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

ConditionLarge B-Cell Lymphoma (LBCL)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age70+
SponsorRuijin Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically-confirmed large B-cell lymphoma (without central nervous system involvement)

Aged ≥ 70 years old with comprehensive geriatric assessment stratified as unfit or frail, or those who decline immunochemotherapy.

After 1 cycle of ZR2, classified as intermediate-risk or high-risk by AI-based multimodal stratification

Eastern Cooperative Oncology Group Performance Status 0-2

Disqualifiers

Uncontrolled blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseases

uncontrollable or significant cardiovascular diseases, including but not limited to: Left ventricular ejection fraction<50% Cardiomyopathy, such as dilated cardiomyopathy, hypertrophic cardiomyopathy, restrictive cardiomyopathy QTc prolongation with clinical significance, QTc interval>470ms (females) or 480ms (males), type 2 second-degree atrioventricular block or third-degree atrioventricular block

Patients with HbsAg positive are required to have HBV DNA<1.0×10^3 IU/ml before entering the group. In addition, if the patient is HBsAg negative but HBcAb positive (regardless of HBsAb status), HBV DNA test is also required, and HBV DNA<1.0×10^3 IU/ml is required before entering the group

Patients with psychiatric disorders or patients who are known or suspected to be unable to fully comply with the study protocol

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 (R)

    Drug

    Rituximab IV infusion 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.

  • Glofitamab

    Drug

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

Treatment groups

112 Participants
are divided into 2 treatment groups
Group A: Polatuzumab vedotin in combination with ZR2 or Pola-ZR-Glo regimenExperimental treatment 5 interventions
Group B: ZR2Active comparator 3 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 completion , an average of 6 months
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 completion , an average of 6 months
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: