Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia (Closed to Accrual 4-22-2011)
NCT ID: NCT00866307
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
PHASE1
Total Enrollment
104 participants
Study Classification
INTERVENTIONAL
Study Start Date
2009-02-23
Study Completion Date
2021-03-31
Brief Summary
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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.
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Detailed Description
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PRIMARY OBJECTIVES:
I. 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).
I. 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).
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
NON_RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Arm I (HR-average)
See Detailed Description.
Group Type
EXPERIMENTAL
Cyclophosphamide
Intervention Type
DRUG
Given IV
Cytarabine
Intervention Type
DRUG
Given IT and IV or SC
Dexamethasone
Intervention Type
DRUG
Given 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 IT and PO
Pegaspargase
Intervention Type
DRUG
Given IV
Thioguanine
Intervention Type
DRUG
Given PO
Vincristine Sulfate
Intervention Type
DRUG
Given IV
Arm II (HR-high)
See Detailed Description.
Group Type
EXPERIMENTAL
Cyclophosphamide
Intervention Type
DRUG
Given IV
Cytarabine
Intervention Type
DRUG
Given IT and IV or SC
Daunorubicin Hydrochloride
Intervention Type
DRUG
Given IV
Dexamethasone
Intervention Type
DRUG
Given 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 IT and PO
Pegaspargase
Intervention Type
DRUG
Given IV
Prednisone
Intervention Type
DRUG
Given IV or PO
Prophylactic Cranial Irradiation
Intervention Type
RADIATION
Undergo radiation
Thioguanine
Intervention Type
DRUG
Given PO
Vincristine Sulfate
Intervention Type
DRUG
Given IV
Interventions
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Cyclophosphamide
Given IV
Intervention Type
DRUG
Cytarabine
Given IT and IV or SC
Intervention Type
DRUG
Daunorubicin Hydrochloride
Given IV
Intervention Type
DRUG
Dexamethasone
Given 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 IT and PO
Intervention Type
DRUG
Pegaspargase
Given IV
Intervention Type
DRUG
Prednisone
Given IV or PO
Intervention Type
DRUG
Prophylactic Cranial Irradiation
Undergo radiation
Intervention Type
RADIATION
Thioguanine
Given PO
Intervention Type
DRUG
Vincristine Sulfate
Given IV
Intervention Type
DRUG
Other Intervention Names
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(-)-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
PCI
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 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
* 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
* 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
Minimum Eligible Age
1 Year
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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ZoAnn E Dreyer
Role: PRINCIPAL_INVESTIGATOR
Children's Oncology Group
Locations
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Phoenix Childrens Hospital
Phoenix, Arizona, United States
Site Status
Miller Children's and Women's Hospital Long Beach
Long Beach, California, United States
Site Status
Children's Hospital Los Angeles
Los Angeles, California, United States
Site Status
Valley Children's Hospital
Madera, California, United States
Site Status
Rady Children's Hospital - San Diego
San Diego, California, United States
Site Status
UCSF Medical Center-Mount Zion
San Francisco, California, United States
Site Status
UCSF Medical Center-Parnassus
San Francisco, California, United States
Site Status
Harbor-University of California at Los Angeles Medical Center
Torrance, California, United States
Site Status
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, United States
Site Status
Children's Healthcare of Atlanta - Egleston
Atlanta, Georgia, United States
Site Status
Advocate Children's Hospital-Oak Lawn
Oak Lawn, Illinois, United States
Site Status
Saint Vincent Hospital and Health Care Center
Indianapolis, Indiana, United States
Site Status
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States
Site Status
Norton Children's Hospital
Louisville, Kentucky, United States
Site Status
C S Mott Children's Hospital
Ann Arbor, Michigan, United States
Site Status
University of Mississippi Medical Center
Jackson, Mississippi, United States
Site Status
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park, New York, United States
Site Status
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Site Status
Nationwide Children's Hospital
Columbus, Ohio, United States
Site Status
Dayton Children's Hospital
Dayton, Ohio, United States
Site Status
Legacy Emanuel Children's Hospital
Portland, Oregon, United States
Site Status
Legacy Emanuel Hospital and Health Center
Portland, Oregon, United States
Site Status
Children's Oncology Group
Philadelphia, Pennsylvania, United States
Site Status
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, United States
Site Status
Methodist Children's Hospital of South Texas
San Antonio, Texas, United States
Site Status
Royal Children's Hospital
Parkville, Victoria, Australia
Site Status
Princess Margaret Hospital for Children
Perth, Western Australia, Australia
Site Status
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
Site Status
Countries
Review the countries where the study has at least one active or historical site.
United States
Australia
Canada
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2009-01169
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000636174
Identifier Type: -
Identifier Source: secondary_id
COG-AALL08P1
Identifier Type: -
Identifier Source: secondary_id
AALL08P1
Identifier Type: OTHER
Identifier Source: secondary_id
AALL08P1
Identifier Type: OTHER
Identifier Source: secondary_id
AALL08P1
Identifier Type: -
Identifier Source: org_study_id
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