Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia (Closed to Accrual 4-22-2011)

Sponsor
Children's Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00866307
Collaborator
National Cancer Institute (NCI) (NIH)
104
28
2
145.2
3.7
0

Study Details

Study Description

Brief Summary

This pilot clinical trial studies the side effects of pegaspargase when given together with combination chemotherapy in treating patients with newly diagnosed high-risk acute lymphoblastic leukemia. Pegaspargase 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 more than one drug (combination chemotherapy) together with pegaspargase may kill more cancer cells.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

PRIMARY OBJECTIVES:
  1. To demonstrate that biweekly intravenous (IV) pegaspargase beginning with Consolidation and ending with completion of delayed intensification (DI) in combination with hemi-augmented BFM therapy (hABFM) is feasible and safe in children with high risk (HR) acute lymphoblastic leukemia (ALL).

OUTLINE: Patients are stratified according to risk assignment (high-risk [HR]-average [day 29 minimal residual disease (MRD) < 0.01%] vs HR-high [MRD >= 0.01%, presence of central nervous system [CNS]3 leukemia, testicular disease, myeloid/mixed lineage leukemia [MLL] rearrangement, hypodiploidy, or steroid therapy within the past month]). Patients are assigned to 1 of 2 treatment groups.*

(Note: *Amendment 2 [4-22-2011] requires changes in the regimens. See the changes below, after Maintenance therapy.)

INDUCTION THERAPY: All patients receive cytarabine intrathecally (IT) on day 1; vincristine sulfate IV on days 1, 8, 15, and 22; prednisone IV or orally (PO) twice daily (BID) on days 1-28; daunorubicin hydrochloride IV over 15 minutes on days 1, 8, 15, and 22; methotrexate IT on days 8 and 29*; and pegaspargase IV over 1-2 hours on day 4.

(Note: *Patients with CNS3 disease [white blood cells [(WBC)] >= 5/uL and positive for blasts on cytospin] also receive methotrexate IT on days 15 and 22.)

CONSOLIDATION THERAPY (begins on day 36 of induction therapy):

GROUP A (HR-AVERAGE): Patients receive cyclophosphamide IV over 1 hour on days 1 and 29; cytarabine IV over 15 minutes or subcutaneously (SC) on days 1-4, 8-11, 29-32, and 36-39; mercaptopurine PO once daily (QD) on days 1-14 and 29-42; vincristine sulfate IV on days 15, 22, 43, and 50; methotrexate IT on days 1, 8, 15*, and 22*; and pegaspargase IV over 1-2 hours on days 15 and 43.

GROUP B (HR-HIGH): Patients receive cyclophosphamide, cytarabine, mercaptopurine, vincristine sulfate, and methotrexate as in Group A. Beginning on day 1, patients also receive pegaspargase IV over 1-2 hours every 2 weeks. Patients with CNS3 disease undergo cranial radiotherapy QD for 10 days and patients with testicular disease undergo testicular radiotherapy QD for 12 days, beginning on day 1 of consolidation.

(Note: *Patients with CNS3 disease [WBC >= 5/uL and positive for blasts on cytospin] do not receive methotrexate IT on days 15 and 22.)

Interim maintenance (IM) therapy (begins on day 57 of consolidation):

GROUP A: Patients receive vincristine sulfate IV on days 1, 11, 21, 31, and 41; methotrexate IV over 10-15 minutes on days 1, 11, 21, 31, and 41; methotrexate IT on days 1 and 31; and pegaspargase IV over 1-2 hours on days 2 and 22.

GROUP B: Patients receive vincristine sulfate and methotrexate as in Group A. Beginning on day 1, patients also receive pegaspargase IV over 1-2 hours every 2 weeks.

DI therapy (begins on day 57 of IM):

GROUP A: Patients receive vincristine sulfate IV on days 1, 8, 15, 43, and 50; dexamethasone IV or PO BID on days 1-7 and 15-21; doxorubicin hydrochloride IV over 15 minutes on days 1, 8, and 15; cyclophosphamide IV over 1 hour on day 29; cytarabine IV over 15 minutes or SC on days 29-32 and 36-39; thioguanine PO on days 29-42; methotrexate IT on days 1, 29, and 36; and pegaspargase IV over 1-2 hours on days 4 and 43.

GROUP B: Patients receive vincristine sulfate, dexamethasone, doxorubicin hydrochloride, cyclophosphamide, cytarabine, thioguanine, and methotrexate as in Group A. Beginning on day 1, patients also receive pegaspargase IV over 1-2 hours every 2 weeks.

MAINTENANCE THERAPY (MT; begins on day 57 of DI): All 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 on days 1-84; methotrexate IT on day 1; and methotrexate PO BID on days 8, 15, 22, 29*, 36, 43, 50, 57, 64, 71, and 78.

In both groups, MT repeats every 12 weeks until total duration of therapy is 2 years from the start of IM for female patients and 3 years from the start of IM for male patients. Patients in Group B who did not undergo radiotherapy to the brain during consolidation therapy undergo prophylactic cranial radiotherapy (CR) daily for 8 days.

([Note: *Patients in Group A also receive methotrexate IT on day 29 of courses 1-4 [no oral methotrexate]).

REVISED MT (RMT): The regimen is the same as standard MT, but 2 of the doses of IT methotrexate are omitted (day 29 of courses 3 and 4).

Study Design

Study Type:
Interventional
Actual Enrollment :
104 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Intensified PEG-Asparaginase in High Risk Acute Lymphoblastic Leukemia (ALL): A Pilot Study
Actual Study Start Date :
Feb 23, 2009
Actual Primary Completion Date :
Jun 30, 2014
Actual Study Completion Date :
Mar 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm I (HR-average)

See Detailed Description.

Drug: Cyclophosphamide
Given IV
Other Names:
  • (-)-Cyclophosphamide
  • 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate
  • Carloxan
  • Ciclofosfamida
  • Ciclofosfamide
  • Cicloxal
  • Clafen
  • Claphene
  • CP monohydrate
  • CTX
  • CYCLO-cell
  • Cycloblastin
  • Cycloblastine
  • Cyclophospham
  • Cyclophosphamid monohydrate
  • Cyclophosphamide Monohydrate
  • Cyclophosphamidum
  • Cyclophosphan
  • Cyclophosphane
  • Cyclophosphanum
  • Cyclostin
  • Cyclostine
  • Cytophosphan
  • Cytophosphane
  • Cytoxan
  • Fosfaseron
  • Genoxal
  • Genuxal
  • Ledoxina
  • Mitoxan
  • Neosar
  • Revimmune
  • Syklofosfamid
  • WR- 138719
  • Drug: Cytarabine
    Given IT and 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-D-arabinofuranosylcytosine
  • 1.beta.-D-Arabinofuranosylcytosine
  • 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-
  • 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-
  • Alexan
  • Ara-C
  • ARA-cell
  • Arabine
  • Arabinofuranosylcytosine
  • Arabinosylcytosine
  • Aracytidine
  • Aracytin
  • Aracytine
  • Beta-Cytosine Arabinoside
  • CHX-3311
  • Cytarabinum
  • Cytarbel
  • Cytosar
  • Cytosine Arabinoside
  • Cytosine-.beta.-arabinoside
  • Cytosine-beta-arabinoside
  • Erpalfa
  • Starasid
  • Tarabine PFS
  • U 19920
  • U-19920
  • Udicil
  • WR-28453
  • Drug: Dexamethasone
    Given IV
    Other Names:
  • 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
  • Drug: Doxorubicin Hydrochloride
    Given IV
    Other Names:
  • 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)
  • ADM
  • 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
  • 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
  • 6H-Purine-6-thione, 1,7-dihydro- (9CI)
  • 7-Mercapto-1,3,4,6-tetrazaindene
  • Alti-Mercaptopurine
  • Azathiopurine
  • Bw 57-323H
  • Flocofil
  • Ismipur
  • Leukerin
  • Leupurin
  • Mercaleukim
  • Mercaleukin
  • Mercaptina
  • Mercaptopurinum
  • Mercapurin
  • Mern
  • NCI-C04886
  • Puri-Nethol
  • Purimethol
  • Purine, 6-mercapto-
  • Purine-6-thiol (8CI)
  • Purine-6-thiol, monohydrate
  • Purinethiol
  • Purinethol
  • U-4748
  • WR-2785
  • Drug: Methotrexate
    Given IT and PO
    Other Names:
  • Abitrexate
  • Alpha-Methopterin
  • Amethopterin
  • Brimexate
  • CL 14377
  • CL-14377
  • Emtexate
  • Emthexat
  • Emthexate
  • Farmitrexat
  • Fauldexato
  • Folex
  • Folex PFS
  • Lantarel
  • Ledertrexate
  • Lumexon
  • Maxtrex
  • Medsatrexate
  • Metex
  • Methoblastin
  • Methotrexate LPF
  • Methotrexate Methylaminopterin
  • Methotrexatum
  • Metotrexato
  • Metrotex
  • Mexate
  • Mexate-AQ
  • MTX
  • Novatrex
  • Rheumatrex
  • Texate
  • Tremetex
  • Trexeron
  • Trixilem
  • WR-19039
  • Drug: 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 Glycol L-Asparaginase
  • Polyethylene Glycol-L-Asparaginase
  • Drug: Thioguanine
    Given PO
    Other Names:
  • 2-Amino 6MP
  • 2-Amino-1,7-dihydro-6H-purine-6-thione
  • 2-Amino-6-mercaptopurine
  • 2-Amino-6-purinethiol
  • 2-Aminopurin-6-thiol
  • 2-Aminopurine-6(1H)-thione
  • 2-Aminopurine-6-thiol
  • 2-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
  • Drug: Vincristine Sulfate
    Given IV
    Other Names:
  • Kyocristine
  • Leurocristine Sulfate
  • Leurocristine, sulfate
  • Oncovin
  • Vincasar
  • Vincosid
  • Vincrex
  • Vincristine, sulfate
  • Experimental: Arm II (HR-high)

    See Detailed Description.

