This is a multi-center, prospective cohort study. The main purpose of study is to evaluate the efficacy and safety of Orelabrutinib combined with Zuberitamab in the initial treatment of MZL Main efficacy indicators Complete response rate (CR) at the end of combination therapy.
Marginal Zone Lymphoma (MZL) is a group of B-cell malignancies believed to originate from B lymphocytes, typically found in the marginal zones of lymphoid follicles in the spleen, lymph nodes, and mucosa-associated lymphoid tissues. Exploring more effective, low-toxicity treatment plans for MZL patients is a scientifically valuable and clinically significant attempt. With the development of new drugs, new drug regimens have become prominent in the treatment of MZL, and there is an increasing amount of research data on BTK inhibitors in the field of MZL. The BTK inhibitor Orelabrutinib has shown good efficacy in MZL and has been approved by the NMPA for the treatment of MZL in patients who have received at least one prior treatment. This is a multi-center, prospective cohort study. The main purpose of study is to evaluate the efficacy and safety of Orelabrutinib combined with Zuberitamab in the initial treatment of MZL. After receiving 6 cycles of ZO regimen induction therapy, patients were treated with Orelabrutinib combined with Zuberitamab (administered every 2 cycles) for 6 cycles or had disease progression or toxicity intolerance. Main efficacy indicators Complete response rate (CR) at the end of combination therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Orelabrutinib 150mg, po, gd, D1-D28, every 28 days, cycle 1-12; Zuberitamab: intravenously administered on day 1 of the cycle at a dose of 375mg/m2 every 28 days, once every cycle for cycles 1-6 and once every 2 cycles for cycles 7-12.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGSun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
NOT_YET_RECRUITING1Y CRR
Complete response rate (CR) at the end of combination therapy Efficacy evaluation was performed every 3 cycles (12 weeks) during the treatment period, every 3 months during the maintenance treatment period, and every 3-6 months during the observation and follow-up period, using Lugano 2014 efficacy evaluation criteria. MRD tests are performed every 6 cycles within 2 years of starting the drug.For the main efficacy indicators, complete response rate (CR) and 95%CI were calculated.
Time frame: 2 years
uMRD
Undetectable rate of total minimal residual lesions For the secondary efficacy indicators, such as 24-month progression-free survival (DFS) and 24-month overall survival (GFS), kaplan-Meier method was used to estimate and 95%CI were calculated, and survival curves were drawn. For secondary efficacy measures, uMRD, ORR and 95%CI were calculated.
Time frame: 2 years
ORR
Objective response rate
Time frame: 2 years
PFSR in 24m
24-month progression-free survival
Time frame: 2 years
OSR in 24m
24-month overall survival
Time frame: 2 years
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