Calaspargase Pegol or Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia
NCT ID: NCT00671034
Last Updated: 2021-04-27
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
166 participants
Study Classification
INTERVENTIONAL
Study Start Date
2008-07-21
Study Completion Date
2021-03-31
Brief Summary
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This randomized clinical trial is studying giving calaspargase pegol together with combination chemotherapy to see how well it works compared with giving pegaspargase together with combination chemotherapy in treating younger patients with newly diagnosed high-risk acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
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Detailed Description
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PRIMARY OBJECTIVES:
I. To determine the pharmacokinetic comparability of EZN-2285 (calaspargase pegol) compared to Oncaspar (pegaspargase) given intravenously during induction and consolidation in patients with high-risk ALL receiving augmented Berlin-Frankfurt-Munster (BFM) therapy.
SECONDARY OBJECTIVES:
I. To describe the pharmacodynamics (PD) of EZN-2285 compared to Oncaspar given intravenously during induction and consolidation in patients with high-risk ALL receiving augmented BFM therapy.
II. To determine end of induction therapy day 29 minimal residual disease (MRD) for patients randomized to the EZN-2285 containing regimen compared to the Oncaspar® containing regimen.
III. To determine the complete remission (CR) rates for patients receiving EZN-2285 by day 29 of induction compared to Oncaspar.
IV. To assess event-free survival (EFS) associated with the administration of EZN-2285 given during augmented post Induction intensification therapy to patients with high-risk ALL compared to Oncaspar.
V. To determine the proportion of patients with an asparaginase level of at least 0.1 IU/mL and the proportion with at least 0.4 IU/mL on days 4, 15, 22 and 29 of induction compared to Oncaspar.
VI. To determine the plasma and cerebrospinal fluid (CSF) concentrations of asparagine after administration of EZN-2285 compared to Oncaspar.
VII. To assess the immunogenicity of EZN-2285 including the detection of binding and neutralizing antibodies compared to Oncaspar.
VIII. To assess the tolerability and toxicities associated with the administration of EZN-2285 given during augmented post induction intensification therapy to patients with high risk ALL compared to Oncaspar.
IX. To explore the relationship between the terminal pharmacokinetics (PK) of EZN-2285 and the presence of antibodies.
OUTLINE: This is a multicenter study. Patients are stratified according to response to induction therapy (slow early responders \[SER\] vs rapid early responders \[RER\]. Patients are randomized to 1 of 2 treatment arms in 2:1 ratio (arm I: arm II) (patients randomized to arm I receive study drug calaspargase pegol\*; patients randomized to arm II receive study drug pegaspargase).
INDUCTION THERAPY\*\* (ALL PATIENTS): Patients receive cytarabine intrathecally (IT) on day 1; vincristine intravenously (IV) and daunorubicin hydrochloride IV over 15 minutes on days 1, 8, 15, and 22; prednisone orally or IV twice daily (BID) on days 1-28; study drug IV over 1 hour on day 4; and methotrexate IT on days 8, 15\*, 22\*, and 29. Patients are assessed for response on day 8 and/or day 15 and day 29. Patients who achieve M1 marrow on day 8 or 15 and negative MRD (i.e., \< 0.1%) on day 29 are considered RER. Patients who achieve M2 or M3 marrow on day 15 OR MRD \>= 0.1% but \< 1% on day 29 are considered SER. Patients with M3 bone marrow are removed from the study. RER and SER proceed to consolidation therapy. Patients with M2 marrow or M1 marrow with \>= 1% MRD receive extended induction therapy. Patients also receive dexamethasone PO or IV BID on days 1-14 (patients \< 10 years) or prednisone BID on days 1-28 (patients \>= 10 years)
NOTE: \*For patients with CNS3 disease only.
