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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/NCT01190930
Registration number
NCT01190930
Ethics application status
Date submitted
27/08/2010
Date registered
30/08/2010
Date last updated
8/02/2024
Titles & IDs
Public title
Risk-Adapted Chemotherapy in Treating Younger Patients With Newly Diagnosed Standard-Risk Acute Lymphoblastic Leukemia or Localized B-Lineage Lymphoblastic Lymphoma
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Scientific title
Treatment of Patients With Newly Diagnosed Standard Risk B-Lymphoblastic Leukemia (B-ALL) or Localized B-Lineage Lymphoblastic Lymphoma (B-LLy)
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Secondary ID [1]
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NCI-2011-02599
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Secondary ID [2]
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0
AALL0932
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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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Adult B Lymphoblastic Lymphoma
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0
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Ann Arbor Stage I B Lymphoblastic Lymphoma
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0
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Ann Arbor Stage II B Lymphoblastic Lymphoma
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0
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Childhood B Acute Lymphoblastic Leukemia
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0
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Childhood B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
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0
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Childhood B Lymphoblastic Lymphoma
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0
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Down Syndrome
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0
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Hypodiploid B Acute Lymphoblastic Leukemia
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0
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Philadelphia Chromosome Positive
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0
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Condition category
Condition code
Cancer
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0
0
0
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
0
0
0
0
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Cancer
0
0
0
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
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0
0
0
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Children's - Leukaemia & Lymphoma
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Human Genetics and Inherited Disorders
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0
0
0
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Down's syndrome
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Human Genetics and Inherited Disorders
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0
0
0
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Cytarabine
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Doxorubicin Hydrochloride
Other interventions - Laboratory Biomarker Analysis
Treatment: Drugs - Leucovorin Calcium
Treatment: Drugs - Mercaptopurine
Treatment: Drugs - Methotrexate
Treatment: Drugs - Pegaspargase
Other interventions - Quality-of-Life Assessment
Other interventions - Questionnaire Administration
Treatment: Drugs - Thioguanine
Treatment: Drugs - Vincristine Sulfate
Experimental: Arm A (risk-adapted chemotherapy) - Patients receive vincristine sulfate IV on days 1, 29, and 57; dexamethasone PO BID on days 1-5, 29-33, and 57-61; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.
Experimental: Arm B (risk-adapted chemotherapy) - Patients receive vincristine sulfate IV on days 1, 29, and 57; dexamethasone PO BID on days 1-5, 29-33, and 57-61; higher-dose methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.
Experimental: Arm B-LLy (4-week cycle maintenance) - See Detailed Description.
Experimental: Arm C (risk-adapted chemotherapy) - Patients receive vincristine sulfate IV on day 1; dexamethasone PO BID on days 1-5; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.
Experimental: Arm D (risk-adapted chemotherapy) - Patients receive vincristine sulfate IV on day 1; dexamethasone PO BID on days 1-5; higher-dose methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.
Experimental: Arm LR-C (risk-adapted chemotherapy) - Patients receive consolidation, interim maintenance I, delayed intensification, interim maintenance II, and maintenance therapy. See detailed description.
Experimental: Arm LR-M (risk-adapted chemotherapy) - Patients receive consolidation and maintenance therapy. See detailed description.
Experimental: Arm SR DS (12-week cycle maintenance) - See Detailed Description
Treatment: Drugs: Cyclophosphamide
Given IV
Treatment: Drugs: Cytarabine
Given IT, IV, or SC
Treatment: Drugs: Dexamethasone
Given orally (PO) or IV
Treatment: Drugs: Doxorubicin Hydrochloride
Given IV
Other interventions: Laboratory Biomarker Analysis
Correlative studies
Treatment: Drugs: Leucovorin Calcium
Given PO
Treatment: Drugs: Mercaptopurine
Given PO
Treatment: Drugs: Methotrexate
Given IT, PO, or IV
Treatment: Drugs: Pegaspargase
Given IV
Other interventions: Quality-of-Life Assessment
Ancillary studies
Other interventions: Questionnaire Administration
Ancillary studies
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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0
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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Disease Free Survival (DFS) in Average Risk (AR) Patients Based on the Methotrexate Dose Randomization
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Assessment method [1]
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DFS is calculated as the time from randomization at the end of interim maintenance II to first event (relapse, second malignancy, remission death) or date of last contact. Five year DFS estimates will be calculated from the point of randomization for both groups. Two-sided 95% confidence intervals will be calculated.
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Timepoint [1]
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5.7 years
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Primary outcome [2]
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0
DFS in Average Risk (AR) Patients Based on the Pulse Frequency Randomization
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Assessment method [2]
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0
DFS is calculated as the time from randomization at the end of interim maintenance II to first event (relapse, second malignancy, remission death) or date of last contact. Five year DFS estimates will be calculated from the point of randomization for both groups. Two-sided 95% confidence intervals will be calculated.
