Novatrex
  • Rheumatrex
  • Texate
  • Tremetex
  • Trexeron
  • Trixilem
  • WR-19039
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Drug: Vincristine Sulfate
Given IV
Other Names:
  • Kyocristine
  • Leurocristine Sulfate
  • Leurocristine, sulfate
  • Oncovin
  • Vincasar
  • Vincosid
  • Vincrex
  • VINCRISTINE SULFATE
  • Vincristine, sulfate
Experimental: Arm D (risk-adapted chemotherapy)
Patients receive vincristine sulfate IV on day 1; dexamethasone PO BID on days 1-5; higher-dose methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.
Drug: Dexamethasone
Given orally (PO) or IV
Other Names:
  • Aacidexam
  • Adexone
  • Aknichthol Dexa
  • Alba-Dex
  • Alin
  • Alin Depot
  • Alin Oftalmico
  • Amplidermis
  • Anemul mono
  • Auricularum
  • Auxiloson
  • Baycuten
  • Baycuten N
  • Cortidexason
  • Cortisumman
  • Decacort
  • Decadrol
  • Decadron
  • Decalix
  • Decameth
  • Decasone R.p.
  • Dectancyl
  • Dekacort
  • Deltafluorene
  • Deronil
  • Desamethasone
  • Desameton
  • Dexa-Mamallet
  • Dexa-Rhinosan
  • Dexa-Scheroson
  • Dexa-sine
  • Dexacortal
  • Dexacortin
  • Dexafarma
  • Dexafluorene
  • Dexalocal
  • Dexamecortin
  • Dexameth
  • DEXAMETHASONE
  • Dexamethasonum
  • Dexamonozon
  • Dexapos
  • Dexinoral
  • Dexone
  • Dinormon
  • Fluorodelta
  • Fortecortin
  • Gammacorten
  • Hexadecadrol
  • Hexadrol
  • Lokalison-F
  • Loverine
  • Methylfluorprednisolone
  • Millicorten
  • Mymethasone
  • Orgadrone
  • Spersadex
  • Visumetazone
Other: Laboratory Biomarker Analysis
Correlative studies
Drug: Mercaptopurine
Given PO
Other Names:
  • 3H-Purine-6-thiol
  • 6 MP
  • 6 Thiohypoxanthine
  • 6 Thiopurine
  • 6-Mercaptopurine
  • 6-Mercaptopurine Monohydrate
  • 6-MP
  • 6-Purinethiol
  • 6-Thiopurine
  • 6-Thioxopurine
  • 6H-Purine-6-thione, 1,7-dihydro- (9CI)
  • 7-Mercapto-1,3,4,6-tetrazaindene
  • Alti-Mercaptopurine
  • Azathiopurine
  • BW 57-323H
  • Flocofil
  • Ismipur
  • Leukerin
  • Leupurin
  • Mercaleukim
  • Mercaleukin
  • Mercaptina
  • MERCAPTOPURINE
  • Mercaptopurinum
  • Mercapurin
  • Mern
  • NCI-C04886
  • Puri-Nethol
  • Purimethol
  • Purine, 6-mercapto-
  • Purine-6-thiol (8CI)
  • Purine-6-thiol, monohydrate
  • Purinethiol
  • Purinethol
  • U-4748
  • WR-2785
Drug: Methotrexate
Given IT, PO, or IV
Other Names:
  • Abitrexate
  • Alpha-Methopterin
  • Amethopterin
  • Brimexate
  • CL 14377
  • CL-14377
  • Emtexate
  • Emthexat
  • Emthexate
  • Farmitrexat
  • Fauldexato
  • Folex
  • Folex PFS
  • Lantarel
  • Ledertrexate
  • Lumexon
  • Maxtrex
  • Medsatrexate
  • Metex
  • Methoblastin
  • METHOTREXATE
  • Methotrexate LPF
  • Methotrexate Methylaminopterin
  • Methotrexatum
  • Metotrexato
  • Metrotex
  • Mexate
  • Mexate-AQ
  • MTX
  • Novatrex
  • Rheumatrex
  • Texate
  • Tremetex
  • Trexeron
  • Trixilem
  • WR-19039
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Drug: Vincristine Sulfate
Given IV
Other Names:
  • Kyocristine
  • Leurocristine Sulfate
  • Leurocristine, sulfate
  • Oncovin
  • Vincasar
  • Vincosid
  • Vincrex
  • VINCRISTINE SULFATE
  • Vincristine, sulfate
Experimental: Arm LR-C (risk-adapted chemotherapy)
Patients receive consolidation, interim maintenance I, delayed intensification, interim maintenance II, and maintenance therapy. See detailed description.
Drug: Cyclophosphamide
Given IV
Other Names:
  • (-)-Cyclophosphamide
  • 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate
  • Carloxan
  • Ciclofosfamida
  • Ciclofosfamide
  • Cicloxal
  • Clafen
  • Claphene
  • CP monohydrate
  • CTX
  • CYCLO-cell
  • Cycloblastin
  • Cycloblastine
  • Cyclophospham
  • Cyclophosphamid monohydrate
  • CYCLOPHOSPHAMIDE
  • Cyclophosphamidum
  • Cyclophosphan
  • Cyclophosphane
  • Cyclophosphanum
  • Cyclostin
  • Cyclostine
  • Cytophosphan
  • Cytophosphane
  • Cytoxan
  • Fosfaseron
  • Genoxal
  • Genuxal
  • Ledoxina
  • Mitoxan
  • Neosar
  • Revimmune
  • Syklofosfamid
  • WR- 138719
Drug: Cytarabine
Given IT, IV, or SC
Other Names:
  • .beta.-Cytosine arabinoside
  • 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone
  • 1-.beta.-D-Arabinofuranosylcytosine
  • 1.beta.-D-Arabinofuranosylcytosine
  • 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-
  • Alexan
  • Ara-C
  • ARA-cell
  • Arabine
  • Arabinofuranosylcytosine
  • Arabinosylcytosine
  • Aracytidine
  • Aracytin
  • Aracytine
  • Beta-Cytosine Arabinoside
  • CHX-3311
  • CYTARABINE
  • Cytarabinum
  • Cytarbel
  • Cytosar
  • Cytosar-U
  • Cytosine Arabinoside
  • Cytosine-.beta.-arabinoside
  • Erpalfa
  • Starasid
  • Tarabine PFS
  • U 19920
  • U-19920
  • Udicil
  • WR-28453
Drug: Dexamethasone
Given orally (PO) or IV
Other Names:
  • Aacidexam
  • Adexone
  • Aknichthol Dexa
  • Alba-Dex
  • Alin
  • Alin Depot
  • Alin Oftalmico
  • Amplidermis
  • Anemul mono
  • Auricularum
  • Auxiloson
  • Baycuten
  • Baycuten N
  • Cortidexason
  • Cortisumman
  • Decacort
  • Decadrol
  • Decadron
  • Decalix
  • Decameth
  • Decasone R.p.
