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Diagnostic Study of Gene Alterations in Patients With Acute Myeloid Leukemia

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00003931
Enrollment
9769
Registered
2003-08-20
Start date
1999-02-28
Completion date
2006-06-30
Last updated
2016-07-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia

Keywords

recurrent adult acute myeloid leukemia, adult acute myeloid leukemia in remission

Brief summary

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.

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.

Interventions

GENETICreverse transcriptase-polymerase chain reaction

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Alliance for Clinical Trials in Oncology
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
frequency of partial tandem duplication of ALL1 (MLL)Up to 10 years

Secondary

MeasureTime frame
predictive value of partial tandem duplication of ALL1Up to 10 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026