Active Comparator Group I Arm III (Maintenance chemotherapy) | Patients receive vincristine sulfate IV on days 1, 29, and 57; prednisone PO BID on days 1-5, 29-33, and 57-61; mercaptopurine PO QD on days 1-84; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; and methotrexate IT on day 1. Treatment repeats every 84 days until the total duration of study treatment is 2 years from the start of interim maintenance therapy (approximately week 119) (for girls with T-ALL) and all patients with T-LLy, and 3 years from the start of interim maintenance therapy (approximately week 171) (for boys with T-ALL). | Drug: Methotrexate Given IT or PO Other names: - Abitrexate
- Alpha-Methopterin
- Amethopterin
- Brimexate
- CL 14377
- CL-14377
- Emtexate
- Emthexat
- Emthexate
- Farmitrexat
- Fauldexato
- Folex
- Folex PFS
Drug: Vincristine SulfateGiven IV Other names: - Kyocristine
- Leurocristine Sulfate
- Leurocristine, sulfate
- Oncovin
- Vincasar
- Vincosid
- Vincrex
- Vincristine, sulfate
Drug: PrednisoneGiven IV or PO Other names: - .delta.1-Cortisone
- 1, 2-Dehydrocortisone
- Adasone
- Cortancyl
- Dacortin
- DeCortin
- Decortisyl
- Decorton
- Delta 1-Cortisone
- Delta-Dome
- Deltacortene
- De
|
Active Comparator Group I Arm IV (Interim maintenance chemotherapy) | Patients receive HDMTX IV over 24 hours and vincristine IV on days 1, 15, 29, and 43; mercaptopurine PO on days 1-56; and methotrexate IT on days 1 and 29. Beginning 42 hours after the start of HDMTX, patients also receive leucovorin calcium IV or PO once every 6 hours for 3 doses. | Drug: Leucovorin Calcium Given PO Other names: - Adinepar
- Calcifolin
- Calcium (6S)-Folinate
- Calcium Folinate
- Calcium Leucovorin
- Calfolex
- Calinat
- Cehafolin
- Citofolin
- Citrec
- Citrovorum Factor
- C
Drug: MethotrexateGiven IT or PO Other names: - Abitrexate
- Alpha-Methopterin
- Amethopterin
- Brimexate
- CL 14377
- CL-14377
- Emtexate
- Emthexat
- Emthexate
- Farmitrexat
- Fauldexato
- Folex
- Folex PFS
Drug: Vincristine SulfateGiven IV Other names: - Kyocristine
- Leurocristine Sulfate
- Leurocristine, sulfate
- Oncovin
- Vincasar
- Vincosid
- Vincrex
- Vincristine, sulfate
Other: Laboratory Biomarker AnalysisCorrelative studies Drug: MercaptopurineGiven 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
|
Experimental Group 0 Induction Therapy | All patients (T-ALL and T-LLy) receive cytarabine intrathecally (IT) on day 1; vincristine sulfate IV on days 1, 8, 15, and 22; prednisone IV or PO twice daily BID on days 1-28; pegaspargase IM (may give IV over 1 to 2 hours) on day 4, 5, or 6; daunorubicin hydrochloride IV on days 1, 8, 15 and 22; and methotrexate IT on days 8 and 29 (and days 15 and 22 for patients with CNS3 disease). | Drug: Daunorubicin Hydrochloride Given IV Other names: - Cerubidin
- Cerubidine
- Cloridrato de Daunorubicina
- Daunoblastin
- Daunoblastina
- Daunoblastine
- Daunomycin Hydrochloride
- Daunomycin, hydrochloride
- Daunorubicin.HC
Drug: MethotrexateGiven IT or PO Other names: - Abitrexate
- Alpha-Methopterin
- Amethopterin
- Brimexate
- CL 14377
- CL-14377
- Emtexate
- Emthexat
- Emthexate
- Farmitrexat
- Fauldexato
- Folex
- Folex PFS
Drug: PegaspargaseGiven IM or 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 SulfateGiven IV Other names: - Kyocristine
- Leurocristine Sulfate
- Leurocristine, sulfate
- Oncovin
- Vincasar
- Vincosid
- Vincrex
- Vincristine, sulfate
Drug: CytarabineGiven 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: PrednisoneGiven IV or PO Other names: - .delta.1-Cortisone
- 1, 2-Dehydrocortisone
- Adasone
- Cortancyl
- Dacortin
- DeCortin
- Decortisyl
- Decorton
- Delta 1-Cortisone
- Delta-Dome
- Deltacortene
- De
|
Active Comparator Group I Arm I (Consolidation chemotherapy) | Patients receive methotrexate IT on days 1, 8, 15, and 22; cyclophosphamide IV over 30 minutes on days 1 and 29; cytarabine IV over 15-30 minutes or SC on days 1-4, 8-11, 29-32, and 36-39; mercaptopurine PO on days 1-14 and 29-42; vincristine sulfate IV on days 15, 22, 43 and 50; and pegaspargase IM or IV over 1-2 hours on days 15 and 43. Patients with DS also receive leucovorin calcium PO at 48 and 60 hours after each methotrexate dose. Patients with persistent testicular disease or with DS and testicular disease undergo testicular radiotherapy on days 11-12, 15-19, and 22-26. (DS patients excluded as of 09/29/10.) Patients with intermediate-risk or high-risk disease (CNS1 or CNS2) undergo prophylactic CRT (1,200 cGy/dose) QD on days 15-21 and 22-28. Patients with low-risk disease do not undergo CRT. Patients with standard risk T-LLy received Arm I, and those with high risk T-LLy were randomized between Arm I and Arm II combination chemotherapy. | 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: Leucovorin CalciumGiven PO Other names: - Adinepar
- Calcifolin
- Calcium (6S)-Folinate
- Calcium Folinate
- Calcium Leucovorin
- Calfolex
- Calinat
- Cehafolin
- Citofolin
- Citrec
- Citrovorum Factor
- C
Drug: MethotrexateGiven IT or PO Other names: - Abitrexate
- Alpha-Methopterin
- Amethopterin
- Brimexate
- CL 14377
- CL-14377
- Emtexate
- Emthexat
- Emthexate
- Farmitrexat
- Fauldexato
- Folex
- Folex PFS
Drug: PegaspargaseGiven IM or 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 TherapySome patients undergo testicular and/or prophylactic cranial RT Other names: - Cancer Radiotherapy
- ENERGY_TYPE
- Irradiate
- Irradiated
- Irradiation
- Radiation
- Radiation Therapy, NOS
- Radiotherapeutics
- Radiotherapy
- RT
- Therapy, Radia
Drug: Vincristine SulfateGiven IV Other names: - Kyocristine
- Leurocristine Sulfate
- Leurocristine, sulfate
- Oncovin
- Vincasar
- Vincosid
- Vincrex
- Vincristine, sulfate
Drug: CytarabineGiven 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: MercaptopurineGiven 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
|
Active Comparator Group I Arm I (Maintenance chemotherapy) | Patients receive vincristine sulfate IV on days 1, 29, and 57; prednisone PO BID on days 1-5, 29-33, and 57-61; mercaptopurine PO QD on days 1-84; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; and methotrexate IT on day 1. Treatment repeats every 84 days until the total duration of study treatment is 2 years from the start of interim maintenance therapy (approximately week 119) (for girls with T-ALL), all patients with T-LLy, and 3 years from the start of interim maintenance therapy (approximately week 171) (for boys with T-ALL). | Drug: Methotrexate Given IT or PO Other names: - Abitrexate
- Alpha-Methopterin
- Amethopterin
- Brimexate
- CL 14377
- CL-14377
- Emtexate
- Emthexat
- Emthexate
- Farmitrexat
- Fauldexato
- Folex
- Folex PFS
Drug: Vincristine SulfateGiven IV Other names: - Kyocristine
- Leurocristine Sulfate
- Leurocristine, sulfate
- Oncovin
- Vincasar
- Vincosid
- Vincrex
- Vincristine, sulfate
Other: Laboratory Biomarker AnalysisCorrelative studies Drug: MercaptopurineGiven 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: Prednisone
Given IV or PO Other names: - .delta.1-Cortisone
- 1, 2-Dehydrocortisone
- Adasone
- Cortancyl
- Dacortin
- DeCortin
- Decortisyl
- Decorton
- Delta 1-Cortisone
- Delta-Dome
- Deltacortene
- De
|
