Chidamide Maintenance for MRD-Positive Double-Expressor DLBCL in First Complete Remission
ConditionDiffuse Large B-Cell Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorRong Tao
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically confirmed diffuse large B-cell lymphoma, CD20-positive.
Double-expressor lymphoma confirmed by pathology, defined as MYC expression >=40% and BCL2 expression >=50% by immunohistochemistry.
Complete response after initial induction therapy.
Age >=18 and <=80 years.
Disqualifiers
Failure to achieve complete response after initial induction therapy.
Prior organ transplantation.
Uncontrolled coagulopathy or active bleeding.
Uncontrolled cardiovascular or cerebrovascular disease, including left ventricular ejection fraction <50%, connective tissue disease, or severe active infection.
Trial design
Design model
Single group
Treatments tested in this trial
Chidamide
DrugChidamide 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.
Treatment groups
69 Participants
are divided into 1 treatment groupGroup A: Chidamide MaintenanceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 months2
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 entrySecondary outcomes
1
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 months2
Overall Survival
Time from study entry to death from any cause.
Time frame
From study entry up to 24 months3
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Rong Tao
Lead sponsor
Fudan University
Sponsor institution
Source ClinicalTrials.gov