Find-A-Study

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

Purpose

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.

Study Contact

Principal Investigator
Anne-Marie Langevin

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

Jaclyn Hung
210-450-5358
hungj@uthscsa.edu

Eligibility

Eligible Ages: Between 2 Years and 21 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

- For patients enrolled on APEC14B1 prior to enrollment on AALL1631, the required diagnostic bone marrow sample has been fulfilled - For patients who have not previously enrolled on APEC14B1 prior to enrollment on AALL1631, a baseline diagnostic sample (or peripheral blood sample with blasts if marrow sample unavailable) 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) or mixed phenotypic acute leukemia (MPAL meeting 2016 World Health Organization [WHO] definition) 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 since fetal toxicities and teratogenic effects have been noted for several of the study drugs; 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

Study Design

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: None (Open Label)
Condition: Acute Lymphoblastic Leukemia
B Acute Lymphoblastic Leukemia
Mixed Phenotype Acute Leukemia
T Acute Lymphoblastic Leukemia

Arm Groups

Arm	Description	Intervention
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 < Drug: Daunorubicin Hydrochloride Given IV Other names: Cerubidin Cerubidine Cloridrato de Daunorubicina Daunoblastin Daunoblastina Daunoblastine Daunomycin hydrochloride Daunomycin, hydrochloride Daunorubicin.HC Drug: Dexrazoxane Hydrochloride Given IV Other names: Cardioxane Totect Zinecard 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 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 Other: Laboratory Biomarker Analysis Correlative studies Drug: Mercaptopurine Given PO Other names: 3H-Purine-6-thiol 6 MP 6 Thiohypoxanthine 6 Thiopurine 6-Mercaptopurine 6-Mercaptopurine Monohydrate 6-MP 6-Purinethiol 6-Thiopurine 6-Thioxopurine Drug: Methotrexate Given IT Other names: Abitrexate Alpha-Methopterin Amethopterin Brimexate CL 14377 CL-14377 Emtexate Emthexat Emthexate Farmitrexat Fauldexato Folex Folex PFS 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 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-thio 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 Drug: Dexamethasone Given PO or IV Other names: Aacidexam Adexone Aknichthol Dexa Alba-Dex Alin Alin Depot Alin Oftalmico Amplidermis Anemul mono Auricularum Auxiloson Baycadron Baycut Drug: Doxorubicin Given IV Other names: Adriablastin Hydroxydaunomycin Hydroxyl Daunorubicin Hydroxyldaunorubicin Biological: Filgrastim Given IV Other names: G-CSF Neupogen r-metHuG-CSF Recombinant Methionyl Human Granulocyte Colony Stimulating Factor rG-CSF Tevagrastim Drug: Imatinib Mesylate Given PO Other names: CGP 57148 CGP57148B Gleevec Glivec STI 571 STI-571 STI571 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: 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: Methylprednisolone Given IV Other names: Adlone Caberdelta M DepMedalone Depo Moderin Depo-Nisolone Duralone Emmetipi Esametone Firmacort Medlone 21 Medrate Medrol Medrol Veride 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 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 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	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 < Drug: Daunorubicin Hydrochloride Given IV Other names: Cerubidin Cerubidine Cloridrato de Daunorubicina Daunoblastin Daunoblastina Daunoblastine Daunomycin hydrochloride Daunomycin, hydrochloride Daunorubicin.HC Drug: Dexrazoxane Hydrochloride Given IV Other names: Cardioxane Totect Zinecard 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 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 Other: Laboratory Biomarker Analysis Correlative studies Drug: Mercaptopurine Given PO Other names: 3H-Purine-6-thiol 6 MP 6 Thiohypoxanthine 6 Thiopurine 6-Mercaptopurine 6-Mercaptopurine Monohydrate 6-MP 6-Purinethiol 6-Thiopurine 6-Thioxopurine Drug: Methotrexate Given IT Other names: Abitrexate Alpha-Methopterin Amethopterin Brimexate CL 14377 CL-14377 Emtexate Emthexat Emthexate Farmitrexat Fauldexato Folex Folex PFS 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 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-thio Procedure: Allogeneic Hematopoietic Stem Cell Transplantation Undergo HSCT Other names: Allogeneic Hematopoietic Cell Transplantation Allogeneic Stem Cell Transplantation HSC HSCT Stem Cell Transplantation, Allogeneic 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 Drug: Dexamethasone Given PO or IV Other names: Aacidexam Adexone Aknichthol Dexa Alba-Dex Alin Alin Depot Alin Oftalmico Amplidermis Anemul mono Auricularum Auxiloson Baycadron Baycut Drug: Doxorubicin Given IV Other names: Adriablastin Hydroxydaunomycin Hydroxyl Daunorubicin Hydroxyldaunorubicin Biological: Filgrastim Given IV Other names: G-CSF Neupogen r-metHuG-CSF Recombinant Methionyl Human Granulocyte Colony Stimulating Factor rG-CSF Tevagrastim Drug: Imatinib Mesylate Given PO Other names: CGP 57148 CGP57148B Gleevec Glivec STI 571 STI-571 STI571 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: 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: Methylprednisolone Given IV Other names: Adlone Caberdelta M DepMedalone Depo Moderin Depo-Nisolone Duralone Emmetipi Esametone Firmacort Medlone 21 Medrate Medrol Medrol Veride 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 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 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 < Drug: Dexrazoxane Hydrochloride Given IV Other names: Cardioxane Totect Zinecard Other: Laboratory Biomarker Analysis Correlative studies Drug: Methotrexate Given IT Other names: Abitrexate Alpha-Methopterin Amethopterin Brimexate CL 14377 CL-14377 Emtexate Emthexat Emthexate Farmitrexat Fauldexato Folex Folex PFS 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 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-thio 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 Drug: Dexamethasone Given PO or IV Other names: Aacidexam Adexone Aknichthol Dexa Alba-Dex Alin Alin Depot Alin Oftalmico Amplidermis Anemul mono Auricularum Auxiloson Baycadron Baycut Drug: Doxorubicin Given IV Other names: Adriablastin Hydroxydaunomycin Hydroxyl Daunorubicin Hydroxyldaunorubicin Drug: Imatinib Mesylate Given PO Other names: CGP 57148 CGP57148B Gleevec Glivec STI 571 STI-571 STI571 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: 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: Methylprednisolone Given IV Other names: Adlone Caberdelta M DepMedalone Depo Moderin Depo-Nisolone Duralone Emmetipi Esametone Firmacort Medlone 21 Medrate Medrol Medrol Veride 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 Drug: Vincristine Sulfate Given IV Other names: Kyocristine Leurocristine sulfate Leurocristine, sulfate Oncovin Vincasar Vincosid Vincrex Vincristine, sulfate

Arm

Description

Intervention

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 <

Drug: Daunorubicin Hydrochloride

Given IV

Other names:

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

Drug: Dexrazoxane Hydrochloride

Given IV

Other names:

Cardioxane
Totect
Zinecard

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

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
Other: Laboratory Biomarker Analysis
Correlative studies
Drug: Mercaptopurine
Given PO
Other names:
- 3H-Purine-6-thiol
- 6 MP
- 6 Thiohypoxanthine
- 6 Thiopurine
- 6-Mercaptopurine
- 6-Mercaptopurine Monohydrate
- 6-MP
- 6-Purinethiol
- 6-Thiopurine
- 6-Thioxopurine
- Drug: Methotrexate
  Given IT
  Other names:
  - Abitrexate
  - Alpha-Methopterin
  - Amethopterin
  - Brimexate
  - CL 14377
  - CL-14377
  - Emtexate
  - Emthexat
  - Emthexate
  - Farmitrexat
  - Fauldexato
  - Folex
  - Folex PFS
- 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
- 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-thio
- 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
- Drug: Dexamethasone
  Given PO or IV
  Other names:
  - Aacidexam
  - Adexone
  - Aknichthol Dexa
  - Alba-Dex
  - Alin
  - Alin Depot
  - Alin Oftalmico
  - Amplidermis
  - Anemul mono
  - Auricularum
  - Auxiloson
  - Baycadron
  - Baycut
- Drug: Doxorubicin
  Given IV
  Other names:
  - Adriablastin
  - Hydroxydaunomycin
  - Hydroxyl Daunorubicin
  - Hydroxyldaunorubicin
- Biological: Filgrastim
  Given IV
  Other names:
  - G-CSF
  - Neupogen
  - r-metHuG-CSF
  - Recombinant Methionyl Human Granulocyte Colony Stimulating Factor
  - rG-CSF
  - Tevagrastim
- Drug: Imatinib Mesylate
  Given PO
  Other names:
  - CGP 57148
  - CGP57148B
  - Gleevec
  - Glivec
  - STI 571
  - STI-571
  - STI571
- 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: 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: Methylprednisolone
    Given IV
    Other names:
    - Adlone
    - Caberdelta M
    - DepMedalone
    - Depo Moderin
    - Depo-Nisolone
    - Duralone
    - Emmetipi
    - Esametone
    - Firmacort
    - Medlone 21
    - Medrate
    - Medrol
    - Medrol Veride
  - 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
  - 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
  - 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

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 <

Drug: Daunorubicin Hydrochloride

Given IV

Other names:

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

Drug: Dexrazoxane Hydrochloride

Given IV

Other names:

Cardioxane
Totect
Zinecard

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

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
Other: Laboratory Biomarker Analysis
Correlative studies
Drug: Mercaptopurine
Given PO
Other names:
- 3H-Purine-6-thiol
- 6 MP
- 6 Thiohypoxanthine
- 6 Thiopurine
- 6-Mercaptopurine
- 6-Mercaptopurine Monohydrate
- 6-MP
- 6-Purinethiol
- 6-Thiopurine
- 6-Thioxopurine
- Drug: Methotrexate
  Given IT
  Other names:
  - Abitrexate
  - Alpha-Methopterin
  - Amethopterin
  - Brimexate
  - CL 14377
  - CL-14377
  - Emtexate
  - Emthexat
  - Emthexate
  - Farmitrexat
  - Fauldexato
  - Folex
  - Folex PFS
- 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
- 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-thio
- Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
  Undergo HSCT
  Other names:
  - Allogeneic Hematopoietic Cell Transplantation
  - Allogeneic Stem Cell Transplantation
  - HSC
  - HSCT
  - Stem Cell Transplantation, Allogeneic
- 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
- Drug: Dexamethasone
  Given PO or IV
  Other names:
  - Aacidexam
  - Adexone
  - Aknichthol Dexa
  - Alba-Dex
  - Alin
  - Alin Depot
  - Alin Oftalmico
  - Amplidermis
  - Anemul mono
  - Auricularum
  - Auxiloson
  - Baycadron
  - Baycut
- Drug: Doxorubicin
  Given IV
  Other names:
  - Adriablastin
  - Hydroxydaunomycin
  - Hydroxyl Daunorubicin
  - Hydroxyldaunorubicin
- Biological: Filgrastim
  Given IV
  Other names:
  - G-CSF
  - Neupogen
  - r-metHuG-CSF
  - Recombinant Methionyl Human Granulocyte Colony Stimulating Factor
  - rG-CSF
  - Tevagrastim
- Drug: Imatinib Mesylate
  Given PO
  Other names:
  - CGP 57148
  - CGP57148B
  - Gleevec
  - Glivec
  - STI 571
  - STI-571
  - STI571
- 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: 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: Methylprednisolone
    Given IV
    Other names:
    - Adlone
    - Caberdelta M
    - DepMedalone
    - Depo Moderin
    - Depo-Nisolone
    - Duralone
    - Emmetipi
    - Esametone
    - Firmacort
    - Medlone 21
    - Medrate
    - Medrol
    - Medrol Veride
  - 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
  - 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
  - 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 <

Drug: Dexrazoxane Hydrochloride

Given IV

Other names:

Cardioxane
Totect
Zinecard

Other: Laboratory Biomarker Analysis

Correlative studies

Drug: Methotrexate

Given IT

Other names:

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

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

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-thio

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

Drug: Dexamethasone

Given PO or IV

Other names:

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

Drug: Doxorubicin

Given IV

Other names:

Adriablastin
Hydroxydaunomycin
Hydroxyl Daunorubicin
Hydroxyldaunorubicin

Drug: Imatinib Mesylate

Given PO

Other names:

CGP 57148
CGP57148B
Gleevec
Glivec
STI 571
STI-571
STI571

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: 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: Methylprednisolone
Given IV
Other names:
- Adlone
- Caberdelta M
- DepMedalone
- Depo Moderin
- Depo-Nisolone
- Duralone
- Emmetipi
- Esametone
- Firmacort
- Medlone 21
- Medrate
- Medrol
- Medrol Veride
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
Drug: Vincristine Sulfate
Given IV
Other names:
- Kyocristine
- Leurocristine sulfate
- Leurocristine, sulfate
- Oncovin
- Vincasar
- Vincosid
- Vincrex
- Vincristine, sulfate

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

Purpose

Category

Study Contact

Eligibility

Inclusion Criteria

Exclusion Criteria

Study Design

Arm Groups