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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
178
Polatuzumab vedotin IV infusion will be administered as per the schedule specified in the respective arm.
Rituximab IV infusion will be administered as per the schedule specified in the respective arm.
Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.
Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.
Prednisone PO will be administered as per the schedule specified in the respective arm.
Zanubrutinib PO will be administered as per the schedule specified in the respective arm.
Lenalidomide PO will be administered as per the schedule specified in the respective arm.
Decitabine IV infusion will be administered as per the schedule specified in the respective arm.
Glofitamab IV infusion will be administered as per the schedule specified in the respective arm.
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Progression-free survival
PFS, defined as the time from randomization to the first occurrence of disease progression or relapse using the 2014 Lugano Response Criteria or death due to any cause, whichever occurs first.
Time frame: From randomization to the first occurrence of disease progression or relapse, or death from any cause, whichever occurs earlier (up to 24 months)
Event-free survival
EFS, defined as the time from date of randomization to the earliest occurrence of any of the following: Disease progression/relapse; Death due to any cause; The primary efficacy reason that leads to initiation of NALT (other than disease progression/relapse). If biopsy is obtained after treatment completion and is positive for residual disease regardless of whether NALT is initiated or not.
Time frame: Up to approximately 24 months
Complete response rate
CR rate at the end of treatment by FDG-PET defined as the proportion of participants with CR at the end of treatment according to the 2014 Lugano Response Criteria
Time frame: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days] )
Objective response rate
ORR at treatment completion or discontinuation defined as the proportion of participants with partial response (PR) or CR at the end of treatment according to the 2014 Lugano Response Criteria
Time frame: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days] )
Overall survival
OS defined as the time from randomization to death from any cause
Time frame: Up to approximately 3 years
Duration of response
Time frame: From documentation of CR/PR until relapse/progression or death due to any reason without documented relapse, whichever came first, assessed up to 3 years.
Duration of complete response
Time frame: From documentation of CR until relapse/progression or death due to any reason without documented relapse, whichever came first, assessed up to 3 years.
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v6.0
Time frame: From enrollment to study completion, a maximum of 4 years
Patient reported outcome assessed by EORTC QLQ-C30 (Verison 3.0)
Time frame: Day 1 of Cycles 1 and 4 (Cycle length=21 days); 30 days after treatment completion
Patient reported outcome assessed by EORTC QLQ-ELD14
Time frame: Day 1 of Cycles 1 and 4 (Cycle length=21 days); 30 days after treatment completion
Patient reported outcome assessed by FACT-Lym LymS
Time frame: Day 1 of Cycles 1 and 4 (Cycle length=21 days); 30 days after treatment completion
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.