EXTENDED INDUCTION THERAPY\*\*: Patients receive vincristine IV on days 1 and 8; prednisone orally (PO) or IV BID on days 1-14; daunorubicin hydrochloride IV over 15 minutes on day 1; and study drug IV over 1 hour on day 4. Patients are assessed for response on day 43. Patients who achieve M1 and MRD \< 1% are treated as SER (proceed to consolidation therapy). All other patients are removed from study.
CONSOLIDATION THERAPY\*\* (ALL PATIENTS): Beginning on day 36 (after completion of induction therapy) or after completion of extended induction therapy, patients (RER and SER) receive cyclophosphamide IV over 30 minutes on days 1 and 29; cytarabine IV or SC on days 1-4, 8-11, 29-32, and 36-39; mercaptopurine PO on days 1-14 and 29-42; vincristine IV on days 15, 22, 43, and 50; study drug IV over 1 hour on days 15 and 43; and methotrexate IT on days 1, 8, 15\*, and 22\*. Patients then proceed to interim maintenance I therapy.
NOTE: \*Omit doses for patients with CNS3 disease.
INTERIM MAINTENANCE I\*\* (ALL PATIENTS): Patients receive vincristine IV and methotrexate\*\* IV on days 1, 11, 21, 31, and 41; study drug IV over 1 hour on days 2 and 22; and methotrexate IT on days 1 and 31. Patients then proceed to delayed intensification I therapy.
DELAYED INTENSIFICATION I\*\* (ALL PATIENTS): Patients receive vincristine IV on days 1, 8, 15, 43, and 50; dexamethasone PO or IV BID on days 1-21 for patients age 1-9, or on days 1-7 and 15-21 for patients age \>= 10; doxorubicin hydrochloride IV over 15 minutes on days 1, 8, and 15; study drug IV over 1 hour on days 4 and 43; cyclophosphamide IV over 30 minutes on day 29; cytarabine IV or subcutaneously (SC) on days 29-32 and 36-39; thioguanine PO on days 29-42; and methotrexate IT on days 1, 29, and 36. Patients treated as RER proceed to maintenance therapy. Patients treated as SER (i.e., patients with CNS3 disease at diagnosis, or pre-treated with steroids, or who are RERs with mixed lineage leukemia \[MLL\] gene rearrangements) proceed to interim maintenance II followed by delayed intensification II.
INTERIM MAINTENANCE II\*\* (SER ONLY): Patients receive vincristine IV, methotrexate IV, study drug IV, and methotrexate IT as in interim maintenance I.
DELAYED INTENSIFICATION II\*\* (SER ONLY): Beginning on day 29, patients (except patients with CNS3 disease) receive 8 daily fractions of cranial radiotherapy. All patients then receive vincristine IV, dexamethasone PO or IV, doxorubicin hydrochloride IV, study drug IV, cyclophosphamide IV, cytarabine IV or SC, thioguanine PO, and methotrexate IT as in delayed intensification I. Patients who were initially diagnosed with CNS3 disease receive cranial radiotherapy on days 1-5 and 8-12. Patients then proceed to maintenance therapy.
MAINTENANCE THERAPY\*\* (ALL PATIENTS): Patients receive vincristine IV on days 1, 29, and 57; oral dexamethasone on days 1-5, 29-33, and 57-61; mercaptopurine PO on days 1-84; methotrexate IT on day 29; and methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78. Treatment repeats every 12 weeks for up to 2 years (for female patients) or up to 3 years (for male patients) from the start of interim maintenance I.
NOTE: \*\* As per amendment #4, most patients receive high-dose methotrexate instead of Capizzi methotrexate at most stages of therapy. CNS3 patients and SER patients who have received cranial irradiation receive planned therapy with no modifications.
NOTE: As per amendment #4, the maximum number of intrathecal treatments is limited by RER/SER/CNS3 status and gender.
Blood and cerebrospinal fluid samples are collected periodically for correlative studies, including immunogenicity, pharmacokinetic, and pharmacodynamic studies.
After completion of study therapy, patients are followed every 2 months for 2 years, every 3 months for 1 year, and then every 6-12 months for 2 years.
