AI-Driven Treatment Strategy vs Pola-R-CHP in Untreated LBCL

Starting soon · Phase 2

Conditions studied: Large B-Cell Lymphoma (LBCL)

In brief

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.

Key facts

Study ID: NCT07594899
Run by: Ruijin Hospital
People needed: 178
Starts: 2026-05-06
Expected to finish: 2029-12-31
Last updated by the study team: 2026-05-19

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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)

You may not qualify if…

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

Where it is running

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China

Full record on ClinicalTrials.gov

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