This is a prospective, single center, single arm, open label study of zanubrutinib, lenalidomide in combination with Rituximab-ICE for treatment of relapsed/refractory diffuse large B-cell lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
* Drug: zanubrutinib Oral Capsule * Drug: lenalidomide Oral Capsule * Drug: R-ICE chemotherapy
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGObjective response rate (ORR)
To evaluate the efficacy in terms of objective response rate including CR and PR rate after three cycles of ZR2-ICE
Time frame: 9 weeks
Complete remission rate (CR)
To evaluate the efficacy in terms of Complete Response Rate after three cycles of ZR2-ICE
Time frame: 9 weeks
DOR
Among participants who experience an objective response, DOR is defined as the date of their first objective response (which is subsequently confirmed) to disease progression
Time frame: Up to 2 years
Progression-free survival
Progression-free survival is defined as the time from enrolment to progression or death due to any cause. The distribution of PFS will be estimated using the method of Kaplan-Meier.
Time frame: Up to 2 years
Overall survival
Overall survival is defined as the time from enrolment to death due to any cause.
Time frame: Up to 2 years
Safety Management Study
Incidence of Treatment-Emergent Adverse Events
Time frame: Up to 100 days
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