Purpose

This randomized phase III trial studies how well combination chemotherapy works in treating young patients with newly diagnosed B acute lymphoblastic leukemia that is likely to come back or spread, and in patients with Philadelphia chromosome (Ph)-like tyrosine kinase inhibitor (TKI) sensitive mutations. Chemotherapy drugs, 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) and giving the drugs in different doses and in different combinations may kill more cancer cells.

Category

IRB Number
20120250HU
NCT Number
NCT02883049
Open to Enrollment
Yes
Sponsor
National Cancer Institute (NCI) -



Study Contact

Principal Investigator
Anne-Marie Langevin

Virginia Diaz
(210) 562-9149
diazvr@uthscsa.edu



Eligibility

Eligible Ages
Between 1 Year and 31 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

    Exclusion Criteria


      Study Design

      Phase
      Phase 3
      Study Type
      Interventional
      Allocation
      Randomized
      Intervention Model
      Parallel Assignment
      Primary Purpose
      Treatment
      Masking
      None (Open Label)
      Condition
    1. B Acute Lymphoblastic Leukemia
    2. Central Nervous System Leukemia
    3. Ph-Like Acute Lymphoblastic Leukemia
    4. Testicular Leukemia
    5. Arm Groups

      ArmDescriptionIntervention
      Experimental

      DS HR B-ALL (SER)

      Patients receive induction, consolidation, interim maintenance, delayed intensification, interim maintenance and maintenance therapies. See outline for details.
    6. 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 <

    7. Drug: Dexamethasone

      PO or IV

      Other names:

      • Aacidexam
      • Adexone
      • Aknichthol Dexa
      • Alba-Dex
      • Alin
      • Alin Depot
      • Alin Oftalmico
      • Amplidermis
      • Anemul mono
      • Auricularum
      • Auxiloson
      • Baycadron
      • Baycut

    8. Other: Laboratory Biomarker Analysis

      Correlative studies

    9. 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

      • Drug: Pegaspargase

        Given IV

        Other names:

        • L-Asparaginase with Polyethylene Glycol
        • Oncaspar
        • Oncaspar-IV
        • PEG-Asparaginase
        • PEG-L-Asparaginase
        • PEG-L-Asparaginase (Enzon - Kyowa Hakko)
        • PEGLA
        • Polyethylene Glyc

      • Radiation: Radiation Therapy

        Undergo radiation therapy

        Other names:

        • Cancer Radiotherapy
        • ENERGY_TYPE
        • Irradiate
        • Irradiated
        • Irradiation
        • Radiation
        • Radiation Therapy, NOS
        • Radiotherapeutics
        • Radiotherapy
        • RT
        • Therapy, Radia

      • Drug: Vincristine Sulfate

        Given IV

        Other names:

        • Kyocristine
        • Leurocristine Sulfate
        • Leurocristine, sulfate
        • Oncovin
        • Vincasar
        • Vincosid
        • Vincrex
        • Vincristine, sulfate

      • 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-arabinofuranosyl-4-amino-2(1H)pyrimidinone
        • 1-Beta

      • Drug: Daunorubicin Hydrochloride

        Given IV

        Other names:

        • Cerubidin
        • Cerubidine
        • Cloridrato de Daunorubicina
        • Daunoblastin
        • Daunoblastina
        • Daunoblastine
        • Daunomycin Hydrochloride
        • Daunomycin, hydrochloride
        • Daunorubicin.HC

      • 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

        • 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
          • C

        • Drug: Methotrexate

          Given IT and IV

          Other names:

          • Abitrexate
          • Alpha-Methopterin
          • Amethopterin
          • Brimexate
          • CL 14377
          • CL-14377
          • Emtexate
          • Emthexat
          • Emthexate
          • Farmitrexat
          • Fauldexato
          • Folex
          • Folex PFS

        • Drug: Prednisone

          Given PO or IV

          Other names:

          • .delta.1-Cortisone
          • 1, 2-Dehydrocortisone
          • Adasone
          • Cortancyl
          • Dacortin
          • DeCortin
          • Decortisyl
          • Decorton
          • Delta 1-Cortisone
          • Delta-Dome
          • Deltacortene
          • De

        • 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-thio

    10. Experimental

      Group I Arm B (HR B-ALL) (CLOSED 03/19/2018)

      Patients receive induction, consolidation, interim maintenance, delayed intensification and maintenance therapies. See outline for details.
    11. 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 <

    12. Drug: Dexamethasone

      PO or IV

      Other names:

      • Aacidexam
      • Adexone
      • Aknichthol Dexa
      • Alba-Dex
      • Alin
      • Alin Depot
      • Alin Oftalmico
      • Amplidermis
      • Anemul mono
      • Auricularum
      • Auxiloson
      • Baycadron
      • Baycut

    13. Other: Laboratory Biomarker Analysis

      Correlative studies

    14. 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

      • Drug: Pegaspargase

        Given IV

        Other names:

        • L-Asparaginase with Polyethylene Glycol
        • Oncaspar
        • Oncaspar-IV
        • PEG-Asparaginase
        • PEG-L-Asparaginase
        • PEG-L-Asparaginase (Enzon - Kyowa Hakko)
        • PEGLA
        • Polyethylene Glyc

      • Radiation: Radiation Therapy

        Undergo radiation therapy

        Other names:

        • Cancer Radiotherapy
        • ENERGY_TYPE
        • Irradiate
        • Irradiated
        • Irradiation
        • Radiation
        • Radiation Therapy, NOS
        • Radiotherapeutics
        • Radiotherapy
        • RT
        • Therapy, Radia

      • Drug: Vincristine Sulfate

        Given IV

        Other names:

        • Kyocristine
        • Leurocristine Sulfate
        • Leurocristine, sulfate
        • Oncovin
        • Vincasar
        • Vincosid
        • Vincrex
        • Vincristine, sulfate

      • 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-arabinofuranosyl-4-amino-2(1H)pyrimidinone
        • 1-Beta

      • Drug: Daunorubicin Hydrochloride

        Given IV

        Other names:

        • Cerubidin
        • Cerubidine
        • Cloridrato de Daunorubicina
        • Daunoblastin
        • Daunoblastina
        • Daunoblastine
        • Daunomycin Hydrochloride
        • Daunomycin, hydrochloride
        • Daunorubicin.HC

      • 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

        • Drug: Hydrocortisone Sodium Succinate

          Given IT

          Other names:

          • (11beta)-21-(3-Carboxy-1-oxopropyl)-11,17-dihydroxypregn-4-ene-3,20-dione, Monosodium Salt
          • A-Hydrocort
          • Buccalsone
          • Corlan
          • Cortisol Sodium Succinate
          • Cortop
          • Efcortelan

        • 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
          • C

        • Drug: Methotrexate

          Given IT and IV

          Other names:

          • Abitrexate
          • Alpha-Methopterin
          • Amethopterin
          • Brimexate
          • CL 14377
          • CL-14377
          • Emtexate
          • Emthexat
          • Emthexate
          • Farmitrexat
          • Fauldexato
          • Folex
          • Folex PFS

        • Drug: Prednisone

          Given PO or IV

          Other names:

          • .delta.1-Cortisone
          • 1, 2-Dehydrocortisone
          • Adasone
          • Cortancyl
          • Dacortin
          • DeCortin
          • Decortisyl
          • Decorton
          • Delta 1-Cortisone
          • Delta-Dome
          • Deltacortene
          • De

        • 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-thio

    15. Experimental

      Group II Arm B (VHR B-ALL - Exp Arm1) (CLOSED 02/15/2017)

      Patients receive consolidation, interim maintenance, delayed intensification and maintenance therapies. See outline for details.
    16. 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 <

    17. Drug: Etoposide

      Given IV

      Other names:

      • Demethyl Epipodophyllotoxin Ethylidine Glucoside
      • EPEG
      • Lastet
      • Toposar
      • Vepesid
      • VP 16
      • VP 16-213
      • VP-16
      • VP-16-213
      • VP16

    18. Other: Laboratory Biomarker Analysis

      Correlative studies

    19. 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

      • Drug: Pegaspargase

        Given IV

        Other names:

        • L-Asparaginase with Polyethylene Glycol
        • Oncaspar
        • Oncaspar-IV
        • PEG-Asparaginase
        • PEG-L-Asparaginase
        • PEG-L-Asparaginase (Enzon - Kyowa Hakko)
        • PEGLA
        • Polyethylene Glyc

      • Radiation: Radiation Therapy

        Undergo radiation therapy

        Other names:

        • Cancer Radiotherapy
        • ENERGY_TYPE
        • Irradiate
        • Irradiated
        • Irradiation
        • Radiation
        • Radiation Therapy, NOS
        • Radiotherapeutics
        • Radiotherapy
        • RT
        • Therapy, Radia

      • Drug: Vincristine Sulfate

        Given IV

        Other names:

        • Kyocristine
        • Leurocristine Sulfate
        • Leurocristine, sulfate
        • Oncovin
        • Vincasar
        • Vincosid
        • Vincrex
        • Vincristine, sulfate

      • 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-arabinofuranosyl-4-amino-2(1H)pyrimidinone
        • 1-Beta

      • Drug: Daunorubicin Hydrochloride

        Given IV

        Other names:

        • Cerubidin
        • Cerubidine
        • Cloridrato de Daunorubicina
        • Daunoblastin
        • Daunoblastina
        • Daunoblastine
        • Daunomycin Hydrochloride
        • Daunomycin, hydrochloride
        • Daunorubicin.HC

      • 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

        • 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
          • C

        • Drug: Methotrexate

          Given IT and IV

          Other names:

          • Abitrexate
          • Alpha-Methopterin
          • Amethopterin
          • Brimexate
          • CL 14377
          • CL-14377
          • Emtexate
          • Emthexat
          • Emthexate
          • Farmitrexat
          • Fauldexato
          • Folex
          • Folex PFS

        • Drug: Prednisone

          Given PO or IV

          Other names:

          • .delta.1-Cortisone
          • 1, 2-Dehydrocortisone
          • Adasone
          • Cortancyl
          • Dacortin
          • DeCortin
          • Decortisyl
          • Decorton
          • Delta 1-Cortisone
          • Delta-Dome
          • Deltacortene
          • De

    20. Experimental

      Group III PH-like predicted TKI-sensitive kinase mutation

      Patients receive induction, consolidation, interim maintenance, delayed intensification, interim maintenance and maintenance therapies. See outline for details.
    21. 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 <

    22. Drug: Dasatinib

      Given PO

      Other names:

      • BMS-354825
      • Dasatinib Hydrate
      • Dasatinib Monohydrate
      • Sprycel

    23. Drug: Dexamethasone

      PO or IV

      Other names:

      • Aacidexam
      • Adexone
      • Aknichthol Dexa
      • Alba-Dex
      • Alin
      • Alin Depot
      • Alin Oftalmico
      • Amplidermis
      • Anemul mono
      • Auricularum
      • Auxiloson
      • Baycadron
      • Baycut

    24. Other: Laboratory Biomarker Analysis

      Correlative studies

    25. 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

      • Drug: Pegaspargase

        Given IV

        Other names:

        • L-Asparaginase with Polyethylene Glycol
        • Oncaspar
        • Oncaspar-IV
        • PEG-Asparaginase
        • PEG-L-Asparaginase
        • PEG-L-Asparaginase (Enzon - Kyowa Hakko)
        • PEGLA
        • Polyethylene Glyc

      • Drug: Vincristine Sulfate

        Given IV

        Other names:

        • Kyocristine
        • Leurocristine Sulfate
        • Leurocristine, sulfate
        • Oncovin
        • Vincasar
        • Vincosid
        • Vincrex
        • Vincristine, sulfate

      • 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-arabinofuranosyl-4-amino-2(1H)pyrimidinone
        • 1-Beta

      • Drug: Daunorubicin Hydrochloride

        Given IV

        Other names:

        • Cerubidin
        • Cerubidine
        • Cloridrato de Daunorubicina
        • Daunoblastin
        • Daunoblastina
        • Daunoblastine
        • Daunomycin Hydrochloride
        • Daunomycin, hydrochloride
        • Daunorubicin.HC

