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Tests treatment safety and results for Diffuse Large B-Cell Lymphoma (DLBCL)
Official 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
ClinicalTrials.gov ID: NCT07608978
What this study is testing
What is POLA-R-CHP+Zanubrutinib?
POLA-R-CHP+Zanubrutinib is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for diffuse large b-cell lymphoma (dlbcl).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a prospective, open-label, single-arm, single-center, Phase II clinical study designed to evaluate the efficacy and safety of 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. After successful screening, enrolled patients will receive 6 treatment cycles (21 days per cycle).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years at the time of signing informed consent. Histologically confirmed Diffuse Large B-Cell Lymphoma (DLBCL) with MCD/BN2/N1 molecular...
- Previously untreated (treatment-naïve). International Prognostic Index (IPI) score of 2-5. Eastern Cooperative Oncology Group (ECOG) performance...
- Left Ventricular Ejection Fraction (LVEF) ≥50% as assessed by echocardiogram (ECHO).
- Adequate hematologic function (unless due to underlying disease, e.g., extensive bone marrow involvement, or splenomegaly secondary to splenic...
- Hemoglobin ≥9.0 g/dL within 7 days prior to first treatment, without packed RBC transfusion.
You likely can't join if
- Contraindication to any component of the Pola-ZRCHP regimen. Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection...
- Suspected or latent tuberculosis (confirmed by positive IFNγ release assay). Currently pregnant or breastfeeding, or planning a pregnancy during the...
- History of confirmed Progressive Multifocal Leukoencephalopathy (PML). Current or history of Central Nervous System (CNS) lymphoma. Evidence of...
- Severe or extensive cardiovascular disease, such as New York Heart Association (NYHA) Class III or IV, or objective assessment of Class C or D...
- Clinically significant liver disease, including active viral hepatitis or other hepatitis, current alcohol abuse, or cirrhosis.
- Any of the following abnormal laboratory values (unless these abnormalities are solely attributable to underlying lymphoma):
See the full eligibility criteria
- Age ≥18 years at the time of signing informed consent. Histologically confirmed Diffuse Large B-Cell Lymphoma (DLBCL) with MCD/BN2/N1 molecular subtypes defined by LymphGen classification.
- Previously untreated (treatment-naïve). International Prognostic Index (IPI) score of 2-5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. Life expectancy ≥6 months. At least one measurable...
- Left Ventricular Ejection Fraction (LVEF) ≥50% as assessed by echocardiogram (ECHO).
- Adequate hematologic function (unless due to underlying disease, e.g., extensive bone marrow involvement, or splenomegaly secondary to splenic involvement deemed by the investigator to be caused by DLBCL; blood product...
- Hemoglobin ≥9.0 g/dL within 7 days prior to first treatment, without packed RBC transfusion.
- Absolute Neutrophil Count (ANC) ≥1.0 × 10⁹/L. Platelet count ≥75 × 10⁹/L. Female participants of childbearing potential: Must agree to abstain from heterosexual intercourse or use contraception, and agree not to donate...
- Male participants: Must agree to abstain from heterosexual intercourse or use contraception, and agree not to donate sperm.
- Contraindication to any component of the Pola-ZRCHP regimen. Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding onychomycosis) at screening, or any major infection occurring...
- Suspected or latent tuberculosis (confirmed by positive IFNγ release assay). Currently pregnant or breastfeeding, or planning a pregnancy during the study period or within 12 months after the last dose.
- History of confirmed Progressive Multifocal Leukoencephalopathy (PML). Current or history of Central Nervous System (CNS) lymphoma. Evidence of significant, uncontrolled concomitant disease that may affect compliance...
- Severe or extensive cardiovascular disease, such as New York Heart Association (NYHA) Class III or IV, or objective assessment of Class C or D cardiac disease; myocardial infarction within the past 6 months; unstable...
- Clinically significant liver disease, including active viral hepatitis or other hepatitis, current alcohol abuse, or cirrhosis.
- Any of the following abnormal laboratory values (unless these abnormalities are solely attributable to underlying lymphoma):
- INR or PT \>1.5 × Upper Limit of Normal (ULN) in the absence of therapeutic anticoagulation.
- PTT or aPTT \>1.5 × ULN in the absence of lupus anticoagulant. Serum AST and ALT ≥2.5 × ULN. Total bilirubin ≥1.5 × ULN. Estimated creatinine clearance \<40 mL/min (using the Cockcroft-Gault formula). Positive HBV DNA...
- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that gives reasonable suspicion of a disease or condition that contraindicates the use of the investigational...
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.