This study aims to preliminarily explore the efficacy and safety of the combination of Obinutuzumab and Zanubrutinib plus Lenalidomide (ZGR) followed by a short cycle of cytarabine and Obinutuzumab in the induction treatment of newly diagnosed mantle cell lymphoma (MCL) . The investigators propose ZGR followed by a short cycle of Obinutuzumab and cytarabine could be an effective first-line treatment for MCL.
Based on the clinical need for first-line treatment of MCL, this study proposed to enroll 39 patients with MCL who have not previously received any systemic therapy for MCL. All patients were treated with ZGR regimen for 6 cycles after enrollment, followed by 3 cycles of Obinutuzumab + cytarabine in 28-day cycles. For non-high-risk patients, lenalidomide and Zanubrutinib were used for maintenance; high-risk patients continued Lenalidomide and Zanubrutinib for maintenance following CAR-T cell therapy for 1 year for Lenalidomide and 2 years for Zanubrutinib. The primary endpoint of CRR and secondary endpoints (including ORR, PFS, DoR, and OS) were followed and recorded to explore the efficacy and safety of ZGR followed by a short cycle of Obinutuzumab and cytarabine induction therapy in treatment-naive MCL.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
No dose adjustment of Obinutuzumab is allowed.
Zanubrutinib was allowed to be titrated to 80 mg bid or 80 mg qd
Lenalidomide was allowed to be titrated to 15 mg/day (induction phase) or 5 mg/day (maintenance phase).
The specific dose is determined by the investigator according to the actual situation of the patient.
zanubrutinib in combination with lenalidomide was allowed for maintenance treatment in high-risk patients for 1 year and zanubrutinib for 2 years after recovery of hemogram 2 months after CAR-T. High-risk Patients with any of the following conditions: Mantle cell lymphoma International Prognostic Index (MIPI-c) high-risk, blastic/pleomorphic type, TP53 mutation/deletion, CDKN2A deletion, MYC amplification/translocation, or incomplete response at induction stage; Non-high-risk group: no high-risk features.
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGInstitute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
RECRUITINGComplete response rate (CRR)
defined as the proportion of patients with complete response as assessed by response to induction therapy using the 2014 Lugano criteria.
Time frame: up to the end of 9 cycles of treatment(each cycle is 28 days)
overall response rate (ORR)
defined as the proportion of patients with complete or partial response as assessed by response to induction therapy.
Time frame: up to the end of 9 cycles of treatment(each cycle is 28 days)
Minimal residual disease (MRD) negative rate of
defined as the proportion of patients with MRD negative (less than 10-4) in bone marrow by flow cytometry after induction therapy in newly diagnosed patients with bone marrow invasion.
Time frame: up to the end of 9 cycles of treatment(each cycle is 28 days)
Progress-free survival (PFS)
defined as the time from the start of treatment to disease progression or death due to any cause.
Time frame: up to 5 years
Duration of tumor remission (DoR)
defined as the time from the first treatment response (including complete response and partial response) to the last assessment of response.
Time frame: up to 5 years
Overall survival (OS)
defined as the time from enrollment to death for any cause.
Time frame: up to 5 years
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