Combination Chemotherapy With or Without Rituximab in Treating Patients With Newly Diagnosed Non-… (NCT00004112) | Clinical Trial Compass
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 range
19 Years – 120 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.