Chidamide maintenance for MRD-positive double-expressor DLBCL in first remission

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this phase 2, multicenter, single-arm trial, adults in first remission after induction for CD20-positive double-expressor DLBCL and with ctDNA MRD positivity receive oral chidamide 20 mg on days 1, 4, 8, and 11 of each 21-day cycle. MRD status is checked every 12 weeks, and maintenance continues until two consecutive MRD-negative results, progression, unacceptable toxicity, withdrawal, or 2 years of therapy. Primary endpoints are ctDNA MRD negativity and 2-year progression-free survival, with secondary endpoints including event-free survival, overall survival, and safety. The study explores whether targeting residual molecular disease with a histone deacetylase inhibitor can translate into better long-term outcomes.

Why it matters

Who can join: the full rules

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-defined virologic criteria for enrollment; patients with positive HBsAg or positive HBcAb require HBV DNA testing and must meet protocol-specified thresholds.
* HIV infection.
* Ongoing antitumor therapy for lymphoma or another malignancy.
* Drug abuse or chronic alcohol abuse that may interfere with study evaluation.
* Psychiatric illness or any condition resulting in inability to comply with the protocol.
* Requirement for ongoing treatment with strong or moderate CYP3A inhibitors or inducers; patients exposed to these agents within 7 days before first study dose, or within fewer than 5 half-lives, are not eligible.
* Inability to swallow capsules or clinically significant gastrointestinal disorders that may affect drug absorption, including malabsorption syndrome, bariatric surgery, inflammatory bowel disease, or partial/complete bowel obstruction.
* Any other uncontrolled medical condition that, in the investigator's judgment, may compromise safety, interfere with oral drug absorption or metabolism, or place the participant at excessive risk.

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Wenhao Zhang, MD — Fudan University
• Study coordinator: Rong Tao, MD & PhD
• Email: rao@shca.org.cn
• Phone: 008621-64175590

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.