NCT07078500

Orelabrutinib Combined With Pola-R-CHP Regimen for the Treatment of Untreated Non-GCB Diffuse Large B-Cell Lymphoma

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Currently, the R-CHOP regimen can cure approximately 60% of DLBCL patients. The Pola-R-CHP regimen has shown further improvement on this basis. However, from the POLARIX study, it was observed that patients under 60 years old, with an IPI score of 2, and those with large masses did not show further benefits from the Pola regimen. Meanwhile, for patients with poor prognosis such as non-GCB, there is still room for further improvement with the Pola-R-CHP regimen. BTK inhibitors have demonstrated ideal therapeutic effects for the aforementioned patient types, and currently, a large number of patients have been treated with this type of therapy in clinical practice. However, the vast majority have been combined with R-CHOP-like regimens. There are no data reported on the combination of BTK inhibitors with the Pola regimen. Therefore, this study plans to 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 (DLBCL). 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.

Conditions

• Diffuse Large B-Cell Lymphoma (DLBCL)

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2025-05-05
• Primary completion: 2026-10-31
• Completion: 2028-12-31
• First posted: 2025-07-22
• Last updated: 2025-08-19

Locations

1 site across 1 country: China