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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
ctDNA MRD Negativity Rate — From first dose up to 24 months 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.
2-Year Progression-Free Survival Rate — 24 months after study entry The proportion of enrolled participants who are alive and free of disease progression 24 months after study entry.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.