      • 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

        • 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
          • C

        • Drug: Methotrexate

          Given IT and IV

          Other names:

          • Abitrexate
          • Alpha-Methopterin
          • Amethopterin
          • Brimexate
          • CL 14377
          • CL-14377
          • Emtexate
          • Emthexat
          • Emthexate
          • Farmitrexat
          • Fauldexato
          • Folex
          • Folex PFS

        • Drug: Prednisone

          Given PO or IV

          Other names:

          • .delta.1-Cortisone
          • 1, 2-Dehydrocortisone
          • Adasone
          • Cortancyl
          • Dacortin
          • DeCortin
          • Decortisyl
          • Decorton
          • Delta 1-Cortisone
          • Delta-Dome
          • Deltacortene
          • De

    26. Experimental

      DS HR B-ALL (RER)

      Patients receive induction, consolidation, interim maintenance, delayed intensification, interim maintenance and maintenance therapies. See outline for details.
    27. 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 <

    28. Drug: Dexamethasone

      PO or IV

      Other names:

      • Aacidexam
      • Adexone
      • Aknichthol Dexa
      • Alba-Dex
      • Alin
      • Alin Depot
      • Alin Oftalmico
      • Amplidermis
      • Anemul mono
      • Auricularum
      • Auxiloson
      • Baycadron
      • Baycut

    29. Other: Laboratory Biomarker Analysis

      Correlative studies

    30. 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

      • Drug: Pegaspargase

        Given IV

        Other names:

        • L-Asparaginase with Polyethylene Glycol
        • Oncaspar
        • Oncaspar-IV
        • PEG-Asparaginase
        • PEG-L-Asparaginase
        • PEG-L-Asparaginase (Enzon - Kyowa Hakko)
        • PEGLA
        • Polyethylene Glyc

      • Radiation: Radiation Therapy

        Undergo radiation therapy

        Other names:

        • Cancer Radiotherapy
        • ENERGY_TYPE
        • Irradiate
        • Irradiated
        • Irradiation
        • Radiation
        • Radiation Therapy, NOS
        • Radiotherapeutics
        • Radiotherapy
        • RT
        • Therapy, Radia

      • Drug: Vincristine Sulfate

        Given IV

        Other names:

        • Kyocristine
        • Leurocristine Sulfate
        • Leurocristine, sulfate
        • Oncovin
        • Vincasar
        • Vincosid
        • Vincrex
        • Vincristine, sulfate

      • 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-arabinofuranosyl-4-amino-2(1H)pyrimidinone
        • 1-Beta

      • 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

        • 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
          • C

        • Drug: Methotrexate

          Given IT and IV

          Other names:

          • Abitrexate
          • Alpha-Methopterin
          • Amethopterin
          • Brimexate
          • CL 14377
          • CL-14377
          • Emtexate
          • Emthexat
          • Emthexate
          • Farmitrexat
          • Fauldexato
          • Folex
          • Folex PFS

        • Drug: Prednisone

          Given PO or IV

          Other names:

          • .delta.1-Cortisone
          • 1, 2-Dehydrocortisone
          • Adasone
          • Cortancyl
          • Dacortin
          • DeCortin
          • Decortisyl
          • Decorton
          • Delta 1-Cortisone
          • Delta-Dome
          • Deltacortene
          • De

        • 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-thio

    31. Experimental

      Group I Arm A (HR B-ALL)

      Patients receive induction, consolidation, interim maintenance, delayed intensification and maintenance therapies. See outline for details.
    32. 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 <

    33. Drug: Dexamethasone

      PO or IV

      Other names:

      • Aacidexam
      • Adexone
      • Aknichthol Dexa
      • Alba-Dex
      • Alin
      • Alin Depot
      • Alin Oftalmico
      • Amplidermis
      • Anemul mono
      • Auricularum
      • Auxiloson
      • Baycadron
      • Baycut

    34. Other: Laboratory Biomarker Analysis

      Correlative studies

    35. 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

      • Drug: Pegaspargase

        Given IV

        Other names:

        • L-Asparaginase with Polyethylene Glycol
        • Oncaspar
        • Oncaspar-IV
        • PEG-Asparaginase
        • PEG-L-Asparaginase
        • PEG-L-Asparaginase (Enzon - Kyowa Hakko)
        • PEGLA
        • Polyethylene Glyc

