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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02883049
Registration number
NCT02883049
Ethics application status
Date submitted
22/08/2016
Date registered
30/08/2016
Date last updated
24/05/2024
Titles & IDs
Public title
Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations
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Scientific title
A Phase III Randomized Trial for Newly Diagnosed High Risk B-Lymphoblastic Leukemia (B-ALL) Including a Stratum Evaluating Dasatinib (NSC#732517) in Patients With Ph-like Tyrosine Kinase Inhibitor (TKI) Sensitive Mutations
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Secondary ID [1]
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NCI-2011-03797
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Secondary ID [2]
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NCI-2011-03797
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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:
B Acute Lymphoblastic Leukemia
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B Acute Lymphoblastic Leukemia, BCR-ABL1-Like
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Central Nervous System Leukemia
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Testicular Leukemia
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Condition category
Condition code
Cancer
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0
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0
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Leukaemia - Acute leukaemia
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Cancer
0
0
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0
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Leukaemia - Chronic leukaemia
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Cancer
0
0
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0
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Children's - Leukaemia & Lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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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 - Clofarabine
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Cytarabine
Treatment: Drugs - Dasatinib
Treatment: Drugs - Daunorubicin Hydrochloride
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Doxorubicin Hydrochloride
Treatment: Drugs - Etoposide
Treatment: Drugs - Hydrocortisone Sodium Succinate
Other interventions - Laboratory Biomarker Analysis
Treatment: Drugs - Leucovorin Calcium
Treatment: Drugs - Mercaptopurine
Treatment: Drugs - Methotrexate
Treatment: Drugs - Pegaspargase
Treatment: Drugs - Prednisone
Treatment: Other - Radiation Therapy
Treatment: Drugs - Thioguanine
Treatment: Drugs - Vincristine Sulfate
Experimental: DS HR B-ALL (RER) - Patients receive induction, consolidation, interim maintenance, delayed intensification, interim maintenance and maintenance therapies.
See outline for details.
Experimental: DS HR B-ALL (SER) - Patients receive induction, consolidation, interim maintenance, delayed intensification, interim maintenance and maintenance therapies.
See outline for details.
Experimental: Group I Arm A (HR B-ALL) - Patients receive induction, consolidation, interim maintenance, delayed intensification and maintenance therapies.
See outline for details.
Experimental: Group I Arm B (HR B-ALL) (CLOSED 03/19/2018) - Patients receive induction, consolidation, interim maintenance, delayed intensification and maintenance therapies.
See outline for details.
Active Comparator: Group II Arm A (VHR B-ALL - Control Arm) - Patients receive induction, consolidation, interim maintenance, delayed intensification and maintenance therapies.
See outline for details.
Experimental: Group II Arm B (VHR B-ALL - Exp Arm1) (CLOSED 02/15/2017) - Patients receive consolidation, interim maintenance, delayed intensification and maintenance therapies.
See outline for details.
Experimental: Group II Arm C (VHR B-ALL - Exp Arm 2) (CLOSED 09/12/2014) - Patients receive induction, consolidation, interim maintenance, delayed intensification and maintenance therapies.
See outline for details.
Experimental: Group III PH-like predicted TKI-sensitive kinase mutation - Patients receive induction, consolidation, interim maintenance, delayed intensification, interim maintenance and maintenance therapies.
See outline for details.
Treatment: Drugs: Clofarabine
Given IV
Treatment: Drugs: Cyclophosphamide
Given IV
Treatment: Drugs: Cytarabine
Given IT, IV, or SC
Treatment: Drugs: Dasatinib
Given PO
Treatment: Drugs: Daunorubicin Hydrochloride
Given IV
Treatment: Drugs: Dexamethasone
PO or IV
Treatment: Drugs: Doxorubicin Hydrochloride
Given IV
Treatment: Drugs: Etoposide
Given IV
Treatment: Drugs: Hydrocortisone Sodium Succinate
Given IT
Other interventions: Laboratory Biomarker Analysis
Correlative studies
Treatment: Drugs: Leucovorin Calcium
Given PO or IV
Treatment: Drugs: Mercaptopurine
Given PO
Treatment: Drugs: Methotrexate
Given IT and IV
Treatment: Drugs: Pegaspargase
Given IV
Treatment: Drugs: Prednisone
Given PO or IV
Treatment: Other: Radiation Therapy
Undergo radiation therapy
Treatment: Drugs: Thioguanine
Given PO
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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Other interventions
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Intervention code [3]
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Treatment: Other
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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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DFS of Non-DS HR Post-induction Patients Receiving Intrathecal (IT) Methotrexate (MTX) Compared With Patients Receiving Intrathecal Triple Therapy (ITT) on a Modified Berlin-Frankfurt-Munster (MBFM) Interim Maintenance High-dose Methotrexate Backbone
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Assessment method [1]
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DFS time is defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. Compared using 2-sided log rank test, alpha = 5%. (Completed effective March 19, 2018)
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Timepoint [1]
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At 5 years
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Primary outcome [2]
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DFS of Non-DS VHR Post-Induction Patients Who Receive a Modified MBFM-IMHDM Regimen That Contains a Second IM (Control Arm) Compared to Patients Receive the Cyclophosphamide + Etoposide Containing Regimen (Experimental Arm 1)
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Assessment method [2]
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(Completed effective February 15, 2017) DFS time is defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. Compared using a 1-sided log rank test, alpha of 2.5%.
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Timepoint [2]
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At 4 years
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Secondary outcome [1]
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Toxicity and Tolerability of Post-induction Age-adjusted ITT Compared to Age-adjusted IT MTX in Children With HR B-ALL
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Assessment method [1]
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(Completed effective March 19, 2018) Percentage of patients who experienced Grade 3 or higher Toxicity Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, will be estimated for each randomized arm.
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Timepoint [1]
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Up to 10 years
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Secondary outcome [2]
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Toxicity and Tolerability of Experimental Arm 1 and Control Arm in Patients With VHR B-ALL
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Assessment method [2]
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Percentage of patients who experienced Grade 3 or higher Toxicity Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, will be estimated for each randomized arm. (Closed effective February 15, 2017)
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Timepoint [2]
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Up to 10 years
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Secondary outcome [3]
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Induction Mortality in Patients With DS and HR B-ALL Treated With Modified Induction
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Assessment method [3]
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Percentage of deaths in induction will be calculated.
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Timepoint [3]
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At 1 month
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Secondary outcome [4]
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5-year DFS in Patients With Down Syndrome (DS) and HR B-ALL Treated With Modified Induction and Post-Induction Therapy Regimen With MBFM-IMIDM
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Assessment method [4]
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DFS time is defined as time from end of induction to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. 5-year DFS will be estimated using the Kaplan-Meier method.
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Timepoint [4]
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At 5 years
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Secondary outcome [5]
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DFS for Children and Young Adults With Ph-like B-ALL and a Predicted Tyrosine Kinase Inhibitor (TKI)-Sensitive Mutation Treated With Dasatinib Plus MBFM-IMHDM
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Assessment method [5]
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DFS time is defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. 4-year DFS will be estimated using the Kaplan-Meier method.
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Timepoint [5]
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Up to 4 years
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Secondary outcome [6]
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Toxicity and Tolerability of MBFM-interim Maintenance Intermediate Dose Methotrexate (IMIDM) in Children With Down Syndrome
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Assessment method [6]
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Percentage of patients who experienced Grade 3 or higher Toxicity Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, will be estimated.
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Timepoint [6]
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Up to 10 years
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Secondary outcome [7]
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Overall Survival (OS) Rate for HR B-ALL Patients, Overall and by Randomized Arm
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Assessment method [7]
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OS time is defined as time from enrollment to death or date of last contact for patients who are alive. 5-year OS will be estimated for the two randomized arms using the Kaplan-Meier method.
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Timepoint [7]
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At 5 years
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Secondary outcome [8]
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Overall Survival (OS) Rate for VHR B-ALL Patients, Overall and by Randomized Arm.
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Assessment method [8]
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OS of VHR-B-ALL post-Induction patients who receive a modified MBFM-IMHDM regimen that contains a second IM (Control Arm) compared to patients receive the cyclophosphamide + etoposide containing regimen (Experimental Arm 1). OS time is defined as time from enrollment to death or date of last contact for patients who are alive. 4-year OS will be estimated for the two randomized arms using the Kaplan-Meier method.
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Timepoint [8]
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At 4 years
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Secondary outcome [9]
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Incidence of Osteonecrosis (ON) Defined by Magnetic Resonance (MR) Imaging in Children, Adolescents, and Young Adults 10 Years of Age and Greater
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Assessment method [9]
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Incidence of ON among patients who have submitted MRI screening data will be estimated.
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Timepoint [9]
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Up to 10 years
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Secondary outcome [10]
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The Prevalence of Cognitive Deficits Measured by CogState (Domain: Working Memory), in Children (Ages 6 to < 13 Years) With HR- and VHR B-ALL at 1 Year Off Therapy
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Assessment method [10]
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The percentage of patients with abnormal results (Z = -1.5) in working memory measured by CogState will be estimated.
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Timepoint [10]
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Up to 10 years
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Secondary outcome [11]
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The Prevalence of Cognitive Deficits Measured by CogState (Domain: Executive Function), in Children (Ages 6 to < 13 Years) With HR- and VHR B-ALL at 1 Year Off Therapy
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Assessment method [11]
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The percentage of patients with abnormal results (Z = -1.5) in executive function measured by CogState will be estimated.
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Timepoint [11]
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Up to 10 years
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Secondary outcome [12]
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The Prevalence of Cognitive Deficits Measured by CogState (Domain: Visual Learning), in Children (Ages 6 to < 13 Years) With HR- and VHR B-ALL at 1 Year Off Therapy
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Assessment method [12]
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The percentage of patients with abnormal results (Z = -1.5) in visual learning measured by CogState will be estimated.
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Timepoint [12]
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Up to 10 years
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Secondary outcome [13]
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The Prevalence of Cognitive Deficits Measured by CogState (Domain: Processing Speed), in Children (Ages 6 to < 13 Years) With HR- and VHR B-ALL at 1 Year Off Therapy
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Assessment method [13]
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The percentage of patients with abnormal results (Z = -1.5) in processing speed measured by CogState will be estimated.
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Timepoint [13]
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Up to 10 years
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Secondary outcome [14]
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The Prevalence of Cognitive Deficits Measured by CogState (Domain: Visual Attention), in Children (Ages 6 to < 13 Years) With HR- and VHR B-ALL at 1 Year Off Therapy
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Assessment method [14]
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The percentage of patients with abnormal results (Z = -1.5) in visual attention measured by CogState will be estimated.
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Timepoint [14]
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Up to 10 years
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Eligibility
Key inclusion criteria
- Patients must be enrolled on APEC14B1 and consented to Eligibility Screening on the
Part A consent form prior to enrollment on AALL1131
- White Blood Cell Count (WBC) Criteria
- Age 1-9.99 years: WBC >= 50 000/uL
- Age 10-30.99 years: Any WBC
- Age 1-30.99 years: Any WBC with:
- Testicular leukemia
- CNS leukemia (CNS3)
- Steroid pretreatment
- Patients must have newly diagnosed B lymphoblastic leukemia (2008 World Health
Organization [WHO] classification) (also termed B-precursor acute lymphoblastic
leukemia); patients with Down syndrome are also eligible
- Organ function requirements for patients with Ph-like ALL and a predicted
TKI-sensitive mutation: patients identified as Ph-like with a TKI-sensitive kinase
mutation must have assessment of organ function performed within 3 days of study entry
onto the dasatinib arm of AALL1131
- Creatinine clearance or radioisotope glomerular filtration rate (GFR) > 70mL/min/1.73
m^2 or a serum creatinine based on age/gender as follows:
- Age: Maximum Serum Creatinine (mg/dL)
- 1 to < 6 months: 0.4 (male) 0.4 (female)
- 6 months to < 1 year: 0.5 (male) 0.5 (female)
- 1 to < 2 years: 0.6 (male) 0.6 (female)
- 2 < 6 years: 0.8 (male) 0.8 (female)
- 6 to < 10 years: 1.0 (male) 1.0 (female)
- 10 to < 13 years: 1.2 (male) 1.2 (female)
- 13 to < 16 years: 1.5 (male) 1.4 (female)
- > 16 years: 1.7 (male) 1.4 (female)
- Direct bilirubin =< 3 x upper limit of normal (ULN) for age, and
- Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 10 x
upper limit of normal (ULN) for age
- Shortening fraction >= 27% by echocardiogram, or ejection fraction >= 50% by gated
radionuclide study
- Patients must have an electrocardiogram (EKG) fewer than 6 days prior to
enrollment on the dasatinib arm; patients who have had cardiac assessments by
