AzTrials
AzTrials

LymphomaPhase 3NCT00003150

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

A Phase 3 study testing rituximab, CHOP regimen and cyclophosphamide in people with Lymphoma, run by Eastern Cooperative Oncology Group at 91 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Lymphoma
What is being tested?
rituximab, CHOP regimen and cyclophosphamide
How many people
630 participants
Where
91 sitesUnited States
Study dates
Dec 1997to Sep 2006
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

91 sites in 1 country.

91 sites in 1 country

United States91 sites

  • Veterans Affairs Medical Center - Albuquerque

    Albuquerque, New Mexico, 87108-5138

  • MBCCOP - University of New Mexico HSC

    Albuquerque, New Mexico, 87131

  • Veterans Affairs Medical Center - Ann Arbor

    Ann Arbor, Michigan, 48105

  • CCOP - Ann Arbor Regional

    Ann Arbor, Michigan, 48106

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0752

  • CCOP - Atlanta Regional

    Atlanta, Georgia, 30342-1701

  • Hematology Oncology Associates

    Atlantis, Florida, 33462

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Veterans Affairs Medical Center - Biloxi

    Biloxi, Mississippi, 39531-2410

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • MBCCOP - University of Illinois at Chicago

    Chicago, Illinois, 60612-7323

  • Barrett Cancer Center, The University Hospital

    Cincinnati, Ohio, 45219

  • Veterans Affairs Medical Center - Cincinnati

    Cincinnati, Ohio, 45220-2288

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • CCOP - Columbus

    Columbus, Ohio, 43206

  • Simmons Cancer Center - Dallas

    Dallas, Texas, 75235-9154

  • Veterans Affairs Medical Center - Dayton

    Dayton, Ohio, 45428

  • CCOP - Central Illinois

    Decatur, Illinois, 62526

  • University of Colorado Cancer Center

    Denver, Colorado, 80010

  • Veterans Affairs Medical Center - Denver

    Denver, Colorado, 80220

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

  • Veterans Affairs Medical Center - Detroit

    Detroit, Michigan, 48201-1932

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Cancer Center and Beckman Research Institute, City of Hope

    Duarte, California, 91010-3000

  • CCOP - Duluth

    Duluth, Minnesota, 55805

  • Dwight David Eisenhower Army Medical Center

    Fort Gordon, Georgia, 30905-5650

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0209

  • CCOP - Grand Rapids Clinical Oncology Program

    Grand Rapids, Michigan, 49503

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)

    Hines, Illinois, 60141

  • Cancer Research Center of Hawaii

    Honolulu, Hawaii, 96813

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216-4505

  • Veterans Affairs Medical Center - Jackson

    Jackson, Mississippi, 39216

  • Veterans Affairs Medical Center - Boston (Jamaica Plain)

    Jamaica Plain, Massachusetts, 02130

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160-7357

  • Veterans Affairs Medical Center - Kansas City

    Kansas City, Missouri, 64128

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Keesler Medical Center - Keesler AFB

    Keesler Air Force Base, Mississippi, 39534-2576

  • CCOP - Dayton

    Kettering, Ohio, 45429

  • Veterans Affairs Medical Center - Lexington

    Lexington, Kentucky, 40511-1093

  • Albert B. Chandler Medical Center, University of Kentucky

    Lexington, Kentucky, 40536-0084

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Veterans Affairs Medical Center - Little Rock (McClellan)