    Drug: Cyclophosphamide
    Given IV
    Other Names:
  • (-)-Cyclophosphamide
  • 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate
  • Carloxan
  • Ciclofosfamida
  • Ciclofosfamide
  • Cicloxal
  • Clafen
  • Claphene
  • CP monohydrate
  • CTX
  • CYCLO-cell
  • Cycloblastin
  • Cycloblastine
  • Cyclophospham
  • Cyclophosphamid monohydrate
  • Cyclophosphamide Monohydrate
  • Cyclophosphamidum
  • Cyclophosphan
  • Cyclophosphane
  • Cyclophosphanum
  • Cyclostin
  • Cyclostine
  • Cytophosphan
  • Cytophosphane
  • Cytoxan
  • Fosfaseron
  • Genoxal
  • Genuxal
  • Ledoxina
  • Mitoxan
  • Neosar
  • Revimmune
  • Syklofosfamid
  • WR- 138719
  • Drug: Cytarabine
    Given IT and 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-D-arabinofuranosylcytosine
  • 1.beta.-D-Arabinofuranosylcytosine
  • 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-
  • 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-
  • Alexan
  • Ara-C
  • ARA-cell
  • Arabine
  • Arabinofuranosylcytosine
  • Arabinosylcytosine
  • Aracytidine
  • Aracytin
  • Aracytine
  • Beta-Cytosine Arabinoside
  • CHX-3311
  • Cytarabinum
  • Cytarbel
  • Cytosar
  • Cytosine Arabinoside
  • Cytosine-.beta.-arabinoside
  • Cytosine-beta-arabinoside
  • Erpalfa
  • Starasid
  • Tarabine PFS
  • U 19920
  • U-19920
  • Udicil
  • WR-28453
  • Drug: Daunorubicin Hydrochloride
    Given IV
    Other Names:
  • Cerubidin
  • Cerubidine
  • Cloridrato de Daunorubicina
  • Daunoblastin
  • Daunoblastina
  • Daunoblastine
  • Daunomycin Hydrochloride
  • Daunomycin, hydrochloride
  • Daunorubicin.HCl
  • Daunorubicini Hydrochloridum
  • FI-6339
  • Ondena
  • RP-13057
  • Rubidomycin Hydrochloride
  • Rubilem
  • Drug: Dexamethasone
    Given IV
    Other Names:
  • 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
  • Drug: Doxorubicin Hydrochloride
    Given IV
    Other Names:
  • 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)
  • ADM
  • 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
  • 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
  • 6H-Purine-6-thione, 1,7-dihydro- (9CI)
  • 7-Mercapto-1,3,4,6-tetrazaindene
  • Alti-Mercaptopurine
  • Azathiopurine
  • Bw 57-323H
  • Flocofil
  • Ismipur
  • Leukerin
  • Leupurin
  • Mercaleukim
  • Mercaleukin
  • Mercaptina
  • Mercaptopurinum
  • Mercapurin
  • Mern
  • NCI-C04886
  • Puri-Nethol
  • Purimethol
  • Purine, 6-mercapto-
  • Purine-6-thiol (8CI)
  • Purine-6-thiol, monohydrate
  • Purinethiol
  • Purinethol
  • U-4748
  • WR-2785
  • Drug: Methotrexate
    Given IT and PO
    Other Names:
  • Abitrexate
  • Alpha-Methopterin
  • Amethopterin
  • Brimexate
  • CL 14377
  • CL-14377
  • Emtexate
  • Emthexat
  • Emthexate
  • Farmitrexat
  • Fauldexato
  • Folex
  • Folex PFS
  • Lantarel
  • Ledertrexate
  • Lumexon
  • Maxtrex
  • Medsatrexate
  • Metex
  • Methoblastin
  • Methotrexate LPF
  • Methotrexate Methylaminopterin
  • Methotrexatum
  • Metotrexato
  • Metrotex
  • Mexate
  • Mexate-AQ
  • MTX
  • Novatrex
  • Rheumatrex
  • Texate
  • Tremetex
  • Trexeron
  • Trixilem
  • WR-19039
  • Drug: 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 Glycol L-Asparaginase
  • Polyethylene Glycol-L-Asparaginase
  • 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
  • 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
  • Radiation: Prophylactic Cranial Irradiation
    Undergo radiation
    Other Names:
  • PCI
  • Drug: Thioguanine
    Given PO
    Other Names:
  • 2-Amino 6MP
  • 2-Amino-1,7-dihydro-6H-purine-6-thione
  • 2-Amino-6-mercaptopurine
  • 2-Amino-6-purinethiol
  • 2-Aminopurin-6-thiol
  • 2-Aminopurine-6(1H)-thione
  • 2-Aminopurine-6-thiol
  • 2-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
  • Drug: Vincristine Sulfate
    Given IV
    Other Names:
  • Kyocristine
  • Leurocristine Sulfate
  • Leurocristine, sulfate
  • Oncovin
  • Vincasar
  • Vincosid
  • Vincrex
  • Vincristine, sulfate
  • Outcome Measures

    Primary Outcome Measures

    1. AALL08P1 Safety Outcome [Consolidation through Delayed Intensification]

      Percentage of Group B (High Risk-High) patients taking less than 49 weeks from day 1 of consolidation to day 1 of maintenance therapy. Only Group B analyzed since this is prespecified in protocol.

    2. AALL08P1 Feasibility Outcome [Consolidation through Delayed Intensification]

      Percentage of Group B (High Risk-High) patients that tolerate at least 8 of the 12-14 total doses of pegaspargase during Consolidation, Interim Maintenance, and Delayed Intensification periods. Only Grp B analyzed since this is prespecified in protocol.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 30 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients must be eligible for and enrolled on AALL03B1 or the successor classification study

    • Patients must have newly diagnosed high-risk B-precursor acute lymphoblastic leukemia (ALL)

    • WBC criteria

    • Age 1.00-9.99 years: WBC >= 50,000/uL

    • Age 10.00 - 30.99 years: Any WBC

    • Prior steroid therapy: Any WBC

    • Patients with testicular leukemia: Any WBC

    • 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; 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 study; the dose and duration of previous steroid therapy should be carefully documented

    • 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

    Exclusion Criteria:
    • Pregnant female patients are ineligible; pregnancy tests with a negative result must be obtained in all post-menarchal females; males and females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method; lactating females must agree that they will not breastfeed a child while on this study

    • Patients with Down syndrome (DS) are ineligible since excessive toxicities and death have been noted for those enrolled on AALL0232 receiving the prednisone/Capizzi methotrexate (PC) arm of treatment, which is the backbone regimen for the current study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Phoenix Childrens Hospital Phoenix Arizona United States 85016
    2 Miller Children's and Women's Hospital Long Beach Long Beach California United States 90806
    3 Children's Hospital Los Angeles Los Angeles California United States 90027
    4 Valley Children's Hospital Madera California United States 93636
    5 Rady Children's Hospital - San Diego San Diego California United States 92123
    6 UCSF Medical Center-Mount Zion San Francisco California United States 94115
    7 UCSF Medical Center-Parnassus San Francisco California United States 94143
    8 Harbor-University of California at Los Angeles Medical Center Torrance California United States 90502
    9 Nemours Children's Clinic-Jacksonville Jacksonville Florida United States 32207
    10 Children's Healthcare of Atlanta - Egleston Atlanta Georgia United States 30322
    11 Advocate Children's Hospital-Oak Lawn Oak Lawn Illinois United States 60453
    12 Saint Vincent Hospital and Health Care Center Indianapolis Indiana United States 46260
    13 University of Kentucky/Markey Cancer Center Lexington Kentucky United States 40536
    14 Norton Children's Hospital Louisville Kentucky United States 40202
    15 C S Mott Children's Hospital Ann Arbor Michigan United States 48109
    16 University of Mississippi Medical Center Jackson Mississippi United States 39216
    17 The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park New York United States 11040
    18 UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina United States 27599
    19 Nationwide Children's Hospital Columbus Ohio United States 43205
    20 Dayton Children's Hospital Dayton Ohio United States 45404
    21 Legacy Emanuel Children's Hospital Portland Oregon United States 97227
    22 Legacy Emanuel Hospital and Health Center Portland Oregon United States 97227
    23 Children's Oncology Group Philadelphia Pennsylvania United States 19104
    24 Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston Texas United States 77030
    25 Methodist Children's Hospital of South Texas San Antonio Texas United States 78229
    26 Royal Children's Hospital Parkville Victoria Australia 3052
    27 Princess Margaret Hospital for Children Perth Western Australia Australia 6008
    28 Children's Hospital of Eastern Ontario Ottawa Ontario Canada K1H 8L1

