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
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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 |
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 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 |

Group/Cohort | Intervention/treatment |
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All Patients
Completion of Telephone Study Entry Form, Additional On Study Form, and Specimen Transmittal Form.
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Genetic: Southern blotting Genetic: chromosomal translocation analysis Genetic: cytogenetic analysis Genetic: gene rearrangement analysis Genetic: mutation analysis |
- Clinical, morphologic, immunologic, cytogenetic, and molecular characteristics of acute lymphoblastic leukemia and de novo and secondary acute myeloid leukemia (AML)
- 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

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

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
Study Chair: | Beverly J. Lange, MD | Children's Hospital of Philadelphia | |
OverallOfficial: | Carolyn A. Felix, MD | Children's Hospital of Philadelphia |
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 |
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 |
Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Neoplasms Leukemia, Lymphoid |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |