Chidamide maintenance for lymphoma with residual cancer DNA after remission

Trial details

Who runs it

Rong Tao

Trial code

NCT07507318

Record updated

18 June 2026

Original description

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.Read full original descriptionShow less

A Prospective, Multicenter, Single-Arm, Open-Label Phase 2 Study of Chidamide Maintenance in Patients With Newly Diagnosed Double-Expressor Diffuse Large B-Cell Lymphoma Who Achieve Complete Response After Induction Therapy But Remain ctDNA MRD-Positive

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.

Inclusion: 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: Prior organ transplantation; Major organ surgery within 6 weeks before screening; Drug abuse or chronic alcohol abuse that may interfere with study evaluation; 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; Failure to achieve complete response after initial induction therapy; Uncontrolled coagulopathy or active bleeding; 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; Psychiatric illness or any condition resulting in inability to comply with the protocol; 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; Uncontrolled cardiovascular or cerebrovascular disease, including left ventricular ejection fraction <50%, connective tissue disease, or severe active infection; 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.

ClinicalTrials.gov NCT07507318