    Sponsors and Collaborators

    • Children's Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: ZoAnn E Dreyer, Children's Oncology Group

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Children's Oncology Group
    ClinicalTrials.gov Identifier:
    NCT00866307
    Other Study ID Numbers:
    • AALL08P1
    • NCI-2009-01169
    • CDR0000636174
    • COG-AALL08P1
    • AALL08P1
    • AALL08P1
    • U10CA098413
    • U10CA180886
    • U10CA180899
    • U10CA098543
    First Posted:
    Mar 20, 2009
    Last Update Posted:
    Apr 27, 2021
    Last Verified:
    Apr 1, 2021

    Study Results

    Participant Flow

    Recruitment Details Patients with newly diagnosed high-risk B-precursor acute lymphoblastic leukemia (ALL), no prior cytotoxic chemotherapy besides steroids and intrathecal cytarabine and WBC criteria: Age 1.00-9.99 years: WBC >= 50,000/uL; Age 10.00 - 30.99 years or prior steroid therapy or with testicular leukemia: Any WBC
    Pre-assignment Detail Patients with Day 29 Marrow counts >25% (M3) or pegaspargase contraindication go off therapy before risk stratification.
    Arm/Group Title Induction Group A (High Risk-Average) Group B (High Risk-High)
    Arm/Group Description All Patients Patients with day 29 MRD <0.01% and no CNS3, testicular disease, steroid pretreatment, MLL+, or hypodiploidy. Treated with Standard PEG-asparaginase therapy (hABFM) Patients with day 29 MRD >=0.01% or at least one of: CNS3, Testicular disease, Steroid Pre-treatment, MLL+, or hypodiploidy. Received Intensified PEG-asparaginase therapy
    Period Title: Induction
    STARTED 104 0 0
    COMPLETED 84 0 0
    NOT COMPLETED 20 0 0
    Period Title: Induction
    STARTED 0 54 30
    COMPLETED 0 45 14
    NOT COMPLETED 0 9 16

    Baseline Characteristics

    Arm/Group Title Induction
    Arm/Group Description All Patients
    Overall Participants 104
    Age (Count of Participants)
    <=18 years
    96
    92.3%
    Between 18 and 65 years
    8
    7.7%
    >=65 years
    0
    0%
    Sex: Female, Male (Count of Participants)
    Female
    42
    40.4%
    Male
    62
    59.6%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    37
    35.6%
    Not Hispanic or Latino
    63
    60.6%
    Unknown or Not Reported
    4
    3.8%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    Asian
    6
    5.8%
    Native Hawaiian or Other Pacific Islander
    2
    1.9%
    Black or African American
    7
    6.7%
    White
    68
    65.4%
    More than one race
    0
    0%
    Unknown or Not Reported
    21
    20.2%

    Outcome Measures

    1. Primary Outcome
    Title AALL08P1 Safety Outcome
    Description Percentage of Group B (High Risk-High) patients taking less than 49 weeks from day 1 of consolidation to day 1 of maintenance therapy. Only Group B analyzed since this is prespecified in protocol.
    Time Frame Consolidation through Delayed Intensification

    Outcome Measure Data

    Analysis Population Description
    Patients with High Risk-High (Group B) Acute Lymphoblastic Leukemia (ALL)
    Arm/Group Title Group B (High Risk-High)
    Arm/Group Description Patients with day 29 MRD >=0.01% or at least one of: CNS3, Testicular disease, Steroid Pre-treatment, MLL+, or hypodiploidy. Received Intensified PEG-asparaginase therapy
    Measure Participants 30
    Number (90% Confidence Interval) [percentage of participants]
    50.0
    48.1%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group B (High Risk-High)
    Comments Per protocol, percentage of high risk-High patients taking less than 49 weeks from day 1 of consolidation to day 1 of maintenance therapy is compared to a null fixed rate (<=73%). A 90% two-sided Agresti-Coull confidence interval will be constructed and the lower bound examined. Will reject null if lower bound of confidence interval is above 73%.
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage
    Estimated Value 50.0
    Confidence Interval (2-Sided) 90%
    35.6 to 64.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Primary Outcome
    Title AALL08P1 Feasibility Outcome
    Description Percentage of Group B (High Risk-High) patients that tolerate at least 8 of the 12-14 total doses of pegaspargase during Consolidation, Interim Maintenance, and Delayed Intensification periods. Only Grp B analyzed since this is prespecified in protocol.
    Time Frame Consolidation through Delayed Intensification

