CompletedPhase 2

Rituximab and Combination Chemotherapy in Treating Older Patients With Previously Untreated B-Cell Lymphoma

Czechia, France, Germany586 participantsStarted 2004-02

Plain-language summary

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating older patients with previously untreated B-cell lymphoma.

Who can participate

Age range

61 Years – 80 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: * Histological diagnosis of aggressive B-cell lymphoma * Previously untreated disease * Stage I-IV disease * CD20-positive disease * Any International Prognostic Index (IPI) score * No secondary lymphoma after prior chemotherapy or radiotherapy * No primary CNS lymphoma * No primary gastrointestinal (MALT) lymphoma PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy ≥ 3 months * AST and ALT ≤ 3 times normal unless related to lymphoma * Bilirubin ≤ 2 mg/dL unless related to lymphoma * Creatinine ≤ 2 times normal unless related to lymphoma * Fertile patients must use effective contraception * No known allergic reactions against foreign proteins * No active infections requiring systemically administered antibiotics or antiviral medications * No noncompensated heart failure * No dilatative cardiomyopathy * No coronary heart disease with ST-segment depression in ECG * No myocardial infarction during the past 6 months * No chronic lung disease with hypoxemia * No severe noncompensated hypertension * No severe noncompensated diabetes mellitus * No clinical signs of cerebral dysfunction * No severe psychiatric disease * No known HIV infection * No active chronic hepatitis B or C infection * No other concurrent diseases that exclude the administration of therapy as outlined by the study protocol PRIOR CONCURRENT THERAPY: * See Disease Characteristics * More than 12 weeks since prior clinical trial participation * No prior partici…

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

Pharmacokinetics (in first 20 patients of each cohort with a distinct variation of the rituximab schedule) assessed on days -4, -1, 10, 29, 57, 99, 155, 239, 267, 295, 407, and 491 of treatment

Timeframe: -4 to 491 days of treatment

Safety and treatment related deaths at 3 months after study completion

Timeframe: 3 months after study completion

Toxicity assessed by NCI criteria, adverse events, serious adverse events, protocol adherence, and treatment-related deaths at 3 months after study completion

Timeframe: 3 months after study completion

Trial details

NCT IDNCT00290667

SponsorGerman High-Grade Non-Hodgkin's Lymphoma Study Group

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-12

View on ClinicalTrials.gov More Lymphoma trials

Plain-language summary

Who can participate

Age range

61 Years – 80 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.

What they're measuring

Pharmacokinetics (in first 20 patients of each cohort with a distinct variation of the rituximab schedule) assessed on days -4, -1, 10, 29, 57, 99, 155, 239, 267, 295, 407, and 491 of treatment

Timeframe: -4 to 491 days of treatment

Safety and treatment related deaths at 3 months after study completion

Timeframe: 3 months after study completion

Toxicity assessed by NCI criteria, adverse events, serious adverse events, protocol adherence, and treatment-related deaths at 3 months after study completion

Timeframe: 3 months after study completion