This study evaluates the efficacy and safety of penpulimab plus lenalidomide, rituximab, gemcitabine and oxaliplatin (R2-GemOx) in patients with relapsed/refractory diffuse large B cell lymphoma (DLBCL). All patients will receive six cycles of penpulimab plus R2-GemOx. Afterwards, 1) patients who achieve complete response (CR)/unconfirmed (CRu)/partial response (PR) assessed by positron emission tomography/computedtomography (PET-CT) and are eligible for autologous stem cell transplantation (ASCT) will undergo ASCT. 2) Patients who achieve CR/CRu/PR assessed by PET-CT and are not eligible for ASCT will directly receive penpulimab and lenalidomide as maintenance treatment, penpulimab for a maximum of 6 months, lenalidomide monotherapy for 18 months. 3) Patients achieved stable disease (SD) or progression disease (PD) assessed by PET-CT will withdraw from this study and receive proper treatment based on investigator's decision.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
54
Patients receive penpulimab+R2-GemOx two weeks for a cycle, detailed as follows: Combination therapy Anti-PD-1 antibody (penpulimab): Fixed dose of 200 mg every 2 weeks, d0, intravenous drip (without pretreatment), for 6 cycles. R2-GemOx: lenalidomide 10 mg,d1-7; Rituximab 375mg/m2, d0; Gemcitabine 1000mg, d1; Oxaliplatin 100mg/m2, d1; every 2 weeks for a cycle, 6 cycles as protocol specified. Maintenance treatment: Combination of two drugs: * Anti-PD-1 antibody (penpulimab): Fixed dose of 200 mg every 2 weeks, d0, intravenous drip (without pretreatment), , for 6 months * lenalidomide: 10 mg, po, for 18 months.
The First affiliated Hospital of AnHui Medical Universtiy
Hefei, Anhui, China
ChangZhou First People's Hospital
Changzhou, Jiangsu, China
Hematological Department, People's Hospital of Jiangsu Province
Nanjing, Jiangsu, China
The First Affiliated Hospital Of Nantong University
Nantong, Jiangsu, China
Complete response rate
Complete response rate after treated by penpulimab and R2-GemOx
Time frame: 6 weeks after the last dose of the combination therapy (each cycle is 14 days)
Overall Survival (OS)
from date of inclusion to date of death from any cause
Time frame: 2 years
Progression-free survival(PFS)
from date of inclusion to date of progression, relapse, or death from any cause
Time frame: 2 years
Rate of grade 3 or 4 treatment related adverse effect
All the adverse events of the patients related will be assessed and graded by NCI CTCAE v 5.0
Time frame: Up to 30 days after the last cycle of per-protocol treatment and 90 days after last dose of anti-PD-1 antibody
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