Actively Recruiting
Efficacy and Safety of Polatuzumab Vedotin with Zanubrutinib, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone for Previously Untreated Diffuse Large B-Cell Lymphoma of MCD/BN2/N1 Subtypes
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2026-05-27
35
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of a combination treatment for patients with previously untreated Diffuse Large B-Cell Lymphoma (DLBCL) of the MCD, BN2, or N1 molecular subtypes. This Phase II, open-label study aims to assess how well this new drug combination works and its safety profile in this specific group of lymphoma patients. The study is conducted at a single center and is sponsored by The First Affiliated Hospital with Nanjing Medical University. Participants will receive six cycles of a combination treatment called Pola-ZRCHP, which includes Polatuzumab Vedotin, Zanubrutinib, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone, with each cycle lasting 21 days. Rituximab is given for eight cycles overall. After the initial treatment phase, patients who have stable disease or better will continue to a maintenance phase where they receive Zanubrutinib and Tislelizumab for up to one year or until disease progression or unacceptable side effects occur. Patients whose disease does not respond adequately will stop the study treatment. During the study, participants will have their disease monitored through CT or PET-CT scans to assess response to treatment according to established criteria. Safety and tumor response will be regularly checked by investigators. The primary measure of success is the 2-year event-free survival rate, with additional outcomes including response rates and overall survival tracked over two years. Treatment-related side effects will be monitored from the start of treatment until 30 days after the last dose. Overall participation can last up to two years from the start of treatment.
CONDITIONS
Brief Title
Efficacy and Safety of Polatuzumab Vedotin in Combination With Zanubrutinib, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone in Patients With Previously Untreated Diffuse Large B-Cell Lymphoma of the MCD/BN2/N1 Subtypes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of informed consent
- Histologically confirmed Diffuse Large B-Cell Lymphoma with MCD, BN2, or N1 molecular subtypes
- Previously untreated (treatment-na�ve) for DLBCL
- International Prognostic Index score of 2 to 5
- ECOG performance status of 0, 1, or 2
- Life expectancy of at least 6 months
- At least one measurable lesion larger than 1.5 cm by CT or MRI
- Left Ventricular Ejection Fraction of 50% or higher by echocardiogram
- Adequate blood counts unless due to lymphoma involvement
- Hemoglobin 9.0 g/dL or higher without recent transfusion
- Absolute neutrophil count of 1.0 x 10^9/L or higher
- Platelet count of 75 x 10^9/L or higher
- Female participants of childbearing potential must use contraception and not donate eggs
- Male participants must use contraception and not donate sperm
You will not qualify if you...
- Contraindication to any component of the study treatment regimen
- Active or recent major infection within 4 weeks prior to treatment
- Suspected or latent tuberculosis
- Pregnant, breastfeeding, or planning pregnancy during study or within 12 months after last dose
- History of Progressive Multifocal Leukoencephalopathy
- Current or past Central Nervous System lymphoma
- Significant uncontrolled diseases affecting protocol compliance or result interpretation
- Severe cardiovascular disease including recent heart attack or unstable conditions
- Significant liver disease or alcohol abuse
- Abnormal lab values not related to lymphoma, including elevated INR/PT/PTT, liver enzymes, bilirubin, low kidney function
- Positive hepatitis B or active hepatitis C infection
- Any other disease or condition that contraindicates use of the study drugs
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 - Approximately 18 weeks (6 cycles of 21 days each)
Participants receive 6 cycles of Polatuzumab Vedotin with Zanubrutinib, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone every 21 days. Rituximab is administered for a total of 8 cycles during this period.
6 treatment cycles with multiple visits for drug administration and monitoring
Duration - Up to 1 year
Participants who achieve at least stable disease after induction continue maintenance treatment with Zanubrutinib twice daily and Tislelizumab every 3 weeks for up to 1 year, continuing until disease progression or unacceptable toxicity.
Regular visits every 3 weeks for Tislelizumab infusions and ongoing oral Zanubrutinib
Trial Site Locations
Total: 1 location
1
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210000
Actively Recruiting
Research Team
J
Jinhua Liang, MD
W
Wei Xu, PhD
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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