Optimize Study - Orelabrutinib Combined With BR/G in Untreated Marginal Zone Lymphoma (MZL)
NCT Number: NCT06504940
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Marginal Zone Lymphoma
Interventions: DRUG: Orelabrutinib combined with bendamustine and rituximab|DRUG: Orelabrutinib combined with obinutuzumab
Sponsor: First Affiliated Hospital of Zhejiang University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 73
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-28
Completion Date: 2029-07-08
Locations: The First Affiliated Hospital ，Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310003, China

Summary:
This is a multi-center, prospective cohort study. The main purpose of Cohort A is to evaluate the efficacy and safety of Orelabrutinib combined with BR (bendamustine and rituximab) for previously untreated young patients with MZL; the purpose of Cohort B is to assess the efficacy and safety of Orelabrutinib combined with G (Obinutuzumab) followed by Orelabrutinib maintenance therapy for previously untreated elderly patients with MZL.

Primary Outcome Measures: Cohort A: The incidence of grade 3-5 adverse events (AEs), Adverse events will be graded by the investigator according to the NCI-CTCAE Version 5.0., From the first administration of the drug to one month after the completion of induction therapy.|Cohort A:the complete response rate (CRR), CRR is defined as the proportion of patients with a response of CR, At 12 months.|Cohort B: The 2-year progression-free survival (PFS) rate., 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., 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]
Secondary Outcome Measures: Overall response rate (ORR), The ORR is defined as the proportion of patients with a response of CR or PR, Up to 2 years|The 2-year overall survival (OS) rate, 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., From date of signing the informed consent until the date of death from any cause, whichever came first, assessed up to 2 years|The 2-year progression-free survival (PFS) rate., 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., 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|Duration of response, 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. Patients alive without progression and relapse will be censored at the latest tumor assessment date or the stopping date., Up to 2 years|TTR, TTR is defined as the time from registration to the first response., Up to 2 years|The frequency of grade 3-5 AEs, Adverse events will be graded by the investigator according to the NCI-CTCAE Version 5.0., From the first drug administration to one month after the end of treatment.|The occurrence of adverse events and serious adverse events, 7. Adverse events will be graded by the investigator according to the NCI-CTCAE Version 5.0., From the first drug administration to one month after the end of treatment.