Diagnostic Study of Gene Alterations in Patients With Acute Myeloid Leukemia

July 1, 2016 updated by: Alliance for Clinical Trials in Oncology

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

9769

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233-1996
        • Veterans Affairs Medical Center - Birmingham
    • California
      • La Jolla, California, United States, 92093-0658
        • University of California San Diego Cancer Center
      • San Francisco, California, United States, 94121
        • Veterans Affairs Medical Center - San Francisco
      • San Francisco, California, United States, 94143-0128
        • UCSF Cancer Center and Cancer Research Institute
    • Delaware
      • Wilmington, Delaware, United States, 19899
        • CCOP - Christiana Care Health Services
    • District of Columbia
      • Washington, District of Columbia, United States, 20307-5000
        • Walter Reed Army Medical Center
      • Washington, District of Columbia, United States, 20007
        • Lombardi Cancer Center
    • Florida
      • Miami Beach, Florida, United States, 33140
        • CCOP - Mount Sinai Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Veterans Affairs Medical Center - Chicago (Westside Hospital)
      • Chicago, Illinois, United States, 60637-1470
        • University of Chicago Cancer Research Center
    • Iowa
      • Iowa City, Iowa, United States, 52242-1009
        • Holden Comprehensive Cancer Center at the University of Iowa
    • Maine
      • Togus, Maine, United States, 04330
        • Veterans Affairs Medical Center - Togus
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Marlene & Stewart Greenebaum Cancer Center, University of Maryland
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts Memorial Medical Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55417
        • Veterans Affairs Medical Center - Minneapolis
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Cancer Center
    • Missouri
      • Columbia, Missouri, United States, 65201
        • Veterans Affairs Medical Center - Columbia (Truman Memorial)
      • Columbia, Missouri, United States, 65203
        • Ellis Fischel Cancer Center - Columbia
      • Saint Louis, Missouri, United States, 63110
        • Barnes-Jewish Hospital
    • Nebraska
      • Omaha, Nebraska, United States, 68198-3330
        • University of Nebraska Medical Center
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • CCOP - Southern Nevada Cancer Research Foundation
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756-0002
        • Norris Cotton Cancer Center
    • New York
      • Buffalo, New York, United States, 14263-0001
        • Roswell Park Cancer Institute
      • Buffalo, New York, United States, 14215
        • Veterans Affairs Medical Center - Buffalo
      • Manhasset, New York, United States, 11030
        • CCOP - North Shore University Hospital
      • Manhasset, New York, United States, 11030
        • Schneider Children's Hospital at North Shore
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center
      • New York, New York, United States, 10021
        • New York Presbyterian Hospital - Cornell Campus
      • New York, New York, United States, 10029
        • Mount Sinai Medical Center, NY
      • Syracuse, New York, United States, 13210
        • State University of New York - Upstate Medical University
      • Syracuse, New York, United States, 13210
        • Veterans Affairs Medical Center - Syracuse
      • Syracuse, New York, United States, 13217
        • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7295
        • Lineberger Comprehensive Cancer Center, UNC
      • Durham, North Carolina, United States, 27705
        • Veterans Affairs Medical Center - Durham
      • Durham, North Carolina, United States, 27710
        • Duke Comprehensive Cancer Center
      • Winston-Salem, North Carolina, United States, 27104-4241
        • CCOP - Southeast Cancer Control Consortium
      • Winston-Salem, North Carolina, United States, 27157-1082
        • Comprehensive Cancer Center at Wake Forest University
    • Ohio
      • Columbus, Ohio, United States, 43210-1240
        • Arthur G. James Cancer Hospital - Ohio State University
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
    • Tennessee
      • Memphis, Tennessee, United States, 38103
        • University of Tennessee, Memphis Cancer Center
      • Memphis, Tennessee, United States, 38104
        • Veterans Affairs Medical Center - Memphis
    • Vermont
      • Burlington, Vermont, United States, 05401-3498
        • Vermont Cancer Center
      • White River Junction, Vermont, United States, 05009
        • Veterans Affairs Medical Center - White River Junction
    • Virginia
      • Richmond, Virginia, United States, 23298-0037
        • MBCCOP - Massey Cancer Center
      • Richmond, Virginia, United States, 23249
        • Veterans Affairs Medical Center - Richmond

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients previously enrolled on CALGB-9665.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
blood or bone marrow samples

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.
Genetic: reverse transcriptase-polymerase chain reaction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
frequency of partial tandem duplication of ALL1 (MLL)
Time Frame: Up to 10 years
Up to 10 years

Secondary Outcome Measures

Outcome Measure
Time Frame
predictive value of partial tandem duplication of ALL1
Time Frame: Up to 10 years
Up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Michael A. Caligiuri, MD, Ohio State University Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 1999

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

August 19, 2003

First Posted (Estimate)

August 20, 2003

Study Record Updates

Last Update Posted (Estimate)

July 4, 2016

Last Update Submitted That Met QC Criteria

July 1, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CALGB-9769
  • U10CA031946 (U.S. NIH Grant/Contract)
  • CLB-9769
  • CDR0000067123 (Registry Identifier: NCI Physician Data Query)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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