DNA Analysis of Bone Marrow and Blood Samples From Young Patients With Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia
NCT ID: NCT00899652
Last Updated: 2017-04-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
149 participants
OBSERVATIONAL
1997-01-31
2006-09-30
Brief Summary
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PURPOSE: This laboratory study is looking at DNA in bone marrow and blood samples from young patients with acute myeloid leukemia or acute lymphoblastic leukemia.
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Detailed Description
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* Characterize the clinical, morphologic, immunologic, cytogenetic, and molecular heterogeneity of acute lymphoblastic leukemia or acute myeloid leukemia (AML) in infants and monoblastic variants of AML in young patients.
* Characterize the clinical, morphologic, immunologic, cytogenetic, and molecular heterogeneity of secondary AML in young patients.
* Compare secondary AML vs de novo AML at the level of Southern blot, breakpoint sequence, and DNA topoisomerase II cleavage sites.
OUTLINE: This is a multicenter study.
Bone marrow or blood are collected and analyzed by Southern blot for chromosome 11q23 breakpoints and translocations. Samples from patients with secondary acute myeloid leukemia are also examined for MLL gene rearrangements.
PROJECTED ACCRUAL: A total of 250 patients will be accrued for this study.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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All Patients
Completion of Telephone Study Entry Form, Additional On Study Form, and Specimen Transmittal Form.
Southern blotting
chromosomal translocation analysis
cytogenetic analysis
gene rearrangement analysis
mutation analysis
Interventions
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Southern blotting
chromosomal translocation analysis
cytogenetic analysis
gene rearrangement analysis
mutation analysis
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of leukemia meeting 1 of the following criteria:
* Acute lymphoblastic leukemia OR acute myeloid leukemia (AML) (\< 1 year of age at diagnosis)
* M4 OR M5 AML (\< 5 years of age at diagnosis)
* Secondary leukemia (\< 21 years of age at diagnosis)
* Bone marrow sample, peripheral blood (WBC \> 10,000/mm³ and 20% peripheral blasts), or pheresis bag available
PATIENT CHARACTERISTICS:
* Not specified
PRIOR CONCURRENT THERAPY:
* Not specified
21 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Beverly J. Lange, MD
Role: STUDY_CHAIR
Children's Hospital of Philadelphia
Carolyn A. Felix, MD
Role:
Children's Hospital of Philadelphia
Other Identifiers
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CCG-B945
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000538662
Identifier Type: OTHER
Identifier Source: secondary_id
COG-B945
Identifier Type: OTHER
Identifier Source: secondary_id
B945
Identifier Type: -
Identifier Source: org_study_id
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