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
Second Affiliated Hospital, School of Medicine, Zhejiang University
48 participants
May 5, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- 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.
Exclusion Criteria14
- Lymphoma involving the central nervous system or leptomeningeal metastasis.
- Transformed lymphoma, that is, transformed from other types of lymphoma, such as follicular lymphoma, marginal zone lymphoma, chronic lymphocytic leukemia, or small B-cell lymphoma.
- Primary mediastinal large B-cell lymphoma.
- Burkitt lymphoma.
- Laboratory values at screening (unless due to lymphoma):
- Neutrophils \<1.5×10⁹/L;
- Platelets \<75×10⁹/L;
- ALT or AST more than 2 times the upper limit of normal, ALP and bilirubin more than 1.5 times the upper limit of normal;
- Creatinine level more than 1.5 times the upper limit of normal.
- Patients with psychiatric disorders or other known or suspected inability to fully comply with the study protocol.
- Pregnant or breastfeeding women.
- Need for continuous treatment with strong or moderate CYP3A inhibitors or CYP3A inducers.
- Inability to swallow capsules or significant gastrointestinal disorders, such as malabsorption syndrome, bariatric surgery, inflammatory bowel disease, or partial or complete intestinal obstruction.
- Other concurrent and uncontrolled medical conditions that the investigator believes will affect the patient's participation in the study.
Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07078500