Phase 1 Trial of Mosunetuzumab Combined With Polatuzumab Vedotin and Lenalidomide for Relapsed or Refractory Diffuse Large B-Cell Lymphoma

What this Trial Is About

Researchers are studying the effects and best dosage of a combination of three drugsmosunetuzumab, polatuzumab vedotin, and lenalidomideto treat patients with diffuse large B-cell lymphoma DLBCL that has returned or not responded to previous treatments. This phase I trial focuses on patients whose lymphoma has relapsed or is refractory, aiming to understand the safety, tolerability, and anti-tumor activity of this combination. The study also explores effectiveness in patients previously treated with polatuzumab vedotin and those who have undergone CAR T-cell therapy. Participants receive mosunetuzumab intravenously on days 1, 8, and 15 of the first cycle and then on day 1 of each following 28-day cycle. Polatuzumab vedotin is given intravenously on day 1 of each cycle, and lenalidomide is taken orally on days 1 to 21 of each cycle. Treatment continues for up to 8 cycles if a complete response is achieved or up to 17 cycles if partial response or stable disease is observed without disease progression or unacceptable side effects. Polatuzumab vedotin is administered for up to 6 cycles. Throughout the study, participants undergo PETCT scans and blood sample collections. During the study, participants are closely monitored with imaging and blood tests to assess tumor response and safety. Follow-up occurs every 3 to 6 months for two years after treatment ends. The main outcomes measured include safety and tolerability during the first cycle, as well as response rates, progression-free survival, and duration of response over up to two years. This comprehensive monitoring helps researchers understand how the combination treatment works and its potential risks.

Testing the Combination of Anti-cancer Drugs Mosunetuzumab, Polatuzumab Vedotin, and Lenalidomide for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma