Aim of this study will evaluate the efficacy and safety of zanubrutinib in combination with R-CHOP for newly diagnosed untreated Non-GCB DLBCL Patients
Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin's lymphoma. According to Hans' algorithms, DLBCL can be identified as 2 subtypes: germinal b-cell-like(GCB) and non-germinal b-cell-like(non-GCB). Approximately 50 to 60% of DLBCL was non-GCB subtype DLBCL.The non-GCB DLBCL revealed poor clinical outcomes. Bruton's tyrosine kinase (BTK) inhibitors have established therapeutic activity in B cell malignancies, with potential activity in non-GCB DLBCL. This study will evaluate the efficacy and safety of zanubrutinib in combination with R-CHOP for newly diagnosed untreated Non-GCB DLBCL Patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
78
Zanubrutinib-160mg bid PO d0-d20(1-21d)
Rituximab-375 mg/m2 i.v d0 (/21d)
Cyclophosphamide-750 mg/m2 i.v d1 (/21d)
The First Affiliated Hospital of USTC Anhui Provincial Hospital
Hefei, Anhui, China
RECRUITINGFujian Medical University Union Hospital
Fuzhou, Fujian, China
Progression-free Survival(PFS)
To measure the duration of response to ZR-CHOP over a follow-up period of 18 months
Time frame: up to 18 months
Overall Response Rate (ORR)
To measure the duration of response to ZR-CHOP over a follow-up period of 18 months
Time frame: up to 18 months
Complete Response Rate
Number of patients who achieved complete response after treatment by ZR-CHOP
Time frame: up to 18 months
Duration of Response
Duration of overall response will be assessed from the first ZR-CHOP given to progression,death or last follow-up.
Time frame: up to 18 months
Overall Survival
OS will be assessed from the first ZR-CHOP given to death or last follow-up.
Time frame: up to 18 months
Adverse events profile
Number of participants with adverse events. Frequencies of toxicities based on the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 will be tabulated
Time frame: Measured from start of treatment until 28 days after last dose
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Doxorubicin-50 mg/m2 i.v d1 (/21d)
Vincristine-1.4 mg/m2 i.v d1 (/21d)(2 mg max)
Prednisone-100 mg p.o d1-d5 (/21d)
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
RECRUITINGThe First People's Hospital of Changzhou
Changzhou, Jiangsu, China
RECRUITINGJiangsu Cancer Hospital
Nanjing, Jiangsu, China
RECRUITINGNanjing Drum Tower Hospital
Nanjing, Jiangsu, China
RECRUITINGZhongda Hospital Southeast University
Nanjing, Jiangsu, China
RECRUITINGNantong Tumor Hospital
Nantong, Jiangsu, China
RECRUITINGThe First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
RECRUITINGChangshu No.1 People's Hospital
Suzhou, Jiangsu, China
RECRUITING...and 6 more locations