      • Radiation: Radiation Therapy

        Undergo radiation therapy

        Other names:

        • Cancer Radiotherapy
        • ENERGY_TYPE
        • Irradiate
        • Irradiated
        • Irradiation
        • Radiation
        • Radiation Therapy, NOS
        • Radiotherapeutics
        • Radiotherapy
        • RT
        • Therapy, Radia

      • Drug: Vincristine Sulfate

        Given IV

        Other names:

        • Kyocristine
        • Leurocristine Sulfate
        • Leurocristine, sulfate
        • Oncovin
        • Vincasar
        • Vincosid
        • Vincrex
        • Vincristine, sulfate

      • 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-arabinofuranosyl-4-amino-2(1H)pyrimidinone
        • 1-Beta

      • Drug: Daunorubicin Hydrochloride

        Given IV

        Other names:

        • Cerubidin
        • Cerubidine
        • Cloridrato de Daunorubicina
        • Daunoblastin
        • Daunoblastina
        • Daunoblastine
        • Daunomycin Hydrochloride
        • Daunomycin, hydrochloride
        • Daunorubicin.HC

      • 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

        • 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
          • C

        • Drug: Methotrexate

          Given IT and IV

          Other names:

          • Abitrexate
          • Alpha-Methopterin
          • Amethopterin
          • Brimexate
          • CL 14377
          • CL-14377
          • Emtexate
          • Emthexat
          • Emthexate
          • Farmitrexat
          • Fauldexato
          • Folex
          • Folex PFS

        • Drug: Prednisone

          Given PO or IV

          Other names:

          • .delta.1-Cortisone
          • 1, 2-Dehydrocortisone
          • Adasone
          • Cortancyl
          • Dacortin
          • DeCortin
          • Decortisyl
          • Decorton
          • Delta 1-Cortisone
          • Delta-Dome
          • Deltacortene
          • De

        • 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-thio

    36. Active Comparator

      Group II Arm A (VHR B-ALL - Control Arm)

      Patients receive induction, consolidation, interim maintenance, delayed intensification and maintenance therapies. See outline for details.
    37. 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 <

    38. Drug: Dexamethasone

      PO or IV

      Other names:

      • Aacidexam
      • Adexone
      • Aknichthol Dexa
      • Alba-Dex
      • Alin
      • Alin Depot
      • Alin Oftalmico
      • Amplidermis
      • Anemul mono
      • Auricularum
      • Auxiloson
      • Baycadron
      • Baycut

    39. Other: Laboratory Biomarker Analysis

      Correlative studies

    40. 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

      • Drug: Pegaspargase

        Given IV

        Other names:

        • L-Asparaginase with Polyethylene Glycol
        • Oncaspar
        • Oncaspar-IV
        • PEG-Asparaginase
        • PEG-L-Asparaginase
        • PEG-L-Asparaginase (Enzon - Kyowa Hakko)
        • PEGLA
        • Polyethylene Glyc

      • Radiation: Radiation Therapy

        Undergo radiation therapy

        Other names:

        • Cancer Radiotherapy
        • ENERGY_TYPE
        • Irradiate
        • Irradiated
        • Irradiation
        • Radiation
        • Radiation Therapy, NOS
        • Radiotherapeutics
        • Radiotherapy
        • RT
        • Therapy, Radia

      • Drug: Vincristine Sulfate

        Given IV

        Other names:

        • Kyocristine
        • Leurocristine Sulfate
        • Leurocristine, sulfate
        • Oncovin
        • Vincasar
        • Vincosid
        • Vincrex
        • Vincristine, sulfate

      • 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-arabinofuranosyl-4-amino-2(1H)pyrimidinone
        • 1-Beta

      • Drug: Daunorubicin Hydrochloride

        Given IV

        Other names:

        • Cerubidin
        • Cerubidine
        • Cloridrato de Daunorubicina
        • Daunoblastin
        • Daunoblastina
        • Daunoblastine
        • Daunomycin Hydrochloride
        • Daunomycin, hydrochloride
        • Daunorubicin.HC

