drugset / Trial / NCT05186558

Penpulimab Plus R2-GemOx Regimen in Relapsed or Refractory DLBCL

NCT05186558

NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2022-05-15
Primary completion
2024-01-15
Completion
2026-02-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Penpulimab Monoclonal antibody 200 mg Intravenous
Background Gemcitabine Small molecule 1000 mg Oral
Background Lenalidomide Other / unclassified 10 mg Oral
Background Oxaliplatin Small molecule 100 mg/m2 Intravenous
Background Rituximab Monoclonal antibody 375 mg/m2 Intravenous