Actively Recruiting
Application of Zanubrutinib-based Combination Regimens in the Treatment of Newly-diagnosed Diffuse Large B-cell Lymphoma: A Phase II, Prospective, Single-center, Single-arm Clinical Study
Led by Beijing Tongren Hospital · Updated on 2026-01-28
50
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin's lymphoma, with first-line treatment using R-CHOP curing only about 50% to 60% of patients. This research evaluates the BTK inhibitor zanubrutinib combined with Pola-R-CHP or zanubrutinib combined with rituximab and high-dose MTX in patients with DLBCL who have specific high-risk factors such as IPI score 2 or more, ABC subtype, double-expressor lymphoma, double-hit lymphoma, and involvement of special sites including the central nervous system. The study aims to improve outcomes for these high-risk patients by exploring new combination therapies. Participants receive zanubrutinib with the Pola-R-CHP regimen, which includes zanubrutinib 160mg twice daily days 1 to 21 of cycles 1 to 6; polatuzumab 1.8mg/kg, rituximab 375mg/m2, cyclophosphamide 750mg/m2, doxorubicin 50mg/m2 intravenously on day 1 of cycles 1 to 6; and prednisone 60mg/m2 days 1 to 5 of each cycle. For those with primary central nervous system DLBCL, zanubrutinib is combined with rituximab and high-dose methotrexate. The treatment period covers six cycles. During the study, participants undergo regular assessments to measure the best complete remission rate within 24 weeks after treatment starts. Secondary outcomes include overall response rate, two-year progression-free survival, and overall survival rates. Safety and efficacy are monitored throughout, with evaluations based on clinical response and lab results. The total study duration includes follow-up for up to two years after treatment initiation for the last participant.
CONDITIONS
Brief Title
Application of Zanubrutinib-based Combination Regimens in the Treatment of Newly-diagnosed Diffuse Large B-cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed diffuse large B-cell lymphoma (DLBCL)
- Presence of measurable lesions
- At least one high-risk factor such as IPI score 2 or more, ABC subtype, double-expressor lymphoma, double-hit lymphoma, CD5-positive DLBCL, MCD subtype, N1 subtype, A53 subtype, extranodal lesions 2 or more, or involvement of special sites like CNS, breast, testis, ovary, uterus, bone marrow, vitreoretinal, paraspinal, paranasal sinuses, or intravascular
- ECOG performance status of 0 to 3
- Expected survival time of 3 months or more
- Adequate blood counts and organ function: white blood cell count ≥3 x 10^9/L, platelet count ≥50 x 10^9/L, serum creatinine ≤1.5 mg/dL, creatinine clearance ≥50 ml/min, ALT and AST ≤3 times upper limit of normal, total bilirubin ≤2 times upper limit of normal
You will not qualify if you...
- Currently having any other malignant tumor
- Prior lymphoma treatments except short-term corticosteroids
- Known allergy to any study drug
- Active infections including uncontrolled HBV, HIV/AIDS, or other serious infectious diseases
- Pregnant or breastfeeding women unwilling to use contraception
- Any condition judged by researchers as unsuitable for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 weeks (6 cycles of treatment)
Participants receive zanubrutinib combined with Pola-R-CHP regimen, consisting of zanubrutinib taken twice daily and intravenous administration of polatuzumab, rituximab, cyclophosphamide, doxorubicin, and prednisone over six cycles.
6 treatment cycles with visits on Day 1 of each cycle and additional visits for drug administration
Duration - Up to 24 months after treatment initiation
Participants are monitored for progression and survival outcomes after completing treatment.
Periodic visits for assessments during the follow-up period
Trial Site Locations
Total: 1 location
1
Beijing Tongren Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
L
Liang Wang, M.D.
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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