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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00557193
Registration number
NCT00557193
Ethics application status
Date submitted
9/11/2007
Date registered
12/11/2007
Titles & IDs
Public title
Combination Chemotherapy With or Without Lestaurtinib in Treating Younger Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
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Scientific 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; NSC#617807)
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Secondary ID [1]
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0
NCI-2009-00313
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Secondary ID [2]
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AALL0631
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute Lymphoblastic Leukemia
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0
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Acute Undifferentiated Leukemia
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0
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Childhood T Acute Lymphoblastic Leukemia
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0
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Condition category
Condition code
Cancer
0
0
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0
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Leukaemia - Acute leukaemia
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Cancer
0
0
0
0
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Leukaemia - Chronic leukaemia
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Cancer
0
0
0
0
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Children's - Leukaemia & Lymphoma
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Cancer
0
0
0
0
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
0
0
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0
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Asparaginase
Treatment: Surgery - Biospecimen Collection
Treatment: Surgery - Bone Marrow Biopsy
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Cytarabine
Treatment: Drugs - Daunorubicin Hydrochloride
Treatment: Drugs - Dexamethasone
Treatment: Surgery - Echocardiography
Treatment: Drugs - Etoposide
Treatment: Other - Filgrastim
Other interventions - Laboratory Biomarker Analysis
Treatment: Drugs - Lestaurtinib
Treatment: Drugs - Leucovorin Calcium
Treatment: Drugs - Mercaptopurine
Treatment: Drugs - Methotrexate
Treatment: Drugs - Methylprednisolone
Treatment: Surgery - Multigated Acquisition Scan
Treatment: Drugs - Pegaspargase
Other interventions - Pharmacological Study
Treatment: Drugs - Prednisone
Treatment: Drugs - Therapeutic Hydrocortisone
Treatment: Drugs - Vincristine Sulfate
Experimental: Arm A (standard risk MLL-G) - Population Description: Eligible patients with MLL-G (germline, or non-rearranged)
Active comparator: Arm B (IR/HR MLL-R chemotherapy) - Population Description: Eligible patients with MLL-R (rearranged). Considered Intermediate Risk (IR) if age \>= 90 days at diagnosis and High Risk (HR) if age \< 90 days at diagnosis.
Experimental: Arm C (IR/HR MLL-R chemotherapy and lestaurtinib) - Population Description: Eligible patients with MLL-R (rearranged). Considered Intermediate Risk (IR) if age \>= 90 days at diagnosis and High Risk (HR) if age \< 90 days at diagnosis.
Treatment: Drugs: Asparaginase
Given IV, IM, or PO
Treatment: Surgery: Biospecimen Collection
Undergo blood sample collection
Treatment: Surgery: Bone Marrow Biopsy
Undergo bone marrow biopsy
Treatment: Drugs: Cyclophosphamide
Given IV
Treatment: Drugs: Cytarabine
Given IV or IT
Treatment: Drugs: Daunorubicin Hydrochloride
Given IV
Treatment: Drugs: Dexamethasone
Given IV or PO
Treatment: Surgery: Echocardiography
Undergo ECHO
Treatment: Drugs: Etoposide
Given IV
Treatment: Other: Filgrastim
Given IV or SC
Other interventions: Laboratory Biomarker Analysis
Correlative studies
Treatment: Drugs: Lestaurtinib
Given PO
Treatment: Drugs: Leucovorin Calcium
Given IV
Treatment: Drugs: Mercaptopurine
Given PO
Treatment: Drugs: Methotrexate
Given IV, IT, or PO
Treatment: Drugs: Methylprednisolone
Given IV
Treatment: Surgery: Multigated Acquisition Scan
Undergo MUGA
Treatment: Drugs: Pegaspargase
Given IM
Other interventions: Pharmacological Study
Correlative studies
Treatment: Drugs: Prednisone
Given PO
Treatment: Drugs: Therapeutic Hydrocortisone
Given IT
Treatment: Drugs: Vincristine Sulfate
Given IV
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Treatment: Surgery
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Intervention code [3]
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Treatment: Other
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Intervention code [4]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percent Probability for Event-free Survival (EFS) for Patients on Arm C at Dose Level 2 (DL2)
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Assessment method [1]
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EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. EFS is constructed using the Kaplan-Meier life table method with confidence interval based on standard errors computed using the method of Peto and Peto.
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Timepoint [1]
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From start of post-induction therapy for up to 10 years
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Secondary outcome [1]
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Percent Probability for Event-free Survival (EFS) of MLL-R Infants Treated With Combination Chemotherapy With or Without Lestaurtinib at DL2
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Assessment method [1]
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Event Free Probability where EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. EFS is constructed using the Kaplan-Meier life table method with confidence interval based on standard errors computed using the method of Peto and Peto. EFS will be compared between patients on treatment Arm C at DL2 to those on Arm B.
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Timepoint [1]
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From start of post-induction therapy for up to 10 years.
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Secondary outcome [2]
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Number of Patients Who Experienced Lestaurtinib-related Dose Limiting Toxicity (DLT)
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Assessment method [2]
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Lestaurtinib-related dose-limiting toxicity proportions, as measured by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, will by summarized by dose level for Safety phase patients.
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Timepoint [2]
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Up to 12 weeks from start of induction
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Secondary outcome [3]
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Pharmacokinetic AGP Levels in Infants Given Lestaurtinib at DL2 in Combination With Chemotherapy
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Assessment method [3]
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Pharmacokinetic AGP levels in infants given lestaurtinib at DL2 in combination with chemotherapy will be described with mean and standard deviation for those with available data.
