Diagnostic Study of Patients With Aggressive Non-Hodgkin's Lymphoma

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

Genetic Changes in Diffuse Aggressive Non-Hodgkin's Lymphoma

RATIONALE: Determination of genetic markers for aggressive non-Hodgkin's lymphoma may help identify patients with this disease and help predict the outcome of treatment.

PURPOSE: Diagnostic study to determine the genetic markers in patients who have aggressive non-Hodgkin's lymphoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Estimate the proportions of patients with diffuse aggressive non-Hodgkin's lymphoma who have rearrangements affecting the MYC, BCL2, and BCL6 genes (determined by fluorescent in situ hybridization), overtly amplified chromosomal regions, and nonrandom copy number changes of chromosomal regions (determined by comparative genomic hybridization).
  • Investigate the prognostic importance of these genetic markers by studying their relationships with clinical outcomes (e.g., response to therapy, failure-free survival, and overall survival) in these patients.
  • Investigate the interrelationships among these genetic and biological markers and their relationships with clinical features of the disease, such as disease site (nodal vs extranodal) and stage, in these patients.

OUTLINE: This is a multicenter study.

Tissue samples are obtained before treatment and at the time of documentation of refractory disease in patients who do not achieve complete remission after induction therapy or at the time of first relapse in patients who achieve a complete remission.

Samples are examined for rearrangements in the MYC, BCL2, BCL6, and IGH genes using fluorescent in situ hybridization. DNA is examined by comparative genomic hybridization, which allows cytogenetic detection of losses and gains of chromosomal regions in tumor cells.

Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment.

Study Type

Observational

Enrollment (Actual)

391

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
      • Anniston, Alabama, United States, 36202-2208
        • Northeast Alabama Regional Medical Center
    • California
      • La Jolla, California, United States, 92093-0843
        • Rebecca and John Moores UCSD Cancer Center
      • San Diego, California, United States, 92161
        • Veterans Affairs Medical Center - San Diego
      • San Diego, California, United States, 92134-3202
        • Naval Medical Center - San Diego
      • San Francisco, California, United States, 94115
        • UCSF Comprehensive Cancer Center
      • San Francisco, California, United States, 94121
        • Veterans Affairs Medical Center - San Francisco
    • Delaware
      • Newark, Delaware, United States, 19713
        • CCOP - Christiana Care Health Services
    • District of Columbia
      • Washington, District of Columbia, United States, 20422
        • Veterans Affairs Medical Center - Washington, DC
      • Washington, District of Columbia, United States, 20007
        • Lombardi Cancer Center at Georgetown University Medical Center
      • Washington, District of Columbia, United States, 20307-5001
        • Walter Reed Army Medical Center
    • Florida
      • Fort Lauderdale, Florida, United States, 33316
        • Broward General Medical Center
      • Hollywood, Florida, United States, 33021
        • Memorial Cancer Institute at Memorial Regional Hospital
      • Miami Beach, Florida, United States, 33140
        • CCOP - Mount Sinai Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60637-1470
        • University of Chicago Cancer Research Center
      • Chicago, Illinois, United States, 60640
        • Louis A. Weiss Memorial Hospital
      • Chicago, Illinois, United States, 60612
        • Veterans Affairs Medical Center - Chicago Westside Hospital
      • Peoria, Illinois, United States, 61615-7828
        • CCOP - Illinois Oncology Research Association
      • River Forest, Illinois, United States, 60305
        • West Suburban Center for Cancer Care
    • Indiana
      • Fort Wayne, Indiana, United States, 46885-5099
        • Fort Wayne Medical Oncology and Hematology, Incorporated
    • Iowa
      • Iowa City, Iowa, United States, 52242-1009
        • Holden Comprehensive Cancer Center at University of Iowa
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Baptist Hospital East - Louisville
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Greenebaum Cancer Center at University of Maryland Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
      • Worcester, Massachusetts, United States, 01655
        • UMASS Memorial Cancer Center - University Campus
    • Michigan
      • Saint Joseph, Michigan, United States, 49085
        • Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
    • 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 at University of Missouri - Columbia
      • Kansas City, Missouri, United States, 64131
        • CCOP - Kansas City
      • Saint Louis, Missouri, United States, 63110
        • Siteman Cancer Center at Barnes-Jewish Hospital
    • Nebraska
      • Omaha, Nebraska, United States, 68198-7680
        • UNMC Eppley Cancer Center at the University of Nebraska Medical Center
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • CCOP - Southern Nevada Cancer Research Foundation
      • Las Vegas, Nevada, United States, 89106
        • Veterans Affairs Medical Center - Las Vegas
    • New Hampshire
      • Hooksett, New Hampshire, United States, 03106
        • New Hampshire Oncology-Hematology, PA - Hooksett
      • Lebanon, New Hampshire, United States, 03756-0002
        • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cancer Institute of New Jersey at the Cooper University Hospital
    • New York
      • Buffalo, New York, United States, 14215
        • Veterans Affairs Medical Center - Buffalo
      • East Syracuse, New York, United States, 13057
        • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
      • Elmhurst, New York, United States, 11373
        • Elmhurst Hospital Center
      • Jamaica, New York, United States, 11432
        • Queens Cancer Center of Queens Hospital
      • Manhasset, New York, United States, 11030
        • CCOP - North Shore University Hospital
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center
      • New York, New York, United States, 10021
        • New York Weill Cornell Cancer Center at Cornell University
      • New York, New York, United States, 10029
        • Mount Sinai Medical Center
      • Syracuse, New York, United States, 13210
        • Veterans Affairs Medical Center - Syracuse
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University Hospital
    • North Carolina
      • Asheville, North Carolina, United States, 28805-9913
        • Veterans Affairs Medical Center - Asheville
      • Chapel Hill, North Carolina, United States, 27599-7295
        • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
      • Concord, North Carolina, United States, 28025
        • NorthEast Oncology Associates - Concord
      • Durham, North Carolina, United States, 27705
        • Veterans Affairs Medical Center - Durham
      • Durham, North Carolina, United States, 27710
        • Duke Comprehensive Cancer Center
      • Fayetteville, North Carolina, United States, 28302-2000
        • Cape Fear Valley Medical Center
      • Goldsboro, North Carolina, United States, 27534-9479
        • CCOP - Southeast Cancer Control Consortium
      • Kinston, North Carolina, United States, 28503-1678
        • Lenoir Memorial Cancer Center
      • Pinehurst, North Carolina, United States, 28374
        • Comprehensive Cancer Center at Moore Regional Hospital
      • Wilmington, North Carolina, United States, 28402-9025
        • Zimmer Cancer Center at New Hanover Regional Medical Center
      • 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 and Solove Research Institute at Ohio State University
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma University Medical Center
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Miriam Hospital at Lifespan
    • Texas
      • Dallas, Texas, United States, 75219
        • Veterans Affairs Medical Center - Dallas
    • Vermont
      • Burlington, Vermont, United States, 05401-3498
        • Vermont Cancer Center at University of Vermont
    • Virginia
      • Charlottesville, Virginia, United States, 22902
        • Cancer Care Center at Martha Jefferson Hospital
      • Norfolk, Virginia, United States, 23502
        • Virginia Oncology Associates - Norfolk
      • Richmond, Virginia, United States, 23298-0037
        • MBCCOP - Massey Cancer Center
      • Roanoke, Virginia, United States, 24014
        • Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke
    • West Virginia
      • Huntington, West Virginia, United States, 25701
        • St. Mary's Medical Center