I. To determine the pharmacokinetic comparability of EZN-2285 (calaspargase pegol) compared to Oncaspar (pegaspargase) given intravenously during induction and consolidation in patients with high-risk ALL receiving augmented Berlin-Frankfurt-Munster (BFM) therapy.
SECONDARY OBJECTIVES:
I. To describe the pharmacodynamics (PD) of EZN-2285 compared to Oncaspar given intravenously during induction and consolidation in patients with high-risk ALL receiving augmented BFM therapy.
II. To determine end of induction therapy day 29 minimal residual disease (MRD) for patients randomized to the EZN-2285 containing regimen compared to the Oncaspar® containing regimen.
III. To determine the complete remission (CR) rates for patients receiving EZN-2285 by day 29 of induction compared to Oncaspar.
IV. To assess event-free survival (EFS) associated with the administration of EZN-2285 given during augmented post Induction intensification therapy to patients with high-risk ALL compared to Oncaspar.
V. To determine the proportion of patients with an asparaginase level of at least 0.1 IU/mL and the proportion with at least 0.4 IU/mL on days 4, 15, 22 and 29 of induction compared to Oncaspar.
VI. To determine the plasma and cerebrospinal fluid (CSF) concentrations of asparagine after administration of EZN-2285 compared to Oncaspar.
VII. To assess the immunogenicity of EZN-2285 including the detection of binding and neutralizing antibodies compared to Oncaspar.
VIII. To assess the tolerability and toxicities associated with the administration of EZN-2285 given during augmented post induction intensification therapy to patients with high risk ALL compared to Oncaspar.
IX. To explore the relationship between the terminal pharmacokinetics (PK) of EZN-2285 and the presence of antibodies.
OUTLINE: This is a multicenter study. Patients are stratified according to response to induction therapy (slow early responders \[SER\] vs rapid early responders \[RER\]. Patients are randomized to 1 of 2 treatment arms in 2:1 ratio (arm I: arm II) (patients randomized to arm I receive study drug calaspargase pegol\*; patients randomized to arm II receive study drug pegaspargase).
INDUCTION THERAPY\*\* (ALL PATIENTS): Patients receive cytarabine intrathecally (IT) on day 1; vincristine intravenously (IV) and daunorubicin hydrochloride IV over 15 minutes on days 1, 8, 15, and 22; prednisone orally or IV twice daily (BID) on days 1-28; study drug IV over 1 hour on day 4; and methotrexate IT on days 8, 15\*, 22\*, and 29. Patients are assessed for response on day 8 and/or day 15 and day 29. Patients who achieve M1 marrow on day 8 or 15 and negative MRD (i.e., \< 0.1%) on day 29 are considered RER. Patients who achieve M2 or M3 marrow on day 15 OR MRD \>= 0.1% but \< 1% on day 29 are considered SER. Patients with M3 bone marrow are removed from the study. RER and SER proceed to consolidation therapy. Patients with M2 marrow or M1 marrow with \>= 1% MRD receive extended induction therapy. Patients also receive dexamethasone PO or IV BID on days 1-14 (patients \< 10 years) or prednisone BID on days 1-28 (patients \>= 10 years)
NOTE: \*For patients with CNS3 disease only.
EXTENDED INDUCTION THERAPY\*\*: Patients receive vincristine IV on days 1 and 8; prednisone orally (PO) or IV BID on days 1-14; daunorubicin hydrochloride IV over 15 minutes on day 1; and study drug IV over 1 hour on day 4. Patients are assessed for response on day 43. Patients who achieve M1 and MRD \< 1% are treated as SER (proceed to consolidation therapy). All other patients are removed from study.
CONSOLIDATION THERAPY\*\* (ALL PATIENTS): Beginning on day 36 (after completion of induction therapy) or after completion of extended induction therapy, patients (RER and SER) receive cyclophosphamide IV over 30 minutes on days 1 and 29; cytarabine IV or SC on days 1-4, 8-11, 29-32, and 36-39; mercaptopurine PO on days 1-14 and 29-42; vincristine IV on days 15, 22, 43, and 50; study drug IV over 1 hour on days 15 and 43; and methotrexate IT on days 1, 8, 15\*, and 22\*. Patients then proceed to interim maintenance I therapy.
NOTE: \*Omit doses for patients with CNS3 disease.
INTERIM MAINTENANCE I\*\* (ALL PATIENTS): Patients receive vincristine IV and methotrexate\*\* IV on days 1, 11, 21, 31, and 41; study drug IV over 1 hour on days 2 and 22; and methotrexate IT on days 1 and 31. Patients then proceed to delayed intensification I therapy.
DELAYED INTENSIFICATION I\*\* (ALL PATIENTS): Patients receive vincristine IV on days 1, 8, 15, 43, and 50; dexamethasone PO or IV BID on days 1-21 for patients age 1-9, or on days 1-7 and 15-21 for patients age \>= 10; doxorubicin hydrochloride IV over 15 minutes on days 1, 8, and 15; study drug IV over 1 hour on days 4 and 43; cyclophosphamide IV over 30 minutes on day 29; cytarabine IV or subcutaneously (SC) on days 29-32 and 36-39; thioguanine PO on days 29-42; and methotrexate IT on days 1, 29, and 36. Patients treated as RER proceed to maintenance therapy. Patients treated as SER (i.e., patients with CNS3 disease at diagnosis, or pre-treated with steroids, or who are RERs with mixed lineage leukemia \[MLL\] gene rearrangements) proceed to interim maintenance II followed by delayed intensification II.
INTERIM MAINTENANCE II\*\* (SER ONLY): Patients receive vincristine IV, methotrexate IV, study drug IV, and methotrexate IT as in interim maintenance I.
DELAYED INTENSIFICATION II\*\* (SER ONLY): Beginning on day 29, patients (except patients with CNS3 disease) receive 8 daily fractions of cranial radiotherapy. All patients then receive vincristine IV, dexamethasone PO or IV, doxorubicin hydrochloride IV, study drug IV, cyclophosphamide IV, cytarabine IV or SC, thioguanine PO, and methotrexate IT as in delayed intensification I. Patients who were initially diagnosed with CNS3 disease receive cranial radiotherapy on days 1-5 and 8-12. Patients then proceed to maintenance therapy.
MAINTENANCE THERAPY\*\* (ALL PATIENTS): Patients receive vincristine IV on days 1, 29, and 57; oral dexamethasone on days 1-5, 29-33, and 57-61; mercaptopurine PO on days 1-84; methotrexate IT on day 29; and methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78. Treatment repeats every 12 weeks for up to 2 years (for female patients) or up to 3 years (for male patients) from the start of interim maintenance I.
NOTE: \*\* As per amendment #4, most patients receive high-dose methotrexate instead of Capizzi methotrexate at most stages of therapy. CNS3 patients and SER patients who have received cranial irradiation receive planned therapy with no modifications.
NOTE: As per amendment #4, the maximum number of intrathecal treatments is limited by RER/SER/CNS3 status and gender.
Blood and cerebrospinal fluid samples are collected periodically for correlative studies, including immunogenicity, pharmacokinetic, and pharmacodynamic studies.
After completion of study therapy, patients are followed every 2 months for 2 years, every 3 months for 1 year, and then every 6-12 months for 2 years.
Conditions
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Acute Lymphoblastic Leukemia
Adult B Acute Lymphoblastic Leukemia
Childhood B Acute Lymphoblastic Leukemia
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Arm I (combination chemotherapy)
Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 4 years.
