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Clinical Trials in China / NCT07717177
Starting soon Phase 2

AI-Driven Treatment Strategy vs ZR2 in Older Treatment-naive Patients With LBCL

NCT07717177 · tracked via the Priya Life Science China tracker
Sponsor
Ruijin Hospital
Phase
Phase 2
Started
2026-06-30
Last updated
2026-07-21

Condition(s) studied

Large B-Cell Lymphoma (LBCL)

Investigational drug(s) / intervention(s)

Polatuzumab VedotinRituximab (R)ZanubrutinibLenalidomideGlofitamab

Polatuzumab Vedotin: Polatuzumab vedotin IV infusion will be administered as per the schedule specified in the respective arm.

Rituximab (R): Rituximab IV infusion 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.

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 older treatment-naive patients with LBCL. 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 ZR2. In the experimental arm, participants will receive polatuzumab vedotin in combination with ZR2 or Pola-ZR-Glo regimen (polatuzumab vedotin, zanubrutinib, lenalidomide, and glofitamab), according to their AI-defined risk group. Participants in the control arm will receive ZR2. The study will evaluate the efficacy and safety of the AI-guided treatment strategy compared with ZR2.

Eligibility

Sex
ALL
Min age
70 Years
Max age
Healthy volunteers
No
Inclusion Criteria: Patients must satisfy all of the following criteria to be enrolled in the study: * Histologically-confirmed large B-cell lymphoma (without central nervous system involvement) * Aged ≥ 70 years old with comprehensive geriatric assessment stratified as unfit or frail, or those who decline immunochemotherapy. * After 1 cycle of ZR2, classified as intermediate-risk or high-risk by AI-based multimodal stratification * Eastern Cooperative Oncology Group Performance Status 0-2 * 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) * Life expectancy of at least 3 months determined by researchers * 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: Presence of any of the following criteria will exclude a patient from enrollment: * Uncontrolled blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseases * Laboratory measures meet the following criteria at screening (unless caused by lymphoma): Neutrophils\<1.0×10\^9/L Platelets\<75×10\^9/L ALT or AST is 2.5 times higher than the upper limits of normal (ULN), serum bilirubin are 1.5 times higher than the ULN. eGFR is lower than 30ml/min/1.73m\^2 (according to Cockcroft-Gault Equation or MDRD Equation). * uncontrollable or significant cardiovascular diseases, including but not limited to: Left ventricular ejection fraction\<50% Cardiomyopathy, such as dilated cardiomyopathy, hypertrophic cardiomyopathy, restrictive cardiomyopathy QTc prolongation with clinical significance, QTc interval\>470ms (females) or 480ms (males), type 2 second-degree atrioventricular block or third-degree atrioventricular block * Patients with HbsAg positive are required to have HBV DNA\<1.0×10\^3 IU/ml before entering the group. In addition, if the patient is HBsAg negative but HBcAb positive (regardless of HBsAb status), HBV DNA test is also required, and HBV DNA\<1.0×10\^3 IU/ml is required before entering the group * Patients with psychiatric disorders or patients who are known or suspected to be unable to fully comply with the study protocol * HIV-infected patients * History of stroke or intracranial hemorrhage within 6 months prior to start of therapy * Other medical conditions determined by the researchers that may affect the study

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Ruijin Hospital Shanghai China

On this site

📄 Brukinsa (zanubrutinib) drug profile → 📄 Revlimid (lenalidomide) drug profile →

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Official registry record

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.

View NCT07717177 on ClinicalTrials.gov ↗ ← All trials in China