RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer cell growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Lenalidomide may stop the growth of non-Hodgkin lymphoma by blocking blood flow to the cancer. It is not yet known whether rituximab is more effective when given alone or together with lenalidomide in treating patients with follicular lymphoma.
PURPOSE: This randomized phase II trial is studying rituximab to see how well it works compared with giving rituximab together with lenalidomide in treating patients with previously untreated follicular 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 follicular lymphoma
* Stage III or IV disease OR stage II disease not suitable for radiotherapy
* Grades 1, 2, or 3a disease
* Previously untreated disease
* CD20-positive disease
* Patients in need of systemic therapy, meeting at least 1 of the following criteria:
* Symptomatic enlarged lymph nodes, spleen, or other lymphoma manifestations
* Bulky disease ≥ 6 cm in long diameter
* Clinically significant progression over at least 6 months of any tumor lesion
* Anemia (hemoglobin \< 100 g/L) or thrombocytopenia (platelet count \< 100 x 10\^9/L) due to lymphoma
* Clinically significant progressive decrease in hemoglobin or platelet count due to lymphoma
* B-symptoms, weight loss \> 10% within the past 6 months, drenching night sweats, or fever \> 38°C not due to infection
* At least one two-dimensionally measurable lesion with longest transverse diameter \> 10 mm
* Paraffin-embedded tumor tissue available
* No known CNS involvement
PATIENT CHARACTERISTICS:
* WHO performance status 0-2
* EF ≥ 50% for patients with a history of cardiac disease or older than 70 years
* Neutrophil count ≥ 1.5 x 10\^9/L
* Platelet count ≥ 100 x 10\^9/L
* Bilirubin ≤ 1.5 x upper limit of normal (ULN) (unless due to Gilbert syndrome)
* ALT ≤ 2.5 x ULN
* Alkaline phosphatase ≤ 2.5 x ULN
* Creatinine clearance ≥ 30 mL/min
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception 4 weeks…
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.