Chidamide Maintenance for MRD-Positive Double-Expressor DLBCL in First Complete Remission (NCT07507318) | Clinical Trial Compass
RecruitingPhase 2
Chidamide Maintenance for MRD-Positive Double-Expressor DLBCL in First Complete Remission
China69 participantsStarted 2026-06-16
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
* ECOG performance status 0-2.
* No prior history of malignant tumor and no concurrent malignancy.
* International Prognostic Index (IPI) score \>1.
* ctDNA MRD-positive at screening/enrollment.
* Life expectancy of at least 6 months, in the opinion of the investigator.
* Written informed consent provided before any study-specific procedure.
Exclusion Criteria:
* 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.
* Major organ surgery within 6 weeks before screening.
* Screening laboratory abnormalities not attributable to lymphoma, including: neutrophil count \<1.5 x 10\^9/L; platelet count \<80 x 10\^9/L (or \<50 x 10\^9/L in patients with bone marrow involvement); total bilirubin \>1.5 x upper limit of normal; ALT/AST \>2.5 x upper limit of normal, or \>5 x upper limit of normal in patients with hepatic involvement; serum creatinine \>1.5 x upper limit of normal.
* Active hepatitis B not meeting protocol-d…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial uses a ctDNA blood test to check for tiny amounts of remaining lymphoma after treatment — is that kind of MRD testing something my care team can do, and does my test currently show MRD-positive results that might make me eligible to discuss this trial?
2Since this is a Phase 2 trial, the main goals are to see whether chidamide can turn MRD-negative and whether it improves 2-year progression-free survival — what do we know so far about how safe and effective chidamide is for DLBCL patients like me at this stage?
3My lymphoma is described as 'double-expressor' DLBCL — can you explain what that means for my prognosis, and why this trial is specifically targeting that subgroup with maintenance therapy after a first complete remission?
4If I'm in complete remission right now, would joining a maintenance trial like this be a better path than watchful waiting, or is there a standard-of-care approach I should consider first before looking at an experimental option?
5What would participation in this trial actually look like for my daily life — how often would I need to come in for ctDNA monitoring, how long would I be taking chidamide, and are there side effects I should know about before deciding whether this fits my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.