Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 29 of 67 for:    "Acute Lymphocytic Leukemia" | "Hydrocortisone"

Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03007147
Recruitment Status : Recruiting
First Posted : January 2, 2017
Last Update Posted : November 18, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
University of Milano Bicocca
Information provided by (Responsible Party):
Children's Oncology Group

Brief Summary:
This randomized phase III trial studies how well imatinib mesylate and combination chemotherapy work in treating patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. 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 imatinib mesylate and combination chemotherapy may work better in treating patients with Philadelphia chromosome positive acute lymphoblastic leukemia.

Condition or disease Intervention/treatment Phase
B Acute Lymphoblastic Leukemia BCR-ABL1 Fusion Protein Expression Minimal Residual Disease Philadelphia Chromosome Positive T Acute Lymphoblastic Leukemia Untreated Adult Acute Lymphoblastic Leukemia Untreated Childhood Acute Lymphoblastic Leukemia Procedure: Allogeneic Hematopoietic Stem Cell Transplantation Drug: Cyclophosphamide Drug: Cytarabine Drug: Daunorubicin Hydrochloride Drug: Dexamethasone Drug: Dexrazoxane Hydrochloride Drug: Doxorubicin Drug: Etoposide Biological: Filgrastim Drug: Ifosfamide Drug: Imatinib Mesylate Other: Laboratory Biomarker Analysis Drug: Leucovorin Calcium Drug: Mercaptopurine Drug: Methotrexate Drug: Methylprednisolone Drug: Pegaspargase Drug: Prednisolone Other: Questionnaire Administration Drug: Therapeutic Hydrocortisone Drug: Thioguanine Drug: Vincristine Sulfate Phase 3

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: International Phase 3 Trial in Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ALL) Testing Imatinib in Combination With Two Different Cytotoxic Chemotherapy Backbones
Actual Study Start Date : July 28, 2017
Estimated Primary Completion Date : June 30, 2028
Estimated Study Completion Date : June 30, 2028


Arm Intervention/treatment
Experimental: Arm A (imatinib mesylate, EsPhALL chemotherapy)
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
  • Cyclophosphamidum
  • Cyclophosphan
  • Cyclophosphane
  • Cyclophosphanum
  • Cyclostin
  • Cyclostine
  • Cytophosphan
  • Cytophosphane
  • Cytoxan
  • Fosfaseron
  • Genoxal
  • Genuxal
  • Ledoxina
  • Mitoxan
  • Neosar
  • Revimmune
  • Syklofosfamid
  • WR- 138719

Drug: Cytarabine
Given IV, SC, or IT
Other Names:
  • .beta.-Cytosine arabinoside
  • 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone
  • 1-.beta.-D-Arabinofuranosylcytosine
  • 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-
  • 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
  • Cytarabinum
  • Cytarbel
  • Cytosar
  • Cytosine Arabinoside
  • Cytosine-.beta.-arabinoside
  • Cytosine-beta-arabinoside
  • Erpalfa
  • Starasid
  • Tarabine PFS
  • U 19920
  • U-19920
  • Udicil
  • WR-28453

Drug: Daunorubicin Hydrochloride
Given IV
Other Names:
  • Cerubidin
  • Cerubidine
  • Cloridrato de Daunorubicina
  • Daunoblastin
  • Daunoblastina
  • Daunoblastine
  • Daunomycin Hydrochloride
  • Daunomycin, hydrochloride
  • Daunorubicin.HCl
  • Daunorubicini Hydrochloridum
  • FI-6339
  • Ondena
  • RP-13057
  • Rubidomycin Hydrochloride
  • Rubilem

Drug: Dexamethasone
Given 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
  • Dexamethasonum
  • Dexamonozon
  • Dexapos
  • Dexinoral
  • Dexone
  • Dinormon
  • Fluorodelta
  • Fortecortin
  • Gammacorten
  • Hexadecadrol
  • Hexadrol
  • Lokalison-F
  • Loverine
  • Methylfluorprednisolone
  • Millicorten
  • Mymethasone
  • Orgadrone
  • Spersadex
  • Visumetazone

Drug: Dexrazoxane Hydrochloride
Given IV
Other Names:
  • Cardioxane
  • Totect
  • Zinecard

Drug: Doxorubicin
Given IV
Other Names:
  • Adriablastin
  • Hydroxyl Daunorubicin
  • Hydroxyldaunorubicin

Drug: Etoposide
Given IV
Other Names:
  • Demethyl Epipodophyllotoxin Ethylidine Glucoside
  • EPEG
  • Lastet
  • Toposar
  • Vepesid
  • VP 16-213
  • VP-16
  • VP-16-213

Biological: Filgrastim
Given IV
Other Names:
  • FILGRASTIM, LICENSE HOLDER UNSPECIFIED
  • G-CSF
  • Neupogen
  • r-metHuG-CSF
  • Recombinant Methionyl Human Granulocyte Colony Stimulating Factor
  • rG-CSF
  • Tevagrastim

Drug: Ifosfamide
Given IV
Other Names:
  • Asta Z 4942
  • Asta Z-4942
  • Cyfos
  • Holoxan
  • Holoxane
  • Ifex
  • IFO
  • IFO-Cell
  • Ifolem
  • Ifomida
  • Ifomide
  • Ifosfamidum
  • Ifoxan
  • IFX
  • Iphosphamid
  • Iphosphamide
  • Iso-Endoxan
  • Isoendoxan
  • Isophosphamide
  • Mitoxana
  • MJF 9325
  • MJF-9325
  • Naxamide
  • Seromida
  • Tronoxal
  • Z 4942
  • Z-4942

Drug: Imatinib Mesylate
Given PO
Other Names:
  • CGP 57148
  • CGP57148B
  • Gleevec
  • Glivec
  • STI 571
  • STI-571
  • STI571

Other: Laboratory Biomarker Analysis
Correlative studies

Drug: Leucovorin Calcium
Given PO or IV
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
  • 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
  • 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: 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
  • 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
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 LPF
  • Methotrexate Methylaminopterin
  • Methotrexatum
  • Metotrexato
  • Metrotex
  • Mexate
  • Mexate-AQ
  • MTX
  • Novatrex
  • Rheumatrex
  • Texate
  • Tremetex
  • Trexeron
  • Trixilem
  • WR-19039

Drug: Methylprednisolone
Given IV
Other Names:
  • Adlone
  • Caberdelta M
  • DepMedalone
  • Depo Moderin
  • Depo-Nisolone
  • Duralone
  • Emmetipi
  • Esametone
  • Firmacort
  • Medlone 21
  • Medrate
  • Medrol
  • Medrol Veriderm
  • Medrone
  • Mega-Star
  • Meprolone
  • Methylprednisolonum
  • Metilbetasone Solubile
  • Metrocort
  • Metypresol
  • Metysolon
  • Predni-M-Tablinen
  • Prednilen
  • Radilem
  • Sieropresol
  • Solpredone
  • Summicort
  • Urbason
  • Veriderm Medrol
  • Wyacort

Drug: Pegaspargase
Given IV
Other Names:
  • L-Asparaginase with Polyethylene Glycol
  • Oncaspar
  • PEG-Asparaginase
  • PEG-L-Asparaginase
  • PEG-L-Asparaginase (Enzon - Kyowa Hakko)
  • PEGLA
  • Polyethylene Glycol L-Asparaginase
  • Polyethylene Glycol-L-Asparaginase

Drug: Prednisolone
Given PO
Other Names:
  • (11beta)-11,17,21-Trihydroxypregna-1,4-diene-3,20-dione
  • .delta.1-Hydrocortisone
  • Adnisolone
  • Aprednislon
  • Capsoid
  • Cortalone
  • Cortisolone
  • Dacortin H
  • Decaprednil
  • Decortin H
  • Delta(1)Hydrocortisone
  • Delta- Cortef
  • Delta-Cortef
  • Delta-Diona
  • Delta-F
  • Delta-Phoricol
  • Delta1-dehydro-hydrocortisone
  • Deltacortril
  • Deltahydrocortisone
  • Deltasolone
  • Deltidrosol
  • Dhasolone
  • Di-Adreson-F
  • Dontisolon D
  • Estilsona
  • Fisopred
  • Frisolona
  • Gupisone
  • Hostacortin H
  • Hydeltra
  • Hydeltrasol
  • Klismacort
  • Kuhlprednon
  • Lenisolone
  • Lepi-Cortinolo
  • Linola-H N
  • Linola-H-Fett N
  • Longiprednil
  • Metacortandralone
  • Meti Derm
  • Meticortelone
  • Opredsone
  • Panafcortelone
  • Precortisyl
  • Pred-Clysma
  • Predeltilone
  • Predni-Coelin
  • Predni-Helvacort
  • Prednicortelone
  • Prednisolonum
  • Prelone
  • Prenilone
  • Sterane

Other: Questionnaire Administration
Ancillary studies

Drug: Therapeutic Hydrocortisone
Given IT
Other Names:
  • Aeroseb-HC
  • Barseb HC
  • Barseb-HC
  • Cetacort
  • Cort-Dome
  • Cortef
  • Cortenema
  • Cortifan
  • Cortisol
  • Cortispray
  • Cortril
  • Dermacort
  • Domolene
  • Eldecort
  • Hautosone
  • Heb-Cort
  • HYDROCORTISONE
  • Hydrocortone
  • Hytone
  • Komed-HC
  • Nutracort
  • Proctocort
  • Rectoid

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
  • 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

Experimental: Arm B (imatinib mesylate, COG/BFM chemotherapy)
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
  • Cyclophosphamidum
  • Cyclophosphan
  • Cyclophosphane
  • Cyclophosphanum
  • Cyclostin
  • Cyclostine
  • Cytophosphan
  • Cytophosphane
  • Cytoxan
  • Fosfaseron
  • Genoxal
  • Genuxal
  • Ledoxina
  • Mitoxan
  • Neosar
  • Revimmune
  • Syklofosfamid
  • WR- 138719

Drug: Cytarabine
Given IV, SC, or IT
Other Names:
  • .beta.-Cytosine arabinoside
  • 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone
  • 1-.beta.-D-Arabinofuranosylcytosine
  • 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-
  • 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
  • Cytarabinum
  • Cytarbel
  • Cytosar
  • Cytosine Arabinoside
  • Cytosine-.beta.-arabinoside
  • Cytosine-beta-arabinoside
  • Erpalfa
  • Starasid
  • Tarabine PFS
  • U 19920
  • U-19920
  • Udicil
  • WR-28453

Drug: Dexamethasone
Given 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
  • Dexamethasonum
  • Dexamonozon
  • Dexapos
  • Dexinoral
  • Dexone
  • Dinormon
  • Fluorodelta
  • Fortecortin
  • Gammacorten
  • Hexadecadrol
  • Hexadrol
  • Lokalison-F
  • Loverine
  • Methylfluorprednisolone
  • Millicorten
  • Mymethasone
  • Orgadrone
  • Spersadex
  • Visumetazone

Drug: Dexrazoxane Hydrochloride
Given IV
Other Names:
  • Cardioxane
  • Totect
  • Zinecard

Drug: Doxorubicin
Given IV
Other Names:
  • Adriablastin
  • Hydroxyl Daunorubicin
  • Hydroxyldaunorubicin

Drug: Imatinib Mesylate
Given PO
Other Names:
  • CGP 57148
  • CGP57148B
  • Gleevec
  • Glivec
  • STI 571
  • STI-571
  • STI571

Other: Laboratory Biomarker Analysis
Correlative studies

Drug: Leucovorin Calcium
Given PO or IV
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
  • 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
  • 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
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 LPF
  • Methotrexate Methylaminopterin
  • Methotrexatum
  • Metotrexato
  • Metrotex
  • Mexate
  • Mexate-AQ
  • MTX
  • Novatrex
  • Rheumatrex
  • Texate
  • Tremetex
  • Trexeron
  • Trixilem
  • WR-19039

Drug: Methylprednisolone
Given IV
Other Names:
  • Adlone
  • Caberdelta M
  • DepMedalone
  • Depo Moderin
  • Depo-Nisolone
  • Duralone
  • Emmetipi
  • Esametone
  • Firmacort
  • Medlone 21
  • Medrate
  • Medrol
  • Medrol Veriderm
  • Medrone
  • Mega-Star
  • Meprolone
  • Methylprednisolonum
  • Metilbetasone Solubile
  • Metrocort
  • Metypresol
  • Metysolon
  • Predni-M-Tablinen
  • Prednilen
  • Radilem
  • Sieropresol
  • Solpredone
  • Summicort
  • Urbason
  • Veriderm Medrol
  • Wyacort

Drug: Pegaspargase
Given IV
Other Names:
  • L-Asparaginase with Polyethylene Glycol
  • Oncaspar
  • PEG-Asparaginase
  • PEG-L-Asparaginase
  • PEG-L-Asparaginase (Enzon - Kyowa Hakko)
  • PEGLA
  • Polyethylene Glycol L-Asparaginase
  • Polyethylene Glycol-L-Asparaginase

Drug: Prednisolone
Given PO
Other Names:
  • (11beta)-11,17,21-Trihydroxypregna-1,4-diene-3,20-dione
  • .delta.1-Hydrocortisone
  • Adnisolone
  • Aprednislon
  • Capsoid
  • Cortalone
  • Cortisolone
  • Dacortin H
  • Decaprednil
  • Decortin H
  • Delta(1)Hydrocortisone
  • Delta- Cortef
  • Delta-Cortef
  • Delta-Diona
  • Delta-F
  • Delta-Phoricol
  • Delta1-dehydro-hydrocortisone
  • Deltacortril
  • Deltahydrocortisone
  • Deltasolone
  • Deltidrosol
  • Dhasolone
  • Di-Adreson-F
  • Dontisolon D
  • Estilsona
  • Fisopred
  • Frisolona
  • Gupisone
  • Hostacortin H
  • Hydeltra
  • Hydeltrasol
  • Klismacort
  • Kuhlprednon
  • Lenisolone
  • Lepi-Cortinolo
  • Linola-H N
  • Linola-H-Fett N
  • Longiprednil
  • Metacortandralone
  • Meti Derm
  • Meticortelone
  • Opredsone
  • Panafcortelone
  • Precortisyl
  • Pred-Clysma
  • Predeltilone
  • Predni-Coelin
  • Predni-Helvacort
  • Prednicortelone
  • Prednisolonum
  • Prelone
  • Prenilone
  • Sterane

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
  • 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

Experimental: Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)
See Detailed Description
Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Undergo HSCT
Other Names:
  • Allogeneic Hematopoietic Cell Transplantation
  • Allogeneic Stem Cell Transplantation
  • HSC
  • HSCT

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
  • Cyclophosphamidum
  • Cyclophosphan
  • Cyclophosphane
  • Cyclophosphanum
  • Cyclostin
  • Cyclostine
  • Cytophosphan
  • Cytophosphane
  • Cytoxan
  • Fosfaseron
  • Genoxal
  • Genuxal
  • Ledoxina
  • Mitoxan
  • Neosar
  • Revimmune
  • Syklofosfamid
  • WR- 138719

Drug: Cytarabine
Given IV, SC, or IT
Other Names:
  • .beta.-Cytosine arabinoside
  • 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone
  • 1-.beta.-D-Arabinofuranosylcytosine
  • 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-
  • 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
  • Cytarabinum
  • Cytarbel
  • Cytosar
  • Cytosine Arabinoside
  • Cytosine-.beta.-arabinoside
  • Cytosine-beta-arabinoside
  • Erpalfa
  • Starasid
  • Tarabine PFS
  • U 19920
  • U-19920
  • Udicil
  • WR-28453

Drug: Daunorubicin Hydrochloride
Given IV
Other Names:
  • Cerubidin
  • Cerubidine
  • Cloridrato de Daunorubicina
  • Daunoblastin
  • Daunoblastina
  • Daunoblastine
  • Daunomycin Hydrochloride
  • Daunomycin, hydrochloride
  • Daunorubicin.HCl
  • Daunorubicini Hydrochloridum
  • FI-6339
  • Ondena
  • RP-13057
  • Rubidomycin Hydrochloride
  • Rubilem

Drug: Dexamethasone
Given 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
  • Dexamethasonum
  • Dexamonozon
  • Dexapos
  • Dexinoral
  • Dexone
  • Dinormon
  • Fluorodelta
  • Fortecortin
  • Gammacorten
  • Hexadecadrol
  • Hexadrol
  • Lokalison-F
  • Loverine
  • Methylfluorprednisolone
  • Millicorten
  • Mymethasone
  • Orgadrone
  • Spersadex
  • Visumetazone