  • Dectancyl
  • Dekacort
  • Deltafluorene
  • Deronil
  • Desamethasone
  • Desameton
  • Dexa-Mamallet
  • Dexa-Rhinosan
  • Dexa-Scheroson
  • Dexa-sine
  • Dexacortal
  • Dexacortin
  • Dexafarma
  • Dexafluorene
  • Dexalocal
  • Dexamecortin
  • Dexameth
  • DEXAMETHASONE
  • Dexamethasonum
  • Dexamonozon
  • Dexapos
  • Dexinoral
  • Dexone
  • Dinormon
  • Fluorodelta
  • Fortecortin
  • Gammacorten
  • Hexadecadrol
  • Hexadrol
  • Lokalison-F
  • Loverine
  • Methylfluorprednisolone
  • Millicorten
  • Mymethasone
  • Orgadrone
  • Spersadex
  • Visumetazone
Drug: Doxorubicin Hydrochloride
Given IV
Other Names:
  • 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)
  • ADM
  • Adriacin
  • Adriamycin
  • Adriamycin Hydrochloride
  • Adriamycin PFS
  • Adriamycin RDF
  • ADRIAMYCIN, HYDROCHLORIDE
  • Adriamycine
  • Adriblastina
  • Adriblastine
  • Adrimedac
  • Chloridrato de Doxorrubicina
  • DOX
  • DOXO-CELL
  • Doxolem
  • DOXORUBICIN HYDROCHLORIDE
  • Doxorubicin.HCl
  • Doxorubin
  • Farmiblastina
  • FI 106
  • FI-106
  • hydroxydaunorubicin
  • Rubex
Other: Laboratory Biomarker Analysis
Correlative studies
Drug: Mercaptopurine
Given PO
Other Names:
  • 3H-Purine-6-thiol
  • 6 MP
  • 6 Thiohypoxanthine
  • 6 Thiopurine
  • 6-Mercaptopurine
  • 6-Mercaptopurine Monohydrate
  • 6-MP
  • 6-Purinethiol
  • 6-Thiopurine
  • 6-Thioxopurine
  • 6H-Purine-6-thione, 1,7-dihydro- (9CI)
  • 7-Mercapto-1,3,4,6-tetrazaindene
  • Alti-Mercaptopurine
  • Azathiopurine
  • BW 57-323H
  • Flocofil
  • Ismipur
  • Leukerin
  • Leupurin
  • Mercaleukim
  • Mercaleukin
  • Mercaptina
  • MERCAPTOPURINE
  • Mercaptopurinum
  • Mercapurin
  • Mern
  • NCI-C04886
  • Puri-Nethol
  • Purimethol
  • Purine, 6-mercapto-
  • Purine-6-thiol (8CI)
  • Purine-6-thiol, monohydrate
  • Purinethiol
  • Purinethol
  • U-4748
  • WR-2785
Drug: Methotrexate
Given IT, PO, or IV
Other Names:
  • Abitrexate
  • Alpha-Methopterin
  • Amethopterin
  • Brimexate
  • CL 14377
  • CL-14377
  • Emtexate
  • Emthexat
  • Emthexate
  • Farmitrexat
  • Fauldexato
  • Folex
  • Folex PFS
  • Lantarel
  • Ledertrexate
  • Lumexon
  • Maxtrex
  • Medsatrexate
  • Metex
  • Methoblastin
  • METHOTREXATE
  • Methotrexate LPF
  • Methotrexate Methylaminopterin
  • Methotrexatum
  • Metotrexato
  • Metrotex
  • Mexate
  • Mexate-AQ
  • MTX
  • Novatrex
  • Rheumatrex
  • Texate
  • Tremetex
  • Trexeron
  • Trixilem
  • WR-19039
Drug: Pegaspargase
Given IV
Other Names:
  • L-Asparaginase with Polyethylene Glycol
  • Oncaspar
  • PEG-Asparaginase
  • PEG-L-Asparaginase
  • PEG-L-Asparaginase (Enzon - Kyowa Hakko)
  • PEGASPARGASE
  • PEGLA
  • Polyethylene Glycol L-Asparaginase
  • Polyethylene Glycol-L-Asparaginase
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Drug: Thioguanine
Given PO
Other Names:
  • 2-Amino 6MP
  • 2-Amino-1,7-dihydro-6H-purine-6-thione
  • 2-Amino-6-mercaptopurine
  • 2-Amino-6-purinethiol
  • 2-Aminopurin-6-thiol
  • 2-Aminopurine-6(1H)-thione
  • 2-Aminopurine-6-thiol
  • 2-Mercapto-6-aminopurine
  • 6-Amino-2-mercaptopurine
  • 6-Mercapto-2-aminopurine
  • 6-Mercaptoguanine
  • 6-TG
  • 6H-Purine-6-thione, 2-amino-1,7-dihydro- (9CI)
  • BW 5071
  • Lanvis
  • Tabloid
  • THIOGUANINE
  • Tioguanin
  • Tioguanine
  • Wellcome U3B
  • WR-1141
  • X 27
Drug: Vincristine Sulfate
Given IV
Other Names:
  • Kyocristine
  • Leurocristine Sulfate
  • Leurocristine, sulfate
  • Oncovin
  • Vincasar
  • Vincosid
  • Vincrex
  • VINCRISTINE SULFATE
  • Vincristine, sulfate
Experimental: Arm LR-M (risk-adapted chemotherapy)
Patients receive consolidation and maintenance therapy. See detailed description.
Drug: Dexamethasone
Given orally (PO) or IV
Other Names:
  • Aacidexam
  • Adexone
  • Aknichthol Dexa
  • Alba-Dex
  • Alin
  • Alin Depot
  • Alin Oftalmico
  • Amplidermis
  • Anemul mono
  • Auricularum
  • Auxiloson
  • Baycuten
  • Baycuten N
  • Cortidexason
  • Cortisumman
  • Decacort
  • Decadrol
  • Decadron
  • Decalix
  • Decameth
  • Decasone R.p.
