This is a single-center, single-arm, prospective study aimed at evaluating the efficacy and safety of orelabrutinib combined with an induction regimen followed by monotherapy maintenance in patients with MCD subtype diffuse large B-cell lymphoma (DLBCL). The primary endpoint is the 2-year progression-free survival (PFS) rate; secondary endpoints include overall response rate (ORR), complete response rate (CRR), overall survival (OS), and treatment-related adverse events (TRAEs). The study plans to enroll 66 patients.
Patients of any gender, aged ≥18 years;
Pathologically, NGS, and imaging confirmed diagnosis of MCD subtype DLBCL (including IP-LBCLs);
No prior treatment history;
Serum creatinine ≤2 times the upper limit of normal or eGFR ≥40 ml/min;
Pregnant or lactating women and women of childbearing age who are unwilling to use contraception;
Patients with a history of stroke or bleeding within the past 6 months;
Patients requiring treatment with strong CYP3A inhibitors;
Patients with comorbid autoimmune deficiency diseases or active hepatitis virus infection;
Ou Bai, MD/PHD
Lead sponsor
The First Hospital of Jilin University
Sponsor institution