NCT07507318

Chidamide Maintenance for MRD-Positive Double-Expressor DLBCL in First Complete Remission

A Prospective, Multicenter, Single-Arm, Open-Label Phase 2 Study of Chidamide Maintenance in Patients With Newly Diagnosed Double-Expressor Diffuse Large B-Cell Lymphoma Who Achieve Complete Response After Induction Therapy But Remain ctDNA MRD-Positive

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 69 (estimated)
• Sponsor: Rong Tao · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multicenter, single-arm, open-label phase 2 study designed to evaluate the efficacy and safety of chidamide maintenance in adults with newly diagnosed double-expressor diffuse large B-cell lymphoma (DLBCL) who achieve complete response after induction therapy but remain ctDNA minimal residual disease (MRD)-positive. Eligible participants will receive oral chidamide 20 mg on Days 1, 4, 8, and 11 of each 21-day cycle. ctDNA MRD will be assessed every 12 weeks. Treatment will continue until two consecutive MRD-negative assessments, disease progression, intolerable toxicity, withdrawal of consent, or completion of 2 years of maintenance. The primary objectives are to evaluate ctDNA MRD negativity and 2-year progression-free survival. Secondary objectives include event-free survival, overall survival, and safety.

Detailed description

Patients with double-expressor DLBCL remain at increased risk of relapse despite achieving complete response after induction therapy. ctDNA-based MRD assessment may identify a subgroup with persistent molecular disease who are at particularly high risk for recurrence. Chidamide is an oral selective histone deacetylase inhibitor with potential antitumor and immune-modulating activity in B-cell lymphomas. This prospective, multicenter, single-arm, open-label phase 2 study will enroll adult patients with newly diagnosed CD20-positive double-expressor DLBCL, defined by MYC expression \>=40% and BCL2 expression \>=50% by immunohistochemistry, who achieve complete response after initial induction therapy but remain ctDNA MRD-positive. Participants will receive chidamide 20 mg orally on Days 1, 4, 8, and 11 of each 21-day cycle. ctDNA MRD will be monitored every 12 weeks. Treatment will stop upon two consecutive MRD-negative assessments, disease progression, intolerable toxicity, withdrawal of consent, or completion of 2 years of maintenance. The study will evaluate ctDNA MRD negativity rate and 2-year progression-free survival as primary endpoints, with event-free survival, overall survival, and safety as secondary endpoints.

Conditions

• Diffuse Large B-Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Chidamide	Chidamide 20 mg orally on Days 1, 4, 8, and 11 of each 21-day cycle. ctDNA MRD assessments will be performed every 12 weeks. Treatment will continue until two consecutive MRD-negative assessments at least 3 months apart, disease progression, intolerable toxicity, withdrawal of consent, or completion of 2 years of maintenance.

Timeline

• Start date: 2026-04-01
• Primary completion: 2029-06-30
• Completion: 2029-06-30
• First posted: 2026-04-02
• Last updated: 2026-04-02

Locations

1 site across 1 country: China