Drug: Dexrazoxane Hydrochloride
Given IV
Other Names:
  • Cardioxane
  • Totect
  • Zinecard

Drug: Doxorubicin
Given IV
Other Names:
  • Adriablastin
  • Hydroxyl Daunorubicin
  • Hydroxyldaunorubicin

Drug: Etoposide
Given IV
Other Names:
  • Demethyl Epipodophyllotoxin Ethylidine Glucoside
  • EPEG
  • Lastet
  • Toposar
  • Vepesid
  • VP 16-213
  • VP-16
  • VP-16-213

Biological: Filgrastim
Given IV
Other Names:
  • FILGRASTIM, LICENSE HOLDER UNSPECIFIED
  • G-CSF
  • Neupogen
  • r-metHuG-CSF
  • Recombinant Methionyl Human Granulocyte Colony Stimulating Factor
  • rG-CSF
  • Tevagrastim

Drug: Ifosfamide
Given IV
Other Names:
  • Asta Z 4942
  • Asta Z-4942
  • Cyfos
  • Holoxan
  • Holoxane
  • Ifex
  • IFO
  • IFO-Cell
  • Ifolem
  • Ifomida
  • Ifomide
  • Ifosfamidum
  • Ifoxan
  • IFX
  • Iphosphamid
  • Iphosphamide
  • Iso-Endoxan
  • Isoendoxan
  • Isophosphamide
  • Mitoxana
  • MJF 9325
  • MJF-9325
  • Naxamide
  • Seromida
  • Tronoxal
  • Z 4942
  • Z-4942

Drug: Imatinib Mesylate
Given PO
Other Names:
  • CGP 57148
  • CGP57148B
  • Gleevec
  • Glivec
  • STI 571
  • STI-571
  • STI571

Other: Laboratory Biomarker Analysis
Correlative studies

Drug: Leucovorin Calcium
Given PO or IV
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
  • 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
  • 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: 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
  • 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
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 LPF
  • Methotrexate Methylaminopterin
  • Methotrexatum
  • Metotrexato
  • Metrotex
  • Mexate
  • Mexate-AQ
  • MTX
  • Novatrex
  • Rheumatrex
  • Texate
  • Tremetex
  • Trexeron
  • Trixilem
  • WR-19039

Drug: Methylprednisolone
Given IV
Other Names:
  • Adlone
  • Caberdelta M
  • DepMedalone
  • Depo Moderin
  • Depo-Nisolone
  • Duralone
  • Emmetipi
  • Esametone
  • Firmacort
  • Medlone 21
  • Medrate
  • Medrol
  • Medrol Veriderm
  • Medrone
  • Mega-Star
  • Meprolone
  • Methylprednisolonum
  • Metilbetasone Solubile
  • Metrocort
  • Metypresol
  • Metysolon
  • Predni-M-Tablinen
  • Prednilen
  • Radilem
  • Sieropresol
  • Solpredone
  • Summicort
  • Urbason
  • Veriderm Medrol
  • Wyacort

Drug: Pegaspargase
Given IV
Other Names:
  • L-Asparaginase with Polyethylene Glycol
  • Oncaspar
  • PEG-Asparaginase
  • PEG-L-Asparaginase
  • PEG-L-Asparaginase (Enzon - Kyowa Hakko)
  • PEGLA
  • Polyethylene Glycol L-Asparaginase
  • Polyethylene Glycol-L-Asparaginase

Drug: Prednisolone
Given PO
Other Names:
  • (11beta)-11,17,21-Trihydroxypregna-1,4-diene-3,20-dione
  • .delta.1-Hydrocortisone
  • Adnisolone
  • Aprednislon
  • Capsoid
  • Cortalone
  • Cortisolone
  • Dacortin H
  • Decaprednil
  • Decortin H
  • Delta(1)Hydrocortisone
  • Delta- Cortef
  • Delta-Cortef
  • Delta-Diona
  • Delta-F
  • Delta-Phoricol
  • Delta1-dehydro-hydrocortisone
  • Deltacortril
  • Deltahydrocortisone
  • Deltasolone
  • Deltidrosol
  • Dhasolone
  • Di-Adreson-F
  • Dontisolon D
  • Estilsona
  • Fisopred
  • Frisolona
  • Gupisone
  • Hostacortin H
  • Hydeltra
  • Hydeltrasol
  • Klismacort
  • Kuhlprednon
  • Lenisolone
  • Lepi-Cortinolo
  • Linola-H N
  • Linola-H-Fett N
  • Longiprednil
  • Metacortandralone
  • Meti Derm
  • Meticortelone
  • Opredsone
  • Panafcortelone
  • Precortisyl
  • Pred-Clysma
  • Predeltilone
  • Predni-Coelin
  • Predni-Helvacort
  • Prednicortelone
  • Prednisolonum
  • Prelone
  • Prenilone
  • Sterane

Other: Questionnaire Administration
Ancillary studies

Drug: Therapeutic Hydrocortisone
Given IT
Other Names:
  • Aeroseb-HC
  • Barseb HC
  • Barseb-HC
  • Cetacort
  • Cort-Dome
  • Cortef
  • Cortenema
  • Cortifan
  • Cortisol
  • Cortispray
  • Cortril
  • Dermacort
  • Domolene
  • Eldecort
  • Hautosone
  • Heb-Cort
  • HYDROCORTISONE
  • Hydrocortone
  • Hytone
  • Komed-HC
  • Nutracort
  • Proctocort
  • Rectoid

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
  • 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




Primary Outcome Measures :
  1. Disease free survival (DFS) [ Time Frame: From randomization to first event (relapse, second malignancy, or death in complete remission) or time to last follow-up for patients without events, assessed up to 3 years ]
    Will compare the DFS of standard risk Philadelphia chromosome (Ph+) acute lymphoblastic leukemia (ALL) patients treated continuous imatinib mesylate with high risk Children's Oncology Group (COG)-ALL chemotherapy backbone or more intensive European (Es)PhALL chemotherapy backbone.


Secondary Outcome Measures :
  1. Imatinib mesylate administration after allogeneic hematopoietic stem cell transplantation (HSCT) in high risk Ph+ ALL patients [ Time Frame: Up to 2 years ]
    Feasibility of post-HSCT imatinib mesylate is determined based on the proportion of patients who receive at least 75% of intended doses.

  2. Event free survival (EFS) of high risk pediatric Ph+ ALL patients treated with EsPhALL chemotherapy, HSCT in first complete remission, and post-HSCT imatinib mesylate [ Time Frame: From the date of bone marrow for minimal residual disease (MRD) assessment at end-IB to first event or time to last follow-up for patients without events, assessed up to 3 years ]
    Will be estimated using the Kaplan-Meier method and standard errors estimated by Greenwood.

  3. Incidence of grade 3 or higher infections in standard risk Ph+ ALL patients in the two randomized arms evaluated according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 3 years ]
    The rate of infections during the post IB/pre-maintenance phases of treatment will be compared accounting for follow-up time.

  4. EFS of all enrolled patients [ Time Frame: From enrollment until the first occurrence of: M3 marrow at the end of Induction IA, relapse, second malignancy, or death as a first event, assessed up to 3 years ]
    Will be estimated using the Kaplan-Meier method and standard errors estimated by Greenwood.

  5. Overall survival (OS) of all enrolled patients [ Time Frame: From study enrollment to death from any cause, assessed up to 3 years ]
    Will be estimated using the Kaplan-Meier method and standard errors estimated by Greenwood. Will be estimated with a maximum standard error of 1.9%.

  6. OS of standard risk patients [ Time Frame: From randomization to death from any cause, assessed up to 3 years ]
    Will be estimated using the Kaplan-Meier method and standard errors estimated by Greenwood. Estimates will also be calculated for each of the randomization groups.

  7. OS of high risk patients [ Time Frame: From the date of MRD assessment at end-IB to death from any cause, assessed up to 3 years ]
    Will be estimated using the Kaplan-Meier method and standard errors estimated by Greenwood. Estimates will also be calculated for each of the randomization groups.


