Sintilimab Plus Rituximab Followed by R-CHOP Regimen in Untreated PMBL

PHASE2RecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

November 12, 2024

Primary Completion Date

December 30, 2027

Study Completion Date

December 30, 2029

Conditions
Primary Mediastinal Diffuse Large B-cell Lymphoma
Interventions
DRUG

Sintlimab+Rituximab follwed by R-CHOP(Cyclophosphamide, doxorubicin, vincristine, prednisone)

First strategy of targeted immunotherapy followed by chemotherapy for PMBL. Participants will first receive sintilimab(200mg) plus rituximab(375mg/m2) for 2 cycles. If patients achieve CR or CMR, they will continue to receive 2 courses of sintilimab plus rituximab, followed by 4 cycles of R-CHOP. Patients will receive 6 courses of R-CHOP if they do not achieve CR or CMR after 2 cycles of sintilimab plus rituximab. Patients will undergo PET-CT assessment and will receive 6 cycles of maintenance treatment with nintedanib if CR/CMR/PR is achieved and will be withdrawn from the study if SD/PD occurs. Total treatment cycles will not exceed 14 cycles.

Trial Locations (2)

51006

RECRUITING

Sun yat-sen university cancer cencer, Guangzhou

350014

ACTIVE_NOT_RECRUITING

Fujian Cancer Hospital, Fuzhou

All Listed Sponsors
lead

Sun Yat-sen University

OTHER