A Phase 2 interventional study of penpulimab, lenalidomide, Rituximab, Gemcitabine, Oxaliplatin in Lymphoma, Large B-Cell, Diffuse and Neoplasms by Histologic Type, sponsored by The First Affiliated Hospital with Nanjing Medical University. Not yet recruiting at 4 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-03-07.
Sponsored by The First Affiliated Hospital with Nanjing Medical University · Phase 2, Interventional, and Treatment
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's planned enrollment of 54 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 543 studies on the registry; 301 are open to participants now.
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Exclusion Criteria:
penpulimab: 200 mg q2w, iv, drip R2-GemOx: lenalidomide 10 mg,po; Rituximab 375mg/m2, iv, drip; Gemcitabine 1000mg, po; Oxaliplatin 100mg/m2, iv, drip;
Drug: penpulimab, lenalidomide, Rituximab, Gemcitabine, Oxaliplatin
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.
Also known as: lenalidomide, Rituximab, Gemcitabine, Oxaliplatin
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
This study is not yet recruiting, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital with Nanjing Medical University