Clinical trial · Interventional
AI-Driven Treatment Strategy vs ZR2 in Older Treatment-naive Patients With LBCL
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)
NCT07717177CI-TRIAL-00118798PRAISEnot yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Large B-Cell Lymphoma (LBCL) | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Glofitamab | Drug | Glofitamab | ALIAS |
| Lenalidomide | Drug | Lenalidomide | ALIAS |
| Polatuzumab Vedotin | Drug | Polatuzumab Vedotin | ALIAS |
| Rituximab (R) | Drug | Rituximab | ALIAS |
| Zanubrutinib | Drug | Zanubrutinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Polatuzumab vedotin in combination with ZR2 or Pola-ZR-Glo regimen
- description
- Participants will receive zanubrutinib 160 mg BID orally (PO) on Days 1-21, lenalidomide 25 mg/day PO on Days 2-11, and rituximab 375 mg/m² intravenously (IV) on Day 1 of the first cycle. For the remaining five cycles, participants will receive either Pola-ZR2 or Pola-ZR-Glo. In the Pola-ZR2 regimen, participants will receive ZR2 in combination with polatuzumab vedotin 1.8 mg/kg IV on Cycle 2 Day 2 and on Day 1 of Cycles 3-6. In the Pola-ZR-Glo regimen, participants will receive zanubrutinib 160 mg BID PO on Days 1-21 of Cycles 1-6, lenalidomide 25 mg/day orally on Days 2-11 of Cycles 1-6, polatuzumab vedotin 1.8 mg/kg intravenously on Cycle 2 Day 2 and on Day 1 of Cycles 3-6, and glofitamab intravenously with step-up dosing of 2.5 mg on Cycle 2 Day 8, 10 mg on Cycle 2 Day 15, and 30 mg on Day 1 of Cycles 3-12. For participants receiving the ZR2 or Pola-ZR2 regimen, lenalidomide maintenance will be continued for 18 weeks after six cycles of treatment. Each treatment cycle is 21 days.
- interventionNames
- Drug: Polatuzumab Vedotin
- Drug: Rituximab (R)
- Drug: Zanubrutinib
- Drug: Lenalidomide
- Drug: Glofitamab
- type
- ACTIVE_COMPARATOR
- label
- ZR2
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.