Active Comparator Group I Arm II (Consolidation chemotherapy) | Patients receive nelarabine IV over 60 minutes on days 1-5 and 43-47; methotrexate IT on days 15, 22, 57, and 64; cyclophosphamide IV over 30 minutes on days 8 and 50; cytarabine IV over 15-30 minutes or SC on days 8-11, 15-18, 50-53 and 57-60; mercaptopurine PO on days 8-21 and 50-63; vincristine sulfate IV on days 22, 29, 64, and 71; and pegaspargase IM or IV over 1-2 hours on days 22 and 64. Patients with persistent testicular disease or with DS and testicular disease undergo testicular radiotherapy on days 15, 22-26, and 29-33 (DS patients excluded as of 09/29/10). (Patients with intermediate-risk or high-risk disease (CNS1 or CNS2) undergo prophylactic CRT QD on days 22-28 and 29-35. Patients with high risk T-LLy were either randomized to Arm I or Arm II. Patients with T-LLy who failed induction therapy were assigned to Arm II. | 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: MethotrexateGiven IT or PO Other names: - Abitrexate
- Alpha-Methopterin
- Amethopterin
- Brimexate
- CL 14377
- CL-14377
- Emtexate
- Emthexat
- Emthexate
- Farmitrexat
- Fauldexato
- Folex
- Folex PFS
Drug: PegaspargaseGiven IM or 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 TherapySome patients undergo testicular and/or prophylactic cranial RT Other names: - Cancer Radiotherapy
- ENERGY_TYPE
- Irradiate
- Irradiated
- Irradiation
- Radiation
- Radiation Therapy, NOS
- Radiotherapeutics
- Radiotherapy
- RT
- Therapy, Radia
Drug: Vincristine SulfateGiven IV Other names: - Kyocristine
- Leurocristine Sulfate
- Leurocristine, sulfate
- Oncovin
- Vincasar
- Vincosid
- Vincrex
- Vincristine, sulfate
Drug: CytarabineGiven 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: MercaptopurineGiven 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: Nelarabine
Given IV Other names: - 2-Amino-6-methoxypurine arabinoside
- 506U78
- Arranon
- Compound 506U78
- GW506U78
|
Active Comparator Group I Arm II (Interim maintenance chemotherapy) | Patients receive vincristine sulfate IV and escalating doses of methotrexate IV on days 1, 11, 21, 31, and 41; pegaspargase* IM or IV over 1-2 hours on days 2 and 22; and methotrexate IT on days 1 and 31.
Note: *Patients with an allergy to pegaspargase receive Erwinia asparaginase on Monday, Wednesday and Friday for two consecutive weeks starting the day of asparaginase substitution. | Drug: Methotrexate Given IT or PO Other names: - Abitrexate
- Alpha-Methopterin
- Amethopterin
- Brimexate
- CL 14377
- CL-14377
- Emtexate
- Emthexat
- Emthexate
- Farmitrexat
- Fauldexato
- Folex
- Folex PFS
Drug: PegaspargaseGiven IM or 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 SulfateGiven IV Other names: - Kyocristine
- Leurocristine Sulfate
- Leurocristine, sulfate
- Oncovin
- Vincasar
- Vincosid
- Vincrex
- Vincristine, sulfate
Drug: AsparaginaseGiven IM or IV Other names: - ASP-1
- Asparaginase II
- Asparaginase-E.Coli
- Colaspase
- Elspar
- Kidrolase
- L-Asnase
- L-ASP
- L-Asparaginase
- L-Asparagine Amidohydrolase
- Laspar
- Lcf-ASP
|
Active Comparator Group I Arm III (Consolidation chemotherapy) | Patients receive methotrexate IT on days 1, 8, 15, and 22; cyclophosphamide IV over 30 minutes on days 1 and 29; cytarabine IV over 15-30 minutes or SC on days 1-4, 8-11, 29-32, and 36-39; mercaptopurine PO on days 1-14 and 29-42; vincristine sulfate IV on days 15, 22, 43 and 50; and pegaspargase IM or IV over 1-2 hours on days 15 and 43. Patients with DS also receive leucovorin calcium PO at 48 and 60 hours after each methotrexate dose. Patients with persistent testicular disease or with DS and testicular disease undergo testicular radiotherapy on days 11-12, 15-19, and 22-26. (DS patients excluded as of 09/29/10.) Patients with intermediate-risk or high-risk disease (CNS1 or CNS2) undergo prophylactic CRT (1,200 cGy/dose) QD on days 15-21 and 22-28. Patients with low-risk disease do not undergo CRT. | 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: Leucovorin CalciumGiven PO Other names: - Adinepar
