This is a single-arm, prospective clinical study to evaluate the efficacy and safety of orelabrutinib combined with rituximab as first-line systemic treatment for marginal zone lymphoma.
Age ≥ 18 years, regardless of gender;
Histologically confirmed CD20-positive marginal zone lymphoma, including MALT, SMZL, and NMZL, with at least one lesion outside the spleen measuring more than 1.5 cm in any axis;
MZL that has progressed or relapsed after prior local therapy (including surgery, radiotherapy, anti-Helicobacter pylori treatment, and anti-hepatitis C treatment), or is not suitable for local therapy;
ECOG performance status of 0-2;
Currently or previously having other malignancies, unless there is evidence of no recurrence or metastasis within the past 5 years after curative treatment;
Lymphoma involvement of the central nervous system or transformation to high-grade lymphoma;
Non-hematological toxicities from prior anti-cancer treatments not recovered to ≤ Grade 1 (excluding alopecia);
New York Heart Association (NYHA) Class II or higher congestive heart failure, unstable angina, myocardial infarction within 6 months before the first administration of the study drug, or arrhythmias requiring treatment at screening, left ventricular ejection fraction (LVEF) < 50%;
Single group
orelabrutinib combined with rituximab regimen
DrugAll participants will receive induction therapy with the orelabrutinib and rituximab regimen. The treatment cycle is 28 days, with a total of 6 cycles. The induction treatment period is as follows: Cycle 1: Rituximab, 375 mg/m², on Day 1. Cycles 2-6:Orelabrutinib, 150 mg, once daily orally, from Day 1 to Day 28. Rituximab, 375 mg/m², on Day 1. Patients who achieve a partial response (PR) or better will enter a 2-year maintenance period with orelabrutinib.
Overall Response Rate (ORR)
ORR is defined as the proportion of patients with a response of CR or PR
Complete Response Rate (CR)
The rate of patients who achieved complete response after treatment
Best Overall Response (BOR)
The best response achieved by the patient from the start of treatment until disease progression or the initiation of a new treatment regimen.
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. Patients alive without progression and relapse will be censored at the latest tumor assessment date or the stopping date.
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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Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead sponsor
The Second Affiliated Hospital of Jiaxing University
Collaborator
Taizhou First People's Hospital
Collaborator
Huzhou Central Hospital
Collaborator
Zhejiang Cancer Hospital
Collaborator
Dongyang People's Hospital
Collaborator
Yuyao People's Hospital
Collaborator
Taizhou Hospital
Collaborator
Shaoxing Central Hospital
Collaborator
Affiliated Hospital of Jiaxing University
Collaborator
Shaoxing People's Hospital
Collaborator
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
Collaborator
The Central Hospital of Lishui City
Collaborator
Second Affiliated Hospital of Wenzhou Medical University
Collaborator
Ningbo People's Hospital
Collaborator
The People's Hospital of Quzhou
Collaborator
Zhejiang University
Collaborator
Zhuji People's Hospital of Zhejiang Province
Collaborator
