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Tucidinostat Plus R-CHOP vs R-CHOP in MYC/BCL2 Double-Expressor Diffuse Large B-Cell Lymphoma: A Randomized Clinical

Peng-Peng Xu1, Yu-Qin Song2, Jian-Zhen Shen3

  • 1Shanghai Institute of Hematology, State Key Laboratory of Medical Genomics; National Research Center for Translational Medicine at Shanghai, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.

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|April 22, 2026
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Summary
This summary is machine-generated.

Tucidinostat plus R-CHOP significantly improved event-free survival in newly diagnosed diffuse large B-cell lymphoma (DLBCL) with MYC/BCL2 coexpression. This epigenetic therapy offers a new first-line treatment for this high-risk DLBCL population.

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Area of Science:

  • Oncology
  • Hematology
  • Epigenetics

Background:

  • Diffuse large B-cell lymphoma (DLBCL) pathogenesis involves epigenetic dysregulation.
  • MYC/BCL2 double-expressor lymphoma (DEL) is a high-risk DLBCL subtype with poor prognosis.
  • Standard R-CHOP immunochemotherapy offers limited efficacy for DEL patients.

Purpose of the Study:

  • To evaluate the efficacy and safety of tucidinostat combined with R-CHOP compared to R-CHOP alone.
  • To assess tucidinostat as a first-line treatment for newly diagnosed DEL patients.

Main Methods:

  • A randomized, double-blind, placebo-controlled phase 3 trial (NCT04231448) enrolled 423 eligible patients.
  • Patients received either oral tucidinostat or placebo, plus 6 cycles of R-CHOP.
  • Primary endpoint was event-free survival; secondary endpoints included response rates and tolerability.

Main Results:

  • Tucidinostat plus R-CHOP reduced the risk of disease progression, relapse, or death by 28% (HR, 0.72; P=.02).
  • Two-year event-free survival was 60.3% with tucidinostat versus 50.5% with placebo.
  • Complete response rate was higher in the tucidinostat group (73.0% vs 61.8%), with manageable toxicity.

Conclusions:

  • Tucidinostat plus R-CHOP significantly improves event-free survival in newly diagnosed DEL.
  • This combination therapy represents a novel first-line treatment targeting MYC and BCL2 oncoproteins in high-risk DLBCL.
  • The study demonstrates the benefit of epigenetic modulators in DLBCL treatment.