  • Dectancyl
  • Dekacort
  • Deltafluorene
  • Deronil
  • Desamethasone
  • Desameton
  • Dexa-Mamallet
  • Dexa-Rhinosan
  • Dexa-Scheroson
  • Dexa-sine
  • Dexacortal
  • Dexacortin
  • Dexafarma
  • Dexafluorene
  • Dexalocal
  • Dexamecortin
  • Dexameth
  • DEXAMETHASONE
  • Dexamethasonum
  • Dexamonozon
  • Dexapos
  • Dexinoral
  • Dexone
  • Dinormon
  • Fluorodelta
  • Fortecortin
  • Gammacorten
  • Hexadecadrol
  • Hexadrol
  • Lokalison-F
  • Loverine
  • Methylfluorprednisolone
  • Millicorten
  • Mymethasone
  • Orgadrone
  • Spersadex
  • Visumetazone
Other: Laboratory Biomarker Analysis
Correlative studies
Drug: Leucovorin Calcium
Given PO
Other Names:
  • Adinepar
  • Calcifolin
  • Calcium (6S)-Folinate
  • Calcium Folinate
  • Calcium Leucovorin
  • Calfolex
  • Calinat
  • Cehafolin
  • Citofolin
  • Citrec
  • Citrovorum Factor
  • Cromatonbic Folinico
  • Dalisol
  • Disintox
  • Divical
  • Ecofol
  • Emovis
  • Factor, Citrovorum
  • Flynoken A
  • Folaren
  • Folaxin
  • FOLI-cell
  • Foliben
  • Folidan
  • Folidar
  • Folinac
  • Folinate Calcium
  • folinic acid
  • Folinic Acid Calcium Salt Pentahydrate
  • Folinoral
  • Folinvit
  • Foliplus
  • Folix
  • Imo
  • Lederfolat
  • Lederfolin
  • Leucosar
  • leucovorin
  • LEUCOVORIN CALCIUM
  • Rescufolin
  • Rescuvolin
  • Tonofolin
  • Wellcovorin
Drug: Mercaptopurine
Given PO
Other Names:
  • 3H-Purine-6-thiol
  • 6 MP
  • 6 Thiohypoxanthine
  • 6 Thiopurine
  • 6-Mercaptopurine
  • 6-Mercaptopurine Monohydrate
  • 6-MP
  • 6-Purinethiol
  • 6-Thiopurine
  • 6-Thioxopurine
  • 6H-Purine-6-thione, 1,7-dihydro- (9CI)
  • 7-Mercapto-1,3,4,6-tetrazaindene
  • Alti-Mercaptopurine
  • Azathiopurine
  • BW 57-323H
  • Flocofil
  • Ismipur
  • Leukerin
  • Leupurin
  • Mercaleukim
  • Mercaleukin
  • Mercaptina
  • MERCAPTOPURINE
  • Mercaptopurinum
  • Mercapurin
  • Mern
  • NCI-C04886
  • Puri-Nethol
  • Purimethol
  • Purine, 6-mercapto-
  • Purine-6-thiol (8CI)
  • Purine-6-thiol, monohydrate
  • Purinethiol
  • Purinethol
  • U-4748
  • WR-2785
Drug: Methotrexate
Given IT, PO, or IV
Other Names:
  • Abitrexate
  • Alpha-Methopterin
  • Amethopterin
  • Brimexate
  • CL 14377
  • CL-14377
  • Emtexate
  • Emthexat
  • Emthexate
  • Farmitrexat
  • Fauldexato
  • Folex
  • Folex PFS
  • Lantarel
  • Ledertrexate
  • Lumexon
  • Maxtrex
  • Medsatrexate
  • Metex
  • Methoblastin
  • METHOTREXATE
  • Methotrexate LPF
  • Methotrexate Methylaminopterin
  • Methotrexatum
  • Metotrexato
  • Metrotex
  • Mexate
  • Mexate-AQ
  • MTX
  • Novatrex
  • Rheumatrex
  • Texate
  • Tremetex
  • Trexeron
  • Trixilem
  • WR-19039
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Drug: Vincristine Sulfate
Given IV
Other Names:
  • Kyocristine
  • Leurocristine Sulfate
  • Leurocristine, sulfate
  • Oncovin
  • Vincasar
  • Vincosid
  • Vincrex
  • VINCRISTINE SULFATE
  • Vincristine, sulfate

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   1 Year to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • B-ALL patients must be enrolled on AALL08B1 prior to treatment and enrollment on AALL0932

    • Note: B-LLy patients are not eligible for AALL08B1, and can enroll directly onto AALL0932
  • B-ALL patients must have an initial white blood cell count < 50,000/uL
  • Patients must have newly diagnosed National Cancer Institute (NCI) Standard Risk B-ALL or B-LLy Murphy stages I or II; patients with Down syndrome are also eligible

    • Note: for B-LLy patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to B-ALL; for tissue processed by other means (i.e. paraffin blocks), the methodology and criteria for immunophenotypic analysis to establish the diagnosis of B-LLy defined by the submitting institution will be accepted
  • All patients and/or their parents or legal guardians must sign a written informed consent
  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Exclusion Criteria:

  • With the exception of steroid pretreatment (defined below) or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B-ALL or B-LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL0932

    • Patients receiving prior steroid therapy may be eligible for AALL0932
  • Patients with central nervous system 3 (CNS3) leukemia

    • CNS status must be known prior to enrollment; (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); B-LLy patients with CNS3 disease are not eligible for this protocol or the COG HR ALL protocol; it is recommended that intrathecal cytarabine be administered at the time of the diagnostic lumbar puncture; this is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture; this is allowed prior to registration; systemic chemotherapy must begin within 72 hours of the first dose of intrathecal therapy
  • B-ALL patients with testicular leukemia are not eligible for AALL0932
  • For B-LLy patients the following additional exclusion criteria apply:

    • T-lymphoblastic lymphoma
    • Morphologically unclassifiable lymphoma
    • Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma
    • CNS3-positive disease or testicular involvement
    • M2 (5% - 25% blasts) or M3 (> 25% blasts) marrow
    • Female patients who are pregnant are ineligible
    • Lactating females are not eligible unless they have agreed not to breastfeed their infants
    • Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained
    • Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01190930

Contacts
Contact: Peter Adamson 612-624-8651 Adamson@email.chop.edu

  Hide Study Locations
Locations
United States, Alabama
Children's Hospital of Alabama Recruiting
Birmingham, Alabama, United States, 35233
Contact: Alyssa T. Reddy    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Alyssa T. Reddy         
University of Alabama at Birmingham Cancer Center Withdrawn
Birmingham, Alabama, United States, 35233
University of South Alabama Active, not recruiting
Mobile, Alabama, United States, 36604
United States, Alaska
Providence Alaska Medical Center Recruiting
Anchorage, Alaska, United States, 99508
Contact: Brenda J. Wittman    907-261-3109      
Principal Investigator: Brenda J. Wittman         
United States, Arizona
Cardon Children's Medical Center Recruiting
Mesa, Arizona, United States, 85202
Contact: Xiaxin Li    602-747-9738      
Principal Investigator: Xiaxin Li         
Phoenix Childrens Hospital Recruiting
Phoenix, Arizona, United States, 85016
Contact: Jessica Boklan    602-546-0920      
Principal Investigator: Jessica Boklan         
The University of Arizona Medical Center-University Campus Recruiting
Tucson, Arizona, United States, 85724
Contact: Lisa M. Kopp    520-626-9008      
Principal Investigator: Lisa M. Kopp         
