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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRuijin Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Absolute neutrophil count <1.0 × 10⁹/L.

Trial design

Treatments tested in this trial

  • Polatuzumab Vedotin
  • rituximab
  • Cyclophosphamide
  • Doxorubicin
  • Prednisone
  • Zanubrutinib
  • Lenalidomide
  • Decitabine
  • Glofitamab

Treatment groups

178 Participants
are divided into 2 treatment groups

Sponsors and collaborators