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Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Older Patients With Non-Hodgkin's Lymphoma

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
rituximab
CHOP regimen
cyclophosphamide
doxorubicin hydrochloride
prednisone
vincristine sulfate
Sponsored by
Eastern Cooperative Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring stage I adult diffuse mixed cell lymphoma, stage I adult diffuse large cell lymphoma, stage I adult immunoblastic large cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage III adult diffuse large cell lymphoma, stage III adult immunoblastic large cell lymphoma, stage IV adult diffuse mixed cell lymphoma, stage IV adult diffuse large cell lymphoma, stage IV adult immunoblastic large 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, noncontiguous stage II adult diffuse mixed cell lymphoma, noncontiguous stage II adult immunoblastic large cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically proven intermediate or high grade B-cell non-Hodgkin's lymphoma (other than Burkitt's, non-Burkitt's, undifferentiated, or lymphoblastic lymphoma) B-cell non-Hodgkin's lymphoma positive for CD19 and/or CD20 by slide-based immunohistochemistry or flow cytometry No mantle cell or follicular lymphoma Measurable disease, defined by at least one of the following: Physical examination Radiographic findings of at least 2 dimensions Bidimensional measurable defect or mass measuring at least 2 cm in diameter on radionuclide or CT scan Enlarged spleen extending at least 2 cm below the costal margin provided that there is no other likely explanation besides lymphomatous involvement Enlarged liver extending at least 5 cm below the costal margin along with biopsy-proven lymphomatous hepatic involvement No history of transformed lymphoma No known posttransplantation lymphoproliferative disorder No CNS involvement CALGB patients 60-65 years of age must not be eligible for any other study of higher priority A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age: See Disease Characteristics 60 and over Performance status: ECOG 0-3 Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm3 (unless due to lymphoma) Platelet count greater than 100,000/mm3 (unless due to lymphoma) Hepatic: Bilirubin no greater than 3.0 mg/dL Renal: Creatinine less than 2.1 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No active heart disease including congestive heart failure, myocardial infarction within the past 3 months, or symptomatic ventricular arrhythmia LVEF at least 45% if prior history of heart disease exists Other: HIV negative No other malignancy within the past 5 years except squamous cell or basal cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No prior biologic response modifier therapy No prior immunotherapy No prior rituximab Chemotherapy: No prior cytotoxic chemotherapy No concurrent dexrazoxane Endocrine therapy: Prior corticosteroids allowed Radiotherapy: No prior radiotherapy No prior radioimmunotherapy Surgery: Not specified

Sites / Locations

  • MBCCOP - Gulf Coast
  • CCOP - Greater Phoenix
  • Veterans Affairs Medical Center - Phoenix (Hayden)
  • Veterans Affairs Medical Center - Tucson
  • Arizona Cancer Center
  • University of Arkansas for Medical Sciences
  • Veterans Affairs Medical Center - Little Rock (McClellan)
  • Cancer Center and Beckman Research Institute, City of Hope
  • Veterans Affairs Medical Center - Long Beach
  • USC/Norris Comprehensive Cancer Center and Hospital
  • Veterans Affairs Medical Center - West Los Angeles
  • Jonsson Comprehensive Cancer Center, UCLA
  • Veterans Affairs Outpatient Clinic - Martinez
  • CCOP - Bay Area Tumor Institute
  • Chao Family Comprehensive Cancer Center
  • University of California Davis Medical Center
  • CCOP - Santa Rosa Memorial Hospital
  • David Grant Medical Center
  • University of Colorado Cancer Center
  • Veterans Affairs Medical Center - Denver
  • Hematology Oncology Associates
  • CCOP - Atlanta Regional
  • Dwight David Eisenhower Army Medical Center
  • Cancer Research Center of Hawaii
  • MBCCOP - University of Illinois at Chicago
  • CCOP - Central Illinois
  • Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
  • Loyola University Medical Center
  • University of Kansas Medical Center
  • CCOP - Wichita
  • Veterans Affairs Medical Center - Wichita
  • Veterans Affairs Medical Center - Lexington
  • Albert B. Chandler Medical Center, University of Kentucky
  • MBCCOP - LSU Health Sciences Center
  • Tulane University School of Medicine
  • Louisiana State University Health Sciences Center - Shreveport
  • Veterans Affairs Medical Center - Shreveport
  • Boston Medical Center
  • Veterans Affairs Medical Center - Boston (Jamaica Plain)
  • Veterans Affairs Medical Center - Ann Arbor
  • CCOP - Ann Arbor Regional
  • University of Michigan Comprehensive Cancer Center
  • Barbara Ann Karmanos Cancer Institute
  • Veterans Affairs Medical Center - Detroit
  • Henry Ford Hospital
  • CCOP - Grand Rapids Clinical Oncology Program
  • Providence Hospital - Southfield
  • CCOP - Duluth
  • Veterans Affairs Medical Center - Biloxi
  • University of Mississippi Medical Center
  • Veterans Affairs Medical Center - Jackson
  • Keesler Medical Center - Keesler AFB
  • Veterans Affairs Medical Center - Kansas City
  • CCOP - Kansas City
  • St. Louis University Health Sciences Center
  • CCOP - St. Louis-Cape Girardeau
  • CCOP - Cancer Research for the Ozarks
  • CCOP - Montana Cancer Consortium
  • Veterans Affairs Medical Center - Albuquerque
  • MBCCOP - University of New Mexico HSC
  • Herbert Irving Comprehensive Cancer Center
  • CCOP - Southeast Cancer Control Consortium
  • Barrett Cancer Center, The University Hospital