United States, Arkansas
Arkansas Children's Hospital Recruiting
Little Rock, Arkansas, United States, 72202-3591
Contact: David L. Becton    501-364-7373      
Principal Investigator: David L. Becton         
University of Arkansas for Medical Sciences Withdrawn
Little Rock, Arkansas, United States, 72205
United States, California
Southern California Permanente Medical Group Recruiting
Downey, California, United States, 90242
Contact: Robert M. Cooper    626-564-3455      
Principal Investigator: Robert M. Cooper         
City of Hope Comprehensive Cancer Center Recruiting
Duarte, California, United States, 91010
Contact: Anne L. Angiolillo         
Principal Investigator: Anne L. Angiolillo         
Loma Linda University Medical Center Recruiting
Loma Linda, California, United States, 92354
Contact: Albert Kheradpour    909-558-3375      
Principal Investigator: Albert Kheradpour         
Miller Children's and Women's Hospital Long Beach Recruiting
Long Beach, California, United States, 90806
Contact: Cecilia H. Fu    323-361-4110      
Principal Investigator: Cecilia H. Fu         
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Leo Mascarenhas    323-361-4110      
Principal Investigator: Leo Mascarenhas         
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Fataneh (Fae) Majlessipour    310-423-8965      
Principal Investigator: Fataneh (Fae) Majlessipour         
David Geffen School of Medicine at UCLA Recruiting
Los Angeles, California, United States, 90095
Contact: Pamela H. Kempert    310-825-6708      
Principal Investigator: Pamela H. Kempert         
Mattel Children's Hospital UCLA Recruiting
Los Angeles, California, United States, 90095
Contact: Pamela H. Kempert    310-825-6708      
Principal Investigator: Pamela H. Kempert         
Children's Hospital Central California Recruiting
Madera, California, United States, 93636-8762
Contact: Vonda L. Crouse    866-353-5437      
Principal Investigator: Vonda L. Crouse         
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         
Kaiser Permanente-Oakland Recruiting
Oakland, California, United States, 94611
Contact: Steven K. Bergstrom    626-564-3455      
Principal Investigator: Steven K. Bergstrom         
Childrens Hospital of Orange County Recruiting
Orange, California, United States, 92868
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         
Sutter General Hospital Recruiting
Sacramento, California, United States, 95816
Contact: Yung S. Yim    415-209-2686    bernicl@sutterhealth.org   
Principal Investigator: Yung S. Yim         
University of California Davis Comprehensive Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Jay Michael S. Balagtas    916-734-3089      
Principal Investigator: Jay Michael S. Balagtas         
Naval Medical Center -San Diego Recruiting
San Diego, California, United States, 92134
Contact: Joanne F. McManaman    619-532-8712      
Principal Investigator: Joanne F. McManaman         
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         
UCSF Medical Center-Parnassus Withdrawn
San Francisco, California, United States, 94143
UCSF Medical Center-Mission Bay Recruiting
San Francisco, California, United States, 94158
Contact: Mignon L. Loh    877-827-3222      
Principal Investigator: Mignon L. Loh         
Santa Barbara Cottage Hospital Recruiting
Santa Barbara, California, United States, 93102
Contact: Daniel J. Greenfield    805-682-7300      
Principal Investigator: Daniel J. Greenfield         
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center Recruiting
Torrance, California, United States, 90502
Contact: Joseph L. Lasky    888-662-8252      
Principal Investigator: Joseph L. Lasky         
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
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: Jeffrey H. Schwartz    904-697-3529      
Principal Investigator: Jeffrey H. Schwartz         
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         
MedStar Georgetown University Hospital Recruiting
Washington, District of Columbia, United States, 20007
Contact: Aziza T. Shad    202-444-0381      
Principal Investigator: Aziza T. Shad         
United States, Florida
Broward Health Medical Center Recruiting
Fort Lauderdale, Florida, United States, 33316
Contact: Hector M. Rodriguez-Cortes    954-355-5346      
Principal Investigator: Hector M. Rodriguez-Cortes         
Golisano Children's Hospital of Southwest Florida Recruiting
Fort Myers, Florida, United States, 33908
Contact: Emad K. Salman    239-343-5333      
Principal Investigator: Emad K. Salman         
Lee Memorial Health System Withdrawn
Fort Myers, Florida, United States, 33901
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: William B. Slayton    352-273-8675    trials@cancer.ufl.edu   
Principal Investigator: William B. Slayton         
Memorial Regional Hospital/Joe DiMaggio Children's Hospital Recruiting
Hollywood, Florida, United States, 33021
Contact: Iftikhar Hanif    954-265-2234      
Principal Investigator: Iftikhar Hanif         
Nemours Children's Clinic-Jacksonville Recruiting
Jacksonville, Florida, United States, 32207
Contact: Jeffrey H. Schwartz    904-697-3529      
Principal Investigator: Jeffrey H. Schwartz         
Baptist Hospital of Miami Recruiting
Miami, Florida, United States, 33176
Contact: Doured Daghistani    800-599-2456    cancerinfo@baptisthealth.net   
Principal Investigator: Doured Daghistani         
Nicklaus Children's Hospital Recruiting
Miami, Florida, United States, 33155
Contact: Enrique A. Escalon    888-624-2778      
Principal Investigator: Enrique A. Escalon         
University of Miami Miller School of Medicine-Sylvester Cancer Center Recruiting
Miami, Florida, United States, 33136
Contact: Julio C. Barredo    866-574-5124    Sylvester@emergingmed.com   
Principal Investigator: Julio C. Barredo         
Arnold Palmer Hospital for Children Recruiting
Orlando, Florida, United States, 32806
Contact: Vincent F. Giusti    321-841-7246    CancerClinicalTrials@orlandohealth.com   
Principal Investigator: Vincent F. Giusti         
Florida Hospital Orlando Recruiting
Orlando, Florida, United States, 32803
Contact: Fouad M. Hajjar    407-303-5623      
Principal Investigator: Fouad M. Hajjar         
Nemours Children's Clinic - Orlando Withdrawn
Orlando, Florida, United States, 32806
Nemours Children's Hospital Recruiting
Orlando, Florida, United States, 32827
Contact: Jeffrey H. Schwartz    904-697-3529      
Principal Investigator: Jeffrey H. Schwartz         
UF Cancer Center at Orlando Health Withdrawn
Orlando, Florida, United States, 32806
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's Hospital/Children's Hospital-Tampa Active, not recruiting
