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About
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 is more effective with or without rituximab in treating patients with non-Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is studying four different combination chemotherapy regimens and rituximab to see how well they work compared to four different combination chemotherapy regimens alone in treating patients with non-Hodgkin's lymphoma.
Full description
OBJECTIVES:
Compare the time to treatment failure in patients with CD20-positive diffuse large B-cell non-Hodgkin's lymphoma treated with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone)-like chemotherapy with vs without rituximab. Compare the tumor control, progression rate, and complete remission rate in patients treated with these regimens. Compare the disease-free and overall survival rate of patients treated with these regimens. Compare the toxicity of these regimens in these patients.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center, bulky disease (no vs yes), International Prognostic Index score (0 vs 1), and chemotherapy (CHOP vs CHOEP vs PMitCEBO vs MACOP-B). Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive 1 of the following chemotherapy regimens according to participating country:
CHOP: Patients receive cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1 and oral prednisone or prednisolone on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. CHOEP-21: Patients receive cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1; etoposide IV on days 1-3; and oral prednisone on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. PMitCEBO: Patients receive mitoxantrone IV, cyclophosphamide IV, and etoposide IV on day 1; vincristine IV and bleomycin IV on day 8; and oral prednisolone daily during weeks 1-4 and every other day during week 5. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity. MACOP-B: Patients receive cyclophosphamide IV and doxorubicin IV on days 1, 15, 29, 43, 57, and 71; methotrexate IV and vincristine IV on days 8, 36, and 64; bleomycin IV and vincristine IV on days 22, 50, and 78; and oral or intramuscular prednisone on days 1-84. Treatment continues in the absence of disease progression or unacceptable toxicity.
Arm II: Patients receive arm I regimens (according to participating country) and rituximab as follows:
CHOP and rituximab: Patients receive CHOP as in arm I and rituximab IV on day 1. CHOEP-21 and rituximab: Patients receive CHOEP-21 as in arm I and rituximab IV on day 1. PMitCEBO and rituximab: Patients receive PMitCEBO as in arm I and rituximab IV on day 1 during courses 1 and 4; on day 8 during courses 2 and 5; and on day 1 at 1 and 4 weeks after completion of the last course of PMitCEBO chemotherapy. MACOP-B and rituximab: Patients receive MACOP-B as in arm I and rituximab IV on days 1, 22, 43, 64, 85, and 106.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 820 patients will be accrued for this study within approximately 2 years.
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Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically confirmed diffuse large B-cell non-Hodgkin's lymphoma according to REAL classification
International Prognostic Index (IPI) score of 0 or 1
Score 0 defined by all of the following:
Score 1 defined by 1 of the following:
Previously untreated disease
Mediastinal B-cell lymphoma allowed
No secondary lymphoma after prior chemotherapy or radiotherapy for other malignancies
No transformed lymphoma
No primary CNS lymphoma
No primary gastrointestinal (MALT) lymphoma
No post-transplant lymphoproliferative disorder
PATIENT CHARACTERISTICS:
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Hematopoietic
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PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Primary purpose
Allocation
Interventional model
Masking
824 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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