This phase 2 trial studies the efficacy and safety of zanubrutinib plus rituximab followed by R-DHAOx (rituximab, dexamethasone, cytarabine and oxaliplatin) regimen then maintenance with zanubrutinib for newly-diagnosed Mantle Cell Lymphoma (MCL).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Zanubrutinb 160mg PO BID d1-28; Rituximab 375mg/m2 iv.drip d1.
Rituximab 375mg/m2 iv.drip d1; Dexamethasone 20mg iv.drip d1-4; Cytarabine 2000mg/m2 (1000mg/m2 for patients aged over 65) iv.drip d2,3 Oxaliplatin 130mg/m2 iv.drip d1.
Zanubrutinb 160mg PO BID.
Guangdong General Hospital
Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, Guangdong, China
Complete remission rate after PART A
Complete remission rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria.
Time frame: 3 years
Complete remission rate after study treatment
Complete remission rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria.
Time frame: 3 years
Objective Response rate
Objective Response rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria.
Time frame: 3 years
Progression Free Survival
The time from the start of treatment to the progression of the tumor or death (due to any cause).
Time frame: 5 years
Overall Survival
The time from the start of treatment to time of death (due to any cause).
Time frame: 5 years
Time to Response
The time from the start of treatment to the first assessment of complete remission or partial remission.
Time frame: 3 years
Duration of Response
The time from the first assessment of complete remission or partial remission to progressive disease or death (due to any cause).
Time frame: 5 years
Percentage of Participants With Adverse Events
Adverse Events will be determined and graded on the basis of investigator assessments according to NCI CTC AE 5.0
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Time frame: 3 years