  • Veterans Affairs Medical Center - Cincinnati
  • Cleveland Clinic Taussig Cancer Center
  • CCOP - Columbus
  • Veterans Affairs Medical Center - Dayton
  • CCOP - Dayton
  • CCOP - Toledo Community Hospital Oncology Program
  • Veterans Affairs Medical Center - Oklahoma City
  • University of Oklahoma Health Sciences Center
  • Oregon Cancer Center
  • Veterans Affairs Medical Center - Portland
  • CCOP - Columbia River Program
  • CCOP - Greenville
  • CCOP - Upstate Carolina
  • Simmons Cancer Center - Dallas
  • Brooke Army Medical Center
  • University of Texas Medical Branch
  • Texas Tech University Health Science Center
  • University of Texas Health Science Center at San Antonio
  • Veterans Affairs Medical Center - San Antonio (Murphy)
  • Veterans Affairs Medical Center - Temple
  • CCOP - Scott and White Hospital
  • Huntsman Cancer Institute
  • Veterans Affairs Medical Center - Salt Lake City
  • CCOP - Virginia Mason Research Center
  • Swedish Cancer Institute
  • Veterans Affairs Medical Center - Seattle
  • CCOP - Northwest
  • Madigan Army Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
June 20, 2013
Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI), Cancer and Leukemia Group B, SWOG Cancer Research Network
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1. Study Identification

Unique Protocol Identification Number
NCT00003150
Brief Title
Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Older Patients With Non-Hodgkin's Lymphoma
Official Title
Phase III Trial of CHOP Versus CHOP and Chimeric Anti-CD20 Monoclonal Antibody (IDEC-C2B8) in Older Patients With Diffuse Mixed, Diffuse Large Cell and Immunoblastic Large Cell Histology Non-Hodgkin's Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
December 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI), Cancer and Leukemia Group B, SWOG Cancer Research Network

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known if combination chemotherapy is more effective with or without rituximab for non-Hodgkin's lymphoma. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without rituximab in treating older patients who have non-Hodgkin's lymphoma.
Detailed Description
OBJECTIVES: I. Compare the efficacy of CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) with or without rituximab in older patients with diffuse mixed, diffuse large, or immunoblastic large cell non-Hodgkin's lymphoma of B-cell lineage with respect to the response rate, time to treatment failure, toxicity, and survival. II. Compare the efficacy of maintenance therapy consisting of rituximab vs observation alone after initial therapy with respect to the time to treatment failure, duration of response, toxicity, and survival of this patient population. III. Determine if maintenance therapy with rituximab results in the conversion of any partial response to complete response. OUTLINE: This is a randomized study. For the first randomization, patients are stratified according to the number of risk factors (0-1 vs 2-4). For the second randomization, in addition to the number of risk factors, patients are stratified according to objective response to initial induction therapy (partial response vs complete response) and induction therapy (CHOP vs CHOP and rituximab). Patients are randomized to one of two treatment arms. Arm I: Patients receive CHOP chemotherapy comprising cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1 and oral prednisone on days 1-5. Treatment repeats every 21 days in the absence of unacceptable toxicity. Arm II: Patients receive treatment as in arm I. Patients also receive rituximab IV on days -7,-3, 41, and 83. Patients who achieve complete response (CR) after 4 courses of CHOP and remain in CR after 6 courses of CHOP are further randomized to one of two arms. Arm I (Maintenance therapy): Patients receive rituximab IV weekly for 4 weeks. Courses repeat every 6 months for 2 years in the absence of unacceptable toxicity. Arm II: Patients are observed. Patients who achieve partial response (PR) after 6 courses OR PR after 4 courses and then CR after 6 courses receive 2 additional courses of CHOP therapy. Patients are then also randomized to receive either maintenance therapy or observation as above. Patients with stable disease or disease progression are removed from the study. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: Approximately 630 patients will be accrued for this study within 4 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
stage I adult diffuse mixed cell lymphoma, stage I adult diffuse large cell lymphoma, stage I adult immunoblastic large cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage III adult diffuse large cell lymphoma, stage III adult immunoblastic large cell lymphoma, stage IV adult diffuse mixed cell lymphoma, stage IV adult diffuse large cell lymphoma, stage IV adult immunoblastic large 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, noncontiguous stage II adult diffuse mixed cell lymphoma, noncontiguous stage II adult immunoblastic large cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
Enrollment
630 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
rituximab
Intervention Type
Drug
Intervention Name(s)
CHOP regimen
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
prednisone
Intervention Type
Drug
Intervention Name(s)