    Outcome Measure Data

    Analysis Population Description
    Patients with High Risk-high Acute Lymphoblastic Leukemia (ALL)
    Arm/Group Title Group B (High Risk-High)
    Arm/Group Description Patients with day 29 MRD >=0.01% or at least one of: CNS3, Testicular disease, Steroid Pre-treatment, MLL+, or hypodiploidy. Received Intensified PEG-asparaginase therapy
    Measure Participants 30
    Number (90% Confidence Interval) [percentage of participants]
    53.3
    51.3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group B (High Risk-High)
    Comments Per protocol, percentage receiving at least 8 doses is compared to a null fixed rate (<=42%). A 90% two-sided Agresti-Coull confidence interval will be constructed. Will reject null if lower bound of confidence interval is above 42%.
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage
    Estimated Value 53.3
    Confidence Interval (2-Sided) 90%
    38.7 to 67.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Induction Group A (High Risk-Average) Group B (High Risk-High)
    Arm/Group Description All Patients Patients with day 29 MRD <0.01% and no CNS3, testicular disease, steroid pretreatment, MLL+, or hypodiploidy. Treated with Standard PEG-asparaginase therapy (hABFM). Patients with day 29 MRD >=0.01% or at least one of: CNS3, Testicular disease, Steroid Pre-treatment, MLL+, or hypodiploidy. Received Intensified PEG-asparaginase therapy.
    All Cause Mortality
    Induction Group A (High Risk-Average) Group B (High Risk-High)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Induction Group A (High Risk-Average) Group B (High Risk-High)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 10/104 (9.6%) 1/54 (1.9%) 4/30 (13.3%)
    Blood and lymphatic system disorders
    Disseminated intravascular coagulation 1/104 (1%) 1 0/54 (0%) 0 0/30 (0%) 0
    Cardiac disorders
    Cardiac arrest 1/104 (1%) 1 0/54 (0%) 0 0/30 (0%) 0
    Cardiac disorders - Other, specify 1/104 (1%) 1 0/54 (0%) 0 0/30 (0%) 0
    Gastrointestinal disorders
    Colitis 1/104 (1%) 1 0/54 (0%) 0 1/30 (3.3%) 1
    Typhlitis 1/104 (1%) 1 0/54 (0%) 0 1/30 (3.3%) 1
    General disorders
    Multi-organ failure 1/104 (1%) 1 0/54 (0%) 0 1/30 (3.3%) 1
    Hepatobiliary disorders
    Hepatic hemorrhage 1/104 (1%) 1 0/54 (0%) 0 0/30 (0%) 0
    Infections and infestations
    Infections and infestations - Other, specify 4/104 (3.8%) 4 0/54 (0%) 0 2/30 (6.7%) 2
    Investigations
    Alanine aminotransferase increased 1/104 (1%) 1 0/54 (0%) 0 1/30 (3.3%) 1
    Blood bilirubin increased 1/104 (1%) 1 0/54 (0%) 0 0/30 (0%) 0
    Fibrinogen decreased 1/104 (1%) 1 0/54 (0%) 0 1/30 (3.3%) 1
    Investigations - Other, specify 1/104 (1%) 1 0/54 (0%) 0 1/30 (3.3%) 1
    Platelet count decreased 1/104 (1%) 1 0/54 (0%) 0 1/30 (3.3%) 1
    Nervous system disorders
    Depressed level of consciousness 1/104 (1%) 1 0/54 (0%) 0 0/30 (0%) 0
    Dysphasia 1/104 (1%) 1 1/54 (1.9%) 1 0/30 (0%) 0
    Intracranial hemorrhage 2/104 (1.9%) 2 0/54 (0%) 0 2/30 (6.7%) 2
    Nervous system disorders - Other, specify 4/104 (3.8%) 6 1/54 (1.9%) 1 0/30 (0%) 0
    Seizure 4/104 (3.8%) 4 1/54 (1.9%) 1 1/30 (3.3%) 1
    Syncope 1/104 (1%) 1 0/54 (0%) 0 1/30 (3.3%) 1
    Respiratory, thoracic and mediastinal disorders
    Bronchopulmonary hemorrhage 1/104 (1%) 1 0/54 (0%) 0 0/30 (0%) 0
    Hypoxia 1/104 (1%) 1 0/54 (0%) 0 1/30 (3.3%) 1
    Pneumonitis 1/104 (1%) 1 0/54 (0%) 0 0/30 (0%) 0
    Vascular disorders
    Hypertension 1/104 (1%) 1 0/54 (0%) 0 0/30 (0%) 0
    Hypotension 3/104 (2.9%) 3 0/54 (0%) 0 2/30 (6.7%) 2
    Thromboembolic event 2/104 (1.9%) 2 0/54 (0%) 0 1/30 (3.3%) 1
    Other (Not Including Serious) Adverse Events
    Induction Group A (High Risk-Average) Group B (High Risk-High)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 97/104 (93.3%) 53/54 (98.1%) 30/30 (100%)
