Phase 3 Trial Comparing BEBT-908 Plus Rituximab to Standard Chemotherapy for Relapsed or Refractory Diffuse Large B-Cell Lymphoma

What this Trial Is About

Researchers are evaluating the safety and effectiveness of BEBT-908 combined with rituximab compared to standard chemotherapy treatments in adults with relapsed or refractory diffuse large B-cell lymphoma rr DLBCL. This Phase III clinical trial aims to improve outcomes for patients who have not responded to previous therapies or whose disease has returned. The study is randomized and open-label, involving multiple centers. Participants will be randomly assigned to one of two groups the experimental group receiving BEBT-908 plus rituximab, or the control group receiving investigator-selected standard chemotherapy regimenseither rituximab-gemcitabine-oxaliplatin R-GemOx or rituximab-ifosfamide-carboplatin-etoposide R-ICE. Treatment cycles last 21 days, with eight cycles planned. Those in the experimental group without disease progression after eight cycles may continue BEBT-908 andor rituximab as maintenance therapy for up to 24 months. The control group stops study medication after eight cycles. Participants undergo a screening phase up to 21 days before treatment begins. Tumor assessments occur every six weeks during the first eight cycles and every nine weeks afterward. After treatment ends, safety follow-up occurs about 28 days later, with ongoing efficacy evaluations every nine weeks and survival checks every three months. Researchers measure overall survival up to 48 months as the primary outcome, along with other outcomes like progression-free survival, response rates, duration of response, and adverse events.

Study Comparing BEBT-908 Combined With R to SOC for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma