This phase 2 trial studies the efficacy and safety of orelabrutinib plus rituximab followed by maintenance with orelabrutinib for relapsed and refractory follicular lymphoma(RR FL)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Orelabrutinib 150mg po qd d1-28; Rituximab 375mg/m2 iv.drip d1.
Orelabrutinib 150mg po qd
Guangdong General Hospital
Guangzhou, Guangdong, China
RECRUITINGSun Yat-Sen Memorial Hospital, Sun Yat-Sen University,
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGSun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University,
Guangzhou, Guangdong, China
RECRUITINGObjective Response rate
Objective Response rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria.
Time frame: 2 years
Complete remission rate
Complete remission rate will be determined on the basis of investigator
Time frame: 2 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: 4 years
Overall Survival
The time from the start of treatment to time of death (due to any cause).
Time frame: 4 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: 4 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
Time frame: 4 years
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