Other Outcome Measures:
  1. Incidence of toxicities associated with post-HSCT administration of imatinib mesylate evaluated according to NCI CTCAE version 4.0 [ Time Frame: Up to 1 year post-HSCT ]
    Frequencies of target toxicities in high risk patients after the initiation of post-HSCT imatinib mesylate will be described. For the high risk patients, the specific targeted toxicities will include grade 4 neutropenia, grade 4 thrombocytopenia, grade 3 or higher bilirubin, grade 4 or higher transaminitis, and grade 3 or higher infection.

  2. Incidence of long-term toxicities in patients treated with chemotherapy plus imatinib mesylate (no transplant) in both arms evaluated according to NCI CTCAE version 4.0 [ Time Frame: Up to 3 years ]
    Frequencies of long-term toxicities will be described and differences between randomized arms will be explored. Specific long-term toxicities to be explored include cardiac (echocardiographic abnormalities, including decreased left ventricular (LV) function and decreased LV wall thickness), growth (linear height, bone age), and second malignant neoplasm.

  3. MRD measured by IGH-T cell receptor (TCR) polymerase chain reaction (PCR) and next generation sequencing (NGS) assay [ Time Frame: At the end of induction IB ]
    For all patients, frequencies and prognostic significance (DFS, EFS, OS) will be explored for MRD levels (i.e., MRD negative, detectable at < 5 x 10^-4, and dectectable at >= 5 x 10^-4) at end of Induction IB.

  4. MRD in high risk patients measured by IGH-TCR PCR and NGS assay [ Time Frame: Up to 12 months post-HSCT ]
    The outcome of high risk patients will be described, including proportion of patients who achieve MRD-negativity just prior to HSCT, and at regular intervals post-HSCT. Associations between these findings and long-term outcomes (e.g., OS, DFS) will be explored.

  5. MRD assessments made by IGH-TCR PCR assay and NGS assay [ Time Frame: Up to 2 years ]
    Concordance of MRD assessments made by IGH-TCR PCR assay and NGS assay will be described and evaluated. Scatter plots and diagrams will be used to examine agreements and patterns of agreement or any differences found. Concordance will be explored both for the overall cohort, as well as by risk group. The increased sensitivity of the NGS will be closely examined to find cases where the MRD levels are detectable by NGS but undetectable by PCR, as well as cases in which one test yields results and the other does not (test failure). Prognostic relationships on outcomes for these subjects will be inspected.

  6. IKZF1 gene aberrations and deletions [ Time Frame: Up to 2 years ]
    For both standard risk and high risk groups, frequencies and prognostic significance (OS, DFS) will be explored for IKZF1 gene aberrations and deletions.

  7. Frequency of p190 and p210 BCR-ABL1 fusion variants [ Time Frame: Up to 2 years ]
    For both standard risk and high risk groups, frequencies and prognostic significance (OS, DFS) will be explored for p190 and p210 BCR-ABL1 fusion variants in pediatric Ph+ ALL.

  8. Adherence to oral chemotherapeutic agents in standard risk Ph+ ALL patients [ Time Frame: Up to 2 years during maintenance phase ]
    Adherence to imatinib mesylate, 6-mercaptopurine, and methotrexate will be evaluated in COG-enrolled participants using an electronic monitoring device. Adherence rate will be computed for each month of adherence monitoring. Longitudinal binomial regression will be conducted using generalized estimating equation methods by modeling monthly adherence rate as an unstructured mean model using five indicator variables of time for the study months. Time in months will also be treated as a continuous variable to explore temporal trends in adherence rate. Compound symmetry will be assumed as the working correlation matrix over time. Covariates that will be considered for adjustment include those hypothesized to be predictors of adherence, annual household income, parental education, time since start of maintenance, risk classification for ALL, and imatinib, 6-mercaptopurine (6MP), and methotrexate dose-intensity.

  9. Adherence to imatinib mesylate after allogeneic HSCT in high risk Ph+ ALL patients [ Time Frame: Up to 12 months post-HSCT ]
    Longitudinal binomial regression will be conducted using generalized estimating equation methods by modeling monthly adherence rate as an unstructured mean model using five indicator variables of time for the study months. Time in months will also be treated as a continuous variable to explore temporal trends in adherence rate. Compound symmetry will be assumed as the working correlation matrix over time. Covariates that will be considered for adjustment include those hypothesized to be predictors of adherence, annual household income, parental education, time since start of maintenance, risk classification for ALL, and imatinib, 6MP, and methotrexate dose-intensity.



Information from the National Library of Medicine

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


Layout table for eligibility information
Ages Eligible for Study:   2 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • For patients enrolled on AALL08B1 or APEC14B1 (if open for ALL patients) prior to enrollment on AALL1631, the required diagnostic bone marrow sample has been fulfilled

    • For patients who have not previously enrolled on AALL08B1 or APEC14B1 (if open for ALL patients) prior to enrollment on AALL1631, a baseline diagnostic sample must be available to develop an MRD probe
    • In addition, laboratory reports detailing evidence of BCR-ABL1 fusion must be submitted for rapid central review within 72 hours of study enrollment
  • Newly diagnosed de novo ALL (B-ALL or T-ALL) with definitive evidence of BCR-ABL1 fusion by karyotype, fluorescence in situ hybridization (FISH) and/or reverse transcriptase (RT)-PCR
  • Patient must have previously started induction therapy, which includes vincristine, a corticosteroid, pegaspargase, with or without anthracycline, and/or other standard cytotoxic chemotherapy
  • Patient has not received more than 14 days of multiagent induction therapy beginning with the first dose of vinCRIStine
  • Patient may have started imatinib prior to study entry but has not received more than 14 days of imatinib
  • Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2
  • Direct bilirubin =< 2.0 mg/dL
  • Shortening fraction of >= 27% by echocardiogram
  • Ejection fraction of >= 50% by radionuclide angiogram or echocardiogram
  • Corrected QT interval, QTc < 480 msec

    • Note: Repeat echocardiogram is not required if echocardiogram was obtained within 21 days of study enrollment
  • Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2
  • Serum creatinine within normal limits based on age/gender, as follows:

    • 1 to < 2 years: maximum serum creatinine 0.6 mg/dL (both male and female)
    • 2 to < 6 years: maximum serum creatinine 0.8 mg/dL (both male and female)
    • 6 to < 10 years: maximum serum creatinine 1 mg/dL (both male and female)
    • 10 to < 13 years: maximum serum creatinine 1.2 mg/dL (both male and female)
    • 13 to < 16 years: maximum serum creatinine 1.5 mg/dL (male), 1.4 mg/dL (female)
    • >= 16 years: maximum serum creatinine 1.7 mg/dL (male), 1.4 mg/dL (female)

Exclusion Criteria:

  • Known history of chronic myelogenous leukemia (CML)
  • ALL developing after a previous cancer treated with cytotoxic chemotherapy
  • Active, uncontrolled infection, or active systemic illness that requires ongoing vasopressor support or mechanical ventilation
  • Down syndrome
  • Pregnancy and breast feeding

    • Female patients who are pregnant; a pregnancy test is required for female patients of childbearing potential
    • Lactating females who plan to breastfeed their infants
    • Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation
  • Patients with congenital long QT syndrome, history of ventricular arrhythmias or heart block
  • Prior treatment with dasatinib, or any BCR-ABL1 inhibitor other than imatinib
  • 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

