OncRef

Clinical Trial: NCT04231448

Phase III Study of Tucidinostat in Combination With R-CHOP in Patients With Newly Diagnosed Double-Expressor DLBCL

Status:

COMPLETED

Phase:

Phase 3

Lead Sponsor:Chipscreen Biosciences, Ltd.
Information Provided By:Chipscreen Biosciences, Ltd.
Last Update Posted:2026-04-08

Study Overview

Brief Summary

Tucidinostat (formerly known as chidamide) is an oral subtype-selective histone deacetylase inhibitor. This Randomized, Double-blind, Placebo-controlled Phase 3 trail is studying the efficacy and safety of Tucidinostat, in Combination with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects With Newly Diagnosed MYC/BCL2 Double-Expressor Diffuse Large B-cell Lymphoma.

Official Title

Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Tucidinostat in Combination With R-CHOP in Patients With Newly Diagnosed MYC/BCL2 Double-Expressor DLBCL

Conditions

Diffuse Large B-cell Lymphoma

Intervention / Treatment

  • Drug: R-CHOP(Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone)
  • Drug: Tucidinostat
  • Drug: Placebo

Other Study ID Numbers

  • CDM302

Start Date (Actual)

2020-05-21

Primary Completion Date (Actual)

2023-01-10

Study Completion Date (Actual)

2025-06-29

Enrollment (Actual)

423

Study Type

Interventional

Phase

Phase 3