Diagnostic Study of Patients With Aggressive Non-Hodgkin's Lymphoma
Official Title
Genetic Changes in Diffuse Aggressive Non-Hodgkin's Lymphoma
Acronym
Not provided
Organization
Alliance for Clinical Trials in OncologyOTHER
Status Module
Record Verification Date
Jul 2016
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jun 1999
Primary Completion Date
May 2005Actual
Completion Date
May 2005Actual
First Submitted Date
Nov 1, 1999
First Submission Date that Met QC Criteria
Jan 26, 2003
First Posted Date
Jan 27, 2003Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jul 1, 2016
Last Update Posted Date
Jul 6, 2016Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Alliance for Clinical Trials in OncologyOTHER
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
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.
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.
Conditions Module
Conditions
Lymphoma
Keywords
stage I adult diffuse small cleaved cell lymphoma
stage I adult diffuse mixed cell lymphoma
stage I adult diffuse large cell lymphoma
stage I adult immunoblastic large cell lymphoma
stage I adult Burkitt lymphoma
stage III adult diffuse small cleaved cell lymphoma
stage III adult diffuse mixed cell lymphoma
stage III adult diffuse large cell lymphoma
stage III adult immunoblastic large cell lymphoma
stage III adult Burkitt lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse large cell lymphoma
stage IV adult immunoblastic large cell lymphoma
Design Module
Study Type
Observational
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
No
Target Follow-Up Duration
Not provided
Phases
Not provided
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
Retention
Enrollment
391Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
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: comparative genomic hybridization
Genetic: cytogenetic analysis
Genetic: fluorescence in situ hybridization
Genetic: gene rearrangement analysis
Interventions
Name
Type
Description
Arm Group Labels
Other Names
comparative genomic hybridization
Genetic
Group 1
cytogenetic analysis
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
response to therapy
Up to 5 years
Secondary Outcomes
Measure
Description
Time Frame
failure-free survival
Up to 5 years
overall survival
Up to 5 years
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Patients diagnosed with non-Hodgkin's lymphoma and previously enrolled on CALGB 59903, 59909, 10002 and 50103.
Sampling Method
Non-Probability Sample
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Raju Chaganti, PhD
Memorial Sloan Kettering Cancer Center
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Northeast Alabama Regional Medical Center
Anniston
Alabama
36202-2208
United States
Rebecca and John Moores UCSD Cancer Center
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
stage IV adult Burkitt lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult Burkitt lymphoma
stage I mantle cell lymphoma
contiguous stage II adult diffuse small cleaved cell lymphoma
contiguous stage II mantle cell lymphoma
contiguous stage II adult diffuse mixed cell lymphoma
contiguous stage II adult immunoblastic large cell lymphoma
contiguous stage II adult diffuse large cell lymphoma
contiguous stage II adult Burkitt lymphoma
noncontiguous stage II adult diffuse small cleaved cell lymphoma
noncontiguous stage II mantle cell lymphoma
noncontiguous stage II adult diffuse mixed cell lymphoma
noncontiguous stage II adult immunoblastic large cell lymphoma
noncontiguous stage II adult diffuse large cell lymphoma
noncontiguous stage II adult Burkitt lymphoma
stage III mantle cell lymphoma
stage IV mantle cell lymphoma
recurrent mantle cell lymphoma
Not provided
Intervention Model Description
Not provided
Primary Purpose
Not provided
Observational Model
Case-Only
Time Perspective
Prospective
Masking Info
No data available
No data is available for this block.
Samples With DNA
Description
Tissue samples
Genetic
Group 1
fluorescence in situ hybridization
Genetic
Group 1
gene rearrangement analysis
Genetic
Group 1
La Jolla
California
92093-0843
United States
Naval Medical Center - San Diego
San Diego
California
92134-3202
United States
Veterans Affairs Medical Center - San Diego
San Diego
California
92161
United States
UCSF Comprehensive Cancer Center
San Francisco
California
94115
United States
Veterans Affairs Medical Center - San Francisco
San Francisco
California
94121
United States
CCOP - Christiana Care Health Services
Newark
Delaware
19713
United States
Lombardi Cancer Center at Georgetown University Medical Center
Washington D.C.
