Trial Information: This is a Phase III trial recruiting 360 Canadian and American patients with indolent lymphoma, including follicular lymphoma, who have been previously treated and are refractory to rituximab. Patients will be randomized to receive bendamustine monotherapy or bendamustine with GA-101 (B-G).
Background Information: GA-101 is a human anti-CD20 monoclonal antibody which may emerge as a successor or alternative to rituximab. It binds to a different part of the CD20 protein and early studies suggested it might be far more effective at killing malignant cells.
There have been several previous Phase I and Phase I/II clinical trials of GA-101 in Canada and the U.S., generally in relapsed and refractory patients who had already been treated with rituximab. In this setting response rates were about 25%-60%, including multiple complete remissions. Side effects include vomiting, infections, and fever, although in the trial setting these are not usually severe enough to be dose-limiting.
Bendamustine is an old East German alkylating agent recently returned to use in Western countries. Recent studies have considered whether bendamustine can replace the full CHOP regimen, in combination with an antibody such as rituximab, ofatumumab, or, in this case, GA-101.
Canadian Locations: Edmonton, AB (Cross Cancer Institute); Moncton, NB (Moncton Hospital); Montreal, QC (CHUM-Hospital Notre-Dame and Jewish General Hospital); and Quebec City, QC (Hopital du Saint Sacrament).
For more information, see ClinicalTrials.gov.
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