A prospective, single center, randomized, clinical controlled study to evaluate the efficacy and prognosis differences between precision treatment based on plasma cfDNA testing results and the current conventional diagnostic and treatment practices for DLBCL patients.
This study is initiated by researchers and is a prospective, single-center, randomized, clinical controlled study. The study subjects are newly diagnosed DLBCL patients with plasma cfDNA positivity (defined as positive for point mutations, CNV, IgH-related fusion, or IG clonal rearrangement). After achieving complete metabolic remission (Lugano response assessment criteria) following 6 cycles of R-CHOP-like chemotherapy, patients undergo plasma cfDNA testing upon enrollment. Plasma cfDNA-negative patients (Group 1) continue to receive monotherapy with rituximab for 2 cycles, while plasma cfDNA-positive patients are randomly assigned to Group 2 and Group 3. Group 2 patients continue monotherapy with rituximab for 2 cycles, and Group 3 patients receive the original regimen for 2 cycles. Plasma cfDNA testing is performed again for all three groups after completion of the entire treatment. Patient progression-free survival (PFS) is observed for 2 years. After treatment completion, follow-up visits are scheduled every 3 months for a total of 24 months. Research Objective: Evaluate the efficacy and prognosis differences between precision treatment based on plasma cfDNA testing results and the current conventional diagnostic and treatment practices for DLBCL patients. Expected Results: Determining subsequent treatment based on plasma cfDNA MRD results at the end of DLBCL patient treatment is expected to aid in identifying high-risk patients for early relapse and improving their prognosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
After achieving complete metabolic remission (Lugano response assessment criteria) following 6 cycles of R-CHOP-like chemotherapy, patients undergo plasma cfDNA testing upon enrollment，and the follow-up treatment plans are based on cfDNA results.
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Progression-free survival（PFS）
Evaluate the PFS among three groups with different treatment practices for diffuse large B-cell lymphoma (DLBCL) patients.
Time frame: From date of randomization until the date of first documented progression or date of death from any cause,whichever came first，assessed up to 24 months.
Sensitivity, and specificity of plasma cfDNA in DLBCL patients
Evaluate the sensitivity, and specificity of plasma cfDNA testing at the end of treatment in DLBCL
Time frame: From date of randomization until the date of first documented progression or date of death from any cause,whichever came first，assessed up to 24 months.
Overall survivals(OS)
overall survival in DLBCL patients.
Time frame: From date of randomization until the date of first documented progression or date of death from any cause,whichever came first，assessed up to 24 months.
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