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Brief Title: Penpulimab Plus R2-GemOx Regimen in Relapsed or Refractory DLBCL
Official Title: A Multi-center, Single-arm, Open Label Study to Assess the Efficacy and Safety of Anti-PD-1 Antibody (Penpulimab) Plus Lenalidomide, Rituximab, Gemcitabine and Oxaliplatin (R2-GemOx) in Patients With Relapsed/ Refractory Diffuse Large B Cell Lymphoma (DLBCL)
Study ID: NCT05186558
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Name: Wei Xu
Affiliation: The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)
Role: PRINCIPAL_INVESTIGATOR