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

ConditionLarge B-Cell Lymphoma (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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Polatuzumab Vedotin

    Drug

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

  • rituximab

    Drug

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

  • Cyclophosphamide

    Drug

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

  • Doxorubicin

    Drug

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

  • Prednisone

    Drug

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

  • Zanubrutinib

    Drug

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

  • Lenalidomide

    Drug

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

  • Decitabine

    Drug

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

  • Glofitamab

    Drug

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

Treatment groups

178 Participants
are divided into 2 treatment groups
Group A: Genotype-guided targeted agents or glofitamab in combination with Pola-R-CHPExperimental treatment 9 interventions
Group B: Pola-R-CHPActive comparator 5 interventions

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

1

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
2

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] )
3

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] )
4

Overall survival

OS defined as the time from randomization to death from any cause

Time frame
Up to approximately 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ruijin Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: