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NCT Number: NCT07717177

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

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.

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Key information

Conditions

Large B-Cell Lymphoma (LBCL)

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients must satisfy all of the following criteria to be enrolled in the study:

  • 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
  • At least 1 measurable site of disease (defined as lymph nodes with the long diameters longer than 1.5cm, or extra-nodal sites with the long diameters longer than 1.0cm; meanwhile, any lesion site with at least 2 measurable vertical diameters)
  • Life expectancy of at least 3 months determined by researchers
  • The patient or his or her legal representative must provide written informed consent prior to any special examination or procedure for the research.
  • Anti-lymphoma drugs have not been used before (except glucocorticoids)

Exclusion criteria

Presence of any of the following criteria will exclude a patient from enrollment:

  • Uncontrolled blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseases
  • Laboratory measures meet the following criteria at screening (unless caused by lymphoma):

Neutrophils<1.0×10^9/L Platelets<75×10^9/L ALT or AST is 2.5 times higher than the upper limits of normal (ULN), serum bilirubin are 1.5 times higher than the ULN.

eGFR is lower than 30ml/min/1.73m^2 (according to Cockcroft-Gault Equation or MDRD Equation).

  • 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
  • HIV-infected patients
  • History of stroke or intracranial hemorrhage within 6 months prior to start of therapy
  • Other medical conditions determined by the researchers that may affect the study

Treatment and study plan

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.

Primary outcomes

  1. Progression-free survival

    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)

    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.

Secondary outcomes

  1. Event-free survival

    Time frame: Up to approximately 24 months

    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.

  2. Complete response rate

    Time frame: End of treatment completion , an average of 6 months

    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

  3. Objective response rate

    Time frame: End of treatment completion , an average of 6 months

    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

  4. Overall survival

    Time frame: Up to approximately 3 years

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

  5. 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.

  6. 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.

  7. 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

  8. Patient reported outcome assessed by EORTC QLQ-C30 (Verison 3.0)

    Time frame: Day 1 of Cycles 1, 4 and 7 (Pola-ZR-Glo regimen only); 30 days after treatment completion. Cycle length=21 days

    Patient-reported outcome will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30, Version 3.0 (EORTC QLQ-C30). Scores are linearly transformed to a scale from 0 to 100. For the global health status/quality of life and functional scales, higher scores indicate better health status, quality of life, or functioning. For symptom scales or symptom items, higher scores indicate greater symptom burden or worse symptoms.

  9. Patient reported outcome assessed by EORTC QLQ-ELD14

    Time frame: Day 1 of Cycles 1, 4 and 7 (Pola-ZR-Glo regimen only); 30 days after treatment completion. Cycle length=21 days

    Patient-reported outcome will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Elderly 14 (EORTC QLQ-ELD14). Scores are linearly transformed to a scale from 0 to 100. Higher scores indicate a higher level of the construct being measured. For functioning or support-related scales, higher scores indicate better functioning or greater support. For symptom, worry, or burden-related scales, higher scores indicate greater symptom burden, worry, or worse outcome.

  10. Patient reported outcome assessed by FACT-Lym LymS

    Time frame: Day 1 of Cycles 1, 4 and 7 (Pola-ZR-Glo regimen only); 30 days after treatment completion. Cycle length=21 days

    Patient-reported outcome will be assessed using the Functional Assessment of Cancer Therapy-Lymphoma lymphoma-specific subscale (FACT-Lym LymS). The FACT-Lym LymS score ranges from 0 to 60, with higher scores indicating better lymphoma-specific quality of life and fewer lymphoma-related symptoms.

Study contacts

Contact information is provided by the study sponsor or research team.

Weili Zhao

CONTACT

[email protected]

+862164370045 Ext. 610707

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

A Study to Evaluate the Efficacy and Safety of an AI-Driven Treatment Strategy Versus ZR2 in Older Treatment-naive Patients With Large B-cell Lymphoma (LBCL)

Acronym: PRAISE

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jul 21, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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