DLBCL - Diffuse Large B Cell LymphomaPhase 2NCT07231250
Glofitamab Plus Polatuzumab Vedotin and Zuberitamab in Patients With Newly Diagnosed Diffuse Large B-cell Lymphoma
A Phase 2 study testing Glofitamab; Polatuzumab vedotin; Zuberitamab; Cyclophosphamide; Doxorubicin; Prednisone in people with DLBCL - Diffuse Large B Cell Lymphoma and Chemo-free Therapy, run by Li Zhiming at 1 site in China.
Trial summary
This is a multi-center, phase II, prospective study. The main purpose of study is to evaluate the efficacy and safety of Glofitamab plus Polatuzumab vedotin and Zuberitamab in patients with newly diagnosed diffuse large B-cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- DLBCL - Diffuse Large B Cell Lymphoma, Chemo-free Therapy, Bispecific Antibody
- What is being tested?
- Glofitamab; Polatuzumab vedotin; Zuberitamab; Cyclophosphamide; Doxorubicin; Prednisone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2026to 15 Sep 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The following criteria must be met to be eligible for the study:
- Written informed consent.
- Age ≥18 years at the time of signing the Informed Consent Form
- IPI score 2-5.
- ECOG performance status of 0-2.
- Histologically confirmed CD20-positive LBCL, including one of the following diagnoses by 2022 WHO classification of lymphoid neoplasms:
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- DLBCL, not otherwise specified (NOS) including germinal B-cell type, activated B-cell type
- T-cell/histiocyte-rich large B-cell lymphoma
- Epstein-Barr virus-positive DLBCL, NOS
- Anaplastic lymphoma kinasepositive large B-cell lymphoma
- Kaposi's sarcomaassociated herpesvirus/human herpesvirus-8positive DLBCL
- DLBCL/HGBCL with MYC and BCL2 rearrangements
- HGBCL, NOS. (6) At least one measurable site of disease (>1.5 cm long axis). (7) No previous treatment for lymphoma. (8) Life expectancy ≥6 months. (9) Left ventricular ejection fraction (LVEF) ≥50% on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO) (10) Patient has adequate liver function:
- Total bilirubin ≤1.5 x ULN (≤3 x ULN in patients with Gilbert's syndrome).
- AST (aspartate aminotransferase) and ALT (alanine aminotransferase) ≤3 x ULN.
- o Patients with documented liver involvement: AST and/or ALT ≤5 x ULN. (11) Patient has adequate hematological function, unless due to lymphoma:
- Hemoglobin ≥9.0 g/dL within 7 days before the first treatment.
- Absolute neutrophil count of ≥1.0 x 109 cells/L (1,000/μL).
- Platelet count of ≥75 x 109 cells/L (75,000/μL). Note: Transfusion of RBCs and platelets is allowed to reach the inclusion criteria. In case screening procedures are leading to situations that would exclude the patient from study participation (such as Hb value below entry criteria), the patient may still be enrolled into the trial after consultation with the principal investigator.
- Patient has adequate renal function:
- Creatinine ≤ 1.5 x ULN, or Creatinine clearance (CrCl) calculated by Cockcroft-Gault formula of ≥ 30 mL/min for patients in whom, in the Investigator's judgment, serum creatinine levels do not adequately reflect renal function.
Who cannot join
- Patients who meet at least one of the following criteria are not eligible for trial participation:
- History of severe cardiac disease: New York Heart Association (NYHA) grade 3-4, congestive heart failure, myocardial infarction or cerebrovascular accident within the past 3 months, unstable arrhythmias, or unstable angina or history of multiple cardiovascular events) or significant pulmonary disease (including obstructive pulmonary disease and history of bronchospasm).
- Note: Congestive heart failure NYHA II patients can be included if they provide an LVEF > 40%.
- Patient with current or history of CNS lymphoma.
- Patient with uncontrolled severe infection, whether bacterial (e.g., tuberculosis), viral (including, but not limited to severe pneumonia, COVID-19, Epstein-Barr virus [EBV], cytomegalovirus [CMV], hepatitis B, hepatitis C, and HIV], fungal, mycobacterial, or other pathogens (excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with IV antibiotics (for IV antibiotics this pertains to completion of last course of antibiotic treatment) within 4 weeks prior to study enrollment.
- Note: Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.
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- Patient with current > Grade 1 peripheral neuropathy.
- Any other prior malignancy than non-melanoma skin cancer or stage 0 (in situ) cervical carcinoma, unless treated with curative intent, and without relapse since 2 years, or low grade prostate cancer, not in need of treatment
- Psychiatric illness or condition which could interfere with their ability to understand the requirements of the study.
- Known hypersensitivity to hamster ovary (CHO) cell products or to any component of the Zuberitamab, polatuzumab vedotin, obinutuzumab, or glofitamab and/or to the contrast agents used 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
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Peng Sun, Doctor, +86 18826437876, sunp@sysucc.org.cn
About this study
Official title: Glofitamab Plus Polatuzumab Vedotin and Zuberitamab in Patients With Newly Diagnosed Diffuse Large B-cell Lymphoma: A Multicenter Phase II Study
This is a multi-center, phase II, prospective study. The main purpose of study is to evaluate the efficacy and safety of Glofitamab plus Polatuzumab vedotin and Zuberitamab in patients with newly diagnosed diffuse large B-cell lymphoma.
Read the detailed description
Nearly 1/3 of newly diagnosed DLBCL patients are over 75 years old, with a median age of 66. The number and proportion of patients unable to tolerate conventional immunochemotherapy continue to rise. Serious long-term toxicities associated with chemotherapy (e.g., reproductive effects, secondary malignancies) have created substantial clinical demand for first-line chemotherapy-free regimens. There is an urgent need for more clinical trials to explore the feasibility of chemo-free or chemo-light regimens in previously untreated DLBCL.
The Smart Stop study from MD Anderson is currently exploring chemotherapy-free, response-adapted therapy based on LTRA (Lymphoma Treatment Response Assessment) protocols. Meanwhile, the MOLTO study demonstrated that atezolizumab combined with venetoclax and obinutuzumab provides effective and well-tolerated treatment for previously untreated transformed DLBCL. This evidence above supports chemo-free or chemo-light regimens as a promising new direction for investigation in previously untreated DLBCL.
Early data suggest that Glofit + Pola-R-CHP in 1L DLBCL has promising efficacy and a similar safety profile to Pola-R-CHP and Glofit + R-CHOP.
This is a multi-center, phase II, prospective study. The main purpose of study is to evaluate the efficacy and safety of Glofitamab plus Polatuzumab vedotin and Zuberitamab in patients with newly diagnosed diffuse large B-cell lymphoma. After receiving 3 cycles of Glofitamab plus Polatuzumab vedotin and Zuberitamab（Anti-CD20 Monoclonal Antibody）, patients were treated with Glofitamab plus Polatuzumab vedotin and Zuberitamab for 5 cycles if CR or Glofitamab plus Polatuzumab vedotin and Zuberitamab-CHP for 6 cycles if PR/SD based on iPET status. The primary efficacy endpoint is CR rate at C4D1.
- Being tested
- Glofitamab; Polatuzumab vedotin; Zuberitamab; Cyclophosphamide; Doxorubicin; Prednisone
- Medical subject headings
- Dendritic Cell Sarcoma, Interdigitating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glofitamab; Polatuzumab vedotin; Zuberitamab; Cyclophosphamide; Doxorubicin; PrednisoneDrug
Step-up cycle (cycle 1) will comprise intravenous (i.v.) application of obinutuzumab 1,000 mg on D1, followed by i.v. application of polatuzumab vedotin 1.8 mg/kg on D2 and i.v. application of glofitamab in escalating doses of 2.5 mg on D8 and 10 mg on D15.
Target dose phase (cycle 2-3) will comprise polatuzumab vedotin 1.8 mg/kg, i.v., glofitamab 30 mg i.v. and Zuberitamab 375mg/m2 i.v. on D1 and repeated Q3W.
