This is a multi-center, prospective study. The main purpose is to evaluate the efficacy and safety of Orelabrutinib combined with Obinutuzumab for previously untreated MZL.
Marginal zone lymphoma (MZL) is a relatively common type of B-cell non-Hodgkin lymphoma (B-NHL), with an incidence rate second only to diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL). It is divided into three subtypes based on different clinical manifestations and pathological characteristics: mucosa-associated lymphoid tissue lymphoma (MALT), also known as extranodal marginal zone lymphoma, nodal marginal zone lymphoma (NMZL), and splenic marginal zone lymphoma (SMZL). Currently, there is no unified and standardized treatment plan for newly diagnosed MZL. Although high-intensity immunochemotherapy regimens have a high remission rate, they also bring higher treatment-related safety risks. Therefore, exploring effective chemotherapy-free regimens for MZL patients is an attempt with scientific value and clinical significance. 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 study is a multi-center, prospectivet clinical study for previously untreated MZL. The patients will be treated with 6 cycles of O2 regimen. Patients with CR/PR after 6 cycles of O2 treatment will be treated with 1 year of single-agent orelabrutinib regimen.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
51
orelabrutinib,150mg,D1-D28 obinutuzumab,1000mg,D1、D8、D15/cycle1 D1/cycle2-6 . The patients will be treated with 6 cycles of O2 regimen. Patients with CR/PR after 6 cycles of O2 treatment will be treated with 1 year of single-agent orelabrutinib regimen.
The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University#Huai'an First People's Hospital#
Huai'an, Jiangsu, China
RECRUITINGOverall response rate (ORR)
The ORR is defined as the proportion of patients with a response of CR or PR
Time frame: At the end of Cycle 6 (each cycle is 28 days)
the complete response rate
CRR is defined as the proportion of patients with a response of CR
Time frame: (up to 2 year)
BOR
The BOR is defined as the proportion of patients with a best response of CR or PR
Time frame: Up to 2 years
Duration of Response (DOR)
Duration of response as defined as the period from the first response (at least PR) to treatment until evidence of disease progression, relapse or death of any cause.
Time frame: [ Time Frame: Up to 3 years ]
TTR
TTR is defined as the time from registration to the first response.
Time frame: [ Time Frame: Up to 3 years ]
24-month time to CR TTCR24
TTCR24 is defined as the time from registration to the first complete response Within 24 months.
Time frame: Up to 2 years
CR at 24 months (CR24)
CR24 is defined as the proportion of patients with a response of CR at 24 months
Time frame: at 24 months
2 years progression-free survival
Progression free survival (PFS) is defined as the time from registration to the first occurrence of progression or relapse as assessed by the investigator, or death from any cause. PFS for patients without disease progression, relapse, or death will be censored at the time of the last tumor assessment.
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Time frame: [Time Frame: From date of signing the informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years]
2 years overall survival
Overall survival is defined as the period from the induction registration to death from any cause. Patients who have not died until the time of the analysis will be censored at their last contact date.
Time frame: [Time Frame: From date of signing the informed consent until the date of death from any cause, whichever came first, assessed up to 2 years]
The occurrence of adverse events
Adverse events will be graded by the investigator according to the NCI-CTCAE Version 5.0.
Time frame: One month after discontinuation of treatment