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).
This study is designed to evaluate the efficacy and safety of 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). Participants 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Participants 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.
the First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
RECRUITINGthe First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
RECRUITINGComplete Response Rate (CRR)
The proportion of patients who achieve Complete Response.
Time frame: up to 12 months
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).
Time frame: up to 12 months
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).
Time frame: up to 24 months
Overall Survival (OS)
The length of time from the start of treatment until a patient's death from any cause.
Time frame: up to 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.