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Home»Non-Hodgkin lymphoma» Looking for patients with relapsed or refractory follicular or diffuse large B-cell lymphoma to test a combination therapy containing polatuzumab vedotin antibody-drug conjugate
Clinical Trial
Looking for patients with relapsed or refractory follicular or diffuse large B-cell lymphoma to test a combination therapy containing polatuzumab vedotin antibody-drug conjugate
This phase 2 clinical trial will test the safety and effectiveness of polatuzumab vedotin with obinutuzumab (Gazyva) and venetoclax (Venclexta) in patients with relapsed or refractory follicular lymphoma (FL) or rituximab (Rituxan) with polatuzumab vedotinand venetoclax in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The primary outcome will be measured by the response to treatment.
The details
Polatuzumab vedotin is an investigational therapy that uses an antibody (a protein in the immune system) to deliver an attached drug to cancerous B-cells. The antibody is designed to bind to a protein found on cancerous B-cells. Once bound, the antibody will be taken into the cancer cell where the drug will be released, resulting in cell death. Venetoclax is a drug that induces cell death in certain cancerous B-cells. Obinutuzumaband rituximab are immunotherapies that use the body’s own immune system to identify and kill cancerous B-cells.
This study will examine the effectiveness of polatuzumab vedotin and venetoclax combined with either obinutuzumab or rituximab. The study will examine the percentage of patients that completely respond to treatment. The trial will also consider the recommended doses, side effects and rate of measurable response to the treatment.
Who are they looking for?
This trial is recruiting 134 patients with relapsed or refractory CD20 positive FL (stage 1-3a) or DLBCL who have received at least 1 chemoimmunotherapy containing an anti-CD20 antibody (such as rituximab).
Candidates should not receive antibody immunotherapy within 4 weeks, or radiotherapy, chemotherapy, or targeted therapy within 2 weeks prior to entry. Pariticipants should not have any active infections, or have received a live vaccine withing 28 days of entering the study. Patients should have adequate liver and kidney function.
How will it work
Patients will FL will receive polatuzumab vedotin, obinutuzumab, and venetoclaxfor 18 weeks. These participants will either receive an increasing dose of the treatment (in the earlier part of the trial) or a predetermined dose (in the later part of the trial).
Patients will DLBCL will receive polatuzumab vedotin, rituximab, and venetoclax for 18 weeks. These participants will either receive an increasing dose of the treatment or a predetermined dose. All participants are eligible for additional treatment if some response occurs.
