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NCT00003931 Clinical Trial

Diagnostic Study of Gene Alterations in Patients With Acute Myeloid Leukemia

Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00003931
Other study ID # CALGB-9769
Secondary ID U10CA031946CLB-9
Status Completed
Phase N/A
First received November 1, 1999
Last updated July 1, 2016
Start date February 1999
Est. completion date June 2006

Study information
Verified date July 2016
Source Alliance for Clinical Trials in Oncology
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 9769
Est. completion date June 2006
Est. primary completion date June 2006
Accepts healthy volunteers No
Gender Both
Age group 15 Years and older
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Genetic:
• reverse transcriptase-polymerase chain reaction

Locations
Country Name City State
United States Marlene & Stewart Greenebaum Cancer Center, University of Maryland Baltimore Maryland
United States Veterans Affairs Medical Center - Birmingham Birmingham Alabama
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Roswell Park Cancer Institute Buffalo New York
United States Veterans Affairs Medical Center - Buffalo Buffalo New York
United States Vermont Cancer Center Burlington Vermont
United States Lineberger Comprehensive Cancer Center, UNC Chapel Hill North Carolina
United States University of Chicago Cancer Research Center Chicago Illinois
United States Veterans Affairs Medical Center - Chicago (Westside Hospital) Chicago Illinois
United States Ellis Fischel Cancer Center - Columbia Columbia Missouri
United States Veterans Affairs Medical Center - Columbia (Truman Memorial) Columbia Missouri
United States Arthur G. James Cancer Hospital - Ohio State University Columbus Ohio
United States Duke Comprehensive Cancer Center Durham North Carolina
United States Veterans Affairs Medical Center - Durham Durham North Carolina
United States Holden Comprehensive Cancer Center at The University of Iowa Iowa City Iowa
United States University of California San Diego Cancer Center La Jolla California
United States CCOP - Southern Nevada Cancer Research Foundation Las Vegas Nevada
United States Norris Cotton Cancer Center Lebanon New Hampshire
United States CCOP - North Shore University Hospital Manhasset New York
United States Schneider Children's Hospital at North Shore Manhasset New York
United States University of Tennessee, Memphis Cancer Center Memphis Tennessee
United States Veterans Affairs Medical Center - Memphis Memphis Tennessee
United States CCOP - Mount Sinai Medical Center Miami Beach Florida
United States University of Minnesota Cancer Center Minneapolis Minnesota
United States Veterans Affairs Medical Center - Minneapolis Minneapolis Minnesota
United States Memorial Sloan-Kettering Cancer Center New York New York
United States Mount Sinai Medical Center, NY New York New York
United States New York Presbyterian Hospital - Cornell Campus New York New York
United States University of Nebraska Medical Center Omaha Nebraska
United States Rhode Island Hospital Providence Rhode Island
United States MBCCOP - Massey Cancer Center Richmond Virginia
United States Veterans Affairs Medical Center - Richmond Richmond Virginia
United States Barnes-Jewish Hospital Saint Louis Missouri
United States UCSF Cancer Center and Cancer Research Institute San Francisco California
United States Veterans Affairs Medical Center - San Francisco San Francisco California
United States CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. Syracuse New York
United States State University of New York - Upstate Medical University Syracuse New York
United States Veterans Affairs Medical Center - Syracuse Syracuse New York
United States Veterans Affairs Medical Center - Togus Togus Maine
United States Lombardi Cancer Center Washington District of Columbia
United States Walter Reed Army Medical Center Washington District of Columbia
United States Veterans Affairs Medical Center - White River Junction White River Junction Vermont
United States CCOP - Christiana Care Health Services Wilmington Delaware
United States CCOP - Southeast Cancer Control Consortium Winston-Salem North Carolina
United States Comprehensive Cancer Center at Wake Forest University Winston-Salem North Carolina
United States University of Massachusetts Memorial Medical Center Worcester Massachusetts

Sponsors (2)
Lead Sponsor Collaborator
Alliance for Clinical Trials in Oncology National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary frequency of partial tandem duplication of ALL1 (MLL) Up to 10 years No
Secondary predictive value of partial tandem duplication of ALL1 Up to 10 years No
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