drugset / Trial / NCT07348575

A Multicenter, Prospective, Randomized, Controlled Study of Decitabine in Combination With R-CHOP for Initial Treatment of EBV+ Diffuse Large B-cell Lymphoma

NCT07348575

Phase 3 Enrolling by invitation 80 enrolled Second Affiliated Hospital of Nanchang University
RandomizedParallel-groupOpen-labelTreatment

Summary

This trial was a prospective, multicenter, randomized, controlled Phase III clinical design to compare the efficacy and safety of decitabine combined with R-CHOP (R-CHOP-D) versus R-CHOP in the treatment of primary EBV+ diffuse large B-cell lymphoma (DLBCL). Sixty patients were randomized 1:1 into R-CHOP-D (trial group) or R-CHOP (control group). The trial consisted of a screening period (days -28 to -1), a treatment period, and a follow-up period (2 years after the end of the last trial).

Timeline

Start
2024-07-01
Primary completion
2026-07-01
Completion
2028-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Decitabine Small molecule