Group Type
EXPERIMENTAL
Calaspargase Pegol-mknl
Intervention Type
DRUG
Given IV
Cyclophosphamide
Intervention Type
DRUG
Given IV
Cytarabine
Intervention Type
DRUG
Given IV, IT, PO, or SC
Daunorubicin Hydrochloride
Intervention Type
DRUG
Given IV
Dexamethasone
Intervention Type
DRUG
Given PO or IV
Doxorubicin Hydrochloride
Intervention Type
DRUG
Given IV
Laboratory Biomarker Analysis
Intervention Type
OTHER
Correlative studies
Mercaptopurine
Intervention Type
DRUG
Given PO
Methotrexate
Intervention Type
DRUG
Given IV, IT, or PO
Pegaspargase
Intervention Type
DRUG
Given IV
Pharmacological Study
Intervention Type
OTHER
Correlative studies
Prednisone
Intervention Type
DRUG
Given IV or PO
Radiation Therapy
Intervention Type
RADIATION
Some patients undergo RT
Thioguanine
Intervention Type
DRUG
Given PO
Vincristine Sulfate
Intervention Type
DRUG
Given IV
Arm II (combination chemotherapy)
Patients receive pegaspargase together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo RT to the head. Treatment may continue for up to 4 years.
Group Type
ACTIVE_COMPARATOR
Cyclophosphamide
Intervention Type
DRUG
Given IV
Cytarabine
Intervention Type
DRUG
Given IV, IT, PO, or SC
Daunorubicin Hydrochloride
Intervention Type
DRUG
Given IV
Dexamethasone
Intervention Type
DRUG
Given PO or IV
Doxorubicin Hydrochloride
Intervention Type
DRUG
Given IV
Laboratory Biomarker Analysis
Intervention Type
OTHER
Correlative studies
Mercaptopurine
Intervention Type
DRUG
Given PO
Methotrexate
Intervention Type
DRUG
Given IV, IT, or PO
Pegaspargase
Intervention Type
DRUG
Given IV
Pharmacological Study
Intervention Type
OTHER
Correlative studies
Prednisone
Intervention Type
DRUG
Given IV or PO
Radiation Therapy
Intervention Type
RADIATION
Some patients undergo RT
Thioguanine
Intervention Type
DRUG
Given PO
Vincristine Sulfate
Intervention Type
DRUG
Given IV
Interventions
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Calaspargase Pegol-mknl
Given IV
Intervention Type
DRUG
Cyclophosphamide
Given IV
Intervention Type
DRUG
Cytarabine
Given IV, IT, PO, or SC
Intervention Type
DRUG
Daunorubicin Hydrochloride
Given IV
Intervention Type
DRUG
Dexamethasone
Given PO or IV
Intervention Type
DRUG
Doxorubicin Hydrochloride
Given IV
Intervention Type
DRUG
Laboratory Biomarker Analysis
Correlative studies
Intervention Type
OTHER
Mercaptopurine
Given PO
Intervention Type
DRUG
Methotrexate
Given IV, IT, or PO
Intervention Type
DRUG
Pegaspargase
Given IV
Intervention Type
DRUG
Pharmacological Study
Correlative studies
Intervention Type
OTHER
Prednisone
Given IV or PO
Intervention Type
DRUG
Radiation Therapy
Some patients undergo RT
Intervention Type
RADIATION
Thioguanine
Given PO
Intervention Type
DRUG
Vincristine Sulfate
Given IV
Intervention Type
DRUG
Other Intervention Names
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Asparaginase (Escherichia coli Isoenzyme II), Conjugate with alpha-(((2,5-Dioxo-1-pyrrolidinyl)oxy)carbonyl)-omega-methoxypoly(oxy-1,2-ethanediyl)
Asparlas
Calaspargase Pegol
EZN-2285
SC-PEG E. Coli L-Asparaginase
Succinimidyl Carbonate Monomethoxypolyethylene Glycol E. coli L-Asparaginase
(-)-Cyclophosphamide
2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate
Carloxan
Ciclofosfamida
Ciclofosfamide
Cicloxal
Clafen
Claphene
CP monohydrate
CTX
CYCLO-cell
Cycloblastin
Cycloblastine
Cyclophospham
Cyclophosphamid monohydrate
Cyclophosphamide Monohydrate
Cyclophosphamidum
Cyclophosphan
Cyclophosphane
Cyclophosphanum
Cyclostin
Cyclostine
Cytophosphan
Cytophosphane
Cytoxan
Fosfaseron
Genoxal
Genuxal
Ledoxina
