A Phase 2 interventional study of Chidamide in Diffuse Large B-Cell Lymphoma, sponsored by Rong Tao. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-18.
Sponsored by Rong Tao · Phase 2, Interventional, and Treatment
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.
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.
1,390 studies on the registry are indexed under Lymphoma, Large B-Cell, Diffuse; 350 are open to participants now.
This study's planned enrollment of 69 is above the median of 47 across 1,185 interventional studies indexed under Lymphoma, Large B-Cell, Diffuse.
Browse Lymphoma, Large B-Cell, Diffuse studies →Rong Tao is the lead sponsor of 8 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Participants with newly diagnosed double-expressor DLBCL who achieve complete response after induction therapy but remain ctDNA MRD-positive will receive chidamide maintenance therapy.
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.
ctDNA MRD Negativity Rate
The proportion of enrolled participants who convert from ctDNA MRD-positive status at study entry to ctDNA MRD-negative status during chidamide maintenance, based on the protocol-specified ctDNA assay.
Time frame: From first dose up to 24 months
2-Year Progression-Free Survival Rate
The proportion of enrolled participants who are alive and free of disease progression 24 months after study entry.
Time frame: 24 months after study entry
Event-Free Survival
Time from study entry to disease progression, initiation of new antitumor therapy, or death from any cause.
Time frame: From study entry up to 24 months
Overall Survival
Time from study entry to death from any cause.
Time frame: From study entry up to 24 months
Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events
Incidence of hematologic and non-hematologic adverse events and serious adverse events, graded according to NCI CTCAE version 5.0.
Time frame: From first dose to 30 days after last dose.
Plan to share: Undecided — A decision regarding sharing de-identified individual participant data has not yet been made. This is an investigator-initiated, multicenter study involving ctDNA MRD-related data, and the sponsor has not yet finalized the data-sharing governance, de-identification standards, request review process, and applicable data-sharing agreements across participating sites. The possibility of sharing de-identified data may be considered after study completion and database lock, in accordance with participant consent, ethics committee requirements, institutional policies, and applicable regulations.
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