Zanubrutinib, as a new generation of BTK inhibitors, has shown more potent antitumor activity and lower adverse reactions than ibrutinib in head-to-head clinical studies, which make it a promising regimen for B cell lymphoma. Chidamide is an oral subtype-selective histone deacetylase inhibitor. This Randomized, Multicenter, Open-Label Phase II Clinical Study is comparing the efficacy and safety of Zanubrutinib, Chidamide, and Rituximab induction therapy sequentially combined with or without CHOP versus R-CHOP in the first-line treatment of patients with newly diagnosed double-expressor DLBCL.
This study is designed to compare the efficacy and safety of zanubrutinib, chidamide, and rituximab (ZCR) induction therapy sequentially combined with or without CHOP regimen versus the standard R-CHOP regimen as first-line treatment for newly diagnosed double-expressor DLBCL. This study targets patients with MYC/BCL2 double-expressing DLBCL, a group with poor prognosis under traditional R-CHOP treatment. The study consists of screening period, treatment period, and follow-up period, with subjects randomly assigned to the experimental group and the control group in a 1:1 ratio. The primary endpoint is the end-of-treatment complete response rate (EOT-CRR), while secondary endpoints include the overall response rate (EOT-ORR), duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety. A total of 128 patients are planned to be enrolled. Efficacy evaluation will be conducted using the 2014 Lugano criteria, with imaging examinations such as PET-CT to objectively measure treatment response. adverse events (AEs) throughout the entire trial and grade the severity of adverse events will be recorded according to the guidelines of the National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) 5.0.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
128
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
EOT-CR
defined as the proportion of subjects with measurable disease who achieve CR at the end of treatment according to 2014 Lugano criteria
Time frame: Approximately 12 months
EOT-ORR
defined as the proportion of subjects with measurable disease who achieve CR and PR at the end of treatment according to 2014 Lugano criteria
Time frame: Approximately 12 months
Duration of response(DOR)
defined as the time from the date of first occurrence of CR or PR to the date of the first documented PD or death due to any cause according to 2014 Lugano criteria.
Time frame: Approximately 24 months
Progression-free survival (PFS)
defined as the time from treatment to disease progression or death from any cause according to 2014 Lugano criteria.
Time frame: Approximately 24 months
Overall survival (OS)
defined as the time from treatment to death from any cause according to 2014 Lugano criteria.
Time frame: Approximately 24 months
Adverse Events (AE)
all adverse events occurring during or after the first treatment will be summarized by treatment arm and NCI CTCAE grade.
Time frame: Approximately 12 months
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