echocardiogram or radionuclide scan at the beginning of induction do not need to
have these repeated prior to study entry; correct QT interval (QTc) < 450 msec on
baseline electrocardiogram as measured by the Friderica or Bazett formula
- No major conduction abnormality (unless a cardiac pacemaker is present)
- No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry > 94% at
sea level if there is clinical indication for determination
- Patients with seizure disorder may be enrolled if on anticonvulsants and well
controlled; however, drugs that induce CYP3A4/5 (carbamazepine, oxcarbazepine,
phenytoin, primidone, phenobarbital) should be avoided
- Eligibility criteria for the Longitudinal, Computerized Assessment of Neurocognitive
Functioning study
- Patients must be aged 6 to 13 years at time of B-ALL diagnosis, enrolled on
AALL1131
- Patients must be English-, French- or Spanish-speaking (languages in which the
assessment is available)
- Patients must have no known history of neurodevelopmental disorder prior to
diagnosis of B-ALL (e.g., Down syndrome, Fragile X, William's Syndrome, mental
retardation)
- Patients must have no significant visual impairment that would prevent computer
use and recognition of the visual test stimuli
- Eligibility criteria for the National Cancer Institute (NCI) standard risk patients
from AALL0932 enrolling on this study at the end of Induction
- Effective March 19, 2018, patients enrolled on AALL0932, without Down syndrome,
meeting the following criteria will NOT be eligible to continue on AALL0932 or the HR
B-ALL stratum of this study at the end of Induction:
- Without favorable cytogenetics (no ETV6-RUNX1 or double trisomies 4+10), with day
8 peripheral blood (PB) minimal residual disease (MRD) >= 1% and day 29 bone
marrow (BM) MRD < 0.01%
- With favorable cytogenetics (ETV6-RUNX1 or double trisomies 4+10), with any day 8
PB MRD and day 29 BM MRD >= 0.01%
- Both NCI standard risk (SR) and HR patients without Down syndrome and with
testicular disease at diagnosis, who do not meet other VHR criteria
- Effective Amendment 6, patients enrolled on AALL0932, without Down syndrome, meeting
the following criteria will NOT be eligible to continue on AALL0932 or the VHR stratum
of AALL1131:
- Intrachromosomal amplification of chromosome 21 (iAMP21)
- Mixed-lineage leukemia (MLL) rearrangement
- Hypodiploidy (n < 44 chromosomes and/or a deoxyribonucleic acid [DNA] index <
0.81)
- Induction failure (M3 BM at day 29)
- Without favorable cytogenetics (no ETV6-RUNX1 or double trisomies 4+10), with day
29 BM MRD >= 0.01%
- Patients enrolled on AALL0932, with Down syndrome, meeting the following criteria will
NOT be eligible to continue on AALL0932 but WILL BE eligible to enroll on the DS HR
B-ALL stratum of this study at the end of Induction:
- Day 29 MRD >= 0.01%
- MLL rearrangement
- Hypodiploidy (n < 45 chromosomes and/or DNA index < 0.81)
- DS HR B-ALL patients initially enrolled on AALL0932 or this study who have Induction
failure (M3 BM day 29) or Philadelphia chromosome (BCR-ABL1) will not be eligible for
post-Induction therapy on either trial (AALL0932 or AALL1131)
- All patients and/or their parents or legal guardians must sign a written informed
consent
- All institutional, Food and Drug Administration (FDA), and NCI requirements for human
studies must be met
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Minimum age
1
Year
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Maximum age
31
Years
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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
- With the exception of steroid pretreatment or the administration of intrathecal
cytarabine, patients must not have received any prior cytotoxic chemotherapy for
either the current diagnosis of B-ALL or any cancer diagnosed prior to the initiation
of protocol therapy on AALL1131; patients cannot have secondary B-ALL that developed
after treatment of a prior malignancy with cytotoxic chemotherapy; patients receiving
prior steroid therapy may be eligible for AALL1131
- Patients with BCR-ABL1 fusion are not eligible for post-induction therapy on this
study but may be eligible to enroll in a successor Children's Oncology Group (COG)
Philadelphia positive (Ph+) ALL trial by day 15 Induction
- DS HR B-ALL patients with Induction failure or BCR-ABL1
- Female patients who are pregnant are ineligible since fetal toxicities and teratogenic
effects have been noted for several of the study drugs
- Lactating females are not eligible unless they have agreed not to breastfeed their
infant
- Female patients of childbearing potential are not eligible unless a negative pregnancy
test result has been obtained
- Sexually active patients of reproductive potential are not eligible unless they have
agreed to use an effective contraceptive method for the duration of their study
participation
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled 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
Active, not recruiting
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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
29/02/2012
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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
22/09/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
5949
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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John Hunter Children's Hospital - Hunter Regional Mail Centre
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Recruitment hospital [2]
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Royal Brisbane and Women's Hospital - Herston
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Recruitment hospital [3]
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Royal Children's Hospital-Brisbane - Herston
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Queensland Children's Hospital - South Brisbane
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Recruitment hospital [5]
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Women's and Children's Hospital-Adelaide - North Adelaide
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Recruitment hospital [6]
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Monash Medical Center-Clayton Campus - Clayton
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Recruitment hospital [7]
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Royal Children's Hospital - Parkville
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Recruitment hospital [8]
