A Phase 2 Clinical Trial of Rituxan and B-Glucan PGG in Relapsed Indolent Non-Hodgkin Lymphoma (NCT02086175) | Clinical Trial Compass
CompletedPhase 2
A Phase 2 Clinical Trial of Rituxan and B-Glucan PGG in Relapsed Indolent Non-Hodgkin Lymphoma
United States25 participantsStarted 2014-12
Plain-language summary
This research study is evaluating a drug combination called Imprime PGG and Rituximab as a possible treatment for relapsed/refractory indolent B cell non-Hodgkin lymphomas (NHL).
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:
* Participants must meet the following criteria on screening examination to be eligible to participate in the study:
* Patients must have histologically determined indolent NHL that is relapsed or primary refractory after initial therapy. Indolent NHL includes the morphologic and clinical variants:
* Follicular lymphoma, grades 1-3a
* Marginal zone lymphoma (extranodal, nodal, or splenic)
* All nodal marginal zone lymphomas are eligible
* Extranodal marginal zone lymphomas of the stomach (gastric MALT lymphomas) may not be candidates for cure with antibiotics or local radiotherapy. Patients who have failed antibiotics or local therapy are eligible for the protocol as long as they have measurable disease and are naïve to chemotherapy and monoclonal antibody therapy.
* Splenic marginal zone lymphoma patients may have received prior splenectomy as long as they have measurable disease and are naïve to chemotherapy and monoclonal antibody therapy.
* Re-biopsy is not mandated at relapse unless there is clinical suspicion about an alternate diagnosis.
* Between 1-3 prior lines of chemoimmunotherapy and/or monotherapy with rituximab. Patients may not have had prior autologous or allogeneic stem cell transplantation.
* Measurable disease that has not been previously irradiated on CT scans of at least 2 cm, OR if the patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation. Imaging mus…
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
Overall Response Rate
Timeframe: Response assessed at week 14 of study calendar (10 weeks after the 4-week treatment regimen).