- Calcifolin
- Calcium (6S)-Folinate
- Calcium Folinate
- Calcium Leucovorin
- Calfolex
- Calinat
- Cehafolin
- Citofolin
- Citrec
- Citrovorum Factor
- C
Drug: MethotrexateGiven IT or PO Other names: - Abitrexate
- Alpha-Methopterin
- Amethopterin
- Brimexate
- CL 14377
- CL-14377
- Emtexate
- Emthexat
- Emthexate
- Farmitrexat
- Fauldexato
- Folex
- Folex PFS
Drug: PegaspargaseGiven IM or 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 TherapySome patients undergo testicular and/or prophylactic cranial RT Other names: - Cancer Radiotherapy
- ENERGY_TYPE
- Irradiate
- Irradiated
- Irradiation
- Radiation
- Radiation Therapy, NOS
- Radiotherapeutics
- Radiotherapy
- RT
- Therapy, Radia
Drug: Vincristine SulfateGiven IV Other names: - Kyocristine
- Leurocristine Sulfate
- Leurocristine, sulfate
- Oncovin
- Vincasar
- Vincosid
- Vincrex
- Vincristine, sulfate
Drug: CytarabineGiven 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: MercaptopurineGiven 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
|
Active Comparator Group I Arm III (Interim maintenance chemotherapy) | Patients receive HDMTX IV over 24 hours and vincristine sulfate IV on days 1, 15, 29, and 43; mercaptopurine PO on days 1-56; and methotrexate IT on days 1 and 29. Beginning 42 hours after the start of HDMTX, patients also receive leucovorin calcium IV or PO once every 6 hours for 3 doses. | Drug: Leucovorin Calcium Given PO Other names: - Adinepar
- Calcifolin
- Calcium (6S)-Folinate
- Calcium Folinate
- Calcium Leucovorin
- Calfolex
- Calinat
- Cehafolin
- Citofolin
- Citrec
- Citrovorum Factor
- C
Drug: MethotrexateGiven IT or PO Other names: - Abitrexate
- Alpha-Methopterin
- Amethopterin
- Brimexate
- CL 14377
- CL-14377
- Emtexate
- Emthexat
- Emthexate
- Farmitrexat
- Fauldexato
- Folex
- Folex PFS
Drug: Vincristine SulfateGiven IV Other names: - Kyocristine
- Leurocristine Sulfate
- Leurocristine, sulfate
- Oncovin
- Vincasar
- Vincosid
- Vincrex
- Vincristine, sulfate
Other: Laboratory Biomarker AnalysisCorrelative studies Drug: MercaptopurineGiven 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
|
Active Comparator Group I Arm IV (Delayed intensification chemotherapy) | Patients receive vincristine sulfate IV on days 1, 8, 15, and 50; dexamethasone IV or PO BID on days 1-21 (for patients < 10 years of age) OR on days 1-7 and 15-21 (for patients >= 10 years of age); doxorubicin IV on days 1, 8, and 15; pegaspargase IM or IV over 1-2 hours on day 4, 5, OR 6 AND day 50; methotrexate IT on days 1, 36, and 43; nelarabine IV over 60 minutes on days 29-33; cyclophosphamide IV over 30 minutes on day 36; cytarabine IV over 15-30 minutes or SC on days 36-39 and 43-46; and thioguanine PO on days 36-49. | 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: Doxorubicin HydrochlorideGiven 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: Methotrexate
Given IT or PO Other names: - Abitrexate
- Alpha-Methopterin
- Amethopterin
- Brimexate
- CL 14377
- CL-14377
- Emtexate
- Emthexat
- Emthexate
- Farmitrexat
- Fauldexato
- Folex
- Folex PFS
- Drug: Pegaspargase
Given IM or 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: Dexamethasone
Given IV or PO Other names: - Aacidexam
- Adexone
- Aknichthol Dexa
- Alba-Dex
- Alin
- Alin Depot
- Alin Oftalmico
- Amplidermis
- Anemul mono
- Auricularum
- Auxiloson
- Baycadron
- Baycut
- Drug: Nelarabine
Given IV Other names: - 2-Amino-6-methoxypurine arabinoside
- 506U78
- Arranon
- Compound 506U78
- GW506U78
- 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
|
Active Comparator Group I Arm IV (Maintenance chemotherapy) | Patients receive vincristine sulfate, prednisone, mercaptopurine, methotrexate PO, methotrexate IT, and nelarabine in Cycles 1, 2 and 3. Patients then receive treatment (without nelarabine) as follows: vincristine, prednisone, mercaptopurine, methotrexate PO, and methotrexate IT as in arm II. Treatment (without nelarabine) repeats every 84 days until the total duration of study treatment is 2 years from the start of interim maintenance therapy (approximately week 121) (for girls with T-ALL), and for those with T-LLY, and 3 years from the start of interim maintenance therapy (approximately week 173) (for boys with T-ALL). | Drug: Methotrexate Given IT or PO Other names: - Abitrexate
- Alpha-Methopterin
- Amethopterin
- Brimexate
- CL 14377
- CL-14377
- Emtexate
- Emthexat
- Emthexate
- Farmitrexat
- Fauldexato
- Folex
- Folex PFS
Drug: Vincristine SulfateGiven IV Other names: - Kyocristine
- Leurocristine Sulfate
- Leurocristine, sulfate
- Oncovin
- Vincasar
- Vincosid
- Vincrex
- Vincristine, sulfate
Drug: MercaptopurineGiven 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: Nelarabine
Given IV Other names: - 2-Amino-6-methoxypurine arabinoside
- 506U78
- Arranon
- Compound 506U78
- GW506U78
- Drug: Prednisone
Given IV or PO Other names: - .delta.1-Cortisone
- 1, 2-Dehydrocortisone
- Adasone
- Cortancyl
- Dacortin
- DeCortin
- Decortisyl
- Decorton
- Delta 1-Cortisone
- Delta-Dome
- Deltacortene
- De
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Active Comparator Group 1 Arm IV (Consolidation chemotherapy) | Patients receive nelarabine IV over 60 minutes on days 1-5 and 43-47; methotrexate IT on days 15, 22, 57, and 64; cyclophosphamide IV over 30 minutes on days 8 and 50; cytarabine IV over 15-30 minutes or SC on days 8-11, 15-18, 50-53 and 57-60; mercaptopurine PO on days 8-21 and 50-63; vincristine sulfate IV on days 22, 29, 64, and 71; and pegaspargase IM or IV over 1-2 hours on days 22 and 64. Patients with persistent testicular disease or with DS and testicular disease undergo testicular radiotherapy on days 15, 22-26, and 29-33 (DS patients excluded as of 09/29/10). (Patients with intermediate-risk or high-risk disease (CNS1 or CNS2) undergo prophylactic CRT QD on days 22-28 and 29-35. | 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: MethotrexateGiven IT or PO Other names: - Abitrexate
- Alpha-Methopterin
- Amethopterin
- Brimexate
- CL 14377
- CL-14377
- Emtexate
- Emthexat
- Emthexate
- Farmitrexat
- Fauldexato
- Folex
- Folex PFS
Drug: PegaspargaseGiven IM or 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 TherapySome patients undergo testicular and/or prophylactic cranial RT Other names: - Cancer Radiotherapy
- ENERGY_TYPE
- Irradiate
- Irradiated
- Irradiation
- Radiation
- Radiation Therapy, NOS
- Radiotherapeutics
- Radiotherapy
- RT
- Therapy, Radia
Drug: CytarabineGiven 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: MercaptopurineGiven 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: Nelarabine
Given IV Other names: - 2-Amino-6-methoxypurine arabinoside
- 506U78
- Arranon
- Compound 506U78
- GW506U78
