drugset / Trial / NCT05422066

Selinexor Plus R-CHOP in High-risk GCB-subtype Diffuse Large B-Cell Lymphoma

NCT05422066

Phase 2 Unknown 50 enrolled Li Zhiming Antengene Corporation · collab
NaSingle-groupOpen-labelTreatment

Summary

This is a phase II, multicenter, single-arm and open-label study to explore Selinexor in combination with standard of care R-CHOP in New Diagnosed high-risk GCB-subtype DLBCL (IPI 3-5). Approximately 35 patients plan to be enrolled in about 6-8 study sites of the study. And the objective is to Evaluate the safety and efficacy of XR-CHOP in High-Risk (IPI 3-5) GCB-subtype DLBCL.The enrollment period for this study is expected to be approximately 18 months. The study will end when all patients have completed 6 cycles treatment/follow-up since the initiation of the study drug, or the last patient has expired, has been lost to follow-up, or has withdrawn consent, whichever occurs first.

Timeline

Start
2022-07-26
Primary completion
2025-07-30
Completion
2025-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Selinexor Other / unclassified 60 mg Oral
Background Cyclophosphamide Other / unclassified 750 mg/m2 Intravenous
Background Doxorubicin Other / unclassified 70 mg/m2 Intravenous
Background Prednisone Other / unclassified 100 mg Oral
Background Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Background Vincristine Small molecule 1.4 mg/m2 Intravenous