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

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:

Genetics Home Reference related topics: core binding factor acute myeloid leukemia cytogenetically normal acute myeloid leukemia familial acute myeloid leukemia with mutated CEBPA

MedlinePlus related topics: Acute Myeloid Leukemia Chronic Lymphocytic Leukemia Leukemia

Genetic and Rare Diseases Information Center resources: Myeloid Leukemia Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia Acute Lymphoblastic Leukemia Childhood Acute Lymphoblastic Leukemia Acute Myelomonocytic Leukemia Acute Monoblastic Leukemia Lymphosarcoma

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)
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


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 (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

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
OverallOfficial:	Carolyn A. Felix, MD	Children's Hospital of Philadelphia

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 )
Study First Received:	May 9, 2009
Last Updated:	April 24, 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

ClinicalTrials.gov processed this record on September 20, 2017