District of Columbia
20007
United States
Walter Reed Army Medical Center
Washington D.C.
District of Columbia
20307-5001
United States
Veterans Affairs Medical Center - Washington, DC
Washington D.C.
District of Columbia
20422
United States
Broward General Medical Center
Fort Lauderdale
Florida
33316
United States
Memorial Cancer Institute at Memorial Regional Hospital
Hollywood
Florida
33021
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
Louis A. Weiss Memorial Hospital
Chicago
Illinois
60640
United States
CCOP - Illinois Oncology Research Association
Peoria
Illinois
61615-7828
United States
West Suburban Center for Cancer Care
River Forest
Illinois
60305
United States
Fort Wayne Medical Oncology and Hematology, Incorporated
Fort Wayne
Indiana
46885-5099
United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City
Iowa
52242-1009
United States
Baptist Hospital East - Louisville
Louisville
Kentucky
40207
United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore
Maryland
21201
United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston
Massachusetts
02115
United States
UMASS Memorial Cancer Center - University Campus
Worcester
Massachusetts
01655
United States
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
Saint Joseph
Michigan
49085
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 at University of Missouri - Columbia
Columbia
Missouri
65203
United States
CCOP - Kansas City
Kansas City
Missouri
64131
United States
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis
Missouri
63110
United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha
Nebraska
68198-7680
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas
Nevada
89106
United States
Veterans Affairs Medical Center - Las Vegas
Las Vegas
Nevada
89106
United States
New Hampshire Oncology-Hematology, PA - Hooksett
Hooksett
New Hampshire
03106
United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon
New Hampshire
03756-0002
United States
Cancer Institute of New Jersey at the Cooper University Hospital
Camden
New Jersey
08103
United States
Veterans Affairs Medical Center - Buffalo
Buffalo
New York
14215
United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
East Syracuse
New York
13057
United States
Elmhurst Hospital Center
Elmhurst
New York
11373
United States
Queens Cancer Center of Queens Hospital
Jamaica
New York
11432
United States
CCOP - North Shore University Hospital
Manhasset
New York
11030
United States
North Shore University Hospital
Manhasset
New York
11030
United States
Memorial Sloan-Kettering Cancer Center
New York
New York
10021
United States
New York Weill Cornell Cancer Center at Cornell University
New York
New York
10021
United States
Mount Sinai Medical Center
New York
New York
10029
United States
SUNY Upstate Medical University Hospital
Syracuse
New York
13210
United States
Veterans Affairs Medical Center - Syracuse
Syracuse
New York
13210
United States
Veterans Affairs Medical Center - Asheville
Asheville
North Carolina
28805-9913
United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill
North Carolina
27599-7295
United States
NorthEast Oncology Associates - Concord
Concord
North Carolina
28025
United States
Veterans Affairs Medical Center - Durham
Durham
North Carolina
27705
United States
Duke Comprehensive Cancer Center
Durham
North Carolina
27710
United States
Cape Fear Valley Medical Center
Fayetteville
North Carolina
28302-2000
United States
CCOP - Southeast Cancer Control Consortium
Goldsboro
North Carolina
27534-9479
United States
Lenoir Memorial Cancer Center
Kinston
North Carolina
28503-1678
United States
Comprehensive Cancer Center at Moore Regional Hospital
Pinehurst
North Carolina
28374
United States
Zimmer Cancer Center at New Hanover Regional Medical Center
Wilmington
North Carolina
28402-9025
United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem
North Carolina
27157-1082
United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus
Ohio
43210-1240
United States
Oklahoma University Medical Center
Oklahoma City
Oklahoma
73104
United States
Miriam Hospital at Lifespan
Providence
Rhode Island
02906
United States
Veterans Affairs Medical Center - Dallas
Dallas
Texas
75219
United States
Vermont Cancer Center at University of Vermont
Burlington
Vermont
05401-3498
United States
Cancer Care Center at Martha Jefferson Hospital
Charlottesville
Virginia
22902
United States
Virginia Oncology Associates - Norfolk
Norfolk
Virginia
23502
United States
MBCCOP - Massey Cancer Center
Richmond
Virginia
23298-0037
United States
Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke