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AI-Driven Treatment Strategy vs ZR2 in Older Treatment-naive Patients With LBCL
Sponsor: Ruijin Hospital
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.
Official title: A Study to Evaluate the Efficacy and Safety of an AI-Driven Treatment Strategy Versus ZR2 in Older Treatment-naive Patients With Large B-cell Lymphoma (LBCL)
Key Details
Gender
All
Age Range
70 Years - Any
Study Type
INTERVENTIONAL
Enrollment
112
Start Date
2026-06-30
Completion Date
2029-12-31
Last Updated
2026-07-21
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
Ruijin Hospital
Shanghai, China