CompletedPhase 3

Combination Chemotherapy With or Without Rituximab in Treating Patients With Newly Diagnosed Non-Hodgkin's Lymphoma

United StatesStarted 1999-09-01

Plain-language 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 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.

Who can participate

Age range19 Years – 120 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 * CD20 positive * 19 years old and over * WHO 0-2 * Karnofsky 70-100% * Life expectancy at least 6 months * Absolute neutrophil count greater than 1,000/mm3 (unless due to non-Hodgkin's lymphoma (NHL) bone marrow involvement) * Bilirubin less than 3.0 mg/dL * Alkaline phosphatase less than 3 times upper limit of normal (ULN) * SGOT less than 3 times ULN * Fertile patients must use effective contraception * HIV negative * Nonsteroidal hormones for non-lymphoma related conditions allowed (e.g., insulin for diabetes) Exclusion Criteria: * No prior T-cell lymphoma * Not pregnant or nursing * No other serious disease or medical condition that would interfere with compliance * No other concurrent chemotherapy * No concurrent corticosteroids (unless for prevention of nausea or vomiting) * No concurrent radiotherapy No other concurrent investigational agents

Trial details

NCT IDNCT00004112

SponsorUniversity of Nebraska

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2000-12-01