Evaluation the efficacy and safety of Zanubrutinib + R-CHOP/R-DHAP for the treatment mantle cell lymphoma.
Histologically confirmed diagnosis of MCL according to WHO classification;
Previously untreated MCL.
Age ≥ 18 and ≤ 70 years old.
ECOG, 0~2.
Known CNS involvement of MCL, Leukemic non-lymphonodular mantle cell lymphoma was excluded.
Major surgery within 4 weeks of screening
Concomitant or previous malignancies within the last 2 years other than basal cell skin cancer or in situ uterine cervix cancer
Clinically significant cardiovascular disease such as uncontrolled arrhythmias and hypertension , congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification or LVEF below 50%（AHA，2016）
Single group
Zanubrutinib and RCHOP/RDHAP
DrugAlternating 3× R-CHOP/ 3× R-DHAOx, every 21 days plus oral Zanubrutinib in cycle 1, 3, 5 in combination with R-CHOP: R-CHOP (cycle 1,3,5): Rituximab 375 mg/m2 D1, I.V. Cyclophosphamide 750 mg/m2 D1, I.V. Doxorubicine 50 mg/m2 D1, I.V. Vincristine 1.4mg/m2(max 2mg)D1, I.V. Prednisone 100mg D1-5, oral Zanubrutinib 160mg BID D1-21, oral R-DHAP(cycle 2,4,6): Dexamethasone 40mg D1-4 oral/I.V. Rituximab 375mg/m2 D1, I.V. Ara-C 2×2g/m2 q12h D2, I.V. Cisplatin 100mg/m2 D1, I.V. Maintenance: Zanubrutinib, 160mg PO BID, rituximab 375mg/m2 repeated every 8 weeks, treatment will continue for up to 2 years or until progressive disease。
CR rate after 6 cycles of induction therapy
To evaluate the CR rate after Zanubrutinib-based induction therapy in subjects with newly diagnosed MCL.
ORR rate after 6 cycles of induction therapy
To evaluate the ORR rate after Zanubrutinib-based induction therapy in subjects with newly diagnosed MCL.
Progression free survival (PFS)
The time from start of treatment to progression or death from any cause
Overall survival (OS)
The time from start of treatment to death from any cause
duration of response, DOR
Defined as the time after the start of treatment from the first time remission criteria are met until disease progression or death is objectively recorded, whichever occurs first.
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