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Timepoint [2]
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0
5.7 years
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Primary outcome [3]
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DFS in Low Risk (LR) Patients Based on Randomization to 1 of 2 Low-intensity Regimens
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Assessment method [3]
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DFS is calculated as the time from randomization at the end of Induction to first event (relapse, second malignancy, remission death) or date of last contact. Five year DFS estimates will be calculated from the point of randomization for both groups. Two-sided 95% confidence intervals will be calculated.
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Timepoint [3]
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5.1 years
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Primary outcome [4]
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DFS for SR Down Syndrome Patients With Standardized Treatment and Enhanced Supportive Care
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Assessment method [4]
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DFS is calculated as the time from end of Induction to first event (relapse, second malignancy, remission death) or date of last contact. The 5-year DFS and 95% confidence interval for these patients will be estimated.
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Timepoint [4]
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5.1 years
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Primary outcome [5]
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Sample Collection of Central Path Review Slides in B-LLy Patients
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Assessment method [5]
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Percent of B-LLy patients who had adequate/usable samples of samples collected will be reported.
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Timepoint [5]
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Up to 1 month
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Primary outcome [6]
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Event Free Survival (EFS) for B-LLy Patients
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Assessment method [6]
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0
EFS is calculated as the Time from study enrollment to first event (induction failure, relapse, second malignancy, remission death) or date of last contact. The 5-year EFS and 95% confidence interval for these patients will be estimated.
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Timepoint [6]
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5 years
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Primary outcome [7]
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Overall Survival (OS) for B-LLy Patients
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Assessment method [7]
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OS is calculated as the time from study enrollment to death or date of last contact. The 5-year OS and 95% confidence interval for these patients will be estimated.
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Timepoint [7]
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5 years
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Secondary outcome [1]
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Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Emotional
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Assessment method [1]
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Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
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Timepoint [1]
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2 Months
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Secondary outcome [2]
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Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: Emotional
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Assessment method [2]
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Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
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Timepoint [2]
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1 year
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Secondary outcome [3]
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0
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: Emotional
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Assessment method [3]
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0
Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
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Timepoint [3]
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1.7 years
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Secondary outcome [4]
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Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Emotional
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Assessment method [4]
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0
Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
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Timepoint [4]
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2.5 years
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Secondary outcome [5]
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0
Burden of Therapy in Boy AR Patients Overall at End of Therapy: Emotional
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Assessment method [5]
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0
Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Genetic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
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Timepoint [5]
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0
3.2 years
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Secondary outcome [6]
0
0
Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Physical
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Assessment method [6]
0
0
Age and gender standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
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Timepoint [6]
0
0
2 Months
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Secondary outcome [7]
0
0
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: Physical
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Assessment method [7]
0
0
Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
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Timepoint [7]
0
0
1 Year
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Secondary outcome [8]
0
0
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: Physical
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Assessment method [8]
0
0
Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
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Timepoint [8]
0
0
1.7 years
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Secondary outcome [9]
0
0
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Physical
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Assessment method [9]
0
0
Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
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Timepoint [9]
0
0
2.4 Years
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Secondary outcome [10]
0
0
Burden of Therapy in Boy AR Patients Overall at End of Therapy: Physical
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Assessment method [10]
0
0
Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
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Timepoint [10]
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0
3.2 years
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Secondary outcome [11]
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0
Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: School
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Assessment method [11]
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0
Age standardized Quality of life, measured by the school subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
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Timepoint [11]
0
0
2 Months
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Secondary outcome [12]
0
0
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: School
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Assessment method [12]
0
0
Age standardized Quality of life, measured by the school subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
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Timepoint [12]
0
0
1 Year
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Secondary outcome [13]
0
0
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: School
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Assessment method [13]
0
0
Age standardized Quality of life, measured by the school subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
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Timepoint [13]
0
0
1.7 Years
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Secondary outcome [14]
0
0
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): School
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Assessment method [14]
0
0
Age standardized Quality of life, measured by the school subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
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Timepoint [14]
0
0
2.4 years
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Secondary outcome [15]
0
0
Burden of Therapy in Boy AR Patients Overall at End of Therapy: School
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Assessment method [15]
0
0
Age standardized Quality of life, measured by the school subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
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Timepoint [15]
0
0
3.2 Years
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Secondary outcome [16]
0
0
Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Social Functioning
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Assessment method [16]
0
0
Age standardized Quality of life, measured by the social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
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Timepoint [16]
0
0
2 Months
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Secondary outcome [17]
0
0
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: Social Functioning
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Assessment method [17]
0
0
Age standardized Quality of life, measured by the social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
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Timepoint [17]
0
0
1 Year
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Secondary outcome [18]
0
0
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: Social Functioning
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Assessment method [18]
0
0
Age standardized Quality of life, measured by the social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
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Timepoint [18]
0
0
1.7 Years
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Secondary outcome [19]
0
0
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Social Functioning
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Assessment method [19]
0
0
Age standardized Quality of life, measured by the social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
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Timepoint [19]
0
0
2.4 Years
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Secondary outcome [20]
0
0
Burden of Therapy in Boy AR Patients Overall at End of Therapy: Social Functioning
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Assessment method [20]
0
0
Age standardized Quality of life, measured by the Social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
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Timepoint [20]
0
0
3.2 Years
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Secondary outcome [21]
0
0
Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: Emotional
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Assessment method [21]
0
0
Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with means and standard deviation reported.
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Timepoint [21]
0
0
1.7 years
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Secondary outcome [22]
0
0
Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Emotional
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Assessment method [22]
0
0
Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported.
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Timepoint [22]
0
0
2.4 Years
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Secondary outcome [23]
0
0
Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: Emotional
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Assessment method [23]
0
0
Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported.
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Timepoint [23]
0
0
3.2 Years
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Secondary outcome [24]
0
0
Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: Physical
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Assessment method [24]
0
0
Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with means and standard deviation reported.
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Timepoint [24]
0
0
1.7 Years
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Secondary outcome [25]
0
0
Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Physical
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Assessment method [25]
0
0
Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported.
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Timepoint [25]
0
0
2.4 Years
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Secondary outcome [26]
0
0
Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: Physical
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Assessment method [26]
0
0
Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported.
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Timepoint [26]
0
0
3.2 Years
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Secondary outcome [27]
0
0
Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: School
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Assessment method [27]
0
0
Age standardized Quality of life, measured by the school subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with means and standard deviation reported.
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Timepoint [27]
0
0
1.7 Years
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Secondary outcome [28]
0
0
Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): School
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Assessment method [28]
0
0
Age standardized Quality of life, measured by the school subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported.
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Timepoint [28]
0
0
2.4 Years
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Secondary outcome [29]
0
0
Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: School
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Assessment method [29]
0
0
Age standardized Quality of life, measured by the school subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported.
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Timepoint [29]
0
0
3.2 Years
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Secondary outcome [30]
0
0
Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: Social Functioning
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Assessment method [30]
0
0
Age standardized Quality of life, measured by the social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with means and standard deviation reported.
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Timepoint [30]
0
0
1.7 Years
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Secondary outcome [31]
0
0
Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Social Functioning
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Assessment method [31]
0
0
Age standardized Quality of life, measured by the social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported.
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Timepoint [31]
0
0
2.4 Years
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Secondary outcome [32]
0
0
Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: Social Functioning
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Assessment method [32]
0
0
Age standardized Quality of life, measured by the social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported.
Query!
Timepoint [32]
0
0
3.2 Years
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Secondary outcome [33]
0
0
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Consolidation Therapy-Right
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Assessment method [33]
0
0
Strength in the right ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for the cohort will be reported.
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Timepoint [33]
0
0
2 Months
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Secondary outcome [34]
0
0
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Consolidation Therapy-Left
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Assessment method [34]
0
0
Strength in the left ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for the cohort will be reported.
Query!
Timepoint [34]
0
0
2 Months
Query!
Secondary outcome [35]
0
0
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Maintenance Cycle 1: Right
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Assessment method [35]
0
0
Strength in the right ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for the cohort will be reported.
Query!
Timepoint [35]
0
0
1 Year
Query!
Secondary outcome [36]
0
0
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Maintenance Cycle 1: Left
Query!
Assessment method [36]
0
0
Strength in the left ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for the cohort will be reported.
Query!
Timepoint [36]
0
0
1 Year
Query!
Secondary outcome [37]
0
0
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Right
Query!
Assessment method [37]
0
0
Strength in the right ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for the cohort will be reported.
Query!
Timepoint [37]
0
0
2.4 Years
Query!
Secondary outcome [38]
0
0
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Left
Query!
Assessment method [38]
0
0
Strength in the left ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for the cohort will be reported.
Query!
Timepoint [38]
0
0
2.4 Years
Query!
Secondary outcome [39]
0
0
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL 12 Months Post Therapy: Right
Query!
Assessment method [39]
0
0
Strength in the right ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for the cohort will be reported.
Query!
Timepoint [39]
0
0
4.2 Years
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Secondary outcome [40]
0
0
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL 12 Months Post Therapy: Left
Query!
Assessment method [40]
0
0
Strength in the left ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for the cohort will be reported.
Query!
Timepoint [40]
0
0
4.2 Years
Query!
Secondary outcome [41]
0
0
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Right
Query!
Assessment method [41]
0
0
Strength in the right ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for each randomization group will be reported.
Query!
Timepoint [41]
0
0
2.4 Years
Query!
Secondary outcome [42]
0
0
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Left
Query!
Assessment method [42]
0
0
Strength in the left ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for each randomization group will be reported.
Query!
Timepoint [42]
0
0
2.4 Years
Query!
Eligibility
Key inclusion criteria
- B-ALL patients must be enrolled on AALL08B1 or APEC14B1 (if open for the
classification of newly diagnosed ALL patients) prior to treatment and enrollment on
AALL0932
- Note: B-LLy patients are not eligible for AALL08B1, and can enroll directly onto
AALL0932
- B-ALL patients must have an initial white blood cell count < 50,000/uL
- Patients must have newly diagnosed National Cancer Institute (NCI) Standard Risk B-ALL
or B-LLy Murphy stages I or II; patients with Down syndrome are also eligible
- Note: for B-LLy patients with tissue available for flow cytometry, the criterion
for diagnosis should be analogous to B-ALL; for tissue processed by other means
(i.e. paraffin blocks), the methodology and criteria for immunophenotypic
analysis to establish the diagnosis of B-LLy defined by the submitting
institution will be accepted
- 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
30
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 (defined below) or the administration of
intrathecal cytarabine, patients must not have received any prior cytotoxic
chemotherapy for either the current diagnosis of B-ALL or B-LLy or for any cancer
diagnosed prior to initiation of protocol therapy on AALL0932
- Patients receiving prior steroid therapy may be eligible for AALL0932
- Patients with central nervous system 3 (CNS3) leukemia
- CNS status must be known prior to enrollment; (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); B-LLy patients with
CNS3 disease are not eligible for this protocol or the COG HR ALL protocol; it is
recommended that intrathecal cytarabine be administered at the time of the
diagnostic lumbar puncture; this is usually done at the time of the diagnostic
bone marrow or venous line placement to avoid a second lumbar puncture; this is
allowed prior to registration; systemic chemotherapy must begin within 72 hours
of the first dose of intrathecal therapy
- B-ALL patients with testicular leukemia are not eligible for AALL0932
- For B-LLy patients the following additional exclusion criteria apply:
- T-lymphoblastic lymphoma
- Morphologically unclassifiable lymphoma
- Absence of both B-cell and T-cell phenotype markers in a case submitted as
lymphoblastic lymphoma
- CNS3-positive disease or testicular involvement
- M2 (5% - 25% blasts) or M3 (> 25% blasts) marrow
- Female patients who are pregnant are ineligible
- Lactating females are not eligible unless they have agreed not to breastfeed
their infants
- 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
9/08/2010
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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
31/03/2028
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Actual
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Sample size
Target
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Accrual to date
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Final
9350
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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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0
John Hunter Children's Hospital - Hunter Regional Mail Centre
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Recruitment hospital [2]
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Sydney Children's Hospital - Randwick
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Royal Brisbane and Women's Hospital - Herston
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Royal Children's Hospital-Brisbane - Herston
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Queensland Children's Hospital - South Brisbane
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Women's and Children's Hospital-Adelaide - North Adelaide
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Monash Medical Center-Clayton Campus - Clayton
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Royal Children's Hospital - Parkville
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Recruitment hospital [9]
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Princess Margaret Hospital for Children - 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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2031 - Randwick
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Recruitment postcode(s) [3]
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4029 - Herston
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4101 - South Brisbane
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5006 - North Adelaide
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Recruitment postcode(s) [6]
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3168 - Clayton
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Recruitment postcode(s) [7]
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3052 - Parkville
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Recruitment postcode(s) [8]
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6008 - Perth
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Recruitment outside Australia
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0
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State/province [1]
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Alabama
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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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Florida
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Louisiana
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Maine
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Wisconsin
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Canada
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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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Co Dublin
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Auckland
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Christchurch
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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
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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Government body
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Name [1]
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National Cancer Institute (NCI)
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Address [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
This partially randomized phase III trial studies the side effects of different combinations
of risk-adapted chemotherapy regimens and how well they work in treating younger patients
with newly diagnosed standard-risk acute lymphoblastic leukemia or B-lineage lymphoblastic
lymphoma that is found only in the tissue or organ where it began (localized). 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), giving the drugs in different doses, and giving the
drugs in different combinations may kill more cancer cells.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01190930
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Anne L Angiolillo
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Address
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Children's Oncology Group
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Contact person for public queries
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01190930
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