To evaluate orelabrutinib in combination with polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP) as first-line treatment for patients with intermediate- to high-risk diffuse large B-cell lymphoma (DLBCL).
Aged ≥ 18 years;
Pathologically confirmed diffuse large B-cell lymphoma (DLBCL) by tumor tissue, with at least one measurable lesion, including DLBCL, not otherwise specified (GCB and non-GCB subtypes), DLBCL with MYC and BCL-2 rearrangements, and high-grade B-cell lymphoma;
No prior receipt of other anti-tumor treatments;
ECOG performance status 0-2;
Lymphoma involving the central nervous system or leptomeningeal metastasis;
Transformed lymphoma, i.e., transformed from other types of lymphoma, such as follicular lymphoma, marginal zone lymphoma, chronic lymphocytic leukemia, or small B-cell lymphoma;
Primary mediastinal large B-cell lymphoma;
Burkitt lymphoma;
Single group
Orelabrutinib Combined with Pola-R-CHP Regimen
DrugParticipants will receive orelabrutinib 150 mg orally once daily on Days 1-21 of each 21-day cycle. Polatuzumab vedotin will be administered intravenously at 1.8 mg/kg once every 21 days in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for 6 cycles. During Cycles 7 and 8, participants will receive rituximab in combination with orelabrutinib. Thereafter, orelabrutinib maintenance therapy will be continued for up to 1 year.
Complete Response Rate (CRR)
The proportion of patients who achieve Complete Response.
Objective Response Rate (ORR):
The proportion of patients who achieve either a complete response (CR) or a partial response (PR, partial reduction of tumor lesions).
Progression-Free Survival (PFS)
The length of time during which a patient's disease does not progress (i.e., no new tumor growth or spread of existing tumors).
Overall Survival (OS)
The length of time from the start of treatment until a patient's death from any cause.
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