      • 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

        • 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
          • C

        • Drug: Methotrexate

          Given IT and IV

          Other names:

          • Abitrexate
          • Alpha-Methopterin
          • Amethopterin
          • Brimexate
          • CL 14377
          • CL-14377
          • Emtexate
          • Emthexat
          • Emthexate
          • Farmitrexat
          • Fauldexato
          • Folex
          • Folex PFS

        • Drug: Prednisone

          Given PO or IV

          Other names:

          • .delta.1-Cortisone
          • 1, 2-Dehydrocortisone
          • Adasone
          • Cortancyl
          • Dacortin
          • DeCortin
          • Decortisyl
          • Decorton
          • Delta 1-Cortisone
          • Delta-Dome
          • Deltacortene
          • De

        • 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-thio

    41. Experimental

      Group II Arm C (VHR B-ALL - Exp Arm 2) (CLOSED 09/12/2014)

      Patients receive induction, consolidation, interim maintenance, delayed intensification and maintenance therapies. See outline for details.
    42. 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 <

    43. Drug: Dexamethasone

      PO or IV

      Other names:

      • Aacidexam
      • Adexone
      • Aknichthol Dexa
      • Alba-Dex
      • Alin
      • Alin Depot
      • Alin Oftalmico
      • Amplidermis
      • Anemul mono
      • Auricularum
      • Auxiloson
      • Baycadron
      • Baycut

    44. Drug: Etoposide

      Given IV

      Other names:

      • Demethyl Epipodophyllotoxin Ethylidine Glucoside
      • EPEG
      • Lastet
      • Toposar
      • Vepesid
      • VP 16
      • VP 16-213
      • VP-16
      • VP-16-213
      • VP16

    45. Other: Laboratory Biomarker Analysis

      Correlative studies

    46. 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

      • Drug: Pegaspargase

        Given IV

        Other names:

        • L-Asparaginase with Polyethylene Glycol
        • Oncaspar
        • Oncaspar-IV
        • PEG-Asparaginase
        • PEG-L-Asparaginase
        • PEG-L-Asparaginase (Enzon - Kyowa Hakko)
        • PEGLA
        • Polyethylene Glyc

      • Radiation: Radiation Therapy

        Undergo radiation therapy

        Other names:

        • Cancer Radiotherapy
        • ENERGY_TYPE
        • Irradiate
        • Irradiated
        • Irradiation
        • Radiation
        • Radiation Therapy, NOS
        • Radiotherapeutics
        • Radiotherapy
        • RT
        • Therapy, Radia

      • Drug: Vincristine Sulfate

        Given IV

        Other names:

        • Kyocristine
        • Leurocristine Sulfate
        • Leurocristine, sulfate
        • Oncovin
        • Vincasar
        • Vincosid
        • Vincrex
        • Vincristine, sulfate

      • Drug: Clofarabine

        Given IV

        Other names:

        • Clofarex
        • Clolar

      • 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-arabinofuranosyl-4-amino-2(1H)pyrimidinone
        • 1-Beta

      • Drug: Daunorubicin Hydrochloride

        Given IV

        Other names:

        • Cerubidin
        • Cerubidine
        • Cloridrato de Daunorubicina
        • Daunoblastin
        • Daunoblastina
        • Daunoblastine
        • Daunomycin Hydrochloride
        • Daunomycin, hydrochloride
        • Daunorubicin.HC

      • 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

        • 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
          • C

        • Drug: Methotrexate

          Given IT and IV

          Other names:

          • Abitrexate
          • Alpha-Methopterin
          • Amethopterin
          • Brimexate
          • CL 14377
          • CL-14377
          • Emtexate
          • Emthexat
          • Emthexate
          • Farmitrexat
          • Fauldexato
          • Folex
          • Folex PFS

        • Drug: Prednisone

          Given PO or IV

          Other names:

          • .delta.1-Cortisone
          • 1, 2-Dehydrocortisone
          • Adasone
          • Cortancyl
          • Dacortin
          • DeCortin
          • Decortisyl
          • Decorton
          • Delta 1-Cortisone
          • Delta-Dome
          • Deltacortene
          • De