Chidamide Maintenance for MRD-Positive Double-Expressor DLBCL in First Complete Remission

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

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.

Conditions2

Interventions1

Related trials

• A Phase 3 Multinational Study of Golidocitinib Versus Investigator's Choice in r/r PTCL (JACKPOT19) — Dizal Pharmaceuticals
• A Study of Chidamide Plus Endocrine in Maintenance Treatment of HR+/HER2- Breast Cancer After First-line Chemotherapy — Tianjin Medical University Cancer Institute and Hospital
• CRP Regimen in Treating Elderly Patients With Previously Untreated Double-Positive DLBCL — Tianjin Medical University Cancer Institute and Hospital
• Chidamide Combination With R-mini CHOP Followed by Chidamide+CD20 Maintenance in Elderly Newly Diagnosed MYC/BCL2+ DLBCL — Ou Bai, MD/PHD
• Chidamide Prevents Recurrence of High-risk AML After Allo-HSCT — Sichuan University
• Chidamide for Maintenance Treatment of HBV-infected Diffuse DLBCL in Patients Initially Treated With R-CHOP — Ou Bai, MD/PHD
• Chidamide in Combination With Azacitidine, Liposomal Mitoxantrone, and Prednisone (CAMP Regimen) for the Treatment of Previously Untreated Nodal TFH Cell Lymphoma — Institute of Hematology & Blood Diseases Hospital, China
• Chidamide in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (R/R PTCL) — Great Novel Therapeutics Biotech & Medicals Corporation

Browse More Trials