Large B-Cell Lymphoma (LBCL)Phase 2PRAISENCT07717177
AI-Driven Treatment Strategy vs ZR2 in Older Treatment-naive Patients With LBCL
A Phase 2 study testing Polatuzumab Vedotin, Rituximab (R) and Zanubrutinib in people with Large B-Cell Lymphoma (LBCL), run by Ruijin Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Large B-Cell Lymphoma (LBCL)
- What is being tested?
- Polatuzumab Vedotin, Rituximab (R) and Zanubrutinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2026to 31 Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Ruijin Hospital
Shanghai, 200020
Weili Zhao, 64370045, zwl_trial@163.com
About this study
Official 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)
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
- Large B-Cell Lymphoma (LBCL)
- Being tested
- Polatuzumab Vedotin, Rituximab (R), Zanubrutinib, Lenalidomide, Glofitamab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polatuzumab VedotinDrug
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.
ZanubrutinibDrug
Zanubrutinib PO will be administered as per the schedule specified in the respective arm.
LenalidomideDrug
Lenalidomide PO will be administered as per the schedule specified in the respective arm.
GlofitamabDrug
Glofitamab IV infusion will be administered as per the schedule specified in the respective arm.
| Study group | Role | What they receive |
|---|---|---|
| Polatuzumab vedotin in combination with ZR2 or Pola-ZR-Glo regimen | Experimental | 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. Receives: Drug: Polatuzumab Vedotin; Drug: Rituximab (R); Drug: Zanubrutinib; Drug: Lenalidomide; Drug: Glofitamab |
| ZR2 | Active comparator | Participants will receive zanubrutinib 160 mg BID orally (PO) on Days 1-21, lenalidomide 25 mg/day orally on Days 2-11, and rituximab 375 mg/m² intravenously (IV) on Day 1 of every 21-day cycle for 6 cycles. Receives: Drug: Rituximab (R); Drug: Zanubrutinib; Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (10)
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.
Measured: 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
Measured: End of treatment completion , an average of 6 months
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
Measured: End of treatment completion , an average of 6 months
Overall survival
OS defined as the time from randomization to death from any cause
Measured: Up to approximately 3 years
Duration of response
Measured: 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
Measured: 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
Measured: From enrollment to study completion, a maximum of 4 years
Patient reported outcome assessed by EORTC QLQ-C30 (Verison 3.0)
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.
Measured: 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 assessed by EORTC QLQ-ELD14
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.
Measured: 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 assessed by FACT-Lym LymS
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.
Measured: Day 1 of Cycles 1, 4 and 7 (Pola-ZR-Glo regimen only); 30 days after treatment completion. Cycle length=21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start30 Jun 2026 (estimated)
- Primary completion30 Jun 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Large B-Cell Lymphoma (LBCL)Studies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Weili, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07717177
- Sponsor's protocol ID
- PRAISE
- Acronym
- PRAISE
- Status last verified
- Jul 2026
- First submitted
- 14 Jun 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT07717177
- Acronym / sponsor ID
- PRAISE / PRAISE
- Conditions
- Large B-Cell Lymphoma (LBCL)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polatuzumab vedotin in combination with ZR2 or Pola-ZR-Glo regimen | Experimental | Drug: Polatuzumab Vedotin, Drug: Rituximab (R), Drug: Zanubrutinib, Drug: Lenalidomide, Drug: GlofitamabParticipants 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. |
| ZR2 | Active comparator | Drug: Rituximab (R), Drug: Zanubrutinib, Drug: LenalidomideParticipants will receive zanubrutinib 160 mg BID orally (PO) on Days 1-21, lenalidomide 25 mg/day orally on Days 2-11, and rituximab 375 mg/m² intravenously (IV) on Day 1 of every 21-day cycle for 6 cycles. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polatuzumab VedotinPolatuzumab vedotin IV infusion will be administered as per the schedule specified in the respective arm. | Drug | Polatuzumab vedotin in combination with ZR2 or Pola-ZR-Glo regimen |
| Rituximab (R)Rituximab IV infusion will be administered as per the schedule specified in the respective arm. | Drug | Polatuzumab vedotin in combination with ZR2 or Pola-ZR-Glo regimen, ZR2 |
| ZanubrutinibZanubrutinib PO will be administered as per the schedule specified in the respective arm. | Drug | Polatuzumab vedotin in combination with ZR2 or Pola-ZR-Glo regimen, ZR2 |
| LenalidomideLenalidomide PO will be administered as per the schedule specified in the respective arm. | Drug | Polatuzumab vedotin in combination with ZR2 or Pola-ZR-Glo regimen, ZR2 |
| GlofitamabGlofitamab IV infusion will be administered as per the schedule specified in the respective arm. | Drug | Polatuzumab vedotin in combination with ZR2 or Pola-ZR-Glo regimen |
Primary outcome
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.
10 secondary outcomes
Event-free survival
Time frame: Up to approximately 24 months
Complete response rate
Time frame: End of treatment completion , an average of 6 months
Objective response rate
Time frame: End of treatment completion , an average of 6 months
Overall survival
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, 4 and 7 (Pola-ZR-Glo regimen only); 30 days after treatment completion. Cycle length=21 days
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 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Polatuzumab Vedotin, Rituximab (R) and Zanubrutinib in people with Large B-Cell Lymphoma (LBCL), run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weili Zhao (+862164370045 Ext. 610707, zwl_trial@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.