    Blood and lymphatic system disorders
    Anemia 32/104 (30.8%) 58 18/54 (33.3%) 35 11/30 (36.7%) 19
    Blood and lymphatic system disorders - Other, specify 1/104 (1%) 1 0/54 (0%) 0 0/30 (0%) 0
    Disseminated intravascular coagulation 1/104 (1%) 1 0/54 (0%) 0 1/30 (3.3%) 1
    Febrile neutropenia 57/104 (54.8%) 130 38/54 (70.4%) 85 18/30 (60%) 44
    Cardiac disorders
    Wolff-Parkinson-White syndrome 1/104 (1%) 1 1/54 (1.9%) 1 0/30 (0%) 0
    Eye disorders
    Optic nerve disorder 1/104 (1%) 1 1/54 (1.9%) 1 0/30 (0%) 0
    Papilledema 1/104 (1%) 1 0/54 (0%) 0 1/30 (3.3%) 1
    Gastrointestinal disorders
    Abdominal pain 11/104 (10.6%) 12 8/54 (14.8%) 9 3/30 (10%) 3
    Ascites 1/104 (1%) 1 1/54 (1.9%) 1 0/30 (0%) 0
    Colitis 1/104 (1%) 1 0/54 (0%) 0 1/30 (3.3%) 1
    Constipation 2/104 (1.9%) 2 1/54 (1.9%) 1 1/30 (3.3%) 1
    Diarrhea 3/104 (2.9%) 3 2/54 (3.7%) 2 1/30 (3.3%) 1
    Dysphagia 1/104 (1%) 1 0/54 (0%) 0 1/30 (3.3%) 1
    Lower gastrointestinal hemorrhage 1/104 (1%) 1 0/54 (0%) 0 0/30 (0%) 0
    Malabsorption 2/104 (1.9%) 2 2/54 (3.7%) 2 0/30 (0%) 0
    Mucositis oral 10/104 (9.6%) 10 6/54 (11.1%) 6 4/30 (13.3%) 4
    Nausea 3/104 (2.9%) 3 2/54 (3.7%) 2 0/30 (0%) 0
    Oral pain 3/104 (2.9%) 3 2/54 (3.7%) 2 1/30 (3.3%) 1
    Pancreatic necrosis 1/104 (1%) 2 1/54 (1.9%) 2 0/30 (0%) 0
    Pancreatitis 7/104 (6.7%) 9 4/54 (7.4%) 6 2/30 (6.7%) 2
    Toothache 1/104 (1%) 1 1/54 (1.9%) 1 0/30 (0%) 0
    Typhlitis 3/104 (2.9%) 3 3/54 (5.6%) 3 0/30 (0%) 0
    Upper gastrointestinal hemorrhage 1/104 (1%) 1 0/54 (0%) 0 0/30 (0%) 0
    Vomiting 4/104 (3.8%) 4 4/54 (7.4%) 4 0/30 (0%) 0
    General disorders
    Fatigue 2/104 (1.9%) 2 1/54 (1.9%) 1 1/30 (3.3%) 1
    Fever 5/104 (4.8%) 5 4/54 (7.4%) 4 0/30 (0%) 0
    Gait disturbance 1/104 (1%) 1 0/54 (0%) 0 1/30 (3.3%) 1
    Pain 4/104 (3.8%) 4 2/54 (3.7%) 2 2/30 (6.7%) 2
    Hepatobiliary disorders
    Hepatobiliary disorders - Other, specify 2/104 (1.9%) 2 1/54 (1.9%) 1 1/30 (3.3%) 1
    Immune system disorders
    Allergic reaction 10/104 (9.6%) 11 7/54 (13%) 8 3/30 (10%) 3
    Anaphylaxis 15/104 (14.4%) 17 9/54 (16.7%) 11 5/30 (16.7%) 5
    Immune system disorders - Other, specify 4/104 (3.8%) 8 3/54 (5.6%) 7 1/30 (3.3%) 1
    Infections and infestations
    Abdominal infection 2/104 (1.9%) 2 2/54 (3.7%) 2 0/30 (0%) 0
    Anorectal infection 2/104 (1.9%) 2 2/54 (3.7%) 2 0/30 (0%) 0
    Appendicitis perforated 1/104 (1%) 1 1/54 (1.9%) 1 0/30 (0%) 0
    Bladder infection 1/104 (1%) 1 1/54 (1.9%) 1 0/30 (0%) 0
    Bronchial infection 1/104 (1%) 1 1/54 (1.9%) 1 0/30 (0%) 0
    Catheter related infection 4/104 (3.8%) 4 2/54 (3.7%) 2 2/30 (6.7%) 2
    Enterocolitis infectious 6/104 (5.8%) 8 6/54 (11.1%) 8 0/30 (0%) 0
    Esophageal infection 1/104 (1%) 1 0/54 (0%) 0 1/30 (3.3%) 1
    Infections and infestations - Other, specify 62/104 (59.6%) 155 39/54 (72.2%) 98 17/30 (56.7%) 39
    Infective myositis 1/104 (1%) 2 1/54 (1.9%) 2 0/30 (0%) 0
    Kidney infection 1/104 (1%) 1 1/54 (1.9%) 1 0/30 (0%) 0
    Lung infection 10/104 (9.6%) 16 7/54 (13%) 11 3/30 (10%) 5
    Lymph gland infection 1/104 (1%) 1 1/54 (1.9%) 1 0/30 (0%) 0
    Mucosal infection 1/104 (1%) 1 1/54 (1.9%) 1 0/30 (0%) 0
    Nail infection 1/104 (1%) 1 1/54 (1.9%) 1 0/30 (0%) 0
    Otitis media 2/104 (1.9%) 2 2/54 (3.7%) 2 0/30 (0%) 0
    Sepsis 2/104 (1.9%) 2 0/54 (0%) 0 1/30 (3.3%) 1
    Sinusitis 4/104 (3.8%) 4 4/54 (7.4%) 4 0/30 (0%) 0
    Skin infection 5/104 (4.8%) 6 2/54 (3.7%) 2 2/30 (6.7%) 3
    Upper respiratory infection 6/104 (5.8%) 7 3/54 (5.6%) 4 3/30 (10%) 3
    Urinary tract infection 4/104 (3.8%) 9 3/54 (5.6%) 4 1/30 (3.3%) 5
    Vaginal infection 1/104 (1%) 1 1/54 (1.9%) 1 0/30 (0%) 0
    Wound infection 1/104 (1%) 4 0/54 (0%) 0 0/30 (0%) 0
    Injury, poisoning and procedural complications
    Intraoperative gastrointestinal injury 1/104 (1%) 1 1/54 (1.9%) 1 0/30 (0%) 0
