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

April 24, 2017 updated by: Children's Oncology Group

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

149

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Beverly J. Lange, MD, Children's Hospital of Philadelphia
  • Carolyn A. Felix, MD, Children's Hospital of Philadelphia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1997

Primary Completion (Actual)

September 1, 2005

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

May 9, 2009

First Submitted That Met QC Criteria

May 9, 2009

First Posted (Estimate)

May 12, 2009

Study Record Updates

Last Update Posted (Actual)

April 26, 2017

Last Update Submitted That Met QC Criteria

April 24, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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