This phase 2 clinical trial will test the safety and effectiveness of blinatumomab (Blincyto) after an R-chemotherapy in treating newly diagnosed patients with diffuse large B-cell lymphoma (DLBCL). The primary outcome will be measured by adverse (negative) side effects.
The details
Blinatumomab 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 cancerous B-cells, which allows other parts of the immune system to identify the cells as malignant and initiate an attack. R-chemotherapies are chemotherapy treatments containing rituximab (Rituxan), which is another antibody immunotherapy. R-CHOP and R-DA-EPOCH are common R-chemotherapies that are standard care of DLBCL.
This study will measure the effectiveness of blinatumomab combined with R-chemothrapy. The main outcomes will be measured through adverse effects, response to treatment, time to disease progression, overall survival, and stem cell transplant rate for 18 months.
Who are they looking for?
This trial is recruiting 38 patients with high-risk DLBCL. Participants must responded to 6 cycles of an R-chemotherapy (included in the study). Patients should have adequate organ and bone marrow function.
Patients should not have an active infection or autoimmune diseases. Those with a history of prior malignancies should be disease free for at least 3 years prior to enrollment. Ideal candidates should not have received other treatment within 30 days prior to entry.
How will it work
Patients will first be treated with an R-chemotherapy for 21 weeks. Those who do not experience disease progression will receive blinatumomabtreatment. Blinatumomab will be administered through an IV (directly into a vein) daily for the first 8 weeks of a 12-week cycle. Doses will be increased on week 2 and 3, where the week 3 dose will be continued through week 8.
Cycle 2 of the study is optional and is 4 weeks in length. Doses will be administered and increased as in cycle 1. The week 3 dose will be continued until the end of week 4.
Patients will be followed for up to 1 year following blinatumomab treatment.