Mitoxan
Neosar
Revimmune
Syklofosfamid
WR- 138719
.beta.-Cytosine arabinoside
1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone
1-.beta.-D-Arabinofuranosylcytosine
1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone
1-Beta-D-arabinofuranosylcytosine
1.beta.-D-Arabinofuranosylcytosine
2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-
2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-
Alexan
Ara-C
ARA-cell
Arabine
Arabinofuranosylcytosine
Arabinosylcytosine
Aracytidine
Aracytin
Aracytine
Beta-Cytosine Arabinoside
CHX-3311
Cytarabinum
Cytarbel
Cytosar
Cytosine Arabinoside
Cytosine-.beta.-arabinoside
Cytosine-beta-arabinoside
Erpalfa
Starasid
Tarabine PFS
U 19920
U-19920
Udicil
WR-28453
Cerubidin
Cerubidine
Cloridrato de Daunorubicina
Daunoblastin
Daunoblastina
Daunoblastine
Daunomycin Hydrochloride
Daunomycin, hydrochloride
Daunorubicin.HCl
Daunorubicini Hydrochloridum
FI-6339
Ondena
RP-13057
Rubidomycin Hydrochloride
Rubilem
Aacidexam
Adexone
Aknichthol Dexa
Alba-Dex
Alin
Alin Depot
Alin Oftalmico
Amplidermis
Anemul mono
Auricularum
Auxiloson
Baycadron
Baycuten
Baycuten N
Cortidexason
Cortisumman
Decacort
Decadrol
Decadron
Decadron DP
Decalix
Decameth
Decasone R.p.
Dectancyl
Dekacort
Deltafluorene
Deronil
Desamethasone
Desameton
Dexa-Mamallet
Dexa-Rhinosan
Dexa-Scheroson
Dexa-sine
Dexacortal
Dexacortin
Dexafarma
Dexafluorene
Dexalocal
Dexamecortin
Dexameth
Dexamethasone Intensol
Dexamethasonum
Dexamonozon
Dexapos
Dexinoral
Dexone
Dinormon
Dxevo
Fluorodelta
Fortecortin
Gammacorten
Hexadecadrol
Hexadrol
Lokalison-F
Loverine
Methylfluorprednisolone
Millicorten
Mymethasone
Orgadrone
Spersadex
TaperDex
Visumetazone
ZoDex
5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)
ADM
Adriacin
Adriamycin
Adriamycin Hydrochloride
Adriamycin PFS
Adriamycin RDF
ADRIAMYCIN, HYDROCHLORIDE
Adriamycine
Adriblastina
Adriblastine
Adrimedac
Chloridrato de Doxorrubicina
DOX
DOXO-CELL
Doxolem
Doxorubicin HCl
Doxorubicin.HCl
Doxorubin
Farmiblastina
FI 106
FI-106
hydroxydaunorubicin
Rubex
3H-Purine-6-thiol
6 MP
6 Thiohypoxanthine
6 Thiopurine
6-Mercaptopurine
6-Mercaptopurine Monohydrate
6-MP
6-Purinethiol
6-Thiopurine
6-Thioxopurine
6H-Purine-6-thione, 1,7-dihydro- (9CI)
7-Mercapto-1,3,4,6-tetrazaindene
Alti-Mercaptopurine
Azathiopurine
Bw 57-323H
Flocofil
Ismipur
Leukerin
Leupurin
Mercaleukim
Mercaleukin
Mercaptina
Mercaptopurinum
Mercapurin
Mern
NCI-C04886
Puri-Nethol
Purimethol
Purine, 6-mercapto-
Purine-6-thiol (8CI)
Purine-6-thiol, monohydrate
Purinethiol
Purinethol
U-4748
WR-2785
Abitrexate
Alpha-Methopterin
Amethopterin
Brimexate
CL 14377
CL-14377
Emtexate
Emthexat
Emthexate
Farmitrexat
Fauldexato
Folex
Folex PFS
Lantarel
Ledertrexate
Lumexon
Maxtrex
Medsatrexate
Metex
Methoblastin
Methotrexate LPF
Methotrexate Methylaminopterin
Methotrexatum
Metotrexato
Metrotex
Mexate
Mexate-AQ
MTX
Novatrex
Rheumatrex
Texate
Tremetex
Trexeron
Trixilem
WR-19039
L-Asparaginase with Polyethylene Glycol
Oncaspar
Oncaspar-IV
PEG-Asparaginase
PEG-L-Asparaginase
PEG-L-Asparaginase (Enzon - Kyowa Hakko)
PEGLA
Polyethylene Glycol L-Asparaginase
Polyethylene Glycol-L-Asparaginase
.delta.1-Cortisone
1, 2-Dehydrocortisone
Adasone
Cortancyl
Dacortin
DeCortin
Decortisyl
Decorton
Delta 1-Cortisone
Delta-Dome
Deltacortene
Deltacortisone
Deltadehydrocortisone
Deltasone
Deltison
Deltra
Econosone
Lisacort
Meprosona-F
Metacortandracin
Meticorten
Ofisolona
Orasone
Panafcort
Panasol-S
Paracort
Perrigo Prednisone
PRED
Predicor
Predicorten
Prednicen-M
Prednicort
Prednidib
Prednilonga
Predniment
Prednisone Intensol
Prednisonum
Prednitone
Promifen
Rayos
Servisone
SK-Prednisone
Cancer Radiotherapy
ENERGY_TYPE
Irradiate
Irradiated
Irradiation
Radiation
Radiation Therapy, NOS
Radiotherapeutics
Radiotherapy
RT
Therapy, Radiation
2-Amino 6MP
2-Amino-1,7-dihydro-6H-purine-6-thione
2-Amino-6-mercaptopurine
2-Amino-6-purinethiol
2-Aminopurin-6-thiol
2-Aminopurine-6(1H)-thione
2-Aminopurine-6-thiol
2-Aminopurine-6-thiol Hemihydrate
2-Mercapto-6-aminopurine
6-Amino-2-mercaptopurine
6-Mercapto-2-aminopurine
6-Mercaptoguanine
6-TG
6H-Purine-6-thione, 2-amino-1,7-dihydro- (9CI)
BW 5071
Lanvis
Tabloid
Thioguanine Hemihydrate
Thioguanine Hydrate
Tioguanin
Tioguanine
Wellcome U3B
WR-1141
X 27
Kyocristine
Leurocristine Sulfate
Leurocristine, sulfate
Oncovin
Vincasar
Vincosid
Vincrex
Vincristine, sulfate
Eligibility Criteria
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Inclusion Criteria
* Patients must be eligible for and enrolled on AALL08B1 or the successor classification study
* Patients must have newly diagnosed high-risk B lymphoblastic leukemia (World Health Organization \[WHO\] 2008 classification) (also termed B-precursor acute lymphoblastic leukemia)
* White blood cell (WBC) \>= 50,000/μL for patients age 1-9 OR any WBC count for patients age 10-30 or for patients treated with prior steroids
* Patients shall have had no prior cytotoxic chemotherapy with the exception of steroids and intrathecal cytarabine; intrathecal chemotherapy with cytarabine is allowed prior to registration for patient convenience; this is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture; (Note: the CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment) systemic chemotherapy must begin within 72 hours of this intrathecal therapy
* Patients receiving prior steroid therapy are eligible for this study; the dose and duration of previous steroid therapy should be carefully documented
* Pregnancy tests with a negative result must be obtained in all post-menarchal females
* Lactating females must agree that they will not breastfeed a child while on this study
* Patients must have newly diagnosed high-risk B lymphoblastic leukemia (World Health Organization \[WHO\] 2008 classification) (also termed B-precursor acute lymphoblastic leukemia)
* White blood cell (WBC) \>= 50,000/μL for patients age 1-9 OR any WBC count for patients age 10-30 or for patients treated with prior steroids
* Patients shall have had no prior cytotoxic chemotherapy with the exception of steroids and intrathecal cytarabine; intrathecal chemotherapy with cytarabine is allowed prior to registration for patient convenience; this is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture; (Note: the CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment) systemic chemotherapy must begin within 72 hours of this intrathecal therapy
* Patients receiving prior steroid therapy are eligible for this study; the dose and duration of previous steroid therapy should be carefully documented
* Pregnancy tests with a negative result must be obtained in all post-menarchal females
* Lactating females must agree that they will not breastfeed a child while on this study
Exclusion Criteria
* Patients with Down syndrome are excluded from this study
* Patients with testicular leukemia at diagnosis are excluded from this study
* Pregnant female patients are excluded from this study
* Patients with testicular leukemia at diagnosis are excluded from this study
* Pregnant female patients are excluded from this study
Minimum Eligible Age
2 Years
Maximum Eligible Age