Information from the National Library of Medicine

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

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03007147


  Hide Study Locations
Locations
Layout table for location information
United States, Alabama
Children's Hospital of Alabama Recruiting
Birmingham, Alabama, United States, 35233
Contact: Site Public Contact    205-638-9285    oncologyresearch@peds.uab.edu   
Principal Investigator: Matthew A. Kutny         
United States, Alaska
Providence Alaska Medical Center Recruiting
Anchorage, Alaska, United States, 99508
Contact: Site Public Contact    907-212-6871    AKPAMC.OncologyResearchSupport@providence.org   
Principal Investigator: Brenda J. Wittman         
United States, Arizona
Cardon Children's Medical Center Recruiting
Mesa, Arizona, United States, 85202
Contact: Site Public Contact    602-747-9738      
Principal Investigator: Santosh S. Hanmod         
Phoenix Childrens Hospital Recruiting
Phoenix, Arizona, United States, 85016
Contact: Site Public Contact    602-546-0920      
Principal Investigator: Jessica Boklan         
United States, Arkansas
Arkansas Children's Hospital Recruiting
Little Rock, Arkansas, United States, 72202-3591
Contact: Site Public Contact    501-364-7373      
Principal Investigator: David L. Becton         
United States, California
Kaiser Permanente Downey Medical Center Recruiting
Downey, California, United States, 90242
Contact: Site Public Contact    626-564-3455      
Principal Investigator: Robert M. Cooper         
City of Hope Comprehensive Cancer Center Recruiting
Duarte, California, United States, 91010
Contact: Site Public Contact    800-826-4673    becomingapatient@coh.org   
Principal Investigator: Anna B. Pawlowska         
Loma Linda University Medical Center Recruiting
Loma Linda, California, United States, 92354
Contact: Site Public Contact    909-558-3375      
Principal Investigator: Albert Kheradpour         
Miller Children's and Women's Hospital Long Beach Recruiting
Long Beach, California, United States, 90806
Contact: Site Public Contact    562-933-5600      
Principal Investigator: Jacqueline N. Casillas         
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Site Public Contact    323-361-4110      
Principal Investigator: Leo Mascarenhas         
Cedars Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Site Public Contact    310-423-8965      
Principal Investigator: Fataneh (Fae) Majlessipour         
Valley Children's Hospital Recruiting
Madera, California, United States, 93636
Contact: Site Public Contact    559-353-3000    Research@valleychildrens.org   
Principal Investigator: Vonda L. Crouse         
Children's Hospital and Research Center at Oakland Recruiting
Oakland, California, United States, 94609-1809
Contact: Site Public Contact    510-428-3324    cgolden@mail.cho.org   
Principal Investigator: Carla B. Golden         
Kaiser Permanente-Oakland Recruiting
Oakland, California, United States, 94611
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Laura A. Campbell         
Children's Hospital of Orange County Recruiting
Orange, California, United States, 92868
Contact: Site Public Contact    714-997-3000      
Principal Investigator: Elyssa M. Rubin         
Lucile Packard Children's Hospital Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Site Public Contact    800-694-0012    ccto-office@stanford.edu   
Principal Investigator: Jay Michael S. Balagtas         
University of California Davis Comprehensive Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Site Public Contact    916-734-3089      
Principal Investigator: Marcio H. Malogolowkin         
Rady Children's Hospital - San Diego Recruiting
San Diego, California, United States, 92123
Contact: Site Public Contact    858-966-5934      
Principal Investigator: William D. Roberts         
UCSF Medical Center-Mission Bay Recruiting
San Francisco, California, United States, 94158
Contact: Site Public Contact    877-827-3222      
Principal Investigator: Mignon L. Loh         
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Site Public Contact    303-764-5056    josh.b.gordon@nsmtp.kp.org   
Principal Investigator: Kelly W. Maloney         
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Recruiting
Denver, Colorado, United States, 80218
Contact: Site Public Contact    303-839-6000      
Principal Investigator: Jennifer J. Clark         
United States, Connecticut
Connecticut Children's Medical Center Recruiting
Hartford, Connecticut, United States, 06106
Contact: Site Public Contact    860-545-9981      
Principal Investigator: Michael S. Isakoff         
United States, Delaware
Alfred I duPont Hospital for Children Recruiting
Wilmington, Delaware, United States, 19803
Contact: Site Public Contact    302-651-6884    dperry@nemours.org   
Principal Investigator: Emi H. Caywood         
United States, District of Columbia
MedStar Georgetown University Hospital Suspended
Washington, District of Columbia, United States, 20007
Children's National Medical Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Site Public Contact    202-884-2549      
Principal Investigator: Jeffrey S. Dome         
United States, Florida
Broward Health Medical Center Recruiting
Fort Lauderdale, Florida, United States, 33316
Contact: Site Public Contact    954-355-5346      
Principal Investigator: Hector M. Rodriguez-Cortes         
Golisano Children's Hospital of Southwest Florida Recruiting
Fort Myers, Florida, United States, 33908
Contact: Site Public Contact    239-343-5333    molly.arnstrom@leehealth.org   
Principal Investigator: Emad K. Salman         
University of Florida Health Science Center - Gainesville Recruiting
Gainesville, Florida, United States, 32610
Contact: Site Public Contact    352-273-8010    cancer-center@ufl.edu   
Principal Investigator: William B. Slayton         
Memorial Regional Hospital/Joe DiMaggio Children's Hospital Recruiting
Hollywood, Florida, United States, 33021
Contact: Site Public Contact    954-265-1847    OHR@mhs.net   
Principal Investigator: Iftikhar Hanif         
Nemours Children's Clinic-Jacksonville Recruiting
Jacksonville, Florida, United States, 32207
Contact: Site Public Contact    904-697-3529      
Principal Investigator: Emi H. Caywood         
University of Miami Miller School of Medicine-Sylvester Cancer Center Recruiting
Miami, Florida, United States, 33136
Contact: Site Public Contact    305-243-2647      
Principal Investigator: Julio C. Barredo         
Nicklaus Children's Hospital Recruiting
Miami, Florida, United States, 33155
Contact: Site Public Contact    888-624-2778      
Principal Investigator: Enrique A. Escalon         
Miami Cancer Institute Recruiting
Miami, Florida, United States, 33176
Contact: Site Public Contact    786-596-2000      
Principal Investigator: Doured Daghistani         
AdventHealth Orlando Recruiting
Orlando, Florida, United States, 32803
Contact: Site Public Contact    407-303-2090    FH.Cancer.Research@flhosp.org   
Principal Investigator: Fouad M. Hajjar         
Arnold Palmer Hospital for Children Recruiting
Orlando, Florida, United States, 32806
Contact: Site Public Contact    321-843-2584    melissa.leffin@orlandohealth.com   
Principal Investigator: Amy A. Smith         
Nemours Children's Hospital Recruiting
Orlando, Florida, United States, 32827
Contact: Site Public Contact    407-650-7150      
Principal Investigator: Emi H. Caywood         
Johns Hopkins All Children's Hospital Recruiting
Saint Petersburg, Florida, United States, 33701
Contact: Site Public Contact    727-767-4784    Ashley.Repp@jhmi.edu   
Principal Investigator: Jennifer L. Mayer         
Saint Joseph's Hospital/Children's Hospital-Tampa Recruiting
Tampa, Florida, United States, 33607
Contact: Site Public Contact    813-356-7168    Katelynn.Colgain@baycare.org   
Principal Investigator: Dana A. Obzut         
Saint Mary's Hospital Recruiting
West Palm Beach, Florida, United States, 33407
Contact: Site Public Contact    561-881-2815      
Principal Investigator: Narayana Gowda         
United States, Georgia
Children's Healthcare of Atlanta - Egleston Recruiting
Atlanta, Georgia, United States, 30322
Contact: Site Public Contact    404-785-2025    Leann.Schilling@choa.org   
Principal Investigator: Daniel J. Bergsagel         
Medical Center of Central Georgia Recruiting
Macon, Georgia, United States, 31201
Contact: Site Public Contact    478-633-2152    weatherall.andrew@navicenthealth.org   
Principal Investigator: Sushmita Nair         
Memorial Health University Medical Center Recruiting
Savannah, Georgia, United States, 31404
Contact: Site Public Contact    912-350-7887    clayter1@memorialhealth.com   
Principal Investigator: Andrew L. Pendleton         
United States, Hawaii
Kapiolani Medical Center for Women and Children Recruiting
Honolulu, Hawaii, United States, 96826
Contact: Site Public Contact    808-983-6090      
Principal Investigator: Wade T. Kyono         
