This study aims to evaluate the safety and efficacy of orelabrutinib (O) in combination with obinutuzumab (G) and short-course venetoclax (V) in patients with treatment-naïve MCL.
Voluntarily participate and sign the informed consent form;
Age ≥ 18 years, male or female;
Life expectancy ≥ 3 months;
Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Patients with ECOG 3 may be enrolled only if the decline in performance status is attributed to the underlying disease and the investigator determines that they may benefit from the treatment;
Received prior treatment for lymphoma within 2 weeks before study enrollment;
Uncontrolled hypertension (defined as blood pressure that remains uncontrolled after at least 4 weeks of treatment with a reasonable and tolerable regimen of 3 or more antihypertensive agents [including diuretics] at adequate doses, or requiring 4 or more antihypertensive agents to achieve adequate control);
Uncontrolled congestive heart failure within 6 months prior to screening (New York Heart Association [NYHA] Class III [moderate] or Class IV [severe] cardiac disease);
Left ventricular ejection fraction (LVEF) < 50%;
Single group
Orelabrutinib
DrugOrelabrutinib: 150 mg, d1-d28, C1-C6 (Induction Phase ) ; 150 mg, d1-d28, C7-C24 (Maintenance Phase)
Obinutuzumab
DrugObinutuzumab: 1000 mg/m², on d1, d8, and d15 in C1; and on d1 in C2-C6 (Induction Phase ) ; 1000 mg/m², d1, once every 2 cycles, C7-C24 (Maintenance Phase)
Venetoclax
DrugVenetoclax: dose ramp-up in C2 (20 mg → 400 mg); 400 mg on d1-d14 in C3-C6(Induction Phase ) ; 400 mg, d1-d14, C7-C24(Maintenance Phase)
Complete response rate (CRR)
The CRR is defined as the proportion of patients who achieve a CR following therapy, calculated among all treated patients.
MRD negativity rate
The MRD negativity rate is defined as the proportion of patients who achieve MRD negativity in peripheral blood following treatment, calculated among all treated patients.
Objective response rate (ORR)
The objective response rate (ORR) is defined as the proportion of patients who achieve a complete response (CR) or partial response (PR) after treatment, relative to the total treated population.
2-year progression-free survival (PFS)
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.
Overall Survival (OS)
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.
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