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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00381680
Registration number
NCT00381680
Ethics application status
Date submitted
26/09/2006
Date registered
28/09/2006
Titles & IDs
Public title
Low-Dose or High-Dose Vincristine and Combination Chemotherapy in Treating Young Patients With Relapsed B-Cell Acute Lymphoblastic Leukemia
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Scientific title
Intensive Treatment for Intermediate-Risk Relapse of Childhood B-precursor Acute Lymphoblastic Leukemia (ALL): A Randomized Trial of Vincristine Strategies
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Secondary ID [1]
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NCI-2009-00306
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Secondary ID [2]
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AALL0433
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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-cell Childhood Acute Lymphoblastic Leukemia
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L1 Childhood Acute Lymphoblastic Leukemia
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L2 Childhood Acute Lymphoblastic Leukemia
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Intermediate Risk Recurrent Childhood Acute Lymphoblastic Leukemia
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Condition category
Condition code
Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Cancer
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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 - vincristine sulfate
Treatment: Drugs - prednisone
Treatment: Drugs - doxorubicin hydrochloride
Treatment: Drugs - pegaspargase
Treatment: Drugs - cytarabine
Treatment: Drugs - methotrexate
Treatment: Drugs - dexamethasone
Treatment: Drugs - etoposide
Treatment: Drugs - cyclophosphamide
Treatment: Drugs - leucovorin calcium
Treatment: Other - filgrastim
Treatment: Drugs - asparaginase
Treatment: Drugs - mercaptopurine
Active comparator: Regimen A: Standard vincristine dosing - See detailed description.
Experimental: Arm B: Randomized High Dose Vincristine regimen - See detailed description. Closed to accrual as of 09/2010).
Treatment: Drugs: vincristine sulfate
Given IV
Treatment: Drugs: prednisone
Given PO
Treatment: Drugs: doxorubicin hydrochloride
Given IV
Treatment: Drugs: pegaspargase
Given IM
Treatment: Drugs: cytarabine
Given IT or IV
Treatment: Drugs: methotrexate
Given IT or IV
Treatment: Drugs: dexamethasone
Given PO
Treatment: Drugs: etoposide
Given IV
Treatment: Drugs: cyclophosphamide
Given IV
Treatment: Drugs: leucovorin calcium
Given IV or PO
Treatment: Other: filgrastim
Given IV or SC
Treatment: Drugs: asparaginase
Given IM
Treatment: Drugs: mercaptopurine
Given PO
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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: 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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Event Free Survival. EFS
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Assessment method [1]
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Percentage of patients who were event free at 3 years among those on Standard VCR dosing who did not undergo Hematopoietic Stem Cell Transplant (SCT).
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Timepoint [1]
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3 years after enrollment
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Secondary outcome [1]
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Frequency and Severity of Adverse Effects
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Assessment method [1]
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Percentage of patients who developed at least 1 episode of grade 2 to 4 neuropathy.
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Timepoint [1]
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Up to 107 weeks
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Secondary outcome [2]
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Gene Expression Profile
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Assessment method [2]
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Percent of unfavorable gene expression profile of early versus late marrow relapse.
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Timepoint [2]
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Up to 36 months
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Secondary outcome [3]
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Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 1
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Assessment method [3]
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Percentage of patients who had minimal residual disease (MRD) \< 0.01% among those with isolated BM or combined BM relapse \>= 36 months and had successful MRD determinations at End Block 1
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Timepoint [3]
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End of Block 1 (35 days) of Induction therapy
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Secondary outcome [4]
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Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 3
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Assessment method [4]
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Percentage of patients who had minimal residual disease (MRD) \< 0.01% among those with isolated BM or combined BM relapse \>= 36 months and had successful MRD determinations at End Block 3.
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Timepoint [4]
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End of Block 3 (105 days) of Induction therapy
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Secondary outcome [5]
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Event Free Survival (EFS)
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Assessment method [5]
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Percentage of patients who were event free at 3 years among those with isolated BM or combined BM relapse \>= 36 months.
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Timepoint [5]
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3 years
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Secondary outcome [6]
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Adjusted Event Free Survival
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Assessment method [6]
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Adjusted percentage of patients who were event free at 3 years. For patients who received matched donor SCT, EFS was adjusted to start from the actual SCT date. For patients who did not undergo SCT, EFS was adjusted to start from median time to SCT based on patients who received matched related SCT (where patients who had events prior to SCT date were excluded from the calculation of median time to SCT).
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Timepoint [6]
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3 years
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Eligibility
Key inclusion criteria
* Diagnosis of acute lymphoblastic leukemia (ALL)
* Bone marrow with > 25% L1 or L2 lymphoblasts (M3 marrow)
* Patients with > 25% L3 marrow lymphoblasts and/or evidence of c-myc translocation are not eligible (considered Burkitt's or mature B-cell leukemia)
* Intermediate-risk relapsed disease, meeting 1 of the following criteria:
* Bone marrow relapse = 36 months after initial diagnosis (defined as M3 marrow after previous remission from ALL)
* Combined bone marrow and extramedullary (CNS* and/or testicular**) relapse = 36 months after initial diagnosis
* Isolated extramedullary (CNS* and/or testicular**) relapse < 18 months after initial diagnosis
* The following subtypes are not allowed:
* T-lineage ALL
* Mature B-cell (Burkitt's) leukemia (defined as L3 morphology and/or evidence of c-myc translocation)
* Philadelphia-chromosome positive disease
* No Down syndrome (trisomy 21)
* Shortening fraction >= 27% by echocardiogram OR ejection fraction >= 50% by radionuclide angiogram
* Bilirubin < 3.0 mg/dL
* Not pregnant
* Fertile patients must use effective contraception
* No history of peripheral neuropathy >= grade 3 within the past month
* No toxicity (i.e. peripheral neuropathy) >= grade 3 attributable to vincristine within the past month
* At least 5 days since prior intrathecal chemotherapy
* No prior hematopoietic stem cell or marrow transplantation
* No prior cranial radiotherapy > 1200 cGy (for patients with CNS relapse)
* No concurrent stem cell transplant
* No concurrent alternative therapy
* No concurrent itraconazole in patients receiving vincristine
* No concurrent intensity-modulated radiotherapy
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Minimum age
1
Year
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Maximum age
29
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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
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
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
1/03/2007
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Date of last participant enrolment
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Actual
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Date of last data collection
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Actual
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Sample size
Target
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Accrual to date
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Final
275
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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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California
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Colorado
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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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Name [1]
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National Cancer Institute (NCI)
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Ethics approval
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Summary
Brief summary
This randomized phase III trial is studying low-dose vincristine to see how well it works compared with high-dose vincristine when given together with different combination chemotherapy regimens in treating young patients with intermediate-risk relapsed B-cell acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving the drugs in different ways and different doses may kill more cancer cells..
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Trial website
https://clinicaltrials.gov/study/NCT00381680
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Trial related presentations / publications
Lew G, Chen Y, Lu X, Rheingold SR, Whitlock JA, Devidas M, Hastings CA, Winick NJ, Carroll WL, Wood BL, Borowitz MJ, Pulsipher MA, Hunger SP. Outcomes after late bone marrow and very early central nervous system relapse of childhood B-acute lymphoblastic leukemia: a report from the Children's Oncology Group phase III study AALL0433. Haematologica. 2021 Jan 1;106(1):46-55. doi: 10.3324/haematol.2019.237230.
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Public notes
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Contacts
Principal investigator
Name
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Glen Lew, MD
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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
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00381680