United States, Idaho
Saint Luke's Mountain States Tumor Institute Recruiting
Boise, Idaho, United States, 83712
Contact: Site Public Contact    208-381-2774    eslinget@slhs.org   
Principal Investigator: Eugenia Chang         
United States, Illinois
University of Illinois Recruiting
Chicago, Illinois, United States, 60612
Contact: Site Public Contact    312-355-3046      
Principal Investigator: Mary L. Schmidt         
Advocate Children's Hospital-Oak Lawn Recruiting
Oak Lawn, Illinois, United States, 60453
Contact: Site Public Contact    847-723-7570      
Principal Investigator: Rebecca E. McFall         
Advocate Children's Hospital-Park Ridge Recruiting
Park Ridge, Illinois, United States, 60068
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Rebecca E. McFall         
Saint Jude Midwest Affiliate Recruiting
Peoria, Illinois, United States, 61637
Contact: Site Public Contact    888-226-4343      
Principal Investigator: Jaime M. Libes         
United States, Indiana
Riley Hospital for Children Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Site Public Contact    800-248-1199      
Principal Investigator: Sandeep Batra         
Saint Vincent Hospital and Health Care Center Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Site Public Contact    317-338-2194    research@stvincent.org   
Principal Investigator: Bassem I. Razzouk         
United States, Iowa
Blank Children's Hospital Recruiting
Des Moines, Iowa, United States, 50309
Contact: Site Public Contact    515-241-8912    samantha.mallory@unitypoint.org   
Principal Investigator: Samantha L. Mallory         
University of Iowa/Holden Comprehensive Cancer Center Recruiting
Iowa City, Iowa, United States, 52242
Contact: Site Public Contact    800-237-1225      
Principal Investigator: Mariko Sato         
United States, Kentucky
University of Kentucky/Markey Cancer Center Recruiting
Lexington, Kentucky, United States, 40536
Contact: Site Public Contact    859-257-3379      
Principal Investigator: Vlad C. Radulescu         
Norton Children's Hospital Recruiting
Louisville, Kentucky, United States, 40202
Contact: Site Public Contact    502-629-5500    CancerResource@nortonhealthcare.org   
Principal Investigator: Ashok B. Raj         
United States, Louisiana
Ochsner Medical Center Jefferson Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Site Public Contact    504-703-8712    Gregory.Johnstone@ochsner.org   
Principal Investigator: Craig Lotterman         
United States, Maine
Maine Children's Cancer Program Recruiting
Scarborough, Maine, United States, 04074
Contact: Site Public Contact    207-396-7581    sverwys@mmc.org   
Principal Investigator: Eric C. Larsen         
United States, Maryland
Sinai Hospital of Baltimore Recruiting
Baltimore, Maryland, United States, 21215
Contact: Site Public Contact    410-601-6120    pridgely@lifebridgehealth.org   
Principal Investigator: Jason M. Fixler         
Johns Hopkins University/Sidney Kimmel Cancer Center Recruiting
Baltimore, Maryland, United States, 21287
Contact: Site Public Contact    410-955-8804    jhcccro@jhmi.edu   
Principal Investigator: Patrick A. Brown         
Walter Reed National Military Medical Center Recruiting
Bethesda, Maryland, United States, 20889-5600
Contact: Site Public Contact    301-319-2100      
Principal Investigator: Kenneth Lieuw         
United States, Massachusetts
Floating Hospital for Children at Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Site Public Contact    617-636-5535      
Principal Investigator: Jason Law         
Massachusetts General Hospital Cancer Center Recruiting
Boston, Massachusetts, United States, 02114
Contact: Site Public Contact    877-726-5130      
Principal Investigator: Lewis B. Silverman         
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Site Public Contact    877-442-3324      
Principal Investigator: Lewis B. Silverman         
United States, Michigan
C S Mott Children's Hospital Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Site Public Contact    800-865-1125      
Principal Investigator: Rajen Mody         
Helen DeVos Children's Hospital at Spectrum Health Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Site Public Contact    616-391-1230    crcwm-regulatory@crcwm.org   
Principal Investigator: Kathleen J. Yost         
Bronson Methodist Hospital Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Site Public Contact    616-391-1230    crcwm-regulatory@crcwm.org   
Principal Investigator: Kathleen J. Yost         
Beaumont Children's Hospital-Royal Oak Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Site Public Contact    248-551-7695      
Principal Investigator: Laura K. Gowans         
United States, Minnesota
Children's Hospitals and Clinics of Minnesota - Minneapolis Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Site Public Contact    612-813-5193      
Principal Investigator: Michael K. Richards         
University of Minnesota/Masonic Cancer Center Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Site Public Contact    612-624-2620      
Principal Investigator: Peter M. Gordon         
United States, Mississippi
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
Contact: Site Public Contact    601-815-6700      
Principal Investigator: Anderson (Andy) B. Collier         
United States, Missouri
Children's Mercy Hospitals and Clinics Recruiting
Kansas City, Missouri, United States, 64108
Contact: Site Public Contact    816-302-6808    rryan@cmh.edu   
Principal Investigator: Keith J. August         
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Site Public Contact    800-600-3606    info@siteman.wustl.edu   
Principal Investigator: Robert J. Hayashi         
Mercy Hospital Saint Louis Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Site Public Contact    314-251-7066      
Principal Investigator: Bethany G. Sleckman         
United States, Nebraska
Children's Hospital and Medical Center of Omaha Recruiting
Omaha, Nebraska, United States, 68114
Contact: Site Public Contact    402-955-3949      
Principal Investigator: Minnie Abromowitch         
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Site Public Contact    402-559-6941    unmcrsa@unmc.edu   
Principal Investigator: Minnie Abromowitch         
United States, Nevada
University Medical Center of Southern Nevada Recruiting
Las Vegas, Nevada, United States, 89102
Contact: Site Public Contact    702-384-0013    research@sncrf.org   
Principal Investigator: Alan K. Ikeda         
Sunrise Hospital and Medical Center Recruiting
Las Vegas, Nevada, United States, 89109
Contact: Site Public Contact    702-384-0013    research@sncrf.org   
Principal Investigator: Alan K. Ikeda         
Alliance for Childhood Diseases/Cure 4 the Kids Foundation Recruiting
Las Vegas, Nevada, United States, 89135
Contact: Site Public Contact    702-384-0013    research@sncrf.org   
Principal Investigator: Alan K. Ikeda         
Summerlin Hospital Medical Center Recruiting
Las Vegas, Nevada, United States, 89144
Contact: Site Public Contact    702-384-0013    research@sncrf.org   
Principal Investigator: Alan K. Ikeda         
United States, New Hampshire
Dartmouth Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Site Public Contact    800-639-6918    cancer.research.nurse@dartmouth.edu   
Principal Investigator: Julie Kim         
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Site Public Contact    201-996-2879      
Principal Investigator: Burton E. Appel         
Morristown Medical Center Recruiting
Morristown, New Jersey, United States, 07960
Contact: Site Public Contact    973-971-5900      
Principal Investigator: John J. Gregory         
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Site Public Contact    732-235-8675      
Principal Investigator: Richard A. Drachtman         
Saint Joseph's Regional Medical Center Recruiting
Paterson, New Jersey, United States, 07503
Contact: Site Public Contact    973-754-2207    HallL@sjhmc.org   
Principal Investigator: Alissa Kahn         
United States, New Mexico
University of New Mexico Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87102
Contact: Site Public Contact    505-925-0366    LByatt@nmcca.org   
Principal Investigator: John F. Kuttesch         
United States, New York
Montefiore Medical Center - Moses Campus Not yet recruiting
Bronx, New York, United States, 10467
Contact: Site Public Contact    718-379-6866    aaraiza@montefiore.org   
Principal Investigator: Lisa Gennarini         
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Site Public Contact    800-767-9355    askroswell@roswellpark.org   
Principal Investigator: Clare J. Twist         
The Steven and Alexandra Cohen Children's Medical Center of New York Recruiting
New Hyde Park, New York, United States, 11040
Contact: Site Public Contact    718-470-3460      
Principal Investigator: Arlene S. Redner         
Laura and Isaac Perlmutter Cancer Center at NYU Langone Recruiting
New York, New York, United States, 10016