vincristine sulfate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven intermediate or high grade B-cell non-Hodgkin's lymphoma (other than Burkitt's, non-Burkitt's, undifferentiated, or lymphoblastic lymphoma) B-cell non-Hodgkin's lymphoma positive for CD19 and/or CD20 by slide-based immunohistochemistry or flow cytometry No mantle cell or follicular lymphoma Measurable disease, defined by at least one of the following: Physical examination Radiographic findings of at least 2 dimensions Bidimensional measurable defect or mass measuring at least 2 cm in diameter on radionuclide or CT scan Enlarged spleen extending at least 2 cm below the costal margin provided that there is no other likely explanation besides lymphomatous involvement Enlarged liver extending at least 5 cm below the costal margin along with biopsy-proven lymphomatous hepatic involvement No history of transformed lymphoma No known posttransplantation lymphoproliferative disorder No CNS involvement CALGB patients 60-65 years of age must not be eligible for any other study of higher priority A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age: See Disease Characteristics 60 and over Performance status: ECOG 0-3 Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm3 (unless due to lymphoma) Platelet count greater than 100,000/mm3 (unless due to lymphoma) Hepatic: Bilirubin no greater than 3.0 mg/dL Renal: Creatinine less than 2.1 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No active heart disease including congestive heart failure, myocardial infarction within the past 3 months, or symptomatic ventricular arrhythmia LVEF at least 45% if prior history of heart disease exists Other: HIV negative No other malignancy within the past 5 years except squamous cell or basal cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No prior biologic response modifier therapy No prior immunotherapy No prior rituximab Chemotherapy: No prior cytotoxic chemotherapy No concurrent dexrazoxane Endocrine therapy: Prior corticosteroids allowed Radiotherapy: No prior radiotherapy No prior radioimmunotherapy Surgery: Not specified
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas M. Habermann, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Vicki A. Morrison, MD
Organizational Affiliation
Veterans Affairs Medical Center - Minneapolis
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
James K. Weick, MD
Organizational Affiliation
Hematology Oncology Associates of the Palm Beaches
Official's Role
Study Chair
Facility Information:
Facility Name
MBCCOP - Gulf Coast
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36688
Country
United States
Facility Name
CCOP - Greater Phoenix
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006-2726
Country
United States
Facility Name
Veterans Affairs Medical Center - Phoenix (Hayden)
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Veterans Affairs Medical Center - Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723
Country
United States
Facility Name
Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Veterans Affairs Medical Center - Little Rock (McClellan)
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Cancer Center and Beckman Research Institute, City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States
Facility Name
Veterans Affairs Medical Center - Long Beach
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
USC/Norris Comprehensive Cancer Center and Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033-0804
Country
United States
Facility Name
Veterans Affairs Medical Center - West Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
Jonsson Comprehensive Cancer Center, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States
Facility Name
Veterans Affairs Outpatient Clinic - Martinez
City
Martinez
State/Province
California
ZIP/Postal Code
94553
Country
United States
Facility Name
CCOP - Bay Area Tumor Institute
City
Oakland
State/Province
California
ZIP/Postal Code
94609-3305
Country
United States
Facility Name
Chao Family Comprehensive Cancer Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
University of California Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
CCOP - Santa Rosa Memorial Hospital
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
David Grant Medical Center
City
Travis Air Force Base
State/Province
California
ZIP/Postal Code
94535
Country
United States
Facility Name
University of Colorado Cancer Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80010
Country
United States
Facility Name
Veterans Affairs Medical Center - Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Hematology Oncology Associates
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
CCOP - Atlanta Regional
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342-1701
Country
United States
Facility Name
Dwight David Eisenhower Army Medical Center
City
Fort Gordon
State/Province
Georgia
ZIP/Postal Code
30905-5650
Country
United States
Facility Name
Cancer Research Center of Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
MBCCOP - University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612-7323
Country
United States
Facility Name
CCOP - Central Illinois
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
City
Hines
State/Province
Illinois
ZIP/Postal Code
60141
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160-7357
Country
United States
Facility Name
CCOP - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214-3882
Country
United States
Facility Name
Veterans Affairs Medical Center - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67218
Country
United States
Facility Name
Veterans Affairs Medical Center - Lexington
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40511-1093
Country
United States
Facility Name
Albert B. Chandler Medical Center, University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0084
Country
United States
Facility Name
MBCCOP - LSU Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Tulane University School of Medicine
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Louisiana State University Health Sciences Center - Shreveport
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130-3932
Country
United States
Facility Name
Veterans Affairs Medical Center - Shreveport
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Veterans Affairs Medical Center - Boston (Jamaica Plain)
City
Jamaica Plain
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States
Facility Name
Veterans Affairs Medical Center - Ann Arbor
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
CCOP - Ann Arbor Regional
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0752
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1379
Country
United States
Facility Name
Veterans Affairs Medical Center - Detroit
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1932
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
CCOP - Grand Rapids Clinical Oncology Program
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Providence Hospital - Southfield
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075-9975
Country
United States
Facility Name
CCOP - Duluth
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Veterans Affairs Medical Center - Biloxi
City
Biloxi
State/Province
Mississippi
ZIP/Postal Code
39531-2410
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216-4505
Country
United States
Facility Name
Veterans Affairs Medical Center - Jackson
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Keesler Medical Center - Keesler AFB
City
Keesler AFB
State/Province
Mississippi
ZIP/Postal Code
39534-2576
Country
United States
Facility Name
Veterans Affairs Medical Center - Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64128
Country
United States
Facility Name
CCOP - Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
St. Louis University Health Sciences Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110-0250
Country
United States
Facility Name
CCOP - St. Louis-Cape Girardeau
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
CCOP - Cancer Research for the Ozarks
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
CCOP - Montana Cancer Consortium
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Veterans Affairs Medical Center - Albuquerque
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108-5138
Country
United States
Facility Name
MBCCOP - University of New Mexico HSC
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Herbert Irving Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
CCOP - Southeast Cancer Control Consortium
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27104-4241
Country
United States
Facility Name
Barrett Cancer Center, The University Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Veterans Affairs Medical Center - Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220-2288
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
CCOP - Columbus
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43206
Country
United States
Facility Name
Veterans Affairs Medical Center - Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45428
Country
United States
Facility Name
CCOP - Dayton
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
CCOP - Toledo Community Hospital Oncology Program
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623-3456
Country
United States
Facility Name
Veterans Affairs Medical Center - Oklahoma City
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73190
Country
United States
Facility Name
Oregon Cancer Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201-3098
Country
United States
Facility Name
Veterans Affairs Medical Center - Portland
City
Portland
State/Province
Oregon
ZIP/Postal Code
97207
Country
United States
Facility Name
CCOP - Columbia River Program
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
CCOP - Greenville
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
CCOP - Upstate Carolina
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Simmons Cancer Center - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235-9154
Country
United States
Facility Name
Brooke Army Medical Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555-0209
Country
United States
Facility Name
Texas Tech University Health Science Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79423
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78284-7811
Country
United States
Facility Name
Veterans Affairs Medical Center - San Antonio (Murphy)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78284
Country
United States
Facility Name
Veterans Affairs Medical Center - Temple
City
Temple
State/Province
Texas
ZIP/Postal Code
76504
Country
United States
Facility Name
CCOP - Scott and White Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Veterans Affairs Medical Center - Salt Lake City
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84148
Country
United States
Facility Name
CCOP - Virginia Mason Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Swedish Cancer Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Veterans Affairs Medical Center - Seattle
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
Facility Name
CCOP - Northwest
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405-0986
Country
United States
Facility Name
Madigan Army Medical Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431-5000
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20735398
Citation
Advani RH, Chen H, Habermann TM, Morrison VA, Weller EA, Fisher RI, Peterson BA, Gascoyne RD, Horning SJ; Eastern Cooperative Oncology Group; Cancer and Leukemia Group B; Southwest Oncology Group. Comparison of conventional prognostic indices in patients older than 60 years with diffuse large B-cell lymphoma treated with R-CHOP in the US Intergroup Study (ECOG 4494, CALGB 9793): consideration of age greater than 70 years in an elderly prognostic index (E-IPI). Br J Haematol. 2010 Oct;151(2):143-51. doi: 10.1111/j.1365-2141.2010.08331.x.
Results Reference
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PubMed Identifier
20371683
Citation
Winter JN, Li S, Aurora V, Variakojis D, Nelson B, Krajewska M, Zhang L, Habermann TM, Fisher RI, Macon WR, Chhanabhai M, Felgar RE, Hsi ED, Medeiros LJ, Weick JK, Weller EA, Melnick A, Reed JC, Horning SJ, Gascoyne RD. Expression of p21 protein predicts clinical outcome in DLBCL patients older than 60 years treated with R-CHOP but not CHOP: a prospective ECOG and Southwest Oncology Group correlative study on E4494. Clin Cancer Res. 2010 Apr 15;16(8):2435-42. doi: 10.1158/1078-0432.CCR-09-1219. Epub 2010 Apr 6.
Results Reference
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Citation
Aurora V, Li S, Horning SJ, et al.: Prognostic significance of p53/p21 expression in DLBCL treated with CHOP or R-CHOP: a correlative study of E4494. [Abstract] J Clin Oncol 25 (Suppl 18): A-8038, 450s, 2007.
Results Reference
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Citation
Morrison VA, Weller EA, Habermann TM, et al.: Maintenance rituximab (MR) compared to observation (OBS) after R-CHOP or CHOP in older patients (pts) with diffuse large B-cell lymphoma (DLBCL): an Intergroup E4494/C9793 update. [Abstract] J Clin Oncol 25 (Suppl 18): A-8011, 443s, 2007.
Results Reference
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Citation
Advani RH, Chen H, Habermann TM, et al.: Prognostic indices in older DLBCL patients receiving R-CHOP: an analysis of the U.S. Intergroup study (E4494, CALGB 9793). [Abstract] Blood 108 (11): A-813, 2006.
Results Reference
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PubMed Identifier
16754935
Citation
Habermann TM, Weller EA, Morrison VA, Gascoyne RD, Cassileth PA, Cohn JB, Dakhil SR, Woda B, Fisher RI, Peterson BA, Horning SJ. Rituximab-CHOP versus CHOP alone or with maintenance rituximab in older patients with diffuse large B-cell lymphoma. J Clin Oncol. 2006 Jul 1;24(19):3121-7. doi: 10.1200/JCO.2005.05.1003. Epub 2006 Jun 5.
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PubMed Identifier
16449523
Citation
Winter JN, Weller EA, Horning SJ, Krajewska M, Variakojis D, Habermann TM, Fisher RI, Kurtin PJ, Macon WR, Chhanabhai M, Felgar RE, Hsi ED, Medeiros LJ, Weick JK, Reed JC, Gascoyne RD. Prognostic significance of Bcl-6 protein expression in DLBCL treated with CHOP or R-CHOP: a prospective correlative study. Blood. 2006 Jun 1;107(11):4207-13. doi: 10.1182/blood-2005-10-4222. Epub 2006 Jan 31. Erratum In: Blood. 2007 Mar 15;109(6):2292.
Results Reference
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Citation
Morrison V, Weller E, Habermann T, et al.: Dose intensity of CHOP alone or with rituximab in diffuse large B-cell lymphoma (DLBCL) in patients >60 years of age: an analysis of the intergroup trial ( CALGB 9793, ECOG-SWOG 4494). [Abstract] Ann Oncol 16 (Suppl 5): A-224, v102, 2005.
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Citation
Habermann TM, Weller E, Morrison VA, et al.: Rituximab-CHOP versus CHOP with or without maintenance rituximab in patients 60 years of age or older with diffuse large B-cell lymphoma (DLBCL): an update. [Abstract] Blood 104 (11): A-127, 2004.
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PubMed Identifier
27967294
Citation
Morrison VA, Weller EA, Habermann TM, Li S, Fisher RI, Cheson BD, Peterson BA. Patterns of growth factor usage and febrile neutropenia among older patients with diffuse large B-cell non-Hodgkin lymphoma treated with CHOP or R-CHOP: the Intergroup experience (CALGB 9793; ECOG-SWOG 4494). Leuk Lymphoma. 2017 Aug;58(8):1814-1822. doi: 10.1080/10428194.2016.1265111. Epub 2016 Dec 14.
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Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Older Patients With Non-Hodgkin's Lymphoma

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