Tampa, Florida, United States, 33607
Tampa General Hospital Recruiting
Tampa, Florida, United States, 33606
Contact: Cameron K. Tebbi    800-882-4123    hkourtellis@tgh.org   
Principal Investigator: Cameron K. Tebbi         
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: Frank G. Keller    888-785-1112      
Principal Investigator: Frank G. Keller         
Georgia Regents University Medical Center Recruiting
Augusta, Georgia, United States, 30912
Contact: Colleen H. McDonough    706-721-1663    cancer@georgiahealth.edu   
Principal Investigator: Colleen H. McDonough         
Memorial University Medical Center Recruiting
Savannah, Georgia, United States, 31404
Contact: J. M. Johnston    912-350-8568      
Principal Investigator: J. M. Johnston         
United States, Hawaii
Tripler Army Medical Center Recruiting
Honolulu, Hawaii, United States, 96859
Contact: Tonya M. Kratovil    808-433-6336      
Principal Investigator: Tonya M. Kratovil         
Kapiolani Medical Center for Women and Children Recruiting
Honolulu, Hawaii, United States, 96826
Contact: Robert W. Wilkinson    808-983-6090      
Principal Investigator: Robert W. Wilkinson         
University of Hawaii Cancer Center Withdrawn
Honolulu, Hawaii, United States, 96813
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
Lurie Children's Hospital-Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Elaine R. Morgan    773-880-4562      
Principal Investigator: Elaine R. Morgan         
University of Chicago Comprehensive Cancer Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Susan L. Cohn    773-834-7424      
Principal Investigator: Susan L. Cohn         
University of Illinois Recruiting
Chicago, Illinois, United States, 60612
Contact: Mary L. Schmidt    312-355-3046      
Principal Investigator: Mary L. Schmidt         
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Eugene Suh    708-226-4357      
Principal Investigator: Eugene Suh         
Advocate Children's Hospital-Oak Lawn Recruiting
Oak Lawn, Illinois, United States, 60453
Contact: Rebecca E. McFall    847-723-7570      
Principal Investigator: Rebecca E. McFall         
Advocate Children's Hospital-Park Ridge Recruiting
Park Ridge, Illinois, United States, 60068
Contact: Jong-Hyo Kwon    847-384-3621      
Principal Investigator: Jong-Hyo Kwon         
Advocate Lutheran General Hospital. Withdrawn
Park Ridge, Illinois, United States, 60068
Saint Jude Midwest Affiliate Recruiting
Peoria, Illinois, United States, 61637
Contact: Karen S. Fernandez    309-655-3258      
Principal Investigator: Karen S. Fernandez         
Southern Illinois University School of Medicine Recruiting
Springfield, Illinois, United States, 62702
Contact: Gregory P. Brandt    217-545-7929      
Principal Investigator: Gregory P. Brandt         
United States, Indiana
Riley Hospital for Children Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Robert J. Fallon    888-823-5923    ctsucontact@westat.com   
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
Blank Children's Hospital Recruiting
Des Moines, Iowa, United States, 50309
Contact: Wendy L. Woods-Swafford    515-241-6729      
Principal Investigator: Wendy L. Woods-Swafford         
University of Iowa/Holden Comprehensive Cancer Center Recruiting
Iowa City, Iowa, United States, 52242
Contact: Mariko Sato    800-237-1225      
Principal Investigator: Mariko Sato         
United States, Kentucky
University of Kentucky/Markey Cancer Center Recruiting
Lexington, Kentucky, United States, 40536
Contact: Lars M. Wagner    859-257-3379      
Principal Investigator: Lars M. Wagner         
Kosair Children's Hospital Recruiting
Louisville, Kentucky, United States, 40202
Contact: Kenneth G. Lucas    866-530-5516      
Principal Investigator: Kenneth G. Lucas         
United States, Louisiana
Children's Hospital New Orleans Recruiting
New Orleans, Louisiana, United States, 70118
Contact: Lolie C. Yu    504-894-5377      
Principal Investigator: Lolie C. Yu         
Ochsner Medical Center Jefferson Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Craig Lotterman    888-562-4763      
Principal Investigator: Craig Lotterman         
Tulane University Health Sciences Center Withdrawn
New Orleans, Louisiana, United States, 70112
United States, Maine
Eastern Maine Medical Center Active, not recruiting
Bangor, Maine, United States, 04401
Maine Children's Cancer Program Recruiting
Scarborough, Maine, United States, 04074
Contact: Eric C. Larsen    207-396-8090    wrighd@mmc.org   
Principal Investigator: Eric C. Larsen         
United States, Maryland
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         
Johns Hopkins University/Sidney Kimmel Cancer Center Recruiting
Baltimore, Maryland, United States, 21287
Contact: Patrick A. Brown    410-955-8804    jhcccro@jhmi.edu   
Principal Investigator: Patrick A. Brown         
University of Maryland/Greenebaum Cancer Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Teresa A. York    800-888-8823      
Principal Investigator: Teresa A. York         
Walter Reed National Military Medical Center Active, not recruiting
Bethesda, Maryland, United States, 20889-5600
United States, Massachusetts
Floating Hospital for Children at Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Michael J. Kelly    617-636-5000    ContactUsCancerCenter@TuftsMedicalCenter.org   
Principal Investigator: Michael J. Kelly         
Massachusetts General Hospital Cancer Center Active, not recruiting
Boston, Massachusetts, United States, 02114
Baystate Medical Center Recruiting
Springfield, Massachusetts, United States, 01199
Contact: Joanna G. Luty    413-794-3565    tamara.wrenn@baystatehealth.org   
Principal Investigator: Joanna G. Luty         
University of Massachusetts Medical School Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Christopher P. Keuker    508-856-3216    cancer.research@umassmed.edu   
Principal Investigator: Christopher P. Keuker         
United States, Michigan
C S Mott Children's Hospital Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Raymond J. Hutchinson    800-865-1125      
Principal Investigator: Raymond J. Hutchinson         
Saint John Hospital and Medical Center Recruiting
Detroit, Michigan, United States, 48236
Contact: Hadi Sawaf    313-343-3166      
Principal Investigator: Hadi Sawaf         
Wayne State University/Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Jeffrey W. Taub    313-576-9363      
Principal Investigator: Jeffrey W. Taub         
Michigan State University Clinical Center Recruiting
East Lansing, Michigan, United States, 48824-7016
Contact: Renuka Gera    517-975-9547      
Principal Investigator: Renuka Gera         
Hurley Medical Center Active, not recruiting
Flint, Michigan, United States, 48502
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         
Beaumont Children's Hospital-Royal Oak Active, not recruiting
Royal Oak, Michigan, United States, 48073
William Beaumont Hospital-Royal Oak Withdrawn
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Children's Hospitals and Clinics of Minnesota - Minneapolis Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Michael K. Richards    612-813-5193      
Principal Investigator: Michael K. Richards         
University of Minnesota Medical Center-Fairview Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Peter M. Gordon    612-624-2620      
Principal Investigator: Peter M. Gordon         
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 Recruiting
Jackson, Mississippi, United States, 39216
Contact: Gail C. Megason    601-815-6700      
Principal Investigator: Gail C. Megason         
United States, Missouri
Columbia Regional Active, not recruiting
Columbia, Missouri, United States, 65201
University of Missouri - Ellis Fischel Withdrawn
Columbia, Missouri, United States, 65212
The Childrens Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Contact: Maxine L. Hetherington    816-234-3265      
Principal Investigator: Maxine L. Hetherington         
Mercy Hospital Saint Louis Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Bethany G. Sleckman    913-948-5588      
Principal Investigator: Bethany G. Sleckman         
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Robert J. Hayashi    800-600-3606    info@siteman.wustl.edu   
Principal Investigator: Robert J. Hayashi         
Cardinal Glennon Children's Medical Center Recruiting
Saint Louis, Missouri, United States, 63104
Contact: William S. Ferguson    314-268-4000      
Principal Investigator: William S. Ferguson         
United States, Nebraska
Children's Hospital and Medical Center of Omaha Recruiting
Omaha, Nebraska, United States, 68114
Contact: Minnie Abromowitch    402-955-3949      
Principal Investigator: Minnie Abromowitch         
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Minnie Abromowitch    402-955-3949      
Principal Investigator: Minnie Abromowitch         
United States, Nevada
University Medical Center of Southern Nevada Recruiting
Las Vegas, Nevada, United States, 89102
Contact: Jonathan Bernstein    702-384-0013      
Principal Investigator: Jonathan Bernstein         
Children's Specialty Center of Nevada II Recruiting
Las Vegas, Nevada, United States, 89109
Contact: Jonathan Bernstein    702-384-0013      
Principal Investigator: Jonathan Bernstein         
Nevada Cancer Research Foundation CCOP Recruiting
Las Vegas, Nevada, United States, 89106
Contact: Jonathan Bernstein    702-384-0013      
Principal Investigator: Jonathan Bernstein         
Sunrise Hospital and Medical Center Recruiting
Las Vegas, Nevada, United States, 89109
Contact: Nik Farahana N. Rashid    702-384-0013      
Principal Investigator: Nik Farahana N. Rashid         
Summerlin Hospital Medical Center Recruiting
Las Vegas, Nevada, United States, 89144
Contact: Jonathan Bernstein    702-384-0013      
Principal Investigator: Jonathan Bernstein         
United States, New Hampshire
Dartmouth Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Sara Chaffee    800-639-6918    cancer.research.nurse@dartmouth.edu   
Principal Investigator: Sara Chaffee         
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 Terminated
Livingston, New Jersey, United States, 07039
Morristown Medical Center Recruiting
Morristown, New Jersey, United States, 07960
Contact: Steven L. Halpern    973-971-5900      
Principal Investigator: Steven L. Halpern         
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         
UMDNJ - Robert Wood Johnson University Hospital Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Richard A. Drachtman    732-235-8675      
Principal Investigator: Richard A. Drachtman         
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 Recruiting
Albuquerque, New Mexico, United States, 87102
Contact: Anne L. Angiolillo         
Principal Investigator: Anne L. Angiolillo         
University of New Mexico Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Koh B. Boayue    505-272-6972      
Principal Investigator: Koh B. Boayue         
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 - Moses Campus Recruiting
Bronx, New York, United States, 10467-2490
Contact: Peter D. Cole    718-904-2730    aecc@aecom.yu.edu   
Principal Investigator: Peter D. Cole         
Brooklyn Hospital Center Withdrawn
Brooklyn, New York, United States, 11201
Roswell Park Cancer Institute Active, not recruiting
Buffalo, New York, United States, 14263
Winthrop University Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Mark E. Weinblatt    866-946-8476      
Principal Investigator: Mark E. Weinblatt         
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         
Laura and Issac Perlmutter Cancer Center at NYU Langone Recruiting
New York, New York, United States, 10016
Contact: Linda Granowetter    212-263-4434    prmc.coordinator@nyumc.org   
Principal Investigator: Linda Granowetter         
Memorial Sloan-Kettering Cancer Center Active, not recruiting
New York, New York, United States, 10065
Mount Sinai Medical Center Recruiting
New York, New York, United States, 10029
Contact: Birte Wistinghausen    212-824-7320    jenny.figueroa@mssm.edu   
Principal Investigator: Birte Wistinghausen         
Weill Medical College of Cornell University Recruiting
New York, New York, United States, 10065
Contact: Alexander Aledo    212-746-1848      
Principal Investigator: Alexander Aledo         
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Jeffrey R. Andolina    585-275-5830      
Principal Investigator: Jeffrey R. Andolina         
Stony Brook University Medical Center Active, not recruiting
Stony Brook, New York, United States, 11794
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 Recruiting
Valhalla, New York, United States, 10595
Contact: Jessica C. Hochberg    914-594-3794      
Principal Investigator: Jessica C. Hochberg         
United States, North Carolina
Mission Hospital-Memorial Campus Recruiting
Asheville, North Carolina, United States, 28801
Contact: Douglas J. Scothorn    828-213-4150      
Principal Investigator: Douglas J. Scothorn         
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Stuart H. Gold    877-668-0683    cancerclinicaltrials@med.unc.edu   
Principal Investigator: Stuart H. Gold         
Carolinas Medical Center/Levine Cancer Institute Active, not recruiting
Charlotte, North Carolina, United States, 28203
Novant Health Presbyterian Medical Center Active, not recruiting
