Orelabrutinib Combined With R-CDOP for DLBCL Patients With High-risk of CNS Relapse Defined by CNS-IPI

PHASE2RecruitingINTERVENTIONAL
Enrollment

62

Participants

Timeline

Start Date

March 30, 2023

Primary Completion Date

March 30, 2025

Study Completion Date

March 20, 2026

Conditions
Diffuse Large B-cell Lymphoma
Interventions
DRUG

Orelabrutinib combined with R-CDOP regimen

All participants were treated with the orelabrutinib combined with R-CHOP regimen (O-RCDOP). The treatment plan involved orelabrutinib tablets at 150mg QD (once daily) from day 1 to day 21, Rituximab at 375mg/m2 on day 1; Cyclophosphamide at 750mg/m2 on day 1; Liposomal Doxorubicin at 30mg/m2 on day 0; Vincristine at 25mg/m2 on day 1 (maximum dose 40mg); and Prednisone at 100mg from day 1 to day 5. The treatment cycles were set every 21 days for a total of 6-8 cycles. Dose adjustments were made for elderly patients for Cyclophosphamide and Liposomal Doxorubicin based on age: 70-80% of the dose for those aged 70-80 years old, and 50-60% of the dose for those older than 80 years.

Trial Locations (6)

Unknown

RECRUITING

Second Affiliated Hospital, School of Medicine, Zhejiang University, Zhejiang

RECRUITING

Huzhou Central Hospital, Huzhou

RECRUITING

Affiliated hospital of Jiaxing University , the First Hospital of Jiaxing, Jiaxing

RECRUITING

Affiliated hospital of Jiaxing University , the Second Hospital of Jiaxing, Jiaxing

RECRUITING

Ningbo Medical Center LiHuili Hospital, Ningbo

RECRUITING

Taizhou Hospital of Zhejiang, Taizhou

All Listed Sponsors
collaborator

Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

OTHER

collaborator

Huizhou Municipal Central Hospital

OTHER

collaborator

Ningbo Medical Center Lihuili Hospital

OTHER_GOV

collaborator

Affiliated Hospital of Jiaxing University

OTHER

collaborator

The Second Affiliated Hospital of Jiaxing University

OTHER

lead

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER