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Home»Non-Hodgkin lymphoma» Searching for patients with relapsed or refractory non-Hodgkin’s lymphoma to test the effectiveness of a PI3K inhibitor alone or with other drugs
Clinical Trial
Searching for patients with relapsed or refractory non-Hodgkin’s lymphoma to test the effectiveness of a PI3K inhibitor alone or with other drugs
This phase 2 clinical trial will test the effectiveness and safety of ublituximab (TG-1101) and TGR-1202 with or without bendamustine (Treanda), as well as TGR-1202 alone in treating patients with relapsed or refractory non-Hodgkin’s lymphoma. The primary outcome will be measured by the overall response.
The details
Ublituximab is an immunotherapy that uses the body’s own immune system to identify and kill cancerous B-cells. It is an antibody (a protein in the immune system) that binds to a protein found on B-cells, which alerts other parts of the immune system to attack. TGR-1202 inhibits a protein that helps carry out signals for growth and division in early B-cells. Blocking this protein will stop the growth of cancerous B-cells, eventually leading to cell death. Bendamustine, is a chemotherapy drug that is typically used to treat lymphoma. TGR-1202 alone or with one or both of the other treatments may provide an optimal response rate.
The study will examine the overall response and time to disease progression for up to 2 years.
Who are they looking for?
This trial is recruiting 500 patients with relapsed or refractory (did not respond to treatment) non-Hodgkin's lymphoma who have received prior therapy and are not currently eligible for high-dose therapy or autologous (obtained from the patient) stem cell transplant.
Participants cannot have received prior PI3K inhibitors or allogeneic (from a donor) stem cell transplant. Previous autologous stem cell transplants must have occurred at least 6 months prior to study enrollment. Ideal candidates should not have received surgery, chemotherapy, or immunotherapy within 21 days of enrollment.
How will it work
Patients will be divided into three experimental groups. Group 1 will be administered a once daily dose of TGR-1202, taken by mouth, and intravenous (through IV into a vein) ublituximab. Group 2 will be given a daily dose of TGR-1202 only. Group 3 will receive a daily dose of TGR-1202 along with an intravenous administration of ublituximab and bendamustine.
