Trial record 1 of 1 for:    AALL0631
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Combination Chemotherapy With or Without Lestaurtinib in Treating Infants With Newly Diagnosed Acute Lymphoblastic Leukemia

This study is currently recruiting participants.
Verified February 2014 by Children's Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00557193
First received: November 9, 2007
Last updated: February 5, 2014
Last verified: February 2014
  Purpose

This phase III trial is studying giving lestaurtinib together with combination chemotherapy to see how well it works compared to combination chemotherapy alone in treating infants with newly diagnosed acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of stop cancer cells, either by killing the cells or by stopping them from dividing. Lestaurtinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving more than one drug (combination chemotherapy) together with lestaurtinib may kill more cancer cells.


Condition Intervention Phase
Acute Undifferentiated Leukemia
T-cell Childhood Acute Lymphoblastic Leukemia
Untreated Childhood Acute Lymphoblastic Leukemia
Drug: asparaginase
Drug: daunorubicin hydrochloride
Drug: lestaurtinib
Drug: cyclophosphamide
Drug: pegaspargase
Drug: prednisone
Drug: methylprednisolone
Drug: dexamethasone
Drug: cytarabine
Drug: methotrexate
Biological: filgrastim
Drug: leucovorin calcium
Drug: etoposide
Drug: mercaptopurine
Drug: vincristine sulfate
Drug: hydrocortisone sodium succinate
Other: laboratory biomarker analysis
Other: pharmacological study
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Study of Risk Directed Therapy for Infants With Acute Lymphoblastic Leukemia (ALL): Randomization of Highest Risk Infants to Intensive Chemotherapy +/- FLT3 Inhibition (CEP-701, Lestaurtinib; IND #76431; NSC#617807)

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Event-free survival of MLL-R infants randomized to a modified P9407 backbone with or without lestaurtinib [ Time Frame: At 3 years ] [ Designated as safety issue: No ]
    All randomized patients will be included in the intent-to-treat efficacy analyses. Event-free survival time will be calculated from the time of randomization, which is just prior to beginning Induction Intensification.


Secondary Outcome Measures:
  • Safe, tolerable, and biologically active dose of lestaurtinib as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 10 years ] [ Designated as safety issue: Yes ]
    Lestaurtinib-related dose limiting toxicity (DLT) is defined as any grade 4 non-hematologic (i.e., excluding blood/bone marrow) toxicity that occurs after the first dose of lestaurtinib and is at least possibly related to lestaurtinib. Any grade 3 non-hematologic (i.e., excluding blood/bone marrow) toxicity that occurs after the first dose of lestaurtinib, is at least possibly attributable to lestaurtinib and results in omission or delay of the beginning of the subsequent course of chemotherapy for greater than 7 days.

  • Pharmacokinetic profile of lestaurtinib by plasma inhibitory activity (PIA) assay [ Time Frame: At baseline and during weeks 6-9 and 10-12 of lestaurinib treatment ] [ Designated as safety issue: No ]
    Cells (FLT3/ITD) incubated with plasma are washed, lysed, and analyzed for FLT3 phosphorylation by FLT3 immunoprecipitation and sequential immunoblotting with 4G10 anti-phosphotyrosine antibody and anti-FLT3 antibody. Densitometric analysis will be used to calculate the PIA (the percent inhibition of FLT3 phosphorylation of each timepoint relative to the pre-treatment sample). These results will be used to determine whether a given dose of lestaurtinib is biologically active.


Estimated Enrollment: 315
Study Start Date: January 2008
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (Post-induction chemotherapy A)
Patients receive induction therapy (weeks 1-5) comprising vincristine sulfate (VCR) IV; daunorubicin hydrochloride (DNR) IV; cyclophosphamide (CPM) IV; pegaspargase (PEG) or asparaginase (ASP) IM; prednisone (PED) PO or methylprednisolone IV; dexamethasone (DEX) IV or PO; cytarabine (ARAC) IV; methotrexate (MTX), ARAC, and hydrocortisone sodium succinate (HC) IT [triple IT chemotherapy]; and filgrastim IV or SC. Patients then receive post-induction therapy A comprising high-dose (HD) MTX; triple IT chemotherapy; leucovorin calcium IV; CPM; etoposide IV, VCR; DNR; PEG and ASP; DEX; HD ARAC; mercaptopurine PO; and filgrastim IV or SC for up to 104 weeks.
Drug: asparaginase
Given IV, IM, or PO
Other Names:
  • ASNase
  • Colaspase
  • Crasnitin
  • Elspar
  • L-ASP
Drug: daunorubicin hydrochloride
Given IV
Other Names:
  • Cerubidin
  • Cerubidine
  • daunomycin hydrochloride
  • daunorubicin
  • RP-13057
Drug: cyclophosphamide
Given IV
Other Names:
  • CPM
  • CTX
  • Cytoxan
  • Endoxan
  • Endoxana
Drug: pegaspargase
Given IM
Other Names:
  • L-asparaginase with polyethylene glycol
  • Oncaspar
  • PEG-ASP
  • PEG-L-asparaginase
Drug: prednisone
Given PO
Other Names:
  • DeCortin
  • Deltra
Drug: methylprednisolone
Given IV
Other Names:
  • Depo-Medrol
  • Medrol
  • MePRDL
  • Solu-Medrol
  • Wyacort
Drug: dexamethasone
Given IV or PO
Other Names:
  • Aeroseb-Dex
  • Decaderm
  • Decadron
  • DM
  • DXM
Drug: cytarabine
Given IV or IT
Other Names:
  • ARA-C
  • arabinofuranosylcytosine
  • arabinosylcytosine
  • Cytosar-U
  • cytosine arabinoside
Drug: methotrexate
Given IV, IT, or PO
Other Names:
  • amethopterin
  • Folex
  • methylaminopterin
  • Mexate
  • MTX
Biological: filgrastim
Given IV or SC
Other Names:
  • G-CSF
  • Neupogen
Drug: leucovorin calcium
Given IV
Other Names:
  • CF
  • CFR
  • LV
Drug: etoposide
Given IV
Other Names:
  • EPEG
  • VP-16
  • VP-16-213
Drug: mercaptopurine
Given PO
Other Names:
  • 6-mercaptopurine
  • 6-MP
  • Leukerin
  • MP
Drug: vincristine sulfate
Given IV
Other Names:
  • leurocristine sulfate
  • VCR
  • Vincasar PFS
Drug: hydrocortisone sodium succinate
Given IT
Other Names:
  • Sodium hydrocortisone succinate
  • Solu-Cortef
  • Solu-Glyc
Other: laboratory biomarker analysis
Correlative studies
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Active Comparator: Treatment (Post-induction chemotherapy B)
Patients receive induction therapy (weeks 1-5) comprising vincristine sulfate (VCR) IV; daunorubicin hydrochloride (DNR) IV; cyclophosphamide (CPM) IV; pegaspargase (PEG) or asparaginase (ASP) IM; prednisone (PED) PO or methylprednisolone IV; dexamethasone (DEX) IV or PO; cytarabine (ARAC) IV; methotrexate (MTX), ARAC, and hydrocortisone sodium succinate (HC) IT [triple IT chemotherapy]; and filgrastim IV or SC. Patients then receive post-induction therapy B comprising high-dose (HD) MTX; triple IT chemotherapy; leucovorin calcium IV; CPM; etoposide IV, VCR; DNR; PEG and ASP; DEX; HD ARAC; mercaptopurine PO; and filgrastim IV or SC for up to 104 weeks.
Drug: asparaginase
Given IV, IM, or PO
Other Names:
  • ASNase
  • Colaspase
  • Crasnitin
  • Elspar
  • L-ASP
Drug: daunorubicin hydrochloride
Given IV
Other Names:
  • Cerubidin
  • Cerubidine
  • daunomycin hydrochloride
  • daunorubicin
  • RP-13057
Drug: cyclophosphamide
Given IV
Other Names:
  • CPM
  • CTX
  • Cytoxan
  • Endoxan
  • Endoxana
Drug: pegaspargase
Given IM
Other Names:
  • L-asparaginase with polyethylene glycol
  • Oncaspar
  • PEG-ASP
  • PEG-L-asparaginase
Drug: prednisone
Given PO
Other Names:
  • DeCortin
  • Deltra
Drug: methylprednisolone
Given IV
Other Names:
  • Depo-Medrol
  • Medrol
  • MePRDL
  • Solu-Medrol
  • Wyacort
Drug: dexamethasone
Given IV or PO
Other Names:
  • Aeroseb-Dex
  • Decaderm
  • Decadron
  • DM
  • DXM
Drug: cytarabine
Given IV or IT
Other Names:
  • ARA-C
  • arabinofuranosylcytosine
  • arabinosylcytosine
  • Cytosar-U
  • cytosine arabinoside
Drug: methotrexate
Given IV, IT, or PO
Other Names:
  • amethopterin
  • Folex
  • methylaminopterin
  • Mexate
  • MTX
Biological: filgrastim
Given IV or SC
Other Names:
  • G-CSF
  • Neupogen
Drug: leucovorin calcium
Given IV
Other Names:
  • CF
  • CFR
  • LV
Drug: etoposide
Given IV
Other Names:
  • EPEG
  • VP-16
  • VP-16-213
Drug: mercaptopurine
Given PO
Other Names:
  • 6-mercaptopurine
  • 6-MP
  • Leukerin
  • MP
Drug: vincristine sulfate
Given IV
Other Names:
  • leurocristine sulfate
  • VCR
  • Vincasar PFS
Drug: hydrocortisone sodium succinate
Given IT
Other Names:
  • Sodium hydrocortisone succinate
  • Solu-Cortef
  • Solu-Glyc
Other: laboratory biomarker analysis
Correlative studies
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Experimental: Treatment (Post-induction chemotherapy C)
Patients receive induction therapy (weeks 1-5) comprising vincristine sulfate (VCR) IV; daunorubicin hydrochloride (DNR) IV; cyclophosphamide (CPM) IV; pegaspargase (PEG) or asparaginase (ASP) IM; prednisone (PED) PO or methylprednisolone IV; dexamethasone (DEX) IV or PO; cytarabine (ARAC) IV; methotrexate (MTX), ARAC, and hydrocortisone sodium succinate (HC) IT [triple IT chemotherapy]; and filgrastim IV or SC. Patients then receive post-induction therapy C comprising high-dose (HD) MTX; lestaurtinib PO; triple IT chemotherapy; leucovorin calcium IV; CPM; etoposide IV, VCR; DNR; PEG and ASP; DEX; HD ARAC; mercaptopurine PO; and filgrastim IV or SC for up to 104 weeks.
Drug: asparaginase
Given IV, IM, or PO
Other Names:
  • ASNase
  • Colaspase
  • Crasnitin
  • Elspar
  • L-ASP
Drug: daunorubicin hydrochloride
Given IV
Other Names:
  • Cerubidin
  • Cerubidine
  • daunomycin hydrochloride
  • daunorubicin
  • RP-13057
Drug: lestaurtinib
Given PO
Other Names:
  • CEP 701
  • CEP-701
  • KT-5555
Drug: cyclophosphamide
Given IV
Other Names:
  • CPM
  • CTX
  • Cytoxan
  • Endoxan
  • Endoxana
Drug: pegaspargase
Given IM
Other Names:
  • L-asparaginase with polyethylene glycol
  • Oncaspar
  • PEG-ASP
  • PEG-L-asparaginase
Drug: prednisone
Given PO
Other Names:
  • DeCortin
  • Deltra
Drug: methylprednisolone
Given IV
Other Names:
  • Depo-Medrol
  • Medrol
  • MePRDL
  • Solu-Medrol
  • Wyacort
Drug: dexamethasone
Given IV or PO
Other Names:
  • Aeroseb-Dex
  • Decaderm
  • Decadron
  • DM
  • DXM
Drug: cytarabine
Given IV or IT
Other Names:
  • ARA-C
  • arabinofuranosylcytosine
  • arabinosylcytosine
  • Cytosar-U
  • cytosine arabinoside
Drug: methotrexate
Given IV, IT, or PO
Other Names:
  • amethopterin
  • Folex
  • methylaminopterin
  • Mexate
  • MTX
Biological: filgrastim
Given IV or SC
Other Names:
  • G-CSF
  • Neupogen
Drug: leucovorin calcium
Given IV
Other Names:
  • CF
  • CFR
  • LV
Drug: etoposide
Given IV
Other Names:
  • EPEG
  • VP-16
  • VP-16-213
Drug: mercaptopurine
Given PO
Other Names:
  • 6-mercaptopurine
  • 6-MP
  • Leukerin
  • MP
Drug: vincristine sulfate
Given IV
Other Names:
  • leurocristine sulfate
  • VCR
  • Vincasar PFS
Drug: hydrocortisone sodium succinate
Given IT
Other Names:
  • Sodium hydrocortisone succinate
  • Solu-Cortef
  • Solu-Glyc
Other: laboratory biomarker analysis
Correlative studies
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies

  Hide Detailed Description

Detailed Description:

PRIMARY OBJECTIVES:

I. To compare the 3-year event-free survival (EFS) of infants with MLL-R ALL randomized to treatment with a modified P9407 and the Interfant-99 chemotherapy backbone with or without the FLT3 inhibitor lestaurtinib.

SECONDARY OBJECTIVES:

I. To determine a safe, tolerable and biologically active dose of lestaurtinib given in sequential combination with chemotherapy in MLL-R infants.

II. To characterize the pharmacokinetics and pharmacodynamics of lestaurtinib in infants when given at the proposed dose in sequential combination with chemotherapy.

III. To identify molecular mechanisms of resistance to lestaurtinib in leukemic blasts.

IV. To describe levels of minimal residual disease in infants with ALL within the context of the proposed therapy, and correlate with outcome.

V. To identify gene expression patterns in diagnostic infant leukemia samples that correlate with outcome within the context of the proposed therapy.

VI. To describe the outcome of infants with MLL-G ALL treated with a modified P9407 chemotherapy backbone that includes an extended Continuation phase.

OUTLINE: Patients are stratified according to risk group (standard risk [MLL-G: germline or non-rearranged] vs intermediate risk [MLL-R: rearranged, age ≥ 90 days at diagnosis] vs high risk [MLL-R, age < 90 days at diagnosis]).

All patients receive induction therapy (weeks 1-5) comprising vincristine intravenously (IV) on days 8,15, 22, and 29; daunorubicin hydrochloride IV over 30 minutes on days 8 and 9; cyclophosphamide IV over 30 minutes every 12 hours on days 3 and 4 (closed as of 05/19/09); pegaspargase or asparaginase intramuscularly (IM) on days 15, 18, 22, and 25; prednisone orally (PO) or methylprednisolone IV three times daily on days 1-7; dexamethasone IV or PO on days 8-28; cytarabine IV over 39 minutes on days 8-21; triple intrathecal (IT) chemotherapy comprising methotrexate, cytarabine, and hydrocortisone on days 1, 15, and 29; and filgrastim IV or subcutaneously (SC) beginning on day 5 and continuing until blood counts recover. Standard-risk patients are nonrandomly assigned to receive a less intensive chemotherapy regimen without lestaurtinib (post-induction therapy A).

POST-INDUCTION THERAPY A: (for standard-risk patients [MLL-G])

INDUCTION INTENSIFICATION: (weeks 6-9) Patients receive high-dose methotrexate IV continuously over 24 hours on days 1 and 8; triple IT chemotherapy on days 1 and 8; leucovorin calcium IV every 6 hours beginning 42 hours after start of high-dose methotrexate and continuing until methotrexate level is < 0.1 μM; cyclophosphamide IV over 30 minutes on days 15-19; etoposide IV over 2 hours on days 15-19; and filgrastim IV or SC beginning on day 20 and continuing until blood counts recover. Patients in morphologic remission proceed to re-induction therapy.

RE-INDUCTION: (weeks 10-12) Patients receive vincristine IV on days 1, 8, and 15; daunorubicin hydrochloride IV over 30 minutes on days 1 and 2; cyclophosphamide IV over 30 minutes every 12 hours on days 3 and 4; pegaspargase or asparaginase IM on day 4; dexamethasone IV or PO twice daily on days 1-7 and 15-21; triple IT chemotherapy on days 1 and 15; and filgrastim IV or SC beginning on day 5 and continuing until blood counts recover.

CONSOLIDATION: (weeks 13-19) Patients receive high-dose methotrexate IV continuously over 24 hours on days 1 and 8; leucovorin calcium IV every 6 hours beginning 42 hours after start of high-dose methotrexate and continuing until methotrexate level is < 0.1 μM; triple IT chemotherapy on day 1; etoposide IV over 2 hours on days 15-19; cyclophosphamide IV over 30 minutes on days 15-19; high-dose cytarabine IV over 3 hours every 12 hours on days 29 and 30; pegaspargase or asparaginase IM on day 30; and filgrastim IV or SC beginning on day 20 and day 31 and continuing until blood counts recover.

CONTINUATION I: (weeks 20-41) Patients receive vincristine IV on day 1 in weeks 20 and 24; dexamethasone IV or PO twice daily on days 1-5 in weeks 20, and 24; triple IT chemotherapy on day 1 in weeks 20 and 24; methotrexate IV on day 1 in weeks 21-24 and 25-27; etoposide IV over 2 hours on day 1-5 in week 28; cyclophosphamide IV over 30 minutes on days 1-5 in week 28; mercaptopurine PO on days 1-7 in weeks 21-23 and 25-27; and filgrastim SC or IV beginning on day 6 in week 28 and continuing until blood counts recover.

CONTINUATION II: (weeks 42-104) Patients receive vincristine IV on days 1, 29, and 57; dexamethasone IV or PO twice daily on days 1-5, 29-33, and 57-61; intrathecal methotrexate (IT MTX) on day 1; methotrexate PO on days 8, 15, 22, 36, 43, 50, 64, 71, and 78; and mercaptopurine PO on days 8-28, 36-56, and 64-84. Treatment repeats every 12 weeks for 2 years from diagnosis.

A safety/activity phase is conducted separately for the intermediate-risk (IR) and high-risk (HR) patients to identify a safe, tolerable, and biologically active dose of lestaurtinib combined with P9407-based chemotherapy backbone. Once a tolerable/active dose of lestaurtinib has been identified for IR patients, subsequent IR patients are eligible to proceed to an efficacy phase, where they are randomized to P9407-based chemotherapy backbone with or without lestaurtinib. HR patients separately proceed to the randomized efficacy phase if a tolerable/active dose is identified for the HR stratum. IR and HR patients are randomized to 1 of 2 post-induction therapy regimens (post-induction therapy B or C).

POST-INDUCTION THERAPY B: (chemotherapy only for IR/HR patients classified as MLL-R; age ≥ 90 days at diagnosis):

INDUCTION INTENSIFICATION (weeks 6-9) Patients receive high-dose methotrexate, leucovorin calcium, cyclophosphamide, etoposide, and filgrastim as in post-induction therapy A induction intensification. Patients in morphologic remission proceed to re-induction.

RE-INDUCTION: (weeks 10-12) Patients receive vincristine, daunorubicin hydrochloride, cyclophosphamide, pegaspargase or asparaginase, dexamethasone, triple IT chemotherapy, and filgrastim as in post-induction therapy A re-induction.

CONSOLIDATION: (weeks 13-19) Patients receive high-dose methotrexate, leucovorin calcium, triple IT chemotherapy, etoposide, cyclophosphamide, high-dose cytarabine, pegaspargase or asparaginase, and filgrastim as in post-induction therapy A consolidation.

CONTINUATION I: (weeks 20-49) Patients receive vincristine on day 1 in weeks 20, 24, 33, 37, and 46; dexamethasone PO or IV twice daily on days 1-5 in weeks 20, 24, 33, 37, and 46; triple IT chemotherapy on day 1 in weeks 20, 24, 33, 37, and 46; methotrexate IV on day 1 in weeks 21-23, 25-26 and 37-45; mercaptopurine PO on days 1-7 in weeks 21-23, 25-26 and 37-45; etoposide IV over 2 hours on days 1-5 in week 27; cyclophosphamide IV over 2 hours on days 1-5 in week 27: high-dose cytarabine IV over 3 hours every 12 hours on days 1 and 2 in week 30; pegaspargase or asparaginase IM on day 2 in week 30: and filgrastim SC or IV beginning on day 3 in weeks 30 and continuing until blood counts recover.