    Vascular access complication 8/104 (7.7%) 11 6/54 (11.1%) 9 1/30 (3.3%) 1
    Wound dehiscence 1/104 (1%) 1 0/54 (0%) 0 0/30 (0%) 0
    Investigations
    Activated partial thromboplastin time prolonged 2/104 (1.9%) 3 2/54 (3.7%) 3 0/30 (0%) 0
    Alanine aminotransferase increased 47/104 (45.2%) 100 28/54 (51.9%) 70 15/30 (50%) 25
    Alkaline phosphatase increased 4/104 (3.8%) 4 3/54 (5.6%) 3 1/30 (3.3%) 1
    Aspartate aminotransferase increased 23/104 (22.1%) 30 14/54 (25.9%) 20 7/30 (23.3%) 8
    Blood bilirubin increased 19/104 (18.3%) 29 10/54 (18.5%) 15 6/30 (20%) 11
    Cholesterol high 1/104 (1%) 1 1/54 (1.9%) 1 0/30 (0%) 0
    Creatinine increased 2/104 (1.9%) 2 1/54 (1.9%) 1 1/30 (3.3%) 1
    Fibrinogen decreased 11/104 (10.6%) 15 7/54 (13%) 11 3/30 (10%) 3
    GGT increased 9/104 (8.7%) 9 1/54 (1.9%) 1 6/30 (20%) 6
    INR increased 1/104 (1%) 1 0/54 (0%) 0 1/30 (3.3%) 1
    Investigations - Other, specify 1/104 (1%) 1 0/54 (0%) 0 1/30 (3.3%) 1
    Lipase increased 10/104 (9.6%) 13 5/54 (9.3%) 8 3/30 (10%) 3
    Lymphocyte count decreased 2/104 (1.9%) 4 2/54 (3.7%) 4 0/30 (0%) 0
    Neutrophil count decreased 72/104 (69.2%) 212 47/54 (87%) 144 21/30 (70%) 61
    Pancreatic enzymes decreased 1/104 (1%) 1 1/54 (1.9%) 1 0/30 (0%) 0
    Platelet count decreased 34/104 (32.7%) 70 20/54 (37%) 37 11/30 (36.7%) 22
    Serum amylase increased 5/104 (4.8%) 6 3/54 (5.6%) 4 1/30 (3.3%) 1
    Weight gain 1/104 (1%) 1 0/54 (0%) 0 1/30 (3.3%) 1
    Weight loss 6/104 (5.8%) 8 4/54 (7.4%) 5 2/30 (6.7%) 3
    White blood cell decreased 37/104 (35.6%) 102 22/54 (40.7%) 64 12/30 (40%) 33
    Metabolism and nutrition disorders
    Anorexia 7/104 (6.7%) 8 3/54 (5.6%) 4 3/30 (10%) 3
    Dehydration 4/104 (3.8%) 4 3/54 (5.6%) 3 1/30 (3.3%) 1
    Glucose intolerance 5/104 (4.8%) 6 4/54 (7.4%) 5 1/30 (3.3%) 1
    Hypercalcemia 1/104 (1%) 2 1/54 (1.9%) 2 0/30 (0%) 0
    Hyperglycemia 24/104 (23.1%) 31 12/54 (22.2%) 18 8/30 (26.7%) 9
    Hyperkalemia 8/104 (7.7%) 8 4/54 (7.4%) 4 3/30 (10%) 3
    Hypermagnesemia 1/104 (1%) 1 1/54 (1.9%) 1 0/30 (0%) 0
    Hypertriglyceridemia 3/104 (2.9%) 3 3/54 (5.6%) 3 0/30 (0%) 0
    Hyperuricemia 2/104 (1.9%) 2 1/54 (1.9%) 1 1/30 (3.3%) 1
    Hypoalbuminemia 9/104 (8.7%) 12 3/54 (5.6%) 3 3/30 (10%) 6
    Hypocalcemia 11/104 (10.6%) 12 7/54 (13%) 8 3/30 (10%) 3
    Hypokalemia 12/104 (11.5%) 16 6/54 (11.1%) 8 4/30 (13.3%) 6
    Hyponatremia 20/104 (19.2%) 24 10/54 (18.5%) 13 7/30 (23.3%) 7
    Hypophosphatemia 7/104 (6.7%) 7 1/54 (1.9%) 1 4/30 (13.3%) 4
    Iron overload 1/104 (1%) 1 1/54 (1.9%) 1 0/30 (0%) 0
    Obesity 2/104 (1.9%) 2 2/54 (3.7%) 2 0/30 (0%) 0
    Tumor lysis syndrome 1/104 (1%) 1 1/54 (1.9%) 1 0/30 (0%) 0
    Musculoskeletal and connective tissue disorders
    Arthralgia 2/104 (1.9%) 2 1/54 (1.9%) 1 1/30 (3.3%) 1
    Avascular necrosis 9/104 (8.7%) 22 7/54 (13%) 19 2/30 (6.7%) 3
    Back pain 3/104 (2.9%) 3 2/54 (3.7%) 2 1/30 (3.3%) 1
    Joint effusion 1/104 (1%) 2 1/54 (1.9%) 2 0/30 (0%) 0
    Joint range of motion decreased 1/104 (1%) 1 1/54 (1.9%) 1 0/30 (0%) 0
    Muscle weakness lower limb 3/104 (2.9%) 7 1/54 (1.9%) 4 1/30 (3.3%) 1
    Neck pain 1/104 (1%) 1 1/54 (1.9%) 1 0/30 (0%) 0
    Pain in extremity 9/104 (8.7%) 13 5/54 (9.3%) 6 3/30 (10%) 3
    Soft tissue necrosis lower limb 1/104 (1%) 1 0/54 (0%) 0 0/30 (0%) 0
    Soft tissue necrosis upper limb 1/104 (1%) 1 0/54 (0%) 0 0/30 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify 1/104 (1%) 1 1/54 (1.9%) 1 0/30 (0%) 0
    Nervous system disorders
    Abducens nerve disorder 1/104 (1%) 1 1/54 (1.9%) 1 0/30 (0%) 0
    Arachnoiditis 1/104 (1%) 1 1/54 (1.9%) 1 0/30 (0%) 0
    Ataxia 2/104 (1.9%) 3 2/54 (3.7%) 3 0/30 (0%) 0
    Cerebrospinal fluid leakage 1/104 (1%) 1 1/54 (1.9%) 1 0/30 (0%) 0
    Cognitive disturbance 1/104 (1%) 1 1/54 (1.9%) 1 0/30 (0%) 0
    Concentration impairment 1/104 (1%) 1 1/54 (1.9%) 1 0/30 (0%) 0
    Depressed level of consciousness 2/104 (1.9%) 2 1/54 (1.9%) 1 1/30 (3.3%) 1
    Dizziness 1/104 (1%) 1 1/54 (1.9%) 1 0/30 (0%) 0
    Dysphasia 2/104 (1.9%) 2 2/54 (3.7%) 2 0/30 (0%) 0
    Encephalopathy 2/104 (1.9%) 2 1/54 (1.9%) 1 0/30 (0%) 0
    Headache 4/104 (3.8%) 5 3/54 (5.6%) 4 1/30 (3.3%) 1
    Ischemia cerebrovascular 2/104 (1.9%) 2 0/54 (0%) 0 2/30 (6.7%) 2
    Leukoencephalopathy 4/104 (3.8%) 4 3/54 (5.6%) 3 1/30 (3.3%) 1
    Neuralgia 2/104 (1.9%) 4 1/54 (1.9%) 2 1/30 (3.3%) 2
    Oculomotor nerve disorder 2/104 (1.9%) 3 1/54 (1.9%) 2 1/30 (3.3%) 1
    Peripheral motor neuropathy 20/104 (19.2%) 30 10/54 (18.5%) 13 9/30 (30%) 16
    Peripheral sensory neuropathy 22/104 (21.2%) 31 13/54 (24.1%) 16 7/30 (23.3%) 12
    Seizure 5/104 (4.8%) 5 4/54 (7.4%) 4 1/30 (3.3%) 1
    Syncope 2/104 (1.9%) 2 1/54 (1.9%) 1 1/30 (3.3%) 1
    Tremor 1/104 (1%) 1 1/54 (1.9%) 1 0/30 (0%) 0
    Psychiatric disorders
    Agitation 4/104 (3.8%) 4 2/54 (3.7%) 2 0/30 (0%) 0
    Anxiety 2/104 (1.9%) 3 2/54 (3.7%) 3 0/30 (0%) 0
    Confusion 2/104 (1.9%) 2 1/54 (1.9%) 1 0/30 (0%) 0
    Depression 1/104 (1%) 1 1/54 (1.9%) 1 0/30 (0%) 0
    Hallucinations 1/104 (1%) 1 0/54 (0%) 0 1/30 (3.3%) 1
    Insomnia 1/104 (1%) 1 1/54 (1.9%) 1 0/30 (0%) 0
    Personality change 3/104 (2.9%) 4 2/54 (3.7%) 2 1/30 (3.3%) 2
    Psychosis 1/104 (1%) 1 1/54 (1.9%) 1 0/30 (0%) 0
    Suicidal ideation 1/104 (1%) 1 1/54 (1.9%) 1 0/30 (0%) 0
    Renal and urinary disorders
    Renal and urinary disorders - Other, specify 1/104 (1%) 2 0/54 (0%) 0 0/30 (0%) 0
    Urinary tract pain 1/104 (1%) 1 0/54 (0%) 0 1/30 (3.3%) 1
    Reproductive system and breast disorders
    Uterine hemorrhage 1/104 (1%) 1 1/54 (1.9%) 1 0/30 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Adult respiratory distress syndrome 1/104 (1%) 1 0/54 (0%) 0 0/30 (0%) 0
    Cough 1/104 (1%) 1 1/54 (1.9%) 1 0/30 (0%) 0
    Dyspnea 1/104 (1%) 1 0/54 (0%) 0 0/30 (0%) 0
    Hypoxia 5/104 (4.8%) 5 3/54 (5.6%) 3 0/30 (0%) 0
    Pharyngeal mucositis 1/104 (1%) 1 1/54 (1.9%) 1 0/30 (0%) 0
    Pharyngolaryngeal pain 1/104 (1%) 1 0/54 (0%) 0 1/30 (3.3%) 1
    Pleural effusion 4/104 (3.8%) 5 2/54 (3.7%) 2 2/30 (6.7%) 3
    Pneumonitis 2/104 (1.9%) 2 2/54 (3.7%) 2 0/30 (0%) 0
    Pneumothorax 1/104 (1%) 1 0/54 (0%) 0 0/30 (0%) 0
    Respiratory, thoracic and mediastinal disorders - Other, specify 1/104 (1%) 1 0/54 (0%) 0 0/30 (0%) 0
    Skin and subcutaneous tissue disorders
    Skin ulceration 1/104 (1%) 1 1/54 (1.9%) 1 0/30 (0%) 0
    Urticaria 1/104 (1%) 1 1/54 (1.9%) 1 0/30 (0%) 0
    Vascular disorders
    Hypertension 7/104 (6.7%) 7 2/54 (3.7%) 2 4/30 (13.3%) 4
    Hypotension 3/104 (2.9%) 3 2/54 (3.7%) 2 1/30 (3.3%) 1
    Thromboembolic event 3/104 (2.9%) 3 3/54 (5.6%) 3 0/30 (0%) 0
    Vascular disorders - Other, specify 2/104 (1.9%) 2 0/54 (0%) 0 0/30 (0%) 0

    Limitations/Caveats

    The COG SDC reviewed the NLM notification related to ct.gov AE/SAE reporting. The information in 'Additional Description' is accurate with respect to data supplied to ct.gov.COG plans to submit data AE/SAE data consistent with the text in this field.

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Must obtain prior Sponsor approval.

    Results Point of Contact

    Name/Title Results Reporting Coordinator
    Organization Children's Oncology Group
    Phone 626-447-0064
    Email resultsreportingcoordinator@childrensoncologygroup.org
    Responsible Party:
    Children's Oncology Group
    ClinicalTrials.gov Identifier:
    NCT00866307
    Other Study ID Numbers:
    • AALL08P1
    • NCI-2009-01169
    • CDR0000636174
    • COG-AALL08P1
    • AALL08P1
    • AALL08P1
    • U10CA098413
    • U10CA180886
    • U10CA180899
    • U10CA098543
    First Posted:
    Mar 20, 2009
    Last Update Posted:
    Apr 27, 2021
    Last Verified:
    Apr 1, 2021