Rituximab and Combination Chemotherapy in Treating Patients With Diffuse Large B-Cell Non-Hodgkin's Lymphoma
Alternate Title
Basic Trial Information
Trial Description
Purpose
Eligibility
Treatment/Intervention
Trial Contact Information
Related Information
Registry Information
Alternate Title
Phase III Randomized Study of Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) Versus Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin and Rituximab (EPOCH-R) in Patients With Previously Untreated De Novo Diffuse Large B-Cell Non-Hodgkin's Lymphoma
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| Phase III | Diagnostic, Treatment | Active | 18 and over | CALGB-50303
ECOG-50303, NCI-05-C-0252, NCT00118209 |
Special Category:
NIH Clinical Center trial
Trial Description
Purpose:
Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective when given with rituximab in treating diffuse large B-cell non-Hodgkin's lymphoma. Imaging procedures, such as fludeoxyglucose F 18 positron emission tomography (FDG-PET)/computed tomography (CT), may help diagnose if recurrent disease is likely.
This randomized phase III trial is studying rituximab when given together with two different combination chemotherapy regimens to compare how well they work in treating patients with diffuse large B-cell non-Hodgkin's lymphoma.
Eligibility:
Eligibility criteria include the following:
- At least 18 years old
- No CNS lymphoma
- No previous rituximab or chemotherapy
- Must be registered on trial CALGB-580603 for imaging studies (beginning July 1, 2012)
- For more information about the eligibility criteria for this trial, refer to the Health Professional version.
Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Treatment/Intervention:
Patients will be randomly assigned (have an equal chance of being placed) to one of two treatment groups.
Patients in group one will receive an infusion of rituximab, an infusion of cyclophosphamide, an infusion of doxorubicin, and an infusion of vincristine in week 1. They will also receive prednisone by mouth for 5 days in week 1. Treatment may repeat every 3 weeks for up to six courses.
Patients in group two will receive an infusion of rituximab, a 96-hour continuous infusion of doxorubicin, etoposide, and vincristine, and an infusion of cyclophosphamide in week 1. They will also receive prednisone by mouth twice a day for 5 days in week 1 and G-CSF once a day for 10 days in weeks 1-3 or until blood counts return to normal. Treatment may repeat every 3 weeks for up to six courses.
Patients will undergo FDG-PET/CT imaging at baseline and during study treatment.
Patients will be evaluated every 3 months for 2 years and every 6 months for up to 3 years.
Important:
For more details about this trial, refer to the Health Professional version of the trial summary.
If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on
NCI's Web site.
Trial Contact Information
Trial Lead Organizations
Cancer and Leukemia Group B
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| Wyndham Wilson, MD, PhD, Protocol chair | | |
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| Andrew D. Zelenetz, MD, PhD, Protocol co-chair | | | Ph: 212-639-2656; 800-525-2225 |
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Trial Sites
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| U.S.A. |
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| California |
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Mountain View |
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| | Camino Medical Group - Treatment Center |
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| | Peter Yu, MD | |
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Palo Alto |
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| | Palo Alto Medical Foundation |
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| | David Leibowitz | |
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Saint Helena |
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| | Saint Helena Hospital |
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| | Gregory Smith | |
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San Diego |
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| | Naval Medical Center - San Diego |
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| | Preston Gable, MD, FACP | |
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| Connecticut |
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Norwich |
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| | Eastern Connecticut Hematology and Oncology Associates |
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| | Dennis Slater, MD | |
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| Delaware |
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Newark |
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| | CCOP - Christiana Care Health Services |
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| | Clinical Trial Office - CCOP - Christiana Care Health Services | |
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| Illinois |
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Chicago |
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| | Creticos Cancer Center at Advocate Illinois Masonic Medical Center |
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| | Clinical Trials Office - Creticos Cancer Center at Advocate Illinois Masonic Medical Center | |
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| | Robert H. Lurie Comprehensive Cancer Center at Northwestern University |
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| | Clinical Trials Office - Robert H. Lurie Comprehensive Cancer Center at Northwestern University | |
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Email:
cancer@northwestern.edu |
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| Maryland |
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Baltimore |
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| | Alvin and Lois Lapidus Cancer Institute at Sinai Hospital |
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| | Roberto Martinez | |
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Bethesda |
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| | National Naval Medical Center |
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| | David Van Echo | |
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| | NIH - Warren Grant Magnuson Clinical Center |
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| | Clinical Trials Office - NIH - Warren Grant Magnuson Clinical Center | |
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| Missouri |
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Saint Louis |
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| | Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis |
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| | Nancy Bartlett, MD | |
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| New Hampshire |
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Concord |
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| | New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care |
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| | Douglas Weckstein, MD | |
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Hooksett |
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| | New Hampshire Oncology - Hematology, PA - Hooksett |
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| | Douglas Weckstein, MD | |
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| New York |
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Glens Falls |
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| | Charles R. Wood Cancer Center at Glens Falls Hospital |
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| | Clinical Trials Office - Charles R. Wood Cancer Center at Glens Falls Hospital | |
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New York |
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| | New York Weill Cornell Cancer Center at Cornell University |
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| | Clinical Trials Office - New York Weill Cornell Cancer Center at Cornell University | |
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| North Carolina |
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Charlotte |
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| | Presbyterian Cancer Center at Presbyterian Hospital |
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| | Clinical Trials Office - Presbyterian Cancer Center at Presbyterian Hospital | |
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Kinston |
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| | Kinston Medical Specialists |
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| | Peter Watson, MD | |
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Winston-Salem |
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| | Wake Forest University Comprehensive Cancer Center |
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| | Clinical Trials Office - Wake Forest University Comprehensive Cancer Center | |
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| North Dakota |
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Grand Forks |
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| | Altru Cancer Center at Altru Hospital |
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| | Clinical Trails Office - Altru Cancer Center at Altru Hospital | |
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| Ohio |
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Columbus |
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| | Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center |
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| | Ohio State University Cancer Clinical Trial Matching Service | |
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Email:
Jamesline@osumc.edu |
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| Pennsylvania |
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Hershey |
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| | Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center |
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| | Clinical Trials Office - Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center | |
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Email:
CTO@hmc.psu.edu |
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| Vermont |
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Berlin |
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| | Mountainview Medical |
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| | Emiliano Mugnaini | |
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| Washington |
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Tacoma |
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| | Madigan Army Medical Center - Tacoma |
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| | Anthony Fadell | |
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| West Virginia |
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Morgantown |
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| | Mary Babb Randolph Cancer Center at West Virginia University Hospitals |
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| | Mehdi Hamadani | | Ph: | 304-293-4500 | | 877-427-2894 |
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| Wisconsin |
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Minocqua |
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| | Marshfield Clinic - Lakeland Center |
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| | Ali Bseiso, MD | |
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Rice Lake |
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| | Marshfield Clinic - Indianhead Center |
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| | Ali Bseiso, MD | |
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Stevens Point |
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| | Saint Michael's Hospital Cancer Center |
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| | Ali Bseiso, MD | |
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Related Information
Web site for additional information
| Registry Information |
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| Official Title | | Phase III Randomized Study of R-CHOP V. Dose-Adjusted EPOCH-R with Molecular Profiling in Untreated De Novo Diffuse Large B-Cell Lymphomas |
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| Trial Start Date | | 2005-05-02 |
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| Trial Completion Date | | 2015-01-31 (estimated) |
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| Registered in ClinicalTrials.gov | | NCT00118209 |
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| Date Submitted to PDQ | | 2005-05-06 |
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| Information Last Verified | | 2012-10-13 |
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| NCI Grant/Contract Number | | CA31946 |
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