Contact: Site Public Contact    212-263-4434    prmc.coordinator@nyumc.org   
Principal Investigator: Sharon L. Gardner         
Mount Sinai Hospital Recruiting
New York, New York, United States, 10029
Contact: Site Public Contact    212-824-7309    CCTO@mssm.edu   
Principal Investigator: Pillai Pallavi Madhusoodhan         
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center Recruiting
New York, New York, United States, 10032
Contact: Site Public Contact    212-305-6361    nr2616@cumc.columbia.edu   
Principal Investigator: Alice Lee         
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Site Public Contact    585-275-5830      
Principal Investigator: Angela R. Girvin         
Stony Brook University Medical Center Recruiting
Stony Brook, New York, United States, 11794
Contact: Site Public Contact    800-862-2215      
Principal Investigator: Laura E. Hogan         
State University of New York Upstate Medical University Recruiting
Syracuse, New York, United States, 13210
Contact: Site Public Contact    315-464-5476      
Principal Investigator: Philip M. Monteleone         
United States, North Carolina
Mission Hospital Inc-Memorial Campus Recruiting
Asheville, North Carolina, United States, 28801
Contact: Site Public Contact    828-213-4150    leslie.verner@msj.org   
Principal Investigator: Douglas J. Scothorn         
UNC Lineberger Comprehensive Cancer Center Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Site Public Contact    877-668-0683    cancerclinicaltrials@med.unc.edu   
Principal Investigator: Stuart H. Gold         
Carolinas Medical Center/Levine Cancer Institute Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Site Public Contact    800-804-9376      
Principal Investigator: Joel A. Kaplan         
Novant Health Presbyterian Medical Center Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Site Public Contact    704-384-5369    nnechiporchik@novanthealth.org   
Principal Investigator: Jessica A. Bell         
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Site Public Contact    888-275-3853      
Principal Investigator: Lars M. Wagner         
East Carolina University Recruiting
Greenville, North Carolina, United States, 27834
Contact: Site Public Contact    252-744-1015    eubankss@ecu.edu   
Principal Investigator: Andrea R. Whitfield         
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Site Public Contact    336-713-6771      
Principal Investigator: Thomas B. Russell         
United States, North Dakota
Sanford Broadway Medical Center Recruiting
Fargo, North Dakota, United States, 58122
Contact: Site Public Contact    701-323-5760    OncologyClinicalTrialsFargo@sanfordhealth.org   
Principal Investigator: Samuel O. Anim         
United States, Ohio
Children's Hospital Medical Center of Akron Recruiting
Akron, Ohio, United States, 44308
Contact: Site Public Contact    330-543-3193      
Principal Investigator: Steven J. Kuerbitz         
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Site Public Contact    513-636-2799    cancer@cchmc.org   
Principal Investigator: Maureen M. O'Brien         
Rainbow Babies and Childrens Hospital Recruiting
Cleveland, Ohio, United States, 44106
Contact: Site Public Contact    216-844-5437      
Principal Investigator: Duncan S. Stearns         
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Site Public Contact    866-223-8100    CancerAnswer@ccf.org   
Principal Investigator: Rabi Hanna         
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Site Public Contact    614-072-2657    amy.yekisa@nationwidechildrens.org   
Principal Investigator: Mark A. Ranalli         
Dayton Children's Hospital Recruiting
Dayton, Ohio, United States, 45404
Contact: Site Public Contact    800-228-4055      
Principal Investigator: Ayman A. El-Sheikh         
The Toledo Hospital/Toledo Children's Hospital Recruiting
Toledo, Ohio, United States, 43606
Contact: Site Public Contact    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: Site Public Contact    405-271-8777    ou-clinical-trials@ouhsc.edu   
Principal Investigator: Rene Y. McNall-Knapp         
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Site Public Contact    503-494-1080    trials@ohsu.edu   
Principal Investigator: Bill H. Chang         
United States, Pennsylvania
Lehigh Valley Hospital-Cedar Crest Recruiting
Allentown, Pennsylvania, United States, 18103
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Felipe S. Bautista-Otanez         
Geisinger Medical Center Recruiting
Danville, Pennsylvania, United States, 17822
Contact: Site Public Contact    570-271-5251    HemonCCTrials@geisinger.edu   
Principal Investigator: Jagadeesh Ramdas         
Penn State Children's Hospital Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Site Public Contact    717-531-6012      
Principal Investigator: Lisa M. McGregor         
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Site Public Contact    267-425-5544    CancerTrials@email.chop.edu   
Principal Investigator: Susan R. Rheingold         
Saint Christopher's Hospital for Children Recruiting
Philadelphia, Pennsylvania, United States, 19134
Contact: Site Public Contact    215-427-8991      
Principal Investigator: Gregory E. Halligan         
Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Site Public Contact    412-692-8570    jean.tersak@chp.edu   
Principal Investigator: Jean M. Tersak         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Site Public Contact    843-792-9321    hcc-clinical-trials@musc.edu   
Principal Investigator: Jacqueline M. Kraveka         
Prisma Health Richland Hospital Recruiting
Columbia, South Carolina, United States, 29203
Contact: Site Public Contact    803-434-3533      
Principal Investigator: Stuart L. Cramer         
BI-LO Charities Children's Cancer Center Recruiting
Greenville, South Carolina, United States, 29605
Contact: Site Public Contact    864-455-8898      
Principal Investigator: Nichole L. Bryant         
United States, South Dakota
Sanford USD Medical Center - Sioux Falls Recruiting
Sioux Falls, South Dakota, United States, 57117-5134
Contact: Site Public Contact    605-312-3320    OncologyClinicalTrialsSF@SanfordHealth.org   
Principal Investigator: Kayelyn J. Wagner         
United States, Tennessee
T C Thompson Children's Hospital Recruiting
Chattanooga, Tennessee, United States, 37403
Contact: Site Public Contact    865-331-1812      
Principal Investigator: Manoo G. Bhakta         
East Tennessee Childrens Hospital Recruiting
Knoxville, Tennessee, United States, 37916
Contact: Site Public Contact    865-541-8266      
Principal Investigator: Ray C. Pais         
The Children's Hospital at TriStar Centennial Recruiting
Nashville, Tennessee, United States, 37203
Contact: Site Public Contact    615-342-1919      
Principal Investigator: Haydar A. Frangoul         
Vanderbilt University/Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Site Public Contact    800-811-8480      
Principal Investigator: Sara Zarnegar-Lumley         
United States, Texas
Dell Children's Medical Center of Central Texas Recruiting
Austin, Texas, United States, 78723
Contact: Site Public Contact    512-628-1902    TXAUS-DL-SFCHemonc.research@ascension.org   
Principal Investigator: Shannon M. Cohn         
Driscoll Children's Hospital Recruiting
Corpus Christi, Texas, United States, 78411
Contact: Site Public Contact    361-694-5311    Crystal.DeLosSantos@dchstx.org   
Principal Investigator: Nkechi I. Mba         
Medical City Dallas Hospital Recruiting
Dallas, Texas, United States, 75230
Contact: Site Public Contact    972-566-5588      
Principal Investigator: Stanton C. Goldman         
UT Southwestern/Simmons Cancer Center-Dallas Recruiting
Dallas, Texas, United States, 75390
Contact: Site Public Contact    214-648-7097    canceranswerline@UTSouthwestern.edu   
Principal Investigator: Tamra L. Slone         
El Paso Children's Hospital Recruiting
El Paso, Texas, United States, 79905
Contact: Site Public Contact    915-298-5444    lisa.hartman@ttuhsc.edu   
Principal Investigator: Lisa L. Hartman         
Cook Children's Medical Center Recruiting
Fort Worth, Texas, United States, 76104
Contact: Site Public Contact    682-885-2103    CookChildrensResearch@cookchildrens.org   
Principal Investigator: Kenneth M. Heym         
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Site Public Contact    713-798-1354    burton@bcm.edu   
Principal Investigator: Rachel E. Rau         
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Site Public Contact    877-632-6789    askmdanderson@mdanderson.org   
Principal Investigator: Najat C. Daw         
Covenant Children's Hospital Recruiting
Lubbock, Texas, United States, 79410
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Kishor M. Bhende         
Children's Hospital of San Antonio Recruiting
San Antonio, Texas, United States, 78207
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Timothy C. Griffin         
