drugset / Trial / NCT06748521

Dynamic CtDNA-guided Targeted Therapy in DLBCL

NCT06748521

Phase 2 Not yet recruiting 108 enrolled Ruijin Hospital
NaSingle-groupOpen-labelTreatment

Summary

This is a prospective, single-arm, noninferiority trial involving patients with previously untreated CD20-positive DLBCL. The aim of this study is to determine the efficacy and safety of treatment stratified based on ctDNA dynamic changes after one cycle of chemotherapy and the targeted therapy based on DLBCL genotype. A total of 108 patients were planned to be enrolled in this trial, and the patients were stratified according to the dynamic changes of ctDNA after one cycle of chemotherapy: the chemotherapy-sensitive group continued the original R-CHOP regimen, and the potential drug resistance group received genotype-guided targeted drug combination. The whole trial included a screening period (day -28 to day -1), a treatment period, and a 2-year follow-up period.

Timeline

Start
2024-12-31
Primary completion
2026-12-13
Completion
2028-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Decitabine Small molecule
Subject Lenalidomide Other / unclassified
Subject Obutinib Unknown
Subject Tucidinostat Small molecule