Large B-Cell Lymphoma (LBCL)Phase 2GUIDANCE-10NCT07594899
AI-Driven Treatment Strategy vs Pola-R-CHP in Untreated LBCL
A Phase 2 study testing Polatuzumab Vedotin, rituximab and Cyclophosphamide 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 participants with previously untreated large B-cell lymphoma. Participants will be stratified into different risk groups using an AI-based multimodal model. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Large B-Cell Lymphoma (LBCL)
- What is being tested?
- Polatuzumab Vedotin, rituximab and Cyclophosphamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteChina
- Study dates
- 6 May 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Life expectancy ≥ 3 months
- 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)
- 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
- 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
- Any of the following abnormal laboratory values (unless any of these abnormalities are due to underlying lymphoma):
- Absolute neutrophil count <1.0 × 10⁹/L.
- Platelet count <75 × 10⁹/L
Show all 16Show fewer
- Serum AST and ALT ≥ 2.5 x ULN
- Total bilirubin ≥ 1.5 x ULN
- Serum creatinine clearance < 30 mL/min (using Cockcroft-Gault formula)
- Any active infection within 7 days prior to Cycle 1 Day 1 that would impact participant safety
- Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen [HBsAg] serology)：Participants with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative HbsAg) may be included if hepatitis B virus (HBV) DNA is undetectable at the time of screening. Such participants must be willing to undergo HBV DNA testing every month and appropriate antiviral therapy as indicated
- Positive test results for hepatitis C (hepatitis C virus [HCV] antibody serology testing)：Participants positive for HCV antibody are eligible only if PCR is negative for HCV RNA
- Participants with a history of progressive multifocal leukoencephalopathy
- Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 12 months after final dose of treatment
- Participants with uncontrolled coagulation disorders, connective tissue diseases, severe infectious diseases
- Other concurrent and uncontrolled medical conditions that, in the opinion of the investigator, would affect the patient's participation in 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 Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 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 Pola-R-CHP in Patients With Previously Untreated Large B-Cell Lymphoma
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.
- Conditions
- Large B-Cell Lymphoma (LBCL)
- Being tested
- Polatuzumab Vedotin, rituximab, Cyclophosphamide, Doxorubicin, Prednisone
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.
rituximabDrug
Rituximab IV infusion will be administered as per the schedule specified in the respective arm.
CyclophosphamideDrug
Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.
DoxorubicinDrug
Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.
PrednisoneDrug
Prednisone PO 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.
DecitabineDrug
Decitabine IV infusion 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 |
|---|---|---|
| Genotype-guided targeted agents or glofitamab in combination with Pola-R-CHP | Experimental | Participants will receive polatuzumab vedotin 1.8 milligrams per kilogram (mg/kg) intravenously (IV) on Day 2, rituximab 375 milligrams per square meter (mg/m²) IV on Day 1, cyclophosphamide 750 mg/m² IV on Day 2, doxorubicin 50 mg/m² IV on Day 2, and prednisone 100 milligrams per day (mg/day) orally (PO) on Days 2-6 of the first 21-day cycle. For the remaining five cycles, participants will receive standard Pola-R-CHP in combination with one of the following: zanubrutinib 160 mg BID PO on Days 1-21, lenalidomide 25 mg/day PO on Days 2-11, decitabine 10 mg/m²/day IV on Days -5 to -1, or glofitamab administered IV 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 8 of Cycles 3-6. Each treatment cycle is 21 days. Receives: Drug: Polatuzumab Vedotin; Drug: rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Prednisone; Drug: Zanubrutinib; Drug: Lenalidomide; Drug: Decitabine; Drug: Glofitamab |
| Pola-R-CHP | Active comparator | Participants will receive polatuzumab vedotin 1.8 milligrams per kilogram (mg/kg) intravenously (IV) on Day2, rituximab 375 milligrams per square meter (mg/m²) IV on Day 1, cyclophosphamide 750 mg/m² IV on Day 2, doxorubicin 50 mg/m² IV on Day 2, and prednisone 100 milligrams per day (mg/day) orally (PO) on Days 2-6 of every 21-day cycle for 6 cycles. Receives: Drug: Polatuzumab Vedotin; Drug: rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Prednisone |
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 visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days] )
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 visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days] )
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)
Measured: Day 1 of Cycles 1 and 4 (Cycle length=21 days); 30 days after treatment completion
Patient reported outcome assessed by EORTC QLQ-ELD14
Measured: Day 1 of Cycles 1 and 4 (Cycle length=21 days); 30 days after treatment completion
Patient reported outcome assessed by FACT-Lym LymS
Measured: Day 1 of Cycles 1 and 4 (Cycle length=21 days); 30 days after treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start6 May 2026 (estimated)
- Primary completion31 May 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
- 178 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
- NCT07594899
- Sponsor's protocol ID
- GUIDANCE-10
- Acronym
- GUIDANCE-10
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 19 May 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 19 May 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 Pola-R-CHP in Patients With Previously Untreated Large B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT07594899
- Acronym / sponsor ID
- GUIDANCE-10 / GUIDANCE-10
- Conditions
- Large B-Cell Lymphoma (LBCL)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 6 May 2026 (estimated)
- Primary completion
- 31 May 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 19 May 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Genotype-guided targeted agents or glofitamab in combination with Pola-R-CHP | Experimental | Drug: Polatuzumab Vedotin, Drug: rituximab, Drug: Cyclophosphamide, Drug: Doxorubicin, Drug: Prednisone, Drug: Zanubrutinib, Drug: Lenalidomide, Drug: Decitabine, Drug: GlofitamabParticipants will receive polatuzumab vedotin 1.8 milligrams per kilogram (mg/kg) intravenously (IV) on Day 2, rituximab 375 milligrams per square meter (mg/m²) IV on Day 1, cyclophosphamide 750 mg/m² IV on Day 2, doxorubicin 50 mg/m² IV on Day 2, and prednisone 100 milligrams per day (mg/day) orally (PO) on Days 2-6 of the first 21-day cycle. For the remaining five cycles, participants will receive standard Pola-R-CHP in combination with one of the following: zanubrutinib 160 mg BID PO on Days 1-21, lenalidomide 25 mg/day PO on Days 2-11, decitabine 10 mg/m²/day IV on Days -5 to -1, or glofitamab administered IV 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 8 of Cycles 3-6. Each treatment cycle is 21 days. |
| Pola-R-CHP | Active comparator | Drug: Polatuzumab Vedotin, Drug: rituximab, Drug: Cyclophosphamide, Drug: Doxorubicin, Drug: PrednisoneParticipants will receive polatuzumab vedotin 1.8 milligrams per kilogram (mg/kg) intravenously (IV) on Day2, rituximab 375 milligrams per square meter (mg/m²) IV on Day 1, cyclophosphamide 750 mg/m² IV on Day 2, doxorubicin 50 mg/m² IV on Day 2, and prednisone 100 milligrams per day (mg/day) orally (PO) on Days 2-6 of every 21-day cycle for 6 cycles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- Life expectancy ≥ 3 months
Key exclusion criteria (16 listed)
- 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
- Any of the following abnormal laboratory values (unless any of these abnormalities are due to underlying lymphoma):
- Any active infection within 7 days prior to Cycle 1 Day 1 that would impact participant safety
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 | Genotype-guided targeted agents or glofitamab in combination with Pola-R-CHP, Pola-R-CHP |
| rituximabRituximab IV infusion will be administered as per the schedule specified in the respective arm. | Drug | Genotype-guided targeted agents or glofitamab in combination with Pola-R-CHP, Pola-R-CHP |
| CyclophosphamideCyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm. | Drug | Genotype-guided targeted agents or glofitamab in combination with Pola-R-CHP, Pola-R-CHP |
| DoxorubicinDoxorubicin IV infusion will be administered as per the schedule specified in the respective arm. | Drug | Genotype-guided targeted agents or glofitamab in combination with Pola-R-CHP, Pola-R-CHP |
| PrednisonePrednisone PO will be administered as per the schedule specified in the respective arm. | Drug | Genotype-guided targeted agents or glofitamab in combination with Pola-R-CHP, Pola-R-CHP |
| ZanubrutinibZanubrutinib PO will be administered as per the schedule specified in the respective arm. | Drug | Genotype-guided targeted agents or glofitamab in combination with Pola-R-CHP |
| LenalidomideLenalidomide PO will be administered as per the schedule specified in the respective arm. | Drug | Genotype-guided targeted agents or glofitamab in combination with Pola-R-CHP |
| DecitabineDecitabine IV infusion will be administered as per the schedule specified in the respective arm. | Drug | Genotype-guided targeted agents or glofitamab in combination with Pola-R-CHP |
| GlofitamabGlofitamab IV infusion will be administered as per the schedule specified in the respective arm. | Drug | Genotype-guided targeted agents or glofitamab in combination with Pola-R-CHP |
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 visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days] )
Objective response rate
Time frame: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days] )
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 and 4 (Cycle length=21 days); 30 days after treatment completion
Patient reported outcome assessed by EORTC QLQ-ELD14
Time frame: Day 1 of Cycles 1 and 4 (Cycle length=21 days); 30 days after treatment completion
Patient reported outcome assessed by FACT-Lym LymS
Time frame: Day 1 of Cycles 1 and 4 (Cycle length=21 days); 30 days after treatment completion
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 19 May 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 and Cyclophosphamide 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 8 inclusion and 16 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 19 May 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 19 May 2026.