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Timepoint [3]
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Up to 12 weeks
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Secondary outcome [4]
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Pharmacokinetic Albumin in Infants Given Lestaurtinib at DL2 in Combination With Chemotherapy
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Assessment method [4]
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Pharmacokinetic albumin in infants given lestaurtinib at DL2 in combination with chemotherapy will be described with mean and standard deviation for those with available data.
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Timepoint [4]
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Up to 12 weeks
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Secondary outcome [5]
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Pharmacodynamics PIA Levels in Infants Given Lestaurtinib at DL2 in Combination With Chemotherapy
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Assessment method [5]
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Summarized with mean and standard deviation for those with available data in Arm C
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Timepoint [5]
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Sampled between weeks 6-12 from start of induction
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Secondary outcome [6]
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Describe FLT3 Protein Expression as a Molecular Mechanism of Primary Resistance to Lestaurtinib in Leukemic Blasts
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Assessment method [6]
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Described via mean and standard deviation by group.
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Timepoint [6]
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Sampled at the start of induction
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Secondary outcome [7]
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Describe FLT3 Protein Expression as a Molecular Mechanism of Acquired Resistance to Lestaurtinib in Leukemic Blasts
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Assessment method [7]
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Described via means and standard deviations in available Arm C relapse samples
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Timepoint [7]
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At relapse (up to 3 years)
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Secondary outcome [8]
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Describe in Vitro Sensitivity as a Molecular Mechanism of Primary Resistance to Lestaurtinib in Leukemic Blasts
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Assessment method [8]
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Described via means and standard deviations in samples which have primary resistance to lestaurtinib
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Timepoint [8]
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Sampled at the start of induction
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Secondary outcome [9]
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Describe in Vitro Sensitivity as a Molecular Mechanism of Acquired Resistance to Lestaurtinib in Leukemic Blasts
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Assessment method [9]
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Described via means and standard deviations in samples which have acquired resistance to lestaurtinib
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Timepoint [9]
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At relapse (up to 3 years)
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Secondary outcome [10]
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Percent Probability of Event Free Survival (EFS) by MRD Status and Treatment Arm
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Assessment method [10]
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Three-year EFS estimates and 90% CI will be reported by treatment arm and end-induction MRD status.
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Timepoint [10]
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3 Years from end of Induction)
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Secondary outcome [11]
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Identification of Gene Expression Patterns in Diagnostic Infant Leukemia Samples That Correlate With Survival Outcomes
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Assessment method [11]
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EFS outcomes will be reported by genotype.
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Timepoint [11]
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At 3 years
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Secondary outcome [12]
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Identification of Gene Expression Patterns in Diagnostic Infant Leukemia Samples That Correlate With PIA Values
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Assessment method [12]
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Means and standard deviations of Plasma Inhibitory Activity (PIA) will be given by genotype
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Timepoint [12]
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At 3 years
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Secondary outcome [13]
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Percent Probability for Event-free Survival (EFS) for Patients on Arm A
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Assessment method [13]
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EFS time is defined as time from treatment assignment to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. EFS is constructed using the Kaplan-Meier life table method with confidence interval based on standard errors computed using the method of Peto and Peto.
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Timepoint [13]
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From start of post-induction therapy for up to 10 years
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Eligibility
Key inclusion criteria
* Patients must be enrolled on a Children's Oncology Group (COG) ALL Classification Study (AALL08B1) prior to enrollment on AALL0631
* Patients must be < 366 days of age at the time of diagnosis; for neonates in the first month of life, patients must be > 36 weeks gestational age at the time of diagnosis
* 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 must be previously untreated with the exception of steroids and intrathecal chemotherapy; no other systemic chemotherapy may have been administered; 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 central nervous system [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, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
* Patients with mature B-cell ALL or acute myelogenous leukemia (AML) are NOT eligible
* Patients with Down syndrome are NOT eligible
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Minimum age
No limit
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Maximum age
1
Year
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/01/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/06/2024
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Sample size
Target
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Accrual to date
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Final
218
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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Princess Margaret Hospital for Children - Perth
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Recruitment postcode(s) [1]
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6008 - Perth
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Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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Connecticut
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Delaware
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District of Columbia
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New Zealand
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Auckland
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Funding & Sponsors
Primary sponsor type
Other
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Name
Children's Oncology Group
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Address
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Other collaborator category [1]
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Name [1]
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National Cancer Institute (NCI)
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Ethics approval
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Summary
Brief summary
This phase III trial studies combination chemotherapy with or without lestaurtinib with to see how well they work in treating younger patients 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, by stopping them from dividing, or by stopping them from spreading. Lestaurtinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether combination chemotherapy is more effective with or without lestaurtinib in treating acute lymphoblastic leukemia.
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Trial website
https://clinicaltrials.gov/study/NCT00557193
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Trial related presentations / publications
Loftus JP, Yahiaoui A, Brown PA, Niswander LM, Bagashev A, Wang M, Schauf A, Tannheimer S, Tasian SK. Combinatorial efficacy of entospletinib and chemotherapy in patient-derived xenograft models of infant acute lymphoblastic leukemia. Haematologica. 2021 Apr 1;106(4):1067-1078. doi: 10.3324/haematol.2019.241729.
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Public notes
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Contacts
Principal investigator
Name
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Joanne M Hilden
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Address
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Children's Oncology Group
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/93/NCT00557193/Prot_SAP_000.pdf
Statistical analysis plan
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/93/NCT00557193/Prot_SAP_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00557193