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Dynamic CtDNA-guided Targeted Therapy in DLBCL
Sponsor: Ruijin Hospital
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.
Official title: Efficacy and Safety of Dynamic CtDNA-guided Targeted Therapy in Patients with Previously Untreated Diffuse Large B-cell Lymphoma
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
108
Start Date
2024-12-31
Completion Date
2028-06-01
Last Updated
2024-12-27
Healthy Volunteers
No
Conditions
Interventions
R-CHOP + X
Eligible participants will receive 1 cycle of R-CHOP therapy with genotyping and ctDNA testing at C1D14. Chemotherapy sensitive patients with C1D14 ctDNA negative or ctDNA LFC ≥ 2 will continue to receive R-CHOP therapy for up to 6 courses. Potentially resistant patients with C1D14 ctDNA positive and LFC \< 2 were stratified by DLBCL genotyping and treated with cycle 2-6 R-CHOP in combination with obutinib or decitabine or lenalidomide or Chidamide.