Diagnostic Study of Gene Alterations in Patients With Acute Myeloid Leukemia - Full Text View

Sponsor:	Cancer and Leukemia Group B
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00003931

Purpose

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.

Condition	Intervention
Leukemia	Genetic: reverse transcriptase-polymerase chain reaction Procedure: autoradiography

Study Type:	Interventional
Study Design:	Diagnostic
Official Title:	Assessment of the Partial Tandem Duplication of ALL1 (MLL) in Patients With Acute Myeloid Leukemia- A CALGB Leukemia Tissue Bank Project

Resource links provided by NLM:

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

February 1999

Detailed 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.

PROJECTED ACCRUAL: Samples from approximately 740 patients will be obtained for this study within 5 years.

Eligibility

Ages Eligible for Study:	15 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Performance status:

Not specified

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Not specified

Renal:

Not specified

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003931

Show 46 Study Locations

Sponsors and Collaborators

Cancer and Leukemia Group B

National Cancer Institute (NCI)

Investigators

Study Chair:

Michael A. Caligiuri, MD

Arthur G. James Cancer Hospital & Richard J. Solove Research Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000067123, CLB-9769
Study First Received:	November 1, 1999
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00003931 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

recurrent adult acute myeloid leukemia
adult acute myeloid leukemia in remission

Additional relevant MeSH terms:

Leukemia
Neoplasms
Neoplasms by Histologic Type
Leukemia, Myeloid
Leukemia, Myeloid, Acute

ClinicalTrials.gov processed this record on November 27, 2009