Clinical Trial

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

Study acronym: GUIDANCE-10
Not Yet Recruiting Phase 2
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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.
Trial Details
NCT Number NCT07594899
Lead Sponsor Ruijin Hospital
Conditions Large B-Cell Lymphoma (LBCL)
Enrollment 178 participants
Start Date 2026-05-06
Primary Completion 2029-05-31 (estimated)
Study Completion 2029-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-05-19