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Princess Margaret Hospital for Children - Perth
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Recruitment hospital [9]
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Perth Children's Hospital - Perth
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Recruitment postcode(s) [1]
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2310 - Hunter Regional Mail Centre
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Recruitment postcode(s) [2]
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4029 - Herston
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Recruitment postcode(s) [3]
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4101 - South Brisbane
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Recruitment postcode(s) [4]
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5006 - North Adelaide
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Recruitment postcode(s) [5]
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3168 - Clayton
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Recruitment postcode(s) [6]
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3052 - Parkville
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Recruitment postcode(s) [7]
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6008 - Perth
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Recruitment postcode(s) [8]
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6009 - Perth
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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United States of America
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Alaska
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Arizona
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Arkansas
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California
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Colorado
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Connecticut
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Delaware
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United States of America
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District of Columbia
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United States of America
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Florida
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Georgia
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Hawaii
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Idaho
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Illinois
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Indiana
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Iowa
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Kentucky
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Louisiana
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Maine
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Mississippi
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Missouri
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Nebraska
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Nevada
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New Hampshire
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0
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New Mexico
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New York
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North Carolina
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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South Carolina
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South Dakota
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Tennessee
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Texas
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Utah
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Vermont
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Virginia
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Washington
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West Virginia
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Wisconsin
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Manitoba
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Canada
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Newfoundland and Labrador
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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Canada
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Saskatchewan
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Ireland
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Co Dublin
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New Zealand
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Auckland
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New Zealand
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Christchurch
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Puerto Rico
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San Juan
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Switzerland
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Geneva
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Switzerland
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Lausanne
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Funding & Sponsors
Primary sponsor type
Government body
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Name
National Cancer Institute (NCI)
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Ethics approval
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Summary
Brief summary
This randomized phase III trial studies how well combination chemotherapy works in treating
young patients with newly diagnosed B acute lymphoblastic leukemia that is likely to come
back or spread, and in patients with Philadelphia chromosome (Ph)-like tyrosine kinase
inhibitor (TKI) sensitive mutations. Chemotherapy drugs, 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) and giving
the drugs in different doses and in different combinations may kill more cancer cells.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02883049
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Public notes
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Contacts
Principal investigator
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Michael J Burke
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Children's Oncology Group
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02883049
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