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

Completed · Phase 3

Conditions studied: Lymphoma

In brief

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.

Key facts

Study ID

NCT00004112

Run by

University of Nebraska

Starts

1999-09-01

Expected to finish

2003-03-01

Last updated by the study team

2024-09-23

Who can join

Age: 19 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Jonsson Comprehensive Cancer Center, UCLA — Los Angeles, California, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

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