This prospective, single-arm, multicenter clinical study aims to enroll 30 frail elderly patients with Non-GCB DLBCL. This study is to evaluate the preliminary efficacy and safety of the combination of Polatuzumab, Rituximab, and orelabrutinib in this population. The primary endpoint is CR rate after induction therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Polatuzumab: 1.8 mg/kg, IV Drip infusion, D1;
Rituximab: 375 mg/m2, IV Drip infusion, D1
Orelabrutinib: 150 mg/time, qd, po, D1-21
Affiliated hospital of Nantong University
Nantong, Jiangsu, China
RECRUITINGJiangsu Province Hospital
Nanjing, China
NOT_YET_RECRUITINGCRR
Complete response rate (CRR) at the end of Induction treatment (6 cycles)
Time frame: 6 months
ORR
Overall response rate (ORR) at the end of Induction treatment (6 cycles)
Time frame: 6 months
2y-PFS rate
defined as the time from the start of treatment to the first documented Disease progression or Death; patients who have not experienced an event at the time of analysis will be censored at the date of the most recent disease assessment
Time frame: 24 months
OS
defined as the time from the start of treatment to the Death of death from any cause; patients who had not experienced an event at the time of analysis were censored at the date the patient was last known to be alive
Time frame: 24 months
EFS
defined as the time from the start of treatment until Disease progression/relapse, Death from any cause, or the start of next-line Lymphoma therapy (NALT); patients who have not experienced an event at the time of analysis will be censored at the date of the most recent disease assessment
Time frame: 24 months
Safety profile
defined as the incidence of Adverse event (AEs) that occurred from the date of the first dose of Carcinoma until 30 days after discontinuation of study drug or PD or initiation of new anti-safety therapy, whichever occurred first, and defined as all Adverse event that occurred after the patient received the study regimen; defined as the incidence of treatment-related AEs that were considered by the investigator to be related to Salvage therapy, Transplant, and consolidation therapy after the patient received the study regimen
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Time frame: 24 months