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DNA Analysis of Bone Marrow and Blood Samples From Young Patients With Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia

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ClinicalTrials.gov Identifier: NCT00899652
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : April 26, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Study Description
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Brief Summary:

RATIONALE: Studying samples of bone marrow and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

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.


Condition or disease Intervention/treatment
Leukemia Genetic: Southern blotting Genetic: chromosomal translocation analysis Genetic: cytogenetic analysis Genetic: gene rearrangement analysis Genetic: mutation analysis

Detailed Description:

OBJECTIVES:

  • 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.

Study Design
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Study Type : Observational
Actual Enrollment : 149 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Molecular Epidemiology of de Novo and Treatment Related 11q23 Leukemia in the Young
Study Start Date : January 1997
Actual Primary Completion Date : September 2005
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
All Patients
Completion of Telephone Study Entry Form, Additional On Study Form, and Specimen Transmittal Form.
 Genetic: Southern blotting
Genetic: chromosomal translocation analysis
Genetic: cytogenetic analysis
Genetic: gene rearrangement analysis
Genetic: mutation analysis


Outcome Measures
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Primary Outcome Measures :
  1. Clinical, morphologic, immunologic, cytogenetic, and molecular characteristics of acute lymphoblastic leukemia and de novo and secondary acute myeloid leukemia (AML)
  2. Comparison of secondary AML vs de novo AML at the level of Southern blot, breakpoint sequence, and DNA topoisomerase II cleavage sites

Biospecimen Retention:   Samples With DNA
marrow, blood, pheresis bag

Eligibility Criteria
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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00899652


Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
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Study Chair: Beverly J. Lange, MD Children's Hospital of Philadelphia
OverallOfficial: Carolyn A. Felix, MD Children's Hospital of Philadelphia
More Information
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Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00899652    
Other Study ID Numbers: B945
CCG-B945 ( Other Identifier: Children's Cancer Group )
CDR0000538662 ( Other Identifier: Clinical Trials.gov )
COG-B945 ( Other Identifier: Children's Oncology Group )
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017
Keywords provided by Children's Oncology Group:
childhood acute myelomonocytic leukemia (M4)
childhood acute monocytic leukemia (M5b)
childhood acute monoblastic leukemia (M5a)
secondary acute myeloid leukemia
 untreated childhood acute lymphoblastic leukemia
untreated childhood acute myeloid leukemia and other myeloid malignancies
recurrent childhood acute lymphoblastic leukemia
recurrent childhood acute myeloid leukemia
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Leukemia, Lymphoid
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases