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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00899652
First received: May 9, 2009
Last updated: February 11, 2014
Last verified: February 2014
History of Changes
  Purpose

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 Intervention
Leukemia
 Genetic: Southern blotting
Genetic: chromosomal translocation analysis
Genetic: cytogenetic analysis
Genetic: gene rearrangement analysis
Genetic: mutation analysis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Molecular Epidemiology of de Novo and Treatment Related 11q23 Leukemia in the Young

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Clinical, morphologic, immunologic, cytogenetic, and molecular characteristics of acute lymphoblastic leukemia and de novo and secondary acute myeloid leukemia (AML) [ Designated as safety issue: No ]
  • Comparison of secondary AML vs de novo AML at the level of Southern blot, breakpoint sequence, and DNA topoisomerase II cleavage sites [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

marrow, blood, pheresis bag
Enrollment: 149
Study Start Date: January 1997
Study Completion Date: September 2006
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility
Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00899652

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Beverly J. Lange, MD Children's Hospital of Philadelphia
Investigator: Carolyn A. Felix, MD Children's Hospital of Philadelphia
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00899652     History of Changes
Other Study ID Numbers: B945, CCG-B945, CDR0000538662, COG-B945
Study First Received: May 9, 2009
Last Updated: February 11, 2014
Health Authority: United States: Federal Government

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:
Leukemia
Leukemia, Lymphoid
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immune System Diseases
 Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on February 25, 2015