Diagnostic Study of Gene Alterations in Patients With Acute Myeloid Leukemia

RATIONALE: Diagnostic procedures, such as genetic testing, may improve the ability to detect acute myeloid leukemia and determine the extent of disease.

PURPOSE: Diagnostic study to try to detect changes in the genes of patients who have acute myeloid leukemia.

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Key information

Conditions

Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Veterans Affairs Medical Center - Birmingham, Birmingham, Alabama, United States

About this study

OBJECTIVES:

Determine the frequency of partial tandem duplication of ALL1 (MLL) in patients with acute myeloid leukemia (AML).
Determine the predictive value of partial tandem duplication of ALL1 to identify a subset of AML patients who have a short duration of complete remission.

OUTLINE: All samples are obtained from specimens collected on CALGB-9665. No additional blood or bone marrow samples are collected.

Samples are examined by Southern blot analysis for gene rearrangement at 11q23. Samples showing evidence of ALL1 gene rearrangement are further analyzed by reverse transcription PCR amplification and/or cytogenetic analysis to detect partial tandem duplication of ALL1.

Who can participate

Healthy volunteers accepted: No

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

DISEASE CHARACTERISTICS:

Prior registration on protocol CALGB-9665
Diagnosed with acute myeloid leukemia (AML)
Treated on a CALGB AML treatment protocol
Diagnostic bone marrow or blood specimen available

PATIENT CHARACTERISTICS:

Age:

15 and over

Treatment and study plan

reverse transcriptase-polymerase chain reaction

Genetic

Primary outcomes

frequency of partial tandem duplication of ALL1 (MLL)

Time frame: Up to 10 years

Secondary outcomes

predictive value of partial tandem duplication of ALL1

Time frame: Up to 10 years

Sponsors and collaborators

Lead sponsor

Alliance for Clinical Trials in Oncology

Other

Collaborators

National Cancer Institute (NCI)

Registry information

Official study title

Assessment of the Partial Tandem Duplication of ALL1 (MLL) in Patients With Acute Myeloid Leukemia- A CALGB Leukemia Tissue Bank Project

Important dates

Study start: 1999
Primary completion: 2006
Study completion: 2006
First posted: Aug 20, 2003
Registry last updated: Jul 4, 2016

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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Completed