    Little Rock, Arkansas, 72205

  • Veterans Affairs Medical Center - Long Beach

    Long Beach, California, 90822

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90033-0804

  • Veterans Affairs Medical Center - West Los Angeles

    Los Angeles, California, 90073

  • Jonsson Comprehensive Cancer Center, UCLA

    Los Angeles, California, 90095-1781

  • Texas Tech University Health Science Center

    Lubbock, Texas, 79423

  • Veterans Affairs Outpatient Clinic - Martinez

    Martinez, California, 94553

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • MBCCOP - Gulf Coast

    Mobile, Alabama, 36688

  • MBCCOP - LSU Health Sciences Center

    New Orleans, Louisiana, 70112

  • Tulane University School of Medicine

    New Orleans, Louisiana, 70112

  • Herbert Irving Comprehensive Cancer Center

    New York, New York, 10032

  • CCOP - Bay Area Tumor Institute

    Oakland, California, 94609-3305

  • Veterans Affairs Medical Center - Oklahoma City

    Oklahoma City, Oklahoma, 73104

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73190

  • Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • CCOP - Greater Phoenix

    Phoenix, Arizona, 85006-2726

  • Veterans Affairs Medical Center - Phoenix (Hayden)

    Phoenix, Arizona, 85012

  • Oregon Cancer Center

    Portland, Oregon, 97201-3098

  • Veterans Affairs Medical Center - Portland

    Portland, Oregon, 97207

  • CCOP - Columbia River Program

    Portland, Oregon, 97213

  • University of California Davis Medical Center

    Sacramento, California, 95817

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • Veterans Affairs Medical Center - Salt Lake City

    Salt Lake City, Utah, 84148

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78284-7811

  • Veterans Affairs Medical Center - San Antonio (Murphy)

    San Antonio, Texas, 78284

  • CCOP - Santa Rosa Memorial Hospital

    Santa Rosa, California, 95403

  • CCOP - Virginia Mason Research Center

    Seattle, Washington, 98101

  • Swedish Cancer Institute

    Seattle, Washington, 98104

  • Veterans Affairs Medical Center - Seattle

    Seattle, Washington, 98108

  • Louisiana State University Health Sciences Center - Shreveport

    Shreveport, Louisiana, 71130-3932

  • Veterans Affairs Medical Center - Shreveport

    Shreveport, Louisiana, 71130

  • Providence Hospital - Southfield

    Southfield, Michigan, 48075-9975

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina, 29303

  • CCOP - Cancer Research for the Ozarks

    Springfield, Missouri, 65807

  • St. Louis University Health Sciences Center

    St Louis, Missouri, 63110-0250

  • CCOP - St. Louis-Cape Girardeau

    St Louis, Missouri, 63141

  • CCOP - Northwest

    Tacoma, Washington, 98405-0986

  • Madigan Army Medical Center

    Tacoma, Washington, 98431-5000

  • Veterans Affairs Medical Center - Temple

    Temple, Texas, 76504

  • CCOP - Scott and White Hospital

    Temple, Texas, 76508

  • CCOP - Toledo Community Hospital Oncology Program

    Toledo, Ohio, 43623-3456

  • David Grant Medical Center

    Travis Air Force Base, California, 94535

  • Veterans Affairs Medical Center - Tucson

    Tucson, Arizona, 85723

  • Arizona Cancer Center

    Tucson, Arizona, 85724

  • CCOP - Wichita

    Wichita, Kansas, 67214-3882

  • Veterans Affairs Medical Center - Wichita

    Wichita, Kansas, 67218

  • CCOP - Southeast Cancer Control Consortium

    Winston-Salem, North Carolina, 27104-4241

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
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
Medical subject headings
Lymphoma, Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Large-Cell, Immunoblastic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Feb 2004 (estimated)
  2. Study startDec 1997
  3. Study completionSep 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Enrolment
630 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003150
Sponsor's protocol ID
CDR0000065935
Other IDs
ECOG-E4494, CLB-9793, SWOG-E4494
Status last verified
Aug 2010
First submitted
1 Nov 1999
Last updated
21 Jun 2013
Results posted
No

Publications

  • 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.

    PubMed 20735398

  • 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.

    PubMed 20371683

  • 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.

  • 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.

  • 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.

  • 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.

    PubMed 16754935

  • 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.

    PubMed 16449523

  • 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.

  • 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.

  • 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.

    PubMed 27967294

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing rituximab, CHOP regimen and cyclophosphamide in people with Lymphoma, run by Eastern Cooperative Oncology Group at 91 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 91 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00003150, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in