Evaluation the efficacy and safety of Zanubrutinib + R-CHOP/R-DHAP for the treatment mantle cell lymphoma.
A single-arm, single-center, open-label phase II study of Zanubrutinib combined with R-CHOP/R-DHAP alternating induction therapy followed by Zanubrutinib rituximab maintenance therapy.The primary objective of this study was to assess CR and ORR rates after 6 cycles of initiation (i.e., at the end of induction therapy), and to collect adverse events during induction and maintenance therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
Alternating 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。
Hematology Department of ShanXi Cancer Hospital
Taiyuan, Shanxi, China
CR rate after 6 cycles of induction therapy
To evaluate the CR rate after Zanubrutinib-based induction therapy in subjects with newly diagnosed MCL.
Time frame: 18 weeks
ORR rate after 6 cycles of induction therapy
To evaluate the ORR rate after Zanubrutinib-based induction therapy in subjects with newly diagnosed MCL.
Time frame: 18 weeks
Progression free survival (PFS)
The time from start of treatment to progression or death from any cause
Time frame: 60 weeks
Overall survival (OS)
The time from start of treatment to death from any cause
Time frame: 60 weeks
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.
Time frame: 60 weeks
MRD negative rate at the end of induction therapy
MRD negative rate in peripheral blood or bone marrow at the end of induction therapy
Time frame: 18 weeks
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