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Home > "C" Clinical Trials Conditions > Combination Chemotherapy With or Without Rituximab in Treating Patients With Newly Diagnosed Non-Hodgkin's Lymphoma  Combination Chemotherapy With or Without Rituximab in Treating Patients With Newly Diagnosed Non-Hodgkin's Lymphoma
Combination Chemotherapy With or Without Rituximab in Treating Patients With Newly Diagnosed Non-Hodgkin's Lymphoma
For Condition: stage 2 adult diffuse small cleaved cell lymphoma,stage 4 mantle cell lymphoma,stage 2 mantle cell lymphoma,stage 3 mantle cell lymphoma,stage 4 adult diffuse mixed cell lymphoma,stage 3 adult diffuse mixed cell lymphoma,stage 2 diffuse small lymphocytic/marginal zone lymphoma,stage 4 diffuse small lymphocytic/marginal zone lymphoma,stage 4 adult diffuse small cleaved cell lymphoma,stage 2 adult diffuse large cell lymphoma,anaplastic large cell lymphoma,stage 3 adult diffuse large cell lymphoma,stage 2 adult diffuse mixed cell lymphoma,stage 3 adult diffuse small cleaved cell lymphoma,stage 3 diffuse small lymphocytic/marginal zone lymphoma,stage 4 adult diffuse large cell lymphoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , University of Nebraska
Synopsis: 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 cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy plus rituximab is more effective than combination chemotherapy alone for non-Hodgkin's lymphoma. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without rituximab in treating patients who have newly diagnosed non-Hodgkin's lymphoma that has not been treated previously.
Details: OBJECTIVES: I. Determine whether the addition of rituximab to cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) increases the failure-free survival of patients with newly diagnosed, previously untreated, aggressive B-cell non-Hodgkin's lymphoma. II. Determine whether the addition of rituximab changes the toxicity profile attributed to CHOP chemotherapy in this patient population. PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified by center, histology (diffuse small cleaved cell, diffuse mixed, and diffuse large cell vs immunoblastic large cell, mantle cell, and marginal zone), and risk group (low vs intermediate vs high). Patients enter one of two treatment arms: Arm I: Patients receive rituximab IV on day 1, followed by cyclophosphamide IV, doxorubicin IV, vincristine IV, and oral prednisone for 5 consecutive days beginning on day 3. Arm II: Patients receive cyclophosphamide IV, doxorubicin IV, vincristine IV, and oral prednisone daily for 5 consecutive days beginning on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients will be followed for 3 years. PROJECTED ACCRUAL: A total of 270 patients (135 per treatment arm) will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 19 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed, newly diagnosed, aggressive (stage II-IV) B-cell non-Hodgkin's lymphoma, including but not limited to: Mantle cell; Diffuse large cell; Diffuse mixed cell; Anaplastic large cell (B-cell type); Diffuse small cleaved cell; Marginal zone lymphoma - No prior T-cell lymphoma - CD20 positive --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No other concurrent chemotherapy - Endocrine therapy: No concurrent corticosteroids (unless for prevention of nausea or vomiting); Nonsteroidal hormones for nonlymphoma related conditions allowed (e.g., insulin for diabetes) - Radiotherapy: No concurrent radiotherapy - Surgery: Not specified - Other: No other concurrent investigational agents --Patient Characteristics-- - Age: 19 and over - Performance status: WHO 0-2; Karnofsky 70-100% - Life expectancy: At least 6 months - Hematopoietic: Absolute neutrophil count greater than 1,000/mm3 (unless due to non-Hodgkin's lymphoma (NHL) bone marrow involvement) - Hepatic: Unless due to NHL: Bilirubin less than 3.0 mg/dL; Alkaline phosphatase less than 3 times upper limit of normal (ULN); SGOT less than 3 times ULN - Renal: Not specified - Other: Not pregnant or nursing; Fertile patients must use effective contraception; HIV negative; No other serious disease or medical condition that would interfere with compliance
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JulieVose, Study Chair, University of Nebraska
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3330
United States
Additional Information:
Study ID Numbers: CDR0000067336; UNMC-447-97,NCI-G99-1601,UCLA-HSPC-9812071
Study Start Date: September 1999
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004112
Other Stage 4 Adult Diffuse Small Cleaved Cell Lymphoma Studies:
1. Antineoplaston Therapy in Treating Patients With Mantle Cell Lymphoma
2. Chemotherapy and Rituximab With Peripheral Stem Cell Transplantation in Treating Patients With Mantle Cell Lymphoma
3. Chemotherapy Plus Rituximab in Treating Patients With Mantle Cell Lymphoma
4. Chemotherapy Followed by Radiation Therapy and Peripheral Stem Cell Transplantation Compared With Chemotherapy Plus Interferon Alfa in Treating Patients With Stage III or Stage IV Mantle Cell Lymphoma
5. Combination Chemotherapy With or Without Rituximab in Treating Patients With Mantle Cell Lymphoma
Related Studies:
Other stage 4 adult diffuse small cleaved cell lymphoma Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Combination Chemotherapy With or Without Rituximab in Treating Patients With Newly Diagnosed Non-Hodgkin's Lymphoma
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