NCT06289959

Plasma cfDNA Testing Guiding the Treatment Decisions of DLBCL

A Prospective, Single-Center, Randomized, Controlled Study Guiding the Treatment of Diffuse Large B-Cell Lymphoma Patients Based on Plasma cfDNA Testing

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Second Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Lymphoma, Large B-Cell, Diffuse

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	cfDNA	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.

Timeline

• Start date: 2024-02-25
• Primary completion: 2029-01-01
• Completion: 2029-01-01
• First posted: 2024-03-04
• Last updated: 2024-03-04

Locations

1 site across 1 country: China