Actively Recruiting
Orelabrutinib Combined With Pola-R-CHP Regimen for the Treatment of Untreated Non-GCB Diffuse Large B-Cell Lymphoma
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-08-19
48
Participants Needed
1
Research Sites
190 weeks
Total Duration
On this page
Sponsors
S
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead Sponsor
T
The Second Affiliated Hospital of Jiaxing University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Orelabrutinib Combined With Pola-R-CHP Regimen for the Treatment of Untreated Non-GCB Diffuse Large B-Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 80 years old
- Confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) by tumor tissue pathology with at least one measurable lesion
- Non-GCB subtype
- No prior anti-tumor treatment
- ECOG performance status score between 0 and 2
- Life expectancy of at least 6 months
- Voluntary written informed consent
You will not qualify if you...
- Lymphoma involving the central nervous system or leptomeningeal metastasis
- Transformed lymphoma from other lymphoma types 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 less than 1.5 x 10^9/L; platelets less than 75 x 10^9/L; ALT or AST more than twice the upper limit of normal; ALP and bilirubin more than 1.5 times the upper limit of normal; creatinine more than 1.5 times the upper limit of normal
- Psychiatric disorders or other inability to fully comply with the study protocol
- Pregnant or breastfeeding women
- Known HIV infection or active hepatitis B or C virus infection confirmed by PCR
- Need for continuous treatment with strong or moderate CYP3A inhibitors or inducers
- Inability to swallow capsules or significant gastrointestinal disorders such as malabsorption syndrome, bariatric surgery, inflammatory bowel disease, or intestinal obstruction
- Other uncontrolled medical conditions that may affect participation as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
H
hui Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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