A Phase 2 interventional study of orelabrutinib combined with the Pola-R-CHP regimen in Diffuse Large B-Cell Lymphoma (DLBCL), sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-08-19.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Phase 2, Interventional, and Treatment
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.
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.
1,390 studies on the registry are indexed under Lymphoma, Large B-Cell, Diffuse; 350 are open to participants now.
This study's planned enrollment of 48 is close to the median of 47 across 1,185 interventional studies indexed under Lymphoma, Large B-Cell, Diffuse.
Browse Lymphoma, Large B-Cell, Diffuse studies →Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Laboratory values at screening (unless due to lymphoma):
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.
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.
2 years Progression free survival (2Y-PFS)
PFS is defined as the time from registration to the first occurrence of progression or relapse as assessed by the investigator, or death from any cause. PFS for patients without disease progression, relapse, or death will be censored at the time of the last tumor assessment
Time frame: up to 2 years
Overall Response Rate (ORR)
ORR is defined as the proportion of patients with a response of CR or PR
Time frame: up to 8 months
Complete Response Rate (CR)
The rate of patients who achieved complete response after treatment
Time frame: up to 8 months
overall survival (OS)
Overall survival is defined as the period from the induction registration to death from any cause. Patients who have not died until the time of the analysis will be censored at their last contact date.
Time frame: up to 3 years
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Lymphoma, Large B-Cell, Diffuse→
Second Affiliated Hospital, School of Medicine, Zhejiang University