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Active Comparator Group I Arm I (Delayed intensification chemotherapy | Patients receive vincristine sulfate IV on days 1, 8, 15, 43, and 50; dexamethasone IV or PO BID on days 1-21 (for patients < 10 years of age) OR on days 1-7 and 15-21 (for patients >= 10 years of age and for patients with DS); doxorubicin hydrochloride IV on days 1, 8, and 15; pegaspargase IM or IV over 1-2 hours on day 4, 5, OR 6, AND day 43; methotrexate IT on days 1, 29, and 36; cyclophosphamide IV over 30 minutes on day 29; cytarabine IV over 15-30 minutes or SC on days 29-32 and 36-39; and thioguanine PO on days 29-42. Patients with DS also receive leucovorin calcium PO at 48 and 60 hours after each methotrexate dose (DS patients excluded as of 09/29/10). Standard risk T-LLy patients were assigned to Arm I and those with high risk were randomized between Arm I and Arm II. | 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: Doxorubicin HydrochlorideGiven 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 Other names: - Adinepar
- Calcifolin
- Calcium (6S)-Folinate
- Calcium Folinate
- Calcium Leucovorin
- Calfolex
- Calinat
- Cehafolin
- Citofolin
- Citrec
- Citrovorum Factor
- C
- Drug: Methotrexate
Given IT or PO Other names: - Abitrexate
- Alpha-Methopterin
- Amethopterin
- Brimexate
- CL 14377
- CL-14377
- Emtexate
- Emthexat
- Emthexate
- Farmitrexat
- Fauldexato
- Folex
- Folex PFS
- Drug: Pegaspargase
Given IM or 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: Dexamethasone
Given IV or PO Other names: - Aacidexam
- Adexone
- Aknichthol Dexa
- Alba-Dex
- Alin
- Alin Depot
- Alin Oftalmico
- Amplidermis
- Anemul mono
- Auricularum
- Auxiloson
- Baycadron
- Baycut
- 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
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Active Comparator Group I Arm I (Interim maintenance chemotherapy) | Patients receive vincristine sulfate IV and escalating doses of methotrexate IV on days 1, 11, 21, 31, and 41; pegaspargase* IM or IV over 1-2 hours on days 2 and 22; and methotrexate IT on days 1 and 31. Patients with DS also receive leucovorin calcium PO 48 and 60 hours after each methotrexate IT dose (DS patients excluded as of 09/29/10).
Note: *Patients with an allergy to pegaspargase receive Erwinia asparaginase on days 2, 4, 6, 8, 10, 12, 22, 24, 26, 28, 30, and 32. | Drug: Leucovorin Calcium Given PO Other names: - Adinepar
- Calcifolin
- Calcium (6S)-Folinate
- Calcium Folinate
- Calcium Leucovorin
- Calfolex
- Calinat
- Cehafolin
- Citofolin
- Citrec
- Citrovorum Factor
- C
Drug: MethotrexateGiven IT or PO Other names: - Abitrexate
- Alpha-Methopterin
- Amethopterin
- Brimexate
- CL 14377
- CL-14377
- Emtexate
- Emthexat
- Emthexate
- Farmitrexat
- Fauldexato
- Folex
- Folex PFS
Drug: PegaspargaseGiven IM or 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 SulfateGiven IV Other names: - Kyocristine
- Leurocristine Sulfate
- Leurocristine, sulfate
- Oncovin
- Vincasar
- Vincosid
- Vincrex
- Vincristine, sulfate
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Active Comparator Group I Arm II (Delayed intensification chemotherapy) | Patients receive vincristine sulfate IV on days 1, 8, 15, and 50; dexamethasone IV or PO BID on days 1-21 (for patients < 10 years of age) OR on days 1-7 and 15-21 (for patients >= 10 years of age); doxorubicin hydrochloride IV on days 1, 8, and 15; pegaspargase IM or IV over 1-2 hours on day 4, 5, OR 6 AND day 50; methotrexate IT on days 1, 36, and 43; nelarabine IV over 60 minutes on days 29-33; cyclophosphamide IV over 30 minutes on day 36; cytarabine IV over 15-30 minutes or SC on days 36-39 and 43-46; and thioguanine PO on days 36-49. | 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: Doxorubicin HydrochlorideGiven 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: Pegaspargase
Given IM or 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: Dexamethasone
