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 tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without rituximab in treating aggressive non-Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is studying how well giving cyclophosphamide, doxorubicin, vincristine, and prednisone together with or without rituximab works in treating older patients who have aggressive non-Hodgkin's lymphoma. (This trial is no longer randomized as of 6/2005).
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:
* Histologically confirmed aggressive non-Hodgkin's lymphoma (NHL) by an excisional biopsy of a lymph node or an extensive biopsy of an extranodal involvement (if there is no lymph node involvement)
* CD20\^+ B-cell lymphoma or CD20\^- B-cell and T-cell lymphoma allowed
* B-cell NHL including the following:
* Stage III follicular lymphoma
* Stage III follicular lymphoma and diffuse B-cell lymphoma
* Lymphoblastic precursor B-cell lymphoma
* Diffuse large cell B-cell lymphoma
* Centroblastic
* Immunoblastic
* Plasmablastic
* Anaplastic large cell
* T-cell-rich B-cell lymphoma
* Primary effusion lymphoma
* Intravasal B-cell lymphoma
* Primary mediastinal B-cell lymphoma
* Mantle zone lymphoma, blastoid
* Burkitt's lymphoma
* Burkitt-like lymphoma
* Aggressive marginal zone lymphoma (monocytoid)
* T-cell NHL including the following:
* Lymphoblastic precursor T-cell lymphoma
* Peripheral T-cell lymphoma (PTCL) not otherwise specified (NOS)
* Lennert's lymphoma
* T-zone lymphoma
* T-cell lymphoma of the angioimmunoblastic lymphadenopathy with dysproteinemia (AILD) type
* Anaplastic large cell lymphoma
* ALK\^+
* ALK\^-
* Extranodal NK/T-cell lymphoma, nasal type
* Intestinal T/NK-cell lymphoma (with or without enteropathy)
* Hepatosplenic gamma-delta lymphoma
* Subcutaneous panniculitis-like PTCL
* Aggressive T/NK PTCL
* Anaplastic large-cell NHL, NOS
* Bone ma…
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
Time to treatment failure at 3 years within the study and then periodically after study completion
Timeframe: 3 years within the study and then periodically after study completion
Trial details
NCT IDNCT00052936
SponsorGerman High-Grade Non-Hodgkin's Lymphoma Study Group