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NCT Number: NCT00899652

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

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.

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Key information

Conditions

Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Southern blotting

Genetic

chromosomal translocation analysis

Genetic

cytogenetic analysis

Genetic

gene rearrangement analysis

Genetic

mutation analysis

Genetic

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Children's Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

The Molecular Epidemiology of de Novo and Treatment Related 11q23 Leukemia in the Young

Important dates

Study start
1997
Primary completion
2005
Study completion
2006
First posted
May 12, 2009
Registry last updated
Apr 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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