Study of Chidamide Plus R-CHOP with Targeted Drugs in Newly Diagnosed Double-Expressor Diffuse Large B-cell Lymphoma

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a combination treatment called CR-CHOP with additional targeted drugs in people newly diagnosed with diffuse large B-cell lymphoma (DLBCL) that shows double expression of MYC and BCL2 proteins. This prospective, open-label phase II trial focuses on patients who have not received prior treatment and aims to tailor therapy based on different genetic subtypes of the disease. Participants first receive one cycle of CR-CHOP chemotherapy, followed by five additional cycles where the treatment is adjusted according to their genetic subtype. These adjustments include adding a PD1 inhibitor in the first cycle, orelabrutinib in the second and third cycles, or decitabine for those with TP53 mutations. After completing chemotherapy, patients who achieve a complete response enter a maintenance phase with chidamide therapy for up to two years unless side effects or disease progression occur. During the study, patients undergo evaluations after each treatment cycle to monitor response and side effects. Researchers measure the rate of complete response at the end of treatment, approximately 6 to 8 weeks after the last dose of the sixth cycle. Ongoing safety monitoring and comprehensive assessments ensure patients’ health and treatment effectiveness are closely followed throughout the study period.

CR-CHOP+X in Previously Untreated DEL