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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
Scientific title
Intensive Treatment for Intermediate-Risk Relapse of Childhood B-precursor Acute Lymphoblastic Leukemia (ALL): A Randomized Trial of Vincristine Strategies
Secondary ID [1] 0 0
NCI-2009-00306
Secondary ID [2] 0 0
AALL0433
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
B-cell Childhood Acute Lymphoblastic Leukemia 0 0
L1 Childhood Acute Lymphoblastic Leukemia 0 0
L2 Childhood Acute Lymphoblastic Leukemia 0 0
Intermediate Risk Recurrent Childhood Acute Lymphoblastic Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Event Free Survival. EFS
Timepoint [1] 0 0
3 years after enrollment
Secondary outcome [1] 0 0
Frequency and Severity of Adverse Effects
Timepoint [1] 0 0
Up to 107 weeks
Secondary outcome [2] 0 0
Gene Expression Profile
Timepoint [2] 0 0
Up to 36 months
Secondary outcome [3] 0 0
Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 1
Timepoint [3] 0 0
End of Block 1 (35 days) of Induction therapy
Secondary outcome [4] 0 0
Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 3
Timepoint [4] 0 0
End of Block 3 (105 days) of Induction therapy
Secondary outcome [5] 0 0
Event Free Survival (EFS)
Timepoint [5] 0 0
3 years
Secondary outcome [6] 0 0
Adjusted Event Free Survival
Timepoint [6] 0 0
3 years

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
Minimum age
1 Year
Maximum age
29 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
275
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
6008 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
Arizona
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United States of America
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Arkansas
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United States of America
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California
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United States of America
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Colorado
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United States of America
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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
Country [20] 0 0
United States of America
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Massachusetts
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Michigan
Country [22] 0 0
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Minnesota
Country [23] 0 0
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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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New Jersey
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United States of America
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New Mexico
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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Rhode Island
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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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Virginia
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Washington
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West Virginia
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Wisconsin
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Canada
State/province [46] 0 0
British Columbia
Country [47] 0 0
Canada
State/province [47] 0 0
Manitoba
Country [48] 0 0
Canada
State/province [48] 0 0
Nova Scotia
Country [49] 0 0
Canada
State/province [49] 0 0
Ontario
Country [50] 0 0
Canada
State/province [50] 0 0
Quebec
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Canada
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Saskatchewan
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Switzerland
State/province [52] 0 0
Bern
Country [53] 0 0
Switzerland
State/province [53] 0 0
Lausanne

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Glen Lew, MD
Address 0 0
Children's Oncology Group
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


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