30 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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National Cancer Institute (NCI)
NIH
Sponsor Role
collaborator
Children's Oncology Group
NETWORK
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Anne L Angiolillo
Role: PRINCIPAL_INVESTIGATOR
Children's Oncology Group
Locations
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University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
Site Status
Children's Hospital of Orange County
Orange, California, United States
Site Status
Lucile Packard Children's Hospital Stanford University
Palo Alto, California, United States
Site Status
Children's Hospital Colorado
Aurora, Colorado, United States
Site Status
University of Connecticut
Farmington, Connecticut, United States
Site Status
Connecticut Children's Medical Center
Hartford, Connecticut, United States
Site Status
Children's National Medical Center
Washington D.C., District of Columbia, United States
Site Status
Lurie Children's Hospital-Chicago
Chicago, Illinois, United States
Site Status
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Site Status
Riley Hospital for Children
Indianapolis, Indiana, United States
Site Status
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States
Site Status
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States
Site Status
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, United States
Site Status
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, United States
Site Status
Washington University School of Medicine
St Louis, Missouri, United States
Site Status
Hackensack University Medical Center
Hackensack, New Jersey, United States
Site Status
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
Site Status
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States
Site Status
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Site Status
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Site Status
Oregon Health and Science University
Portland, Oregon, United States
Site Status
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Site Status
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States
Site Status
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States
Site Status
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States
Site Status
Primary Children's Hospital
Salt Lake City, Utah, United States
Site Status
Seattle Children's Hospital
Seattle, Washington, United States
Site Status
Countries
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United States
References
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Schore RJ, Devidas M, Bleyer A, Reaman GH, Winick N, Loh ML, Raetz EA, Carroll WL, Hunger SP, Angiolillo AL. Plasma asparaginase activity and asparagine depletion in acute lymphoblastic leukemia patients treated with pegaspargase on Children's Oncology Group AALL07P4. Leuk Lymphoma. 2019 Jul;60(7):1740-1748. doi: 10.1080/10428194.2018.1542146. Epub 2019 Jan 10.
Reference Type
DERIVED
Other Identifiers
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NCI-2009-00317
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000594340
Identifier Type: -
Identifier Source: secondary_id
08-606
Identifier Type: -
Identifier Source: secondary_id
COG-AALL07P4
Identifier Type: -
Identifier Source: secondary_id
AALL07P4
Identifier Type: OTHER
Identifier Source: secondary_id
AALL07P4
Identifier Type: OTHER
Identifier Source: secondary_id
AALL07P4
Identifier Type: -
Identifier Source: org_study_id
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