Methodist Children's Hospital of South Texas Recruiting
San Antonio, Texas, United States, 78229
Contact: Site Public Contact    210-575-6240    Vinod.GidvaniDiaz@hcahealthcare.com   
Principal Investigator: Vinod K. Gidvani-Diaz         
University of Texas Health Science Center at San Antonio Not yet recruiting
San Antonio, Texas, United States, 78229
Contact: Site Public Contact    210-450-3800    phoresearchoffice@uthscsa.edu   
Principal Investigator: Anne-Marie R. Langevin         
United States, Utah
Primary Children's Hospital Recruiting
Salt Lake City, Utah, United States, 84113
Contact: Site Public Contact    801-585-5270      
Principal Investigator: Phillip E. Barnette         
United States, Vermont
University of Vermont and State Agricultural College Recruiting
Burlington, Vermont, United States, 05405
Contact: Site Public Contact    802-656-8990    rpo@uvm.edu   
Principal Investigator: Jessica L. Heath         
United States, Virginia
Inova Fairfax Hospital Recruiting
Falls Church, Virginia, United States, 22042
Contact: Site Public Contact    703-208-6650    Stephanie.VanBebber@inova.org   
Principal Investigator: Marshall A. Schorin         
Children's Hospital of The King's Daughters Recruiting
Norfolk, Virginia, United States, 23507
Contact: Site Public Contact    757-066-8724    CCBDCresearch@chkd.org   
Principal Investigator: Eric J. Lowe         
Naval Medical Center - Portsmouth Recruiting
Portsmouth, Virginia, United States, 23708-2197
Contact: Site Public Contact    757-953-5939      
Principal Investigator: Bethany M. Mikles         
Virginia Commonwealth University/Massey Cancer Center Recruiting
Richmond, Virginia, United States, 23298
Contact: Site Public Contact    804-628-1939    mwellons@vcu.edu   
Principal Investigator: Christina M. Wiedl         
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Site Public Contact    866-987-2000      
Principal Investigator: Douglas S. Hawkins         
Providence Sacred Heart Medical Center and Children's Hospital Recruiting
Spokane, Washington, United States, 99204
Contact: Site Public Contact    800-228-6618    HopeBeginsHere@providence.org   
Principal Investigator: Judy L. Felgenhauer         
Mary Bridge Children's Hospital and Health Center Suspended
Tacoma, Washington, United States, 98405
Madigan Army Medical Center Recruiting
Tacoma, Washington, United States, 98431
Contact: Site Public Contact    253-968-0129    mamcdci@amedd.army.mil   
Principal Investigator: Melissa A. Forouhar         
United States, West Virginia
West Virginia University Healthcare Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Site Public Contact    304-293-7374    cancertrialsinfo@hsc.wvu.edu   
Principal Investigator: Stephan R. Paul         
United States, Wisconsin
Saint Vincent Hospital Cancer Center Green Bay Recruiting
Green Bay, Wisconsin, United States, 54301
Contact: Site Public Contact    920-433-8889    Christy.Gilchrist@hshs.org   
Principal Investigator: Catherine A. Long         
University of Wisconsin Hospital and Clinics Recruiting
Madison, Wisconsin, United States, 53792
Contact: Site Public Contact    800-622-8922      
Principal Investigator: Kenneth B. DeSantes         
Marshfield Medical Center-Marshfield Recruiting
Marshfield, Wisconsin, United States, 54449
Contact: Site Public Contact    800-782-8581    oncology.clinical.trials@marshfieldresearch.org   
Principal Investigator: Michelle A. Manalang         
Children's Hospital of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Site Public Contact    414-955-4727    MACCCTO@mcw.edu   
Principal Investigator: Michael J. Burke         
Australia, New South Wales
John Hunter Children's Hospital Recruiting
Hunter Regional Mail Centre, New South Wales, Australia, 2310
Contact: Site Public Contact    (02) 4985 5180      
Principal Investigator: Elizabeth L. Hesketh         
Sydney Children's Hospital Recruiting
Randwick, New South Wales, Australia, 2031
Contact: Site Public Contact    (02) 9382-1721      
Principal Investigator: Draga Barbaric         
The Children's Hospital at Westmead Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Site Public Contact    61-2-9845 1400      
Principal Investigator: Bhavna Padhye         
Australia, Queensland
Queensland Children's Hospital Recruiting
South Brisbane, Queensland, Australia, 4101
Contact: Site Public Contact    61 7 3068 1111      
Principal Investigator: Christopher J. Fraser         
Australia, Western Australia
Princess Margaret Hospital for Children Active, not recruiting
Perth, Western Australia, Australia, 6008
Perth Children's Hospital Recruiting
Perth, Western Australia, Australia, 6009
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Marianne B. Phillips         
Canada, Manitoba
CancerCare Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Contact: Site Public Contact    866-561-1026    ctu_web@cancercare.mb.ca   
Principal Investigator: Tanya R. Brown         
Canada, Nova Scotia
IWK Health Centre Recruiting
Halifax, Nova Scotia, Canada, B3K 6R8
Contact: Site Public Contact    902-470-6767      
Principal Investigator: Conrad V. Fernandez         
Canada, Ontario
McMaster Children's Hospital at Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Site Public Contact    905-521-2100      
Principal Investigator: Uma H. Athale         
Kingston Health Sciences Centre Recruiting
Kingston, Ontario, Canada, K7L 2V7
Contact: Site Public Contact    613-549-6666    cc-clinicaltrials@kgh.kari.net   
Principal Investigator: Mariana P. Silva         
Children's Hospital Recruiting
London, Ontario, Canada, N6A 5W9
Contact: Site Public Contact    519-685-8306      
Principal Investigator: Shayna M. Zelcer         
Children's Hospital of Eastern Ontario Recruiting
Ottawa, Ontario, Canada, K1H 8L1
Contact: Site Public Contact    613-738-3931      
Principal Investigator: Donna L. Johnston         
Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Site Public Contact    416-813-7654 ext 2027    jason.mcguire@sickkids.ca   
Principal Investigator: Sumit Gupta         
Canada, Quebec
The Montreal Children's Hospital of the MUHC Suspended
Montreal, Quebec, Canada, H3H 1P3
Centre Hospitalier Universitaire Sainte-Justine Recruiting
Montreal, Quebec, Canada, H3T 1C5
Contact: Site Public Contact    514-345-4931      
Principal Investigator: Yvan Samson         
Canada, Saskatchewan
Saskatoon Cancer Centre Recruiting
Saskatoon, Saskatchewan, Canada, S7N 4H4
Contact: Site Public Contact    306-655-2914      
Principal Investigator: Christopher Mpofu         
Canada
Centre Hospitalier Universitaire de Quebec Recruiting
Quebec, Canada, G1V 4G2
Contact: Site Public Contact    418-525-4444      
Principal Investigator: Bruno Michon         
New Zealand
Starship Children's Hospital Recruiting
Grafton, Auckland, New Zealand, 1145
Contact: Site Public Contact    0800 728 436      
Principal Investigator: Peter J. Bradbeer         
Christchurch Hospital Recruiting
Christchurch, New Zealand, 8011
Contact: Site Public Contact    03 364 0640      
Principal Investigator: Siobhan F. Cross         
Puerto Rico
HIMA San Pablo Oncologic Hospital Recruiting
Caguas, Puerto Rico, 00726
Contact: Site Public Contact    787-653-3434      
Principal Investigator: Jhon A. Guerra         
San Jorge Children's Hospital Recruiting
San Juan, Puerto Rico, 00912
Contact: Site Public Contact    787-727-1000      
Principal Investigator: Luis A. Clavell         
University Pediatric Hospital Recruiting
San Juan, Puerto Rico, 00926
Contact: Site Public Contact    787-474-0333      
Principal Investigator: Luis A. Clavell         
Saudi Arabia
King Faisal Specialist Hospital and Research Centre Recruiting
Riyadh, Saudi Arabia, 11211
Contact: Site Public Contact    011-966-1-464-7272 ext 38005      
Principal Investigator: Afshan A. Ali         
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
University of Milano Bicocca
Investigators
Layout table for investigator information
Principal Investigator: Lewis Silverman Children's Oncology Group
Principal Investigator: Andrea Biondi EsPhALL

Layout table for additonal information
Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT03007147     History of Changes
Other Study ID Numbers: AALL1631
NCI-2016-01588 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
AALL1631
AALL1631 ( Other Identifier: Childrens Oncology Group )
AALL1631 ( Other Identifier: CTEP )
U10CA180886 ( U.S. NIH Grant/Contract )
2017-000705-20 ( EudraCT Number )
EsPhALL2017 ( Other Identifier: EsPhALL )
First Posted: January 2, 2017    Key Record Dates
Last Update Posted: November 18, 2019
Last Verified: February 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Leukemia
Leukemia, Lymphoid
Neoplasm, Residual
Philadelphia Chromosome
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Translocation, Genetic
Chromosome Aberrations
Pathologic Processes
Neoplastic Processes
Calcium, Dietary
Leucovorin
Folic Acid
Cytarabine
Dexamethasone
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate