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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/NCT01142427




Registration number
NCT01142427
Ethics application status
Date submitted
10/06/2010
Date registered
11/06/2010
Date last updated
3/10/2023

Titles & IDs
Public title
Risk-Based Classification System of Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
Scientific title
Classification of Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)
Secondary ID [1] 0 0
NCI-2011-02235
Secondary ID [2] 0 0
AALL08B1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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 - Cytology Specimen Collection Procedure
Other interventions - Laboratory Biomarker Analysis

Ancillary-Correlative (classification) - Patients undergo blood sample collection and bone marrow biopsies at baseline and during and after induction therapy for immunophenotyping for ALL confirmation and classification, DNA ploidy, genomic variation, and cytogenetic (BCR-ABL, trisomies 4+10, and molecular testing for translocations) analysis by flow cytometry and FISH. Immunophenotype results obtained on this study are used to determine patient's assignment to specific clinical-trial treatments. Some samples (leukemic and germline) may be banked for current and/or future analyses.


Other interventions: Cytology Specimen Collection Procedure
Correlative studies

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 risk classification system to be used to assign patients to treatment on Children?s Oncology Group frontline acute lymphoblastic leukemia (ALL) treatment studies
Timepoint [1] 0 0
Up to 5 years
Primary outcome [2] 0 0
Classification data for correlative studies
Timepoint [2] 0 0
Up to 5 years
Primary outcome [3] 0 0
Development of a central reference guide for required and research ALL studies
Timepoint [3] 0 0
Up to 5 years
Primary outcome [4] 0 0
Development of mechanism for optional leukemia and germline specimens for current and future research
Timepoint [4] 0 0
Up to 5 years

Eligibility
Key inclusion criteria
- Patient has newly diagnosed acute leukemia:

- > 25% blasts on a bone marrow (BM) aspirate or

- If a BM aspirate is not obtained or is not diagnostic of acute leukemia, the
diagnosis can be established by a pathologic diagnosis of acute leukemia on a BM
biopsy or

- A complete blood count (CBC) documenting the presence of at least 1,000/uL
circulating leukemic blasts

- Adequate samples must be provided to the reference and/or COG-approved cytogenetics
laboratories to allow completion of the studies needed for risk-stratification

- If a BM aspirate is not performed, or adequate material cannot be obtained,
peripheral blood (PB) can be substituted for BM if there are at least 1,000
circulating blasts/uL (i.e., a white blood cell [WBC] count of 10,000/uL with 10%
blasts or a WBC count of 5,000/uL with 20% blasts); if only PB is submitted,
please obtain and send twice the volume of PB as the recommended BM volume
specified; the patient will remain on AALL08B1 as long as all required central
laboratory tests can be successfully performed; as long as there are at least
1,000/uL PB blasts, institutions are encouraged to submit PB in addition to BM
samples to make sure that adequate material is available to perform the required
studies

- If an adequate BM aspirate cannot be obtained and there are fewer than 1,000/uL
PB blasts, the patient is not eligible for AALL08B1 or a frontline COG ALL
clinical trial (there are NO exceptions to this rule)

- Patient has suspected ALL:

- Patients whose blast morphology is obviously myeloid, or whose blasts are
myeloperoxidase positive, should not be enrolled on AALL08B1; however, patients
with true biphenotypic or bilineage leukemia (i.e., patient presents with blasts
with significant expression of multiple lymphoid and myeloid markers such that
assignment to a single lineage is not possible) are eligible to enroll in
AALL08B1 for cell banking

- Samples must be sent to a COG-approved cytogenetics laboratory, and COG Reference
Laboratory studies; if informative results needed for treatment stratification are not
available at specified time-points during induction, patients will not be eligible to
receive post-induction therapy on a COG ALL trial

- All patients and/or their parents or legal guardians must sign a written informed
consent

- All institutional, Food and Drug Administration (FDA) and National Cancer Institute
(NCI) requirements for human studies must be met
Minimum age
No limit
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patient must not have received prior cytotoxic therapy except for steroids or
intrathecal chemotherapy

- Patient must not have secondary ALL that developed after treatment of a prior
malignancy with cytotoxic chemotherapy

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
9/08/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/09/2023
Sample size
Target
Accrual to date
Final
17463
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
John Hunter Children's Hospital - Hunter Regional Mail Centre
Recruitment hospital [2] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [3] 0 0
Royal Children's Hospital-Brisbane - Herston
Recruitment hospital [4] 0 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [5] 0 0
Women's and Children's Hospital-Adelaide - North Adelaide
Recruitment hospital [6] 0 0
Monash Medical Center-Clayton Campus - Clayton
Recruitment hospital [7] 0 0
Royal Children's Hospital - Parkville
Recruitment hospital [8] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
2310 - Hunter Regional Mail Centre
Recruitment postcode(s) [2] 0 0
4029 - Herston
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4101 - South Brisbane
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5006 - North Adelaide
Recruitment postcode(s) [5] 0 0
3168 - Clayton
Recruitment postcode(s) [6] 0 0
3052 - Parkville
Recruitment postcode(s) [7] 0 0
6008 - Perth
Recruitment outside Australia
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Alabama
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Alaska
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Auckland
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Christchurch
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San Juan
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Geneva
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Switzerland
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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 research trial studies a risk-based classification system for patients with newly
diagnosed acute lymphoblastic leukemia. Gathering health information about patients with
acute lymphoblastic leukemia may help doctors learn more about the disease and plan the best
treatment.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01142427
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Karen R Rabin
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/ct2/show/NCT01142427