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
4 other identifiers
observational
9,769
1 country
46
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 1999
Longer than P75 for all trials
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 1999
CompletedFirst Submitted
Initial submission to the registry
November 1, 1999
CompletedFirst Posted
Study publicly available on registry
August 20, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2006
CompletedJuly 4, 2016
July 1, 2016
7.3 years
November 1, 1999
July 1, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
frequency of partial tandem duplication of ALL1 (MLL)
Up to 10 years
Secondary Outcomes (1)
predictive value of partial tandem duplication of ALL1
Up to 10 years
Study Arms (1)
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.
Interventions
Eligibility Criteria
Patients previously enrolled on CALGB-9665.
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (46)
Veterans Affairs Medical Center - Birmingham
Birmingham, Alabama, 35233-1996, United States
University of California San Diego Cancer Center
La Jolla, California, 92093-0658, United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121, United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128, United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899, United States
Lombardi Cancer Center
Washington D.C., District of Columbia, 20007, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, 33140, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612, United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470, United States
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, 52242-1009, United States
Veterans Affairs Medical Center - Togus
Togus, Maine, 04330, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655, United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455, United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, 65201, United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203, United States
Barnes-Jewish Hospital
St Louis, Missouri, 63110, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3330, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106, United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002, United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, 14215, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001, United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030, United States
Schneider Children's Hospital at North Shore
Manhasset, New York, 11030, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021, United States
New York Presbyterian Hospital - Cornell Campus
New York, New York, 10021, United States
Mount Sinai Medical Center, NY
New York, New York, 10029, United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210, United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, 13210, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295, United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, 27705, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, 27104-4241, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, 27157-1082, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, 38103, United States
Veterans Affairs Medical Center - Memphis
Memphis, Tennessee, 38104, United States
Vermont Cancer Center
Burlington, Vermont, 05401-3498, United States
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, 05009, United States
Veterans Affairs Medical Center - Richmond
Richmond, Virginia, 23249, United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037, United States
Biospecimen
blood or bone marrow samples
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Michael A. Caligiuri, MD
Ohio State University Comprehensive Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 1999
First Posted
August 20, 2003
Study Start
February 1, 1999
Primary Completion
June 1, 2006
Study Completion
June 1, 2006
Last Updated
July 4, 2016
Record last verified: 2016-07