Charlotte, North Carolina, United States, 28204
Duke University Medical Center Active, not recruiting
Durham, North Carolina, United States, 27710
East Carolina University Recruiting
Greenville, North Carolina, United States, 27858
Contact: George E. Hucks    252-744-2391      
Principal Investigator: George E. Hucks         
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: Samuel O. Anim    701-234-6161      
Principal Investigator: Samuel O. Anim         
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 Recruiting
Cleveland, Ohio, United States, 44195
Contact: Johannes E. Wolff    866-223-8100      
Principal Investigator: Johannes E. Wolff         
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         
Dayton Children's Hospital Recruiting
Dayton, Ohio, United States, 45404
Contact: Ayman A. El-Sheikh    800-237-1225      
Principal Investigator: Ayman A. El-Sheikh         
Mercy Children's Hospital Terminated
Toledo, Ohio, United States, 43608
The Toledo Hospital/Toledo Children's Hospital Recruiting
Toledo, Ohio, United States, 43606
Contact: Jamie L. Dargart    419-824-1842      
Principal Investigator: Jamie L. Dargart         
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         
Natalie Warren Bryant Cancer Center at Saint Francis Recruiting
Tulsa, Oklahoma, United States, 74136
Contact: Gregory B. Kirkpatrick    918-494-2200      
Principal Investigator: Gregory B. Kirkpatrick         
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         
Oregon Health and Science University Active, not recruiting
Portland, Oregon, United States, 97239
United States, Pennsylvania
Lehigh Valley Hospital - Muhlenberg Recruiting
Bethlehem, Pennsylvania, United States, 18017
Contact: Philip M. Monteleone    484-884-2201      
Principal Investigator: Philip M. Monteleone         
Geisinger Medical Center Recruiting
Danville, Pennsylvania, United States, 17822
Contact: Jagadeesh Ramdas    570-271-5251      
Principal Investigator: Jagadeesh Ramdas         
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: Susan R. Rheingold    215-590-2810      
Principal Investigator: Susan R. Rheingold         
Saint Christopher's Hospital for Children Recruiting
Philadelphia, Pennsylvania, United States, 19134
Contact: Akash Nahar    215-427-8991      
Principal Investigator: Akash Nahar         
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, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Jacqueline M. Kraveka    843-792-9321      
Principal Investigator: Jacqueline M. Kraveka         
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 Active, not recruiting
Greenville, South Carolina, United States, 29605
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
T C Thompson Children's Hospital Recruiting
Chattanooga, Tennessee, United States, 37403
Contact: Manoo G. Bhakta    423-778-7289      
Principal Investigator: Manoo G. Bhakta         
East Tennessee Childrens Hospital Recruiting
Knoxville, Tennessee, United States, 37916
Contact: Ray C. Pais    865-541-8266      
Principal Investigator: Ray C. Pais         
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Wayne L. Furman    866-278-5833    info@stjude.org   
Principal Investigator: Wayne L. Furman         
Vanderbilt University/Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Howard M. Katzenstein    800-811-8480      
Principal Investigator: Howard M. Katzenstein         
United States, Texas
Texas Tech University Health Science Center-Amarillo Withdrawn
Amarillo, Texas, United States, 79106
Dell Children's Medical Center of Central Texas Recruiting
Austin, Texas, United States, 78723
Contact: Amy C. Fowler    214-648-7097      
Principal Investigator: Amy C. Fowler         
Driscoll Children's Hospital Recruiting
Corpus Christi, Texas, United States, 78411
Contact: M. C. Johnson    361-694-5311      
Principal Investigator: M. C. Johnson         
UT Southwestern/Simmons Cancer Center-Dallas Recruiting
Dallas, Texas, United States, 75390
Contact: Tamra L. Slone    214-648-7097      
Principal Investigator: Tamra L. Slone         
Medical City Dallas Hospital Active, not recruiting
Dallas, Texas, United States, 75230
El Paso Children's Hospital Recruiting
El Paso, Texas, United States, 79905
Contact: Lisa L. Hartman    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Lisa L. Hartman         
Brooke Army Medical Center Active, not recruiting
Fort Sam Houston, Texas, United States, 78234
Cook Children's Medical Center Recruiting
Fort Worth, Texas, United States, 76104
Contact: Kenneth M. Heym    682-885-2103      
Principal Investigator: Kenneth M. Heym         
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Karen R. Rabin    713-798-1354    burton@bcm.edu   
Principal Investigator: Karen R. Rabin         
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Cesar A. Nunez    713-792-3245      
Principal Investigator: Cesar A. Nunez         
Covenant Children's Hospital Recruiting
Lubbock, Texas, United States, 79410
Contact: Latha Prasannan    806-725-8000    jaccresearch@covhs.org   
Principal Investigator: Latha Prasannan         
Vannie Cook Children's Clinic Recruiting
McAllen, Texas, United States, 78503
Contact: Juan C. Bernini    713-798-1354    burton@bcm.edu   
Principal Investigator: Juan C. Bernini         
Children's Hospital of San Antonio Recruiting
San Antonio, Texas, United States, 78207
Contact: Timothy C. Griffin    713-798-1354    burton@bcm.edu   
Principal Investigator: Timothy C. Griffin         
University of Texas Health Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Anne-Marie R. Langevin    210-450-3800    CTO@uthscsa.edu   
Principal Investigator: Anne-Marie R. Langevin         
Methodist Children's Hospital of South Texas Recruiting
San Antonio, Texas, United States, 78229
Contact: Jaime Estrada    210-575-7000      
Principal Investigator: Jaime Estrada         
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 Hospital 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 College of Medicine Recruiting
Burlington, Vermont, United States, 05405
Contact: Alan C. Homans    802-656-4101      
Principal Investigator: Alan C. Homans         
United States, Virginia
University of Virginia Cancer Center Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Kimberly P. Dunsmore    434-243-6143      
Principal Investigator: Kimberly P. Dunsmore         
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         
Naval Medical Center - Portsmouth Recruiting
Portsmouth, Virginia, United States, 23708-2197
Contact: Bethany M. Mikles    757-953-5939      
Principal Investigator: Bethany M. Mikles         
Virginia Commonwealth University/Massey Cancer Center Recruiting
