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 range18 Years
SexALL
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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…
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).