Given IV or PO Other names: - Aacidexam
- Adexone
- Aknichthol Dexa
- Alba-Dex
- Alin
- Alin Depot
- Alin Oftalmico
- Amplidermis
- Anemul mono
- Auricularum
- Auxiloson
- Baycadron
- Baycut
- Drug: Nelarabine
Given IV Other names: - 2-Amino-6-methoxypurine arabinoside
- 506U78
- Arranon
- Compound 506U78
- GW506U78
- 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
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Active Comparator Group I Arm II (Maintenance chemotherapy) | Patients receive vincristine sulfate, prednisone, mercaptopurine, methotrexate PO, methotrexate IT, and nelarabine in Cycles 1, 2 and 3. Patients then receive treatment (without nelarabine) as follows: vincristine sulfate, prednisone, mercaptopurine, methotrexate PO, and methotrexate IT as in arm II. Treatment (without nelarabine) repeats every 84 days until the total duration of study treatment is 2 years from the start of interim maintenance therapy (approximately week 121) (for girls with T-ALL), and for those with T-LLY, and 3 years from the start of interim maintenance therapy (approximately week 173) (for boys with T-ALL). | Drug: Methotrexate Given IT or PO Other names: - Abitrexate
- Alpha-Methopterin
- Amethopterin
- Brimexate
- CL 14377
- CL-14377
- Emtexate
- Emthexat
- Emthexate
- Farmitrexat
- Fauldexato
- Folex
- Folex PFS
Drug: Vincristine SulfateGiven IV Other names: - Kyocristine
- Leurocristine Sulfate
- Leurocristine, sulfate
- Oncovin
- Vincasar
- Vincosid
- Vincrex
- Vincristine, sulfate
Drug: MercaptopurineGiven 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: Nelarabine
Given IV Other names: - 2-Amino-6-methoxypurine arabinoside
- 506U78
- Arranon
- Compound 506U78
- GW506U78
- Drug: Prednisone
Given IV or PO Other names: - .delta.1-Cortisone
- 1, 2-Dehydrocortisone
- Adasone
- Cortancyl
- Dacortin
- DeCortin
- Decortisyl
- Decorton
- Delta 1-Cortisone
- Delta-Dome
- Deltacortene
- De
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Active Comparator Group I Arm III (Delayed intensification chemotherapy) | Patients receive vincristine sulfate IV on days 1, 8, 15, 43, and 50; dexamethasone IV or PO BID on days 1-21 (for patients < 10 years of age) OR on days 1-7 and 15-21 (for patients >= 10 years of age and for patients with DS); doxorubicin hydrochloride IV on days 1, 8, and 15; pegaspargase IM or IV over 1-2 hours on day 4, 5, OR 6, AND day 43; methotrexate IT on days 1, 29, and 36; cyclophosphamide IV over 30 minutes on day 29; cytarabine IV over 15-30 minutes or SC on days 29-32 and 36-39; and thioguanine PO on days 29-42. Patients with DS also receive leucovorin calcium PO at 48 and 60 hours after each methotrexate dose (DS patients excluded as of 09/29/10). | 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: Doxorubicin HydrochlorideGiven 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 Other names: - Adinepar
- Calcifolin
- Calcium (6S)-Folinate
- Calcium Folinate
- Calcium Leucovorin
- Calfolex
- Calinat
- Cehafolin
- Citofolin
- Citrec
- Citrovorum Factor
- C
- Drug: Methotrexate
Given IT or PO Other names: - Abitrexate
- Alpha-Methopterin
- Amethopterin
- Brimexate
- CL 14377
- CL-14377
- Emtexate
- Emthexat
- Emthexate
- Farmitrexat
- Fauldexato
- Folex
- Folex PFS
- Drug: Pegaspargase
Given IM or 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: Dexamethasone
Given IV or PO Other names: - Aacidexam
- Adexone
- Aknichthol Dexa
- Alba-Dex
- Alin
- Alin Depot
- Alin Oftalmico
- Amplidermis
- Anemul mono
- Auricularum
- Auxiloson
- Baycadron
- Baycut
- 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
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