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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Sponsors and Collaborators

Children's Oncology Group

National Cancer Institute (NCI)

Investigators

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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Children's Oncology Group
ClinicalTrials.gov Identifier:	NCT00899652 History of Changes
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
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:

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