Adaptive treatment phase (cycle 4-9) will include two arms with dose cycle guided by PET/CT after C3: i.) If CR, it will comprise polatuzumab vedotin 1.8 mg/kg, i.v.(C4-6) on D1, glofitamab 30 mg i.v. (C4-8) on D2 and Zuberitamab 375mg/m2 i.v. (C4-8) on D1 and repeated Q3W. ii.) if PR or SD, it will comprise polatuzumab vedotin 1.8 mg/kg, i.v .(C4-6) on D1, glofitamab 30 mg i.v. (C4-8) on D8, Zuberitamab-CHP[Zuberitamab 375mg/m2 i.v., cyclophosphamide i.v., doxorubicin i.v., and prednisone p.o. (C4-9)] on D1 and repeated Q3W.
| Study group | Role | What they receive |
|---|---|---|
| Trial group | Experimental | After receiving 3 cycles of Glofitamab plus Polatuzumab vedotin and Zuberitamab（Anti-CD20 Monoclonal Antibody）, patients were treated with Glofitamab plus Polatuzumab vedotin and Zuberitamab for 5 cycles if CR or Glofitamab plus Polatuzumab vedotin and Zuberitamab-CHP for 6 cycles if PR/SD based on iPET status. Receives: Drug: Glofitamab; Polatuzumab vedotin; Zuberitamab; Cyclophosphamide; Doxorubicin; Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
CR rate at C4D1
CR rate, defined as the proportion of patients achieving complete remission at Cycle 4 Day 1.
Measured: 9 weeks
Secondary outcomes (1)
2-yr Progression-free survival (PFS) rate
PFS, defined as the time from first treatment to disease progression (PD) or relapse after complete remission (CR) as per Lugano Classification of 2014, or death due to any cause, whichever occurs first. Patients who have not experienced an event at the time of analysis will be censored at the most recent date of disease assessment.
Measured: 2 years follow-up after EOT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start15 Jan 2026 (estimated)
- Primary completion15 Sep 2026 (estimated)
- Study completion15 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DLBCL - Diffuse Large B Cell LymphomaStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Li Zhiming
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Li Zhiming, Sun Yat-sen University
- Investigators
- Zhiming Li, Professor, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07231250
- Sponsor's protocol ID
- ML45750
- Status last verified
- Nov 2025
- First submitted
- 13 Nov 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glofitamab Plus Polatuzumab Vedotin and Zuberitamab in Patients With Newly Diagnosed Diffuse Large B-cell Lymphoma: A Multicenter Phase II Study
- ClinicalTrials.gov ID
- NCT07231250
- Acronym / sponsor ID
- ML45750
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Li ZhimingUniversity, hospital or other
- Study start
- 15 Jan 2026 (estimated)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 15 Sep 2028 (estimated)
- First posted
- 17 Nov 2025 (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 multi-center, phase II, prospective study. The main purpose of study is to evaluate the efficacy and safety of Glofitamab plus Polatuzumab vedotin and Zuberitamab in patients with newly diagnosed diffuse large B-cell lymphoma.
Detailed description
Nearly 1/3 of newly diagnosed DLBCL patients are over 75 years old, with a median age of 66. The number and proportion of patients unable to tolerate conventional immunochemotherapy continue to rise. Serious long-term toxicities associated with chemotherapy (e.g., reproductive effects, secondary malignancies) have created substantial clinical demand for first-line chemotherapy-free regimens. There is an urgent need for more clinical trials to explore the feasibility of chemo-free or chemo-light regimens in previously untreated DLBCL.
The Smart Stop study from MD Anderson is currently exploring chemotherapy-free, response-adapted therapy based on LTRA (Lymphoma Treatment Response Assessment) protocols. Meanwhile, the MOLTO study demonstrated that atezolizumab combined with venetoclax and obinutuzumab provides effective and well-tolerated treatment for previously untreated transformed DLBCL. This evidence above supports chemo-free or chemo-light regimens as a promising new direction for investigation in previously untreated DLBCL.
Early data suggest that Glofit + Pola-R-CHP in 1L DLBCL has promising efficacy and a similar safety profile to Pola-R-CHP and Glofit + R-CHOP.
