Polatuzumab Vedotin: Polatuzumab vedotin IV infusion will be administered as per the schedule specified in the respective arm.
rituximab: Rituximab IV infusion will be administered as per the schedule specified in the respective arm.
Cyclophosphamide: Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.
Doxorubicin: Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.
Prednisone: Prednisone PO will be administered as per the schedule specified in the respective arm.
Zanubrutinib: Zanubrutinib PO will be administered as per the schedule specified in the respective arm.
Lenalidomide: Lenalidomide PO will be administered as per the schedule specified in the respective arm.
Decitabine: Decitabine IV infusion will be administered as per the schedule specified in the respective arm.
Glofitamab: Glofitamab IV infusion will be administered as per the schedule specified in the respective arm.
Study summary
This is a prospective, open-label, multicenter, randomized controlled study in participants with previously untreated large B-cell lymphoma. Participants will be stratified into different risk groups using an AI-based multimodal model. Those classified as intermediate- or high-risk will be randomized in a 1:1 ratio to receive either an AI-guided treatment strategy or Pola-R-CHP. In the experimental arm, participants will receive either genotype-guided targeted agents in combination with Pola-R-CHP or Pola-R-CHP combined with glofitamab, according to their AI-defined risk group and molecular features. Participants in the control arm will receive Pola-R-CHP. The study will evaluate the efficacy and safety of the AI-guided treatment strategy compared with Pola-R-CHP.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* Age 18-75 years with comprehensive geriatric assessment stratified as fit
* Previously untreated participants with CD20-positive LBCL (without central nervous system involvement)
* ECOG Performance Status of 0, 1, or 2
* After 1 cycle of Pola-R-CHP, classified as intermediate-risk or high-risk by AI-based multimodal stratification
* Life expectancy ≥ 3 months
* At least 1 measurable site of disease (defined as lymph nodes with the long diameters longer than 1.5cm, or extra-nodal sites with the long diameters longer than 1.0cm; meanwhile, any lesion site with at least 2 measurable vertical diameters)
* The patient or his or her legal representative must provide written informed consent prior to any special examination or procedure for the research.
* Anti-lymphoma drugs have not been used before (except glucocorticoids)
Exclusion Criteria:
* Prior solid organ transplantation or SCT
* Significant or extensive history of cardiovascular disease such as New York Heart Association Class III or IV cardiac disease or Objective Assessment Class C or D, myocardial infarction within the last 6 months prior to the start of Cycle 1, unstable arrhythmias, or unstable angina
* History or presence of an abnormal ECG that is clinically significant in the investigator's opinion
* Any of the following abnormal laboratory values (unless any of these abnormalities are due to underlying lymphoma):
* Absolute neutrophil count \<1.0 × 10⁹/L.
* Platelet count \<75 × 10⁹/L
* Serum AST and ALT ≥ 2.5 x ULN
* Total bilirubin ≥ 1.5 x ULN
* Serum creatinine clearance \< 30 mL/min (using Cockcroft-Gault formula)
* Any active infection within 7 days prior to Cycle 1 Day 1 that would impact participant safety
* Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen \[HBsAg\] serology):Participants with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative HbsAg) may be included if hepatitis B virus (HBV) DNA is undetectable at the time of screening. Such participants must be willing to undergo HBV DNA testing every month and appropriate antiviral therapy as indicated
* Positive test results for hepatitis C (hepatitis C virus \[HCV\] antibody serology testing):Participants positive for HCV antibody are eligible only if PCR is negative for HCV RNA
* Participants with a history of progressive multifocal leukoencephalopathy
* Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 12 months after final dose of treatment
* Participants with uncontrolled coagulation disorders, connective tissue diseases, severe infectious diseases
* Other concurrent and uncontrolled medical conditions that, in the opinion of the investigator, would affect the patient's participation in the study
Primary outcome measure(s)
Progression-free survival — From randomization to the first occurrence of disease progression or relapse, or death from any cause, whichever occurs earlier (up to 24 months) PFS, defined as the time from randomization to the first occurrence of disease progression or relapse using the 2014 Lugano Response Criteria or death due to any cause, whichever occurs first.
Trial sites (1)
Facility
City
Region
Status
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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