Clinical trial · Interventional
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
NCT07078500CI-TRIAL-00093809recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B-Cell Lymphoma (DLBCL) | Diffuse Large B-Cell Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| orelabrutinib combined with the Pola-R-CHP regimen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- orelabrutinib combined with the Pola-R-CHP regimen
- description
- 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.
- interventionNames
- Drug: orelabrutinib combined with the Pola-R-CHP regimen
Primary outcomes (1)
- measure
- 2 years Progression free survival (2Y-PFS)
- timeFrame
- up to 2 years
- description
- 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
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18 to 80 years old. 2. Diffuse large B-cell lymphoma (DLBCL) confirmed by tumor tissue pathology, with at least one measurable lesion. 3. Non-GCB. 4. No prior anti-tumor treatment. 5. ECOG score of 0-2. 6. Life expectancy of ≥6 months. 7. Voluntary written informed consent. Exclusion Criteria: 1. Lymphoma involving the central nervous system or leptomeningeal metastasis. 2. 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. 3. Primary mediastinal large B-cell lymphoma. 4. Burkitt lymphoma. 5. Laboratory values at screening (unless due to lymphoma): 1. Neutrophils \<1.5×10⁹/L; 2. Platelets \<75×10⁹/L; 3. 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; 4. Creatinine level more than 1.5 times the upper limit of normal. 6. Patients with psychiatric disorders or other known or suspected inability to fully comply with the study protocol. 7. Pregnant or breastfeeding women. 8. Known human immunodeficiency virus (HIV) infection, or active hepatitis B or C virus infection (positive result by polymerase chain reaction \[PCR\]). If the patient tests positive for HbsAg, HBV DNA testing is required. If HBV DNA \<10³ IU/ml, the patient may be enrolled. If the patient tests negative for HbsAg but positive for HBcAb (regardless of HBsAb status), HBV DNA testing is also required. If HBV DNA \<10³ IU/ml, the patient may be enrolled. If the patient tests positive for HCV antibody, HCV RNA is detected by PCR. If positive, the patient meets the exclusion criteria. 9. Need for continuous treatment with strong or moderate CYP3A inhibitors or CYP3A inducers. 10. Inability to swallow capsules or significant gastrointestinal disorders, such as malabsorption syndrome, bariatric surgery, inflammatory bowel disease, or partial or complete intestinal obstruction. 11. Other concurrent and uncontrolled medical conditions that the investigator believes will affect the patient's participation in the study.
References
Publications (0)
Data not yet available
No reference posted for this study.