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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00897325




Registration number
NCT00897325
Ethics application status
Date submitted
9/05/2009
Date registered
12/05/2009
Date last updated
18/01/2020

Titles & IDs
Public title
Collecting and Storing Samples of Bone Marrow and Blood From Patients With Relapsed Acute Lymphoblastic Leukemia or Non-Hodgkin Lymphoma
Scientific title
A Children's Oncology Group Protocol for Collecting and Banking Relapsed Acute Lymphoblastic Leukemia Research Specimens
Secondary ID [1] 0 0
NCI-2009-00310
Secondary ID [2] 0 0
AALL05B1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recurrent Adult Acute Lymphoblastic Leukemia 0 0
Recurrent Adult Non-Hodgkin Lymphoma 0 0
Recurrent Childhood Acute Lymphoblastic Leukemia 0 0
Recurrent Childhood Non-Hodgkin Lymphoma 0 0
Condition category
Condition code
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
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
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

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 (Collecting and banking ALL specimens) - Patients undergo collection of bone marrow and peripheral blood at diagnosis of relapse and/or at the end of the first month of treatment.


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
Banking of tumor cells and germline DNA
Timepoint [1] 0 0
Not Provided

Eligibility
Key inclusion criteria
* Diagnosis of acute lymphoblastic leukemia (ALL) or prior history of non-Hodgkin lymphoma
* In first or subsequent marrow relapse with = 25% blasts in bone marrow and/or peripheral blood
* Bone marrow and/or peripheral blood samples (= 5 mL) required at the time of diagnosis of relapse
* No concurrent systemic antileukemic treatment administered for current relapse

* Intrathecal chemotherapy allowed
* On-therapy relapse allowed
Minimum age
No limit
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
25/09/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/12/2019
Sample size
Target
Accrual to date
Final
811
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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United States of America
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Delaware
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United States of America
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District of Columbia
Country [9] 0 0
United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Hawaii
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United States of America
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Idaho
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Illinois
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United States of America
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Indiana
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Iowa
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Kansas
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Kentucky
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Louisiana
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Maryland
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United States of America
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Massachusetts
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Michigan
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Minnesota
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Mississippi
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United States of America
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Missouri
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United States of America
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Nebraska
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Nevada
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United States of America
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New Hampshire
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United States of America
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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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North Dakota
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United States of America
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Ohio
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United States of America
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Oklahoma
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United States of America
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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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South Dakota
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United States of America
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Tennessee
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United States of America
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Texas
Country [42] 0 0
United States of America
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Utah
Country [43] 0 0
United States of America
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Vermont
Country [44] 0 0
United States of America
State/province [44] 0 0
Virginia
Country [45] 0 0
United States of America
State/province [45] 0 0
Washington
Country [46] 0 0
United States of America
State/province [46] 0 0
West Virginia
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United States of America
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Wisconsin
Country [48] 0 0
Canada
State/province [48] 0 0
British Columbia
Country [49] 0 0
Canada
State/province [49] 0 0
Manitoba
Country [50] 0 0
Canada
State/province [50] 0 0
Nova Scotia
Country [51] 0 0
Canada
State/province [51] 0 0
Ontario
Country [52] 0 0
Canada
State/province [52] 0 0
Quebec
Country [53] 0 0
Canada
State/province [53] 0 0
Saskatchewan
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Puerto Rico
State/province [54] 0 0
San Juan
Country [55] 0 0
Switzerland
State/province [55] 0 0
Bern

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
Stephen P Hunger
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

No information has been provided regarding IPD availability


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 not provided in https://clinicaltrials.gov/study/NCT00897325