This is a prospective, single arm trial in patients with ≥ 18 years with relapsed and refractory DLBCL. Aim of this study is to evaluate the efficacy and safety of pirtobrutinib in combination with rituximab, gemcitabine, and oxaliplatin with or without polatuzumab vedotin (Pirto-R-GemOx±pola) in patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) previously treated with covalent BTK inhibitors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Dose:200mg,d1-21
Dose: Rituximab: 375mg/m2, d1; Gemcitabine: 1000mg/m2, d2; Oxaliplatin:100mg/m2, d2
Dose: 1.8mg/kg,iv,d1 (For patient who is CD79b positive and has not previously received polatuzumab Vedotin)
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
complete response rate(CRR)
CRR after treated by pirto-R-GemOx±pola
Time frame: Up to 6 cycles (each cycle is 21 days)
Objective response rate(ORR)
ORR after treated by pirto-R-GemOx
Time frame: Up to 6 cycles (each cycle is 21 days) ± pola
Progression-free survival (PFS)
PFS after treated by pirto-R-GemOx±pola
Time frame: Up to 6 cycles (each cycle is 21 days)
Overall Survival (OS)
OS after treated by pirto-R-GemOx±pola
Time frame: up to 6 cycles(each cycle is 21 days)
undetectable MRD rate
undetectable MRD rate after treated by pirto-R-GemOx
Time frame: Up to 6 cycles (each cycle is 21 days) ± pola
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