The purpose of this study is to evaluate the efficacy and safety of orelabrutinib combined with rituximab,followed by orelabrutinib combined with R-CHOP-like regimen for newly diagnosed untreated Non-GCB DLBCL Patients
The study will start with an initial 21-days of induction therapy with orelabrutinib and rituximab,following imaging examinations to evaluate response rates. Then treatment with 6 cycles chemoimmunotherapy (R-CHOP-like) either alone or in combination with orelabrutinib will depend on response during induction phase. Each cycle is 21 days.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Orelabrutinib 150mg qd PO
Rituximab 375 mg/m2 IV on Day 1 of each 21-day cycle
cyclophosphamide, anthracene nucleus chemotherapeutics(doxorubicin,liposomal doxorubicin, etc.), vinca alkaloids(vincristine, vindesine, etc.),and glucocorticoid (dexamethasone,prednison, etc.).
the First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
RECRUITINGComplete Response Rate
The rate of patients who achieved complete response after treatment by OR-CHOP-like
Time frame: At the end of Cycle 6(each cycle is 21 days)
Overall Response Rate (ORR)
The rate of patients who achieved CR or PR after treatment by OR-CHOP-like
Time frame: At the end of Cycle 3 and Cycle 6(each cycle is 21 days)
Progression-free survival(PFS)
PFS will be assessed from the first OR(Orelabrutinib plus Rituximab) given to date of progression, relapse, death or end of follow-up
Time frame: up to 24 month after the end of last patient's treatment
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
Time frame: initiation of study drug until 30 days after last dose
Mini response rate
The rate of patients who achieve ≥25% tumor reduction after OR treatment
Time frame: the first 21 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.