This is a multi-center, phase II, prospective study. The main purpose of study is to evaluate the efficacy and safety of Glofitamab plus Polatuzumab vedotin and Zuberitamab in patients with newly diagnosed diffuse large B-cell lymphoma. After receiving 3 cycles of Glofitamab plus Polatuzumab vedotin and Zuberitamab（Anti-CD20 Monoclonal Antibody）, patients were treated with Glofitamab plus Polatuzumab vedotin and Zuberitamab for 5 cycles if CR or Glofitamab plus Polatuzumab vedotin and Zuberitamab-CHP for 6 cycles if PR/SD based on iPET status. The primary efficacy endpoint is CR rate at C4D1.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trial group | Experimental | Drug: Glofitamab; Polatuzumab vedotin; Zuberitamab; Cyclophosphamide; Doxorubicin; PrednisoneAfter receiving 3 cycles of Glofitamab plus Polatuzumab vedotin and Zuberitamab（Anti-CD20 Monoclonal Antibody）, patients were treated with Glofitamab plus Polatuzumab vedotin and Zuberitamab for 5 cycles if CR or Glofitamab plus Polatuzumab vedotin and Zuberitamab-CHP for 6 cycles if PR/SD based on iPET status. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- The following criteria must be met to be eligible for the study:
- DLBCL, not otherwise specified (NOS) including germinal B-cell type, activated B-cell type
- T-cell/histiocyte-rich large B-cell lymphoma
- Epstein-Barr virus-positive DLBCL, NOS
- Anaplastic lymphoma kinasepositive large B-cell lymphoma
Key exclusion criteria (10 listed)
- Patients who meet at least one of the following criteria are not eligible for trial participation:
- Note: Congestive heart failure NYHA II patients can be included if they provide an LVEF > 40%.
- Note: Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.
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 |
|---|---|---|
| Glofitamab; Polatuzumab vedotin; Zuberitamab; Cyclophosphamide; Doxorubicin; PrednisoneStep-up cycle (cycle 1) will comprise intravenous (i.v.) application of obinutuzumab 1,000 mg on D1, followed by i.v. application of polatuzumab vedotin 1.8 mg/kg on D2 and i.v. application of glofitamab in escalating doses of 2.5 mg on D8 and 10 mg on D15. Target dose phase (cycle 2-3) will comprise polatuzumab vedotin 1.8 mg/kg, i.v., glofitamab 30 mg i.v. and Zuberitamab 375mg/m2 i.v. on D1 and repeated Q3W. Adaptive treatment phase (cycle 4-9) will include two arms with dose cycle guided by PET/CT after C3: i.) If CR, it will comprise polatuzumab vedotin 1.8 mg/kg, i.v.(C4-6) on D1, glofitamab 30 mg i.v. (C4-8) on D2 and Zuberitamab 375mg/m2 i.v. (C4-8) on D1 and repeated Q3W. ii.) if PR or SD, it will comprise polatuzumab vedotin 1.8 mg/kg, i.v .(C4-6) on D1, glofitamab 30 mg i.v. (C4-8) on D8, Zuberitamab-CHP[Zuberitamab 375mg/m2 i.v., cyclophosphamide i.v., doxorubicin i.v., and prednisone p.o. (C4-9)] on D1 and repeated Q3W. | Drug | Trial group |
Primary outcome
CR rate at C4D1
Time frame: 9 weeks
CR rate, defined as the proportion of patients achieving complete remission at Cycle 4 Day 1.
1 secondary outcome
2-yr Progression-free survival (PFS) rate
Time frame: 2 years follow-up after EOT
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 Nov 2025.
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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.
Zhiming Li, Professor principal investigator
Sun Yat-Sen University Cancer Center
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 Glofitamab; Polatuzumab vedotin; Zuberitamab; Cyclophosphamide; Doxorubicin; Prednisone in people with DLBCL - Diffuse Large B Cell Lymphoma and Chemo-free Therapy, run by Li Zhiming 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 21 inclusion and 10 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 Nov 2025. 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 Zhiming Li, Professor (+86 13719189172, lizhm@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CR rate at C4D1 (time frame: 9 weeks). 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 Nov 2025.