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Efficacy and Safety of Dynamic CtDNA-guided Targeted Therapy in Patients with Previously Untreated Diffuse Large B-cell Lymphoma
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.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Start Date
December 31, 2024
Primary Completion Date
December 13, 2026
Completion Date
June 1, 2028
Last Updated
December 27, 2024
108
ESTIMATED participants
R-CHOP + X
DRUG
Lead Sponsor
Ruijin Hospital
NCT04792489
NCT04772989
Data Source & Attribution
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