CompletedPhase 3

S0016 Combination Chemotherapy With Monoclonal Antibody Therapy in Newly Diagnosed Non-Hodgkin's Lymphoma

United States571 participantsStarted 2001-03

Plain-language summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies can locate tumor cells and either kill them or deliver radioactive tumor-killing substances to them without harming normal cells. It is not yet known which monoclonal antibody plus combination chemotherapy regimen is more effective in treating non-Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is comparing 2 different monoclonal antibodies given together with combination chemotherapy to see how well they work in treating patients with newly-diagnosed non-Hodgkin's lymphoma.

Who can participate

Age range

18 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.

DISEASE CHARACTERISTICS: * Histologically confirmed previously untreated bulky stage II or stage III or IV follicular non-Hodgkin's lymphoma * Grade I-III disease * Cluster of differentiation antigen 20 (CD20) antigen positive * Fewer than 5,000/mm\^3 circulating lymphoid cells on a white blood cell (WBC) differential count * Bidimensionally measurable disease * Bone marrow aspiration and biopsy within the past 42 days * No clinical evidence of central nervous system (CNS) involvement by lymphoma PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Zubrod 0-2 Life expectancy: * Not specified Hematopoietic: * See Disease Characteristics * Granulocyte count greater than 1,500/mm\^3 * Platelet count greater than 100,000/mm\^3 Hepatic: * Not specified Renal: * Not specified Cardiovascular: * No impaired cardiac status, including: * Severe coronary artery disease * Cardiomyopathy * Congestive heart failure * Serious arrhythmia * Ejection fraction at least lower limit of normal by Multi Gated Acquisition Scan (MUGA) or 2-D echocardiogram for questionable cardiac history Other: * No hypersensitivity to iodine * Not pregnant or nursing * Fertile patients must use effective contraception during and for 6 months after study participation * HIV negative * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: …

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.

What they're measuring

Progression-free Survival at 2 Years

Timeframe: 0-2 years

Progression-free Survival at 5 Years

Timeframe: 0-5 years

Overall Survival at 2 Years

Timeframe: 0-2 years

Overall Survival at 5 Years

Timeframe: 0-5 years

Trial details

NCT IDNCT00006721

SponsorSWOG Cancer Research Network

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2011-09

Results submitted2012-11-02

View on ClinicalTrials.gov More Lymphoma trials