NCT07078500 Orelabrutinib Combined With Pola-R-CHP Regimen for the Treatment of Untreated Non-GCB Diffuse Large B-Cell Lymphoma
| NCT ID | NCT07078500 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Condition | Diffuse Large B-Cell Lymphoma (DLBCL) |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2025-05-05 |
| Primary Completion | 2026-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 48 participants in total. It began in 2025-05-05 with a primary completion date of 2026-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07078500 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Diffuse Large B-Cell Lymphoma (DLBCL). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07078500 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07078500 currently recruiting?
Yes, NCT07078500 is actively recruiting participants. Contact the research team at sylen@zju.edu.cn for enrollment information.
Where is the NCT07078500 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT07078500 clinical trial?
NCT07078500 is sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. The trial plans to enroll 48 participants.