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Spots Global Cancer Trial Database for Combination Chemotherapy Plus Rituximab in Treating Patients With Intermediate-Grade or High-Grade Non-Hodgkin's Lymphoma

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Trial Identification

Brief Title: Combination Chemotherapy Plus Rituximab in Treating Patients With Intermediate-Grade or High-Grade Non-Hodgkin's Lymphoma

Official Title: Phase II Trial of Rituximab in Combination With CHOP Chemotherapy in Patients With Previously Untreated Intermediate or High Grade Non-Hodgkin's Lymphoma

Study ID: NCT00005959

Conditions

Lymphoma

Study Description

Brief Summary: RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one chemotherapy drug with rituximab may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of rituximab plus combination chemotherapy in treating patients who have intermediate-grade or high-grade non-Hodgkin's lymphoma.

Detailed Description: OBJECTIVES: I. Determine the rate of complete response and partial response in patients with intermediate or high grade non-Hodgkin's lymphoma treated with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). II. Determine the toxicity of this regimen in these patients. III. Determine the disease-free and overall survival, time to response, and time to disease progression in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients are stratified according to the number of risk factors (0-2 vs 3-5). Risk factors include age (no greater than 60 vs greater than 60), tumor stage (II vs III or IV), number of extranodal sites (no more than 1 vs more than 1), performance status (0-1 vs 2-4), and serum LDH level (no greater than normal vs greater than normal). Patients receive rituximab IV on day 1; cyclophosphamide, doxorubicin, and vincristine IV on day 3; and oral prednisone on days 3-7. Patients over 60 also receive filgrastim (G-CSF) subcutaneously beginning on day 4 and continuing until blood counts recover (all other patients receive G-CSF as secondary prophylaxis). Treatment continues every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients who respond receive 2 more courses. Patients who have no measurable disease after 6 courses receive rituximab IV once weekly for 4 consecutive weeks. This treatment continues every 6 months for 4 courses in the absence of disease progression or unacceptable toxicity. Patients who have measurable disease after 6 courses of chemotherapy receive 2 more courses for a maximum of 8 courses of CHOP, followed by maintenance therapy with rituximab (as described above). Patients are followed every 6 months for 2 years. PROJECTED ACCRUAL: Approximately 100 patients will be accrued for this study.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Montgomery Cancer Center, Montgomery, Alabama, United States

University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States

Providence Saint Joseph Medical Center - Burbank, Burbank, California, United States

Cancer and Blood Institute of the Desert, Rancho Mirage, California, United States

Southeast Florida Hematology-Oncology Group, Fort Lauderdale, Florida, United States

Mount Sinai Comprehensive Cancer Center, Miami Beach, Florida, United States

Oncology-Hematology Group of South Florida, Miami, Florida, United States

Hematology-Oncology Associates, PA, Pensacola, Florida, United States

Hutchinson Clinic, P.A., Hutchinson, Kansas, United States

Hematology/Oncology Care Inc., Crestview Hills, Kentucky, United States

Maine Center for Cancer Medicine and Blood Disorders, Scarborough, Maine, United States

Associates in Oncology and Hematology, Rockville, Maryland, United States

North Shore Cancer Center, Peabody, Massachusetts, United States

Henry Ford Hospital, Detroit, Michigan, United States

Lakeland Medical Center - St. Joseph, Saint Joseph, Michigan, United States

Bond Clinic, Rolla, Missouri, United States

Midwest Hematology Oncology Consultants, Ltd., Saint Louis, Missouri, United States

Hematology Oncology Associates, Morristown, New Jersey, United States

New Mexico Oncology-Hematology, Albuquerque, New Mexico, United States

Our Lady of Mercy Medical Center, Bronx, New York, United States

HemOnCare, P.C., Brooklyn, New York, United States

N.W. Carolina Oncology & Hematology, P.A., Hickory, North Carolina, United States

Oncology/Hematology Care, Inc., Cincinnati, Ohio, United States

University of Tennessee, Memphis, Memphis, Tennessee, United States

Intermountain Hematology/Oncology Associates, Inc., Salt Lake City, Utah, United States

Vermont Center for Cancer Medicine, Inc., Colchester, Vermont, United States

Hematology & Oncology Associates of Virginia, Richmond, Virginia, United States

Contact Details

Name: Carol Brannan, BS, BSN

Affiliation: Amgen

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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