Sintilimab Plus R-GemOx as Second-line Salvage Therapy in Patients With R/R DLBCL
Status:
Not yet recruiting
Trial end date:
2025-12-10
Target enrollment:
Participant gender:
Summary
This study evaluates the addition of Sintilimab to current 2nd line salvage therapy of
Rituximab, Gemcitabine and Oxaliplatin (R-GemOx) for patients with relapsed or refractory
Diffuse Large B-Cell Lymphoma (DLBCL). All patients will receive four cycles of sintilimab
plus R-GemOx. Afterwards, 1) patients who achieve CR assessed by PET-CT and are eligible for
autologous stem cell transplantation (ASCT) will undergo ASCT. After transplantation,
patients will receive sintilimab monotherapy up to 8 cycles or until disease recurrence and
progression, death, intolerance and toxicity, withdrawal of informed consent, or other
reasons specified in the protocol. 2) Patients who achieve CR assessed by PET-CT and are not
eligible for ASCT will directly receive sintilimab monotherapy as maintenance treatment for a
maximum of 8 cycles as described above. 3) Patients achieved PR, SD or PD assessed by PET/CT
will withdraw from this study and receive proper treatment based on investigator's decision.