Rituximab in Treating Patients With Low Tumor Burden Indolent Non-Hodgkin's Lymphoma (NCT00075946) | Clinical Trial Compass
CompletedPhase 3
Rituximab in Treating Patients With Low Tumor Burden Indolent Non-Hodgkin's Lymphoma
United States545 participantsStarted 2004-01-23
Plain-language summary
RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known which rituximab regimen is more effective in treating indolent non-Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is studying two different schedules of rituximab and comparing them to see how well they work in treating patients with low tumor burden indolent stage III non-Hodgkin's lymphoma or stage IV 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.
INCLUSION CRITERIA:
* Histologically confirmed non-Hodgkin's lymphoma, including 1 of the following:
* Follicular grade 1 or 2
* Small lymphocytic
* Marginal zone (nodal)
* Marginal zone (splenic)
* Mucosa-associated lymphoid tissue (MALT)
* Stage III or IV disease
* Must meet the following criteria for low tumor burden:
* No nodal or extranodal mass at least 7 cm
* Less than 3 nodal masses greater than 3 cm in diameter
* No systemic symptoms or B symptoms
* No splenomegaly greater than 16 cm by a computed tomography (CT) scan
* No evidence of risk of compression of a vital organ (i.e., ureteral or epidural)
* No leukemic phase with greater than 5,000/mm\^3 circulating lymphocytes
* No cytopenias, defined as any of the following:
* Platelet count less than 100,000/mm\^3
* Hemoglobin less than 10 g/dL
* Absolute neutrophil count less than 1,500/mm\^3
* At least 1 objective measurable disease parameter
* Abnormal positron emission tomography (PET) scans will not constitute evaluable disease unless verified by CT scan or other appropriate imaging
* Age: 18 and over
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Must meet the following criteria for labs:
* Hematopoietic
* Absolute neutrophil count at least 1,500/mm\^3\*
* Hemoglobin at least 10 g/dL\*
* Platelet count at least 100,000/mm\^3\*
* NOTE: \*Without growth factor and/or transfusion support
* Hepatic
* Bilirubin no greater than 2…
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 Rituximab Failure (TTRF)
Timeframe: Assessed (by restaging CT scans) 26 weeks ± 2 weeks from each rituximab treatment (including induction), counting the first rituximab dose as Day 1, until rituximab failure observed or July 17, 2013, whichever occurred first.