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NOT YET RECRUITING
NCT06748521
PHASE2

Dynamic CtDNA-guided Targeted Therapy in DLBCL

Sponsor: Ruijin Hospital

View on ClinicalTrials.gov

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

Interventions

DRUG

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.