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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00482352




Registration number
NCT00482352
Ethics application status
Date submitted
4/06/2007
Date registered
5/06/2007
Date last updated
3/08/2023

Titles & IDs
Public title
Risk-Group Classification of Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
Scientific title
Classification Of Acute Lymphoblastic Leukemia
Secondary ID [1] 0 0
NCI-2009-00303
Secondary ID [2] 0 0
AALL03B1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Untreated Adult Acute Lymphoblastic Leukemia 0 0
Untreated 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
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - laboratory biomarker analysis

Ancillary-Correlative (marker identification, molecular test) - Patients undergo blood collection and bone marrow biopsies at baseline and at the end of induction therapy for immunophenotyping for marker identification; molecular testing for translocations; trisomy analysis by fluorescence in situ hybridization (FISH); and DNA ploidy. Immunophenotype results obtained on this study are used to determine the patient's assignment to specific treatment clinical trials (consistent with acute lymphoblastic leukemia).


Other interventions: laboratory biomarker analysis
Correlative studies
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Development of a classification guide to help determine patient assignment to a specific treatment clinical trial for newly diagnosed acute lymphoblastic leukemia (ALL)
Timepoint [1] 0 0
Up to 5 years
Primary outcome [2] 0 0
Development of a classification database for correlative studies
Timepoint [2] 0 0
Up to 5 years
Primary outcome [3] 0 0
Development of a central reference guide for all required and research only ALL studies
Timepoint [3] 0 0
Up to 5 years
Primary outcome [4] 0 0
Development of a leukemia and germline specimen bank for current and future research
Timepoint [4] 0 0
Up to 5 years

Eligibility
Key inclusion criteria
* Newly diagnosed acute lymphoblastic leukemia, defined by any of the following:

* At least 25% blasts in the bone marrow
* Absolute blast count at least 10,000/mm^3, if bone marrow aspiration is not performed
* No prior registration on this study
Minimum age
1 Year
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/06/2023
Sample size
Target
Accrual to date
Final
11196
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [2] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [3] 0 0
Women's and Children's Hospital-Adelaide - North Adelaide
Recruitment hospital [4] 0 0
Royal Children's Hospital - Parkville
Recruitment hospital [5] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
5006 - North Adelaide
Recruitment postcode(s) [4] 0 0
3052 - Parkville
Recruitment postcode(s) [5] 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
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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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Florida
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Georgia
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United States of America
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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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New Jersey
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New Mexico
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New York
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North Carolina
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United States of America
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North Dakota
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Ohio
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United States of America
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Oklahoma
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Oregon
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United States of America
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Pennsylvania
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United States of America
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Rhode Island
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United States of America
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South Carolina
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United States of America
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Tennessee
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Texas
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United States of America
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Utah
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United States of America
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Vermont
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United States of America
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Virginia
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United States of America
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Washington
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United States of America
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West Virginia
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United States of America
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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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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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Santurce
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Switzerland
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Bern
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Switzerland
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Geneva
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Switzerland
State/province [60] 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
This clinical trial is studying risk-group classification of patients with newly diagnosed acute lymphoblastic leukemia. Developing a risk-group classification guide may help doctors assign patients with newly diagnosed acute lymphoblastic leukemia to treatment clinical trials.
Trial website
https://clinicaltrials.gov/study/NCT00482352
Trial related presentations / publications
McNeer JL, Devidas M, Dai Y, Carroll AJ, Heerema NA, Gastier-Foster JM, Kahwash SB, Borowitz MJ, Wood BL, Larsen E, Maloney KW, Mattano L, Winick NJ, Schultz KR, Hunger SP, Carroll WL, Loh ML, Raetz EA. Hematopoietic Stem-Cell Transplantation Does Not Improve the Poor Outcome of Children With Hypodiploid Acute Lymphoblastic Leukemia: A Report From Children's Oncology Group. J Clin Oncol. 2019 Apr 1;37(10):780-789. doi: 10.1200/JCO.18.00884. Epub 2019 Feb 11.
Public notes

Contacts
Principal investigator
Name 0 0
Mignon Loh, 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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00482352