Orelabrutinib Combined With Induction Therapy Followed by Sequential Monotherapy Maintenance in MCD Subtype Diffuse Large B-cell Lymphoma

Efficacy and Safety of Orelabrutinib Combined With Induction Therapy Followed by Sequential Monotherapy Maintenance in MCD Subtype Diffuse Large B-cell Lymphoma: a Single-center, Single-arm, Prospective Study

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.

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).

Inclusion Criteria:

• 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;
• Bilirubin <1.5 times the upper limit of normal;
• Understand and voluntarily sign a written informed consent form.

Exclusion Criteria:

• 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;
• Patients with a history of organ transplantation;
• Patients with a history of or concurrent other malignant tumors.