NCT07778212 Orelabrutinib Combined With Pola-R-CHP as First-Line Treatment for Patients With Intermediate- to High-Risk DLBCL
| NCT ID | NCT07778212 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The First Affiliated Hospital of Xiamen University |
| Condition | DLBCL - Diffuse Large B Cell Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-08-30 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2026-08-30 with a primary completion date of 2027-09-30.
⚠ 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
To evaluate orelabrutinib in combination with polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP) as first-line treatment for patients with intermediate- to high-risk diffuse large B-cell lymphoma (DLBCL).
Eligibility Criteria
Inclusion Criteria: 1. Aged ≥ 18 years; 2. Pathologically confirmed diffuse large B-cell lymphoma (DLBCL) by tumor tissue, with at least one measurable lesion, including DLBCL, not otherwise specified (GCB and non-GCB subtypes), DLBCL with MYC and BCL-2 rearrangements, and high-grade B-cell lymphoma; 3. No prior receipt of other anti-tumor treatments; 4. ECOG performance status 0-2; 5. IPI score 2-5, and patients with stage III-IV disease; 6. Life expectancy ≥ 6 months; 7. Voluntarily sign a written informed consent form. Exclusion Criteria: 1. Lymphoma involving the central nervous system or leptomeningeal metastasis; 2. Transformed lymphoma, i.e., 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. Left ventricular ejection fraction \< 50%; 6. Laboratory test values at screening: (unless caused by lymphoma); 1. Neutrophils \< 1.5×10⁹/L; 2. Platelets \< 75×10⁹/L; 3. ALT or AST higher than 2 times the upper limit of normal, AKP and bilirubin higher than 1.5 times the upper limit of normal; 4. Creatinine level higher than 1.5 times the upper limit of normal; 7. Patients with psychiatric disorders or other patients who are known or suspected to be unable to fully comply with the study protocol; 8. Pregnant or lactating women; 9. Known infection with human immunodeficiency virus (HIV), or active hepatitis B or C virus infection (positive result by polymerase chain reaction \[PCR\]). If a patient has a positive HBsAg test result, HBV DNA testing is required. If HBV DNA \< 10³ IU/ml, the patient can be enrolled. If the HBsAg test result is negative, but the HBcAb test is positive (regardless of HBsAb status), HBV DNA testing is also required. If HBV DNA \< 10³ IU/ml, the patient can be enrolled. If a patient is HCV antibody positive, HCV RNA is detected by PCR technology, and a positive result meets the exclusion criterion; 10. Need for continuous treatment with strong or moderate CYP3A inhibitors or CYP3A inducers; 11. nability to swallow capsules or presence of diseases that significantly affect gastrointestinal function, such as malabsorption syndrome, bariatric surgery, inflammatory bowel disease, or partial or complete intestinal obstruction; 12. Other concurrent and uncontrolled medical conditions that the investigator deems will affect the patient's participation in the study.
Contact & Investigator
Bing Xu, PhD，MD
PRINCIPAL INVESTIGATOR
The First Affiliated Hospital of Xiamen University
Frequently Asked Questions
Who can join the NCT07778212 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying DLBCL - Diffuse Large B Cell Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07778212 currently recruiting?
Yes, NCT07778212 is actively recruiting participants. Contact the research team at xubingzhangjian@126.com for enrollment information.
Where is the NCT07778212 trial being conducted?
This trial is being conducted at Xiamen, China, Xiamen, China.
Who is sponsoring the NCT07778212 clinical trial?
NCT07778212 is sponsored by The First Affiliated Hospital of Xiamen University. The principal investigator is Bing Xu, PhD，MD at The First Affiliated Hospital of Xiamen University. The trial plans to enroll 30 participants.