CONTINUATION II: (weeks 50-104) Patients receive vincristine, dexamethasone, IT methotrexate, methotrexate PO, and mercaptopurine PO as in post-induction therapy A continuation II. Treatment repeats every 12 weeks for 2 years from diagnosis.

POST-INDUCTION THERAPY C: (chemotherapy and lestaurtinib for IR/HR patients classified as MLL-R; age < 90 days at diagnosis)

INDUCTION INTENSIFICATION THERAPY: (weeks 6-9) Patients receive high-dose methotrexate, leucovorin calcium, cyclophosphamide, etoposide, and filgrastim as in post-induction therapy B induction intensification. Patients also receive lestaurtinib PO twice daily on days 20-27. Patients in morphologic remission proceed to re-induction.

RE-INDUCTION: (weeks 10-12) Patients receive vincristine, daunorubicin hydrochloride, cyclophosphamide, pegaspargase or asparaginase, dexamethasone, triple IT chemotherapy, and filgrastim as in post-induction therapy B re-induction. Patients also receive lestaurtinib PO on days 5-20.

CONSOLIDATION: (weeks 13-19) Patients receive high-dose methotrexate, leucovorin calcium, triple IT chemotherapy, etoposide, cyclophosphamide, high-dose cytarabine, pegaspargase or asparaginase, and filgrastim as in post-induction therapy B consolidation. Patients also receive lestaurtinib PO on days 20-27 and 31-42.

CONTINUATION I: (weeks 20-49) Patients receive vincristine, dexamethasone, triple IT chemotherapy, methotrexate, mercaptopurine, etoposide, high-dose cytarabine, pegaspargase or asparaginase, and filgrastim as in post-induction therapy B continuation I. Patients also receive lestaurtinib PO on days 2-6 in weeks 20 and 24; days 27-41 in weeks 27-29; days 45-56 in weeks 30-32.

CONTINUATION II: (weeks 50-104) Patients receive vincristine, dexamethasone, IT methotrexate, methotrexate PO, and mercaptopurine PO as in post-induction therapy B continuation II. Patients also receive lestaurtinib on days 2-6, 30-34, and 58-62.

Treatment repeats every 12 weeks for 2 years from diagnosis. Blood samples are collected periodically for pharmacokinetic studies and plasma inhibitory activity assay.

After completion of study treatment, all patients are followed up every 1-6 months for 4 years and then annually thereafter.

  Eligibility

Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must be enrolled on a COG ALL Classification Study (AALL08B1) prior to enrollment on AALL0631
  • Patients must be newly diagnosed with acute lymphoblastic leukemia (ALL) or acute undifferentiated leukemia (AUL); patients with T-cell ALL are eligible; patients with bilineage or biphenotypic acute leukemia are eligible, provided the morphology and immunophenotype are predominately lymphoid
  • Patients with mature B-cell ALL or acute myelogenous leukemia (AML) are NOT eligible
  • Patients with Down syndrome are NOT eligible
  • Patients receiving prior steroid therapy are eligible for study; any amount of steroid pretreatment will not affect initial Induction assignment as long as the patient meets all other eligibility criteria; IT chemotherapy per protocol is allowed for patient convenience at the time of the diagnostic bone marrow or venous line placement to avoid 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 IT therapy
  • All patients and/or their parents or legal guardians must sign a written informed consent
  • All institutional, FDA, and NCI requirements for human studies must be met
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00557193

  Show 159 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Joanne Hilden, MD Children's Oncology Group
  More Information

No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00557193     History of Changes
Other Study ID Numbers: AALL0631, NCI-2009-00313, COG-AALL0631, CDR0000573996, U10CA098543
Study First Received: November 9, 2007
Last Updated: February 5, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, Myeloid
6-Mercaptopurine
Cytarabine
Methotrexate
Cyclophosphamide
Etoposide phosphate
Pegaspargase
Asparaginase
Daunorubicin
Dexamethasone
Etoposide
Methylprednisolone Hemisuccinate
Prednisolone
Prednisone
Vincristine
BB 1101
Lenograstim
Dexamethasone acetate
Cortisol succinate
Hydrocortisone acetate

ClinicalTrials.gov processed this record on April 22, 2014