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NOT YET RECRUITING
NCT07717177
PHASE2

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

Sponsor: Ruijin Hospital

View on ClinicalTrials.gov

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

Interventions

DRUG

Polatuzumab Vedotin

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

DRUG

Rituximab (R)

Rituximab IV infusion will be administered as per the schedule specified in the respective arm.

DRUG

Zanubrutinib

Zanubrutinib PO will be administered as per the schedule specified in the respective arm.

DRUG

Lenalidomide

Lenalidomide PO will be administered as per the schedule specified in the respective arm.

DRUG

Glofitamab

Glofitamab IV infusion will be administered as per the schedule specified in the respective arm.

Locations (1)

Ruijin Hospital

Shanghai, China