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with non-Hodgkin's lymphoma and previously enrolled on CALGB 59903, 59909, 10002 and 50103.

Description

DISEASE CHARACTERISTICS:

  • Histologically proven aggressive non-Hodgkin's lymphoma and registered to front-line CALGB protocols (e.g, CLB-59903, 59909, 10002, and 50103)

    • Diffuse small cleaved cell lymphoma
    • Diffuse mixed small and large cell lymphoma
    • Diffuse large cell lymphoma
    • Diffuse large cell immunoblastic lymphoma
    • Small noncleaved cell lymphoma
    • Mantle cell lymphoma OR
  • Previously entered on similar curative CALGB protocols (CLB-8852, CLB-8854, and CLB-9351) with blocks or unstained slides of initial diagnosis available

PATIENT CHARACTERISTICS:

Age:

  • 18 years and older

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1

Tissue samples are obtained before treatment and at the time of documentation of refractory disease in patients who do not achieve complete remission after induction therapy or at the time of first relapse in patients who achieve a complete remission.

Samples are examined for rearrangements in the MYC, BCL2, BCL6, and IGH genes using fluorescent in situ hybridization. DNA is examined by comparative genomic hybridization, which allows cytogenetic detection of losses and gains of chromosomal regions in tumor cells.

Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment.
Genetic: cytogenetic analysis
Genetic: comparative genomic hybridization
Genetic: gene rearrangement analysis
Genetic: fluorescence in situ hybridization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
response to therapy
Time Frame: Up to 5 years
Up to 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: Up to 5 years
Up to 5 years
failure-free survival
Time Frame: Up to 5 years
Up to 5 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: Raju Chaganti, PhD, Memorial Sloan Kettering 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

June 1, 1999

Primary Completion (Actual)

May 1, 2005

Study Completion (Actual)

May 1, 2005

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

July 6, 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-9764
  • U10CA076001 (U.S. NIH Grant/Contract)
  • CDR0000067027 (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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