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 hydrochloride, 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. Radiation therapy uses high-energy x-rays to kill cancer cells. Giving rituximab and combination chemotherapy together with radiation therapy may kill more cancer cells. It is not yet known which schedule of rituximab and combination chemotherapy is more effective when given with or without radiation therapy in treating non-Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is studying two different schedules of rituximab and combination chemotherapy with or without radiation therapy to compare how well they work in treating patients with aggressive B-cell non-Hodgkin's lymphoma.
Who can participate
Age range
18 Years – 60 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 aggressive B-cell non-Hodgkin's lymphoma, including the following subtypes:
* Grade 3 follicular lymphoma
* Diffuse B-cell lymphoma, including diffuse large cell lymphoma with the following variants:
* Centroblastic
* Immunoblastic
* Plasmablastic
* Anaplastic large cell
* T-cell-rich B-cell lymphoma
* Primary effusion lymphoma
* Intravascular B-cell lymphoma
* Primary mediastinal B-cell lymphoma
* Burkitt's or Burkitt-like lymphoma
* Mantle cell lymphoma (blastoid)
* Aggressive marginal zone lymphoma (monocytoid)
* Previously untreated disease
* CD20-positive disease
* International prognostic index (IPI) score 0 or 1 (age-adjusted)
* Only patients with bulky disease, as defined by largest single or conglomerate tumor ≥ 7.5 cm in diameter, are allowed to have an IPI score of 0
* No mucosa-associated lymphoid tissue (MALT) lymphoma
* No CNS involvement of lymphoma (intracerebral, meningeal, or intraspinal)
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Platelet count ≥ 100,000/mm³
* WBC ≥ 2,500/mm³
* No known hypersensitivity to the study medications
* No known HIV-positivity
* No active hepatitis infection
* Not pregnant or lactating
* Negative pregnancy test
* No other malignancy within the past 5 years except carcinoma in situ or basal cell skin cancer
* No impaired left ventricular function
* No severe cardiac arrhythmias
* No other impaired organ function
* No other …
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
1
3 Years Event-free Survival
Timeframe: Each patient will be observed for 3 years starting from completion of treatment.
Trial details
NCT IDNCT00278408
SponsorGerman High-Grade Non-Hodgkin's Lymphoma Study Group