A Prospective, Multicenter, Single-arm Clinical Study on the Treatment of Newly Diagnosed Diffuse Large B-cell Lymphoma With High-risk of CNS Relapse Defined by CNS-IPI Using Orelabrutinib in Combination With R-CDOP Regimen
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This is a prospective, multicenter, single-arm clinical study on the treatment of newly diagnosed diffuse large B-cell lymphoma with high-risk of CNS relapse defined by CNS-IPI using Orelabrutinib in combination with R-CDOP regimen.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age ≥18 years old; ECOG score 0-3;
• Histologically confirmed diffuse large B-cell lymphoma, including DLBCL and transformed DLBCL;
• CNS-IPI≥4 points
• Previously untreated participants with CD20-positive DLBCL,;
• Heart, liver, and kidney function: creatinine \< 2 times the normal upper limit (ULN); ALT (alanine aminotransferase)/AST (Aspartate Aminotransferase) \< 2.5ULN; Total bilirubin \< 2ULN; Cardiac ejection fraction (EF) ≥50%.
• At least one measurable lesion.
• Have the sufficient understanding ability and voluntarily sign informed consent.
Locations
Other Locations
China
Huzhou Central Hospital
RECRUITING
Huzhou
Affiliated hospital of Jiaxing University , the First Hospital of Jiaxing
RECRUITING
Jiaxing
Affiliated hospital of Jiaxing University , the Second Hospital of Jiaxing
RECRUITING
Jiaxing
Ningbo Medical Center LiHuili Hospital
RECRUITING
Ningbo
Taizhou Hospital of Zhejiang
RECRUITING
Taizhou
Second Affiliated Hospital, School of Medicine, Zhejiang University
RECRUITING
Zhejiang
Contact Information
Primary
Xibin Xiao
xiaoxibinzju@zju.edu.cn
13858015535
Time Frame
Start Date:2023-03-30
Estimated Completion Date:2026-03-20
Participants
Target number of participants:62
Treatments
Experimental: Orelabrutinib combined with R-CDOP regimen
Participants will receive 150 mg of oral orelabrutinib once daily with R-CDOP on day 1 of each cycle (21 days)
Leads: Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators: Huizhou Municipal Central Hospital, Ningbo Medical Center Lihuili Hospital, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, The Second Affiliated Hospital of Jiaxing University, Affiliated Hospital of Jiaxing University