A Prospective, Single-Arm, Multicenter Clinical Study of Orelabrutinib Combined With Pola-R-CHP Regimen for the Treatment of Untreated Non-GCB Diffuse Large B-Cell Lymphoma
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
Assess the preliminary efficacy and safety of orelabrutinib in combination with the Pola-R-CHP regimen for the treatment of treatment-naive Non-GCB diffuse large B-cell lymphoma.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
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• Age 18 to 80 years old.
• Diffuse large B-cell lymphoma (DLBCL) confirmed by tumor tissue pathology, with at least one measurable lesion.
• Non-GCB.
• No prior anti-tumor treatment.
• ECOG score of 0-2.
• Life expectancy of ≥6 months.
• Voluntary written informed consent.
Locations
Other Locations
China
Second Affiliated Hospital, School of Medicine, Zhejiang University
RECRUITING
Hangzhou
Contact Information
Primary
hui Liu
sylen@zju.edu.cn
+86 13819198629
Time Frame
Start Date: 2025-05-05
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 48
Treatments
Experimental: orelabrutinib combined with the Pola-R-CHP regimen
Enrolled patients will receive six cycles of orelabrutinib in combination with the Pola-R-CHP regimen, with each 21-day period being one cycle. At the end of the six cycles, an interim efficacy evaluation will be conducted. Patients with a response of CR or PR will receive an additional two cycles of orelabrutinib in combination with rituximab and undergo a final efficacy evaluation. Patients with a response of CR/PR after eight cycles of induction therapy will receive maintenance treatment with orelabrutinib for up to two years.
Related Therapeutic Areas
Sponsors
Leads: Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators: Huzhou Central Hospital, Dongyang People's Hospital, Ningbo People's Hospital, Shaoxing People's Hospital, Taizhou First People's Hospital, Shaoxing Central Hospital, Yuyao People's Hospital, Zhuji People's hospital, Taizhou Central Hospital affiliated to Taizhou University, Second Affiliated Hospital of Wenzhou Medical University, The People's Hospital of Quzhou, Zhejiang Cancer Hospital, The Second Affiliated Hospital of Jiaxing University, Affiliated Hangzhou First People's Hospital, The Central Hospital of Lishui City, Affiliated Hospital of Jiaxing University