The proposed study is a prospective, single-center, single-arm and open-ended phase II study in patients over the age of 18 with previously untreated mantle cell lymphoma(MCL). The primary objective of this study is to explore the safety and efficacy of a new chemo-free treatment pattern zanubrutinib-rituximab(ZR) in newly diagnosed MCL.
The study will start with an initial 28-days of induction immunotherapy with ZR and 4 cycles of consolidation immunotherapy with ZR,following imaging examinations to evaluate response rates. Patients who are evaluated as SD and PD will be withdrawn from the trial,while those who achieve PR and CR will be further stratified according to their age and physical status. The older or frail patients who are ineligible for ASCT will take zanubrutinib orally until intolerable toxicity or disease progression. Patients who are young and fit for transplantation will receive ASCT consolidation. After ASCT, patients with CR will end therapy and enter the follow-up stage, while patients with PR will continue to take zanubrutinib orally until intolerable toxicity or disease progression.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
zanubrutinib 160mg PO BID d1-28; rituximab 375mg/m2 IVGTT d1,8,15,22. Other name: Part A
zanubrutinib 160mg PO BID d1-28; rituximab 375mg/m2 IVGTT d1. Other name: Part B
semustine 250mg/m2 PO d1; etoposide 200mg/m2 IV d2-5; cytarabine 400mg/m2 IV d2-5; melphalan 140mg/m2 IV d6.
the First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
RECRUITINGOverall Response Rate(ORR) in all patients
The rate of patients who achieved complete response and partial response after ZR combined immunotherapy
Time frame: At the end of cycle 3 and cycle 5(each cycle is 28 days)
Complete Response Rate(CRR) in all patients
The rate of patients who achieved complete response after ZR combined immunotherapy.
Time frame: At the end of cycle 3 and cycle 5(each cycle is 28 days)
Overall Response Rate(ORR) in patients received ASCT
The rate of patients who achieved complete response and partial response after ASCT.
Time frame: 1 month after ASCT
Complete Response Rate(CRR) in patients received ASCT
The rate of patients who achieved complete response after ASCT.
Time frame: 1 month after ASCT
Overall Survival (OS)
OS will be assessed from the first ZR given to date of death or end of follow-up.
Time frame: up to 24 months after the last patient's enrollment.
Progression Free Survival (PFS)
PFS will be assessed from the first ZR given to date of progression, relapse, death or end of follow-up.
Time frame: up to 24 months after the last patient's enrollment.
Incidence of Treatment-Emergent Adverse Events, Treatment-Related Adverse Events and Serious Adverse Events
The safety and tolerability of the therapeutic regimen measured by the incidence of Treatment-Emergent Adverse Events, Treatment-Related Adverse Events and Serious Adverse Events.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
zanubrutinib 160mg PO BID.
Time frame: initiation of study drug until 30 days after last dose.
Minimal Residual Disease (MRD)
Time frame: At the end of cycle 5 ZR (each cycle is 28 days) and 1 month after ASCT.