Diagnostic Study of Gene Alterations in Patients With Acute Myeloid Leukemia

Alliance for Clinical Trials in Oncology

Status: Completed

Conditions: Leukemia

Treatments: Genetic: reverse transcriptase-polymerase chain reaction

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00003931

CLB-9769

CDR0000067123 (Registry Identifier)

CALGB-9769

U10CA031946 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 9,769 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

9,769 participants in 1 patient group

blood or bone marrow samples

Description:

All samples are obtained from specimens collected on CALGB-9665. No additional blood or bone marrow samples are collected CALGB-9769. 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.

Treatment:

Genetic: reverse transcriptase-polymerase chain reaction