Richmond, Virginia, United States, 23298
Contact: Gita V. Massey    804-628-1939      
Principal Investigator: Gita V. Massey         
Carilion Clinic Children's Hospital Recruiting
Roanoke, Virginia, United States, 24014
Contact: Mandy M. Atkinson    540-981-7376      
Principal Investigator: Mandy M. Atkinson         
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Douglas S. Hawkins    866-987-2000      
Principal Investigator: Douglas S. Hawkins         
Providence Sacred Heart Medical Center and Children's Hospital Recruiting
Spokane, Washington, United States, 99204
Contact: Judy L. Felgenhauer    800-228-6618    HopeBeginsHere@providence.org   
Principal Investigator: Judy L. Felgenhauer         
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         
Mary Bridge Children's Hospital and Health Center Recruiting
Tacoma, Washington, United States, 98405
Contact: Robert G. Irwin    253-403-3229      
Principal Investigator: Robert G. Irwin         
United States, West Virginia
West Virginia University Charleston Recruiting
Charleston, West Virginia, United States, 25304
Contact: Howard M. Grodman    304-388-9944      
Principal Investigator: Howard M. Grodman         
West Virginia University Healthcare Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Stephan R. Paul    304-293-2745    sfilburn@hsc.wvu.edu   
Principal Investigator: Stephan R. Paul         
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 Recruiting
Madison, Wisconsin, United States, 53792
Contact: Kenneth B. DeSantes    608-262-5223      
Principal Investigator: Kenneth B. DeSantes         
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, New South Wales
John Hunter Children's Hospital Recruiting
Hunter Regional Mail Centre, New South Wales, Australia, 2310
Contact: Elizabeth L. Hesketh    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Elizabeth L. Hesketh         
Australia, Queensland
Royal Brisbane and Women's Hospital Recruiting
Herston, Queensland, Australia, 4029
Contact: Helen Irving    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Helen Irving         
Royal Children's Hospital-Brisbane Withdrawn
Herston, Queensland, Australia, 4029
Lady Cilento Children's Hospital Recruiting
South Brisbane, Queensland, Australia, 4101
Contact: Helen Irving    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Helen Irving         
Australia, Victoria
Monash Medical Center-Clayton Campus Recruiting
Clayton, Victoria, Australia, 3168
Contact: Peter A. Downie    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Peter A. Downie         
Royal Children's Hospital Recruiting
Parkville, Victoria, Australia, 3052
Contact: Francoise M. Mechinaud       crdo.info@mcri.edu.au   
Principal Investigator: Francoise M. Mechinaud         
Australia, Western Australia
Princess Margaret Hospital for Children Active, not recruiting
Perth, Western Australia, Australia, 6008
Canada, Alberta
Alberta Children's Hospital Recruiting
Calgary, Alberta, Canada, T3B 6A8
Contact: Douglas R. Strother    403-220-6898    research4kids@ucalgary.ca   
Principal Investigator: Douglas R. Strother         
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 Recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Contact: Caron Strahlendorf    604-875-2345 ext 6477      
Principal Investigator: Caron Strahlendorf         
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 Recruiting
Saint John's, Newfoundland and Labrador, Canada, A1B 3V6
Contact: Lisa Anne B. Goodyear    866-722-1126      
Principal Investigator: Lisa Anne B. Goodyear         
Canada, Nova Scotia
IWK Health Centre Recruiting
Halifax, Nova Scotia, Canada, B3K 6R8
Contact: Conrad V. Fernandez    902-470-8394      
Principal Investigator: Conrad V. Fernandez         
Canada, Ontario
McMaster Children's Hospital at Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Carol Portwine    905-521-2100 ext 74595      
Principal Investigator: Carol Portwine         
Cancer Centre of Southeastern Ontario at Kingston General Hospital Active, not recruiting
Kingston, Ontario, Canada, K7L 5P9
Children's Hospital Recruiting
London, Ontario, Canada, N6A 5W9
Contact: Shayna M. Zelcer    519-685-8306      
Principal Investigator: Shayna M. Zelcer         
Children's Hospital of Eastern Ontario Recruiting
Ottawa, Ontario, Canada, K1H 8L1
Contact: Jacqueline M. Halton    613-738-3931      
Principal Investigator: Jacqueline M. Halton         
Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Sarah W. Alexander    416-813-7654 ext 2027    jason.mcguire@sickkids.ca   
Principal Investigator: Sarah W. Alexander         
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
Allan Blair Cancer Centre Withdrawn
Regina, Saskatchewan, Canada, S4T 7T1
Saskatoon Cancer Centre Recruiting
Saskatoon, Saskatchewan, Canada, S7N 4H4
Contact: Christopher Mpofu    306-655-2914      
Principal Investigator: Christopher Mpofu         
Ireland
Our Lady's Children's Hospital Recruiting
Dublin, Co Dublin, Ireland, 12
Contact: Michael L. Capra    353 1 4096419      
Principal Investigator: Michael L. Capra         
New Zealand
Starship Children's Hospital Recruiting
Grafton, Auckland, New Zealand, 1145
Contact: Lochie R. Teague    0800 728 436      
Principal Investigator: Lochie R. Teague         
Christchurch Hospital Recruiting
Christchurch, New Zealand, 8011
Contact: Siobhan F. Cross    03 364 0640      
Principal Investigator: Siobhan F. Cross         
Switzerland
Swiss Pediatric Oncology Group - Geneva Recruiting
Geneva, Switzerland, 1205
Contact: Marc Ansari    031 389 91 89      
Principal Investigator: Marc Ansari         
Swiss Pediatric Oncology Group - Lausanne Active, not recruiting
Lausanne, Switzerland, 1011
Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Anne Angiolillo Children's Oncology Group
  More Information

No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01190930     History of Changes
Other Study ID Numbers: AALL0932, NCI-2011-02599, CDR0000683227, AALL0932, AALL0932, U10CA180886, U10CA098543
Study First Received: August 27, 2010
Last Updated: August 6, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Down Syndrome
Leukemia
Leukemia, Lymphoid
Lymphoma
Lymphoma, Non-Hodgkin
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Abnormalities, Multiple
Chromosome Disorders
Congenital Abnormalities
Genetic Diseases, Inborn
Immune System Diseases
Immunoproliferative Disorders
Intellectual Disability
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
2-Aminopurine
6-Mercaptopurine
Asparaginase
BB 1101
Calcium, Dietary
Cyclophosphamide
Cytarabine
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate

ClinicalTrials.gov processed this record on September 01, 2015