Diffuse Large B Cell Lymphoma (DLBCL)Phase 2NCT07371923
Application of Zanubrutinib-based Combination Regimens in the Treatment of Newly-diagnosed Diffuse Large B-cell Lymphoma
A Phase 2 study testing Zanubrutinib+Pola-R-CHP in people with Diffuse Large B Cell Lymphoma (DLBCL), run by Beijing Tongren Hospital at 1 site in China.
Trial summary
Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin's lymphoma. Currently, the first-line treatment regimen based on R-CHOP can only achieve clinical cure for 50% to 60% of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B Cell Lymphoma (DLBCL)
- What is being tested?
- Zanubrutinib+Pola-R-CHP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2025to 31 Aug 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
- Pathologically confirmed diffuse large B-cell lymphoma (DLBCL);
- Have a "measurable lesions" ;
- Have at least one of the following risk factors, including: IPI score ≥2 points, ABC subtype, double-expressor lymphoma, double-hit lymphoma, CD5-positive DLBCL, MCD subtype, N1 subtype, A53 subtype, extranodal lesions ≥2, special site involvement, such as central nervous system CNS, breast, testis, ovary, uterus, bone marrow, vitreoretinal, paraspinal, paranasal sinuses and intravascular, etc.
- ECOG score 0-3;
- Expected survival time for 3 months or more;
- White blood cell count ≥3 x 10e9/L, the platelet count≥50 x 10e9/L; 1.5 mg/dL or less of serum creatinine, creatinine clearance≥50 ml/min; ALT, AST 3 x ULN or less, total bilirubin 2 x ULN or less.
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- Exclusion Criteria (the subject should not have any one of the following):
- currently suffering from other malignant tumor;
- ever received any treatments for lymphoma, except for short-term use of corticosteroids;
- Allergic to any kind of study drug;
- Active infection or uncontrol of HBV infection, HIV/AIDS or other serious infectious diseases;
- Pregnancy and lactation women of childbearing age and are reluctant to take contraception subjects;
- Researchers think that the subject does not fit to participate in this study.
Who cannot join
None listed.
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, 1 recruiting
- Recruiting
Beijing Tongren Hospital
Beijing, Beijing Municipality, 100730
Liang Wang, 15001108693, wangliangtrhos@126.com
wangliangtrhos@126.com
About this study
Official title: Application of Zanubrutinib-based Combination Regimens in the Treatment of Newly-diagnosed Diffuse Large B-cell Lymphoma: A Phase II, Prospective, Single-center, Single-arm Clinical Study
Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin's lymphoma. Currently, the first-line treatment regimen based on R-CHOP can only achieve clinical cure for 50% to 60% of patients. Previous studies have shown that patients with high-risk factors have a poor response to R-CHOP treatment and need further improvement. These high-risk factors include: IPI score ≥2 points, ABC subtype, double-expressing lymphoma, double-hit lymphoma, CD5-positive DLBCL, MCD subtype, N1 subtype, A53 subtype, extranodal lesions ≥2, special site involvement, such as central nervous system CNS, breast, testis, ovary, uterus, bone marrow, vitreoretinal, paraspinal, paranasal sinuses and intravascular, etc. Patients with DLBCL accompanied by high-risk factors also have a significantly increased risk of secondary CNS infiltration during recurrence. In previous RCHOP+X research strategies, only the combination of polatuzumab achieved significant 2-year PFS benefits in the overall population. None of the other studies achieved significant PFS benefits in the overall population. Therefore, the latest version of the CSCO guidelines recommends the Pola-R-CHP regimen as the first-line treatment for primary DLBCL. However, there is still considerable room for improvement in the survival of DLBCL patients with high-risk factors in clinical practice. Therefore, the strategy of the Pola-R-CHP-based combined with X regimen in high-risk DLBCL patients with specific risk factors can be explored subsequently.
The Phoenix study for young double expression of lymphoma patients, R - CHOP combined with BTK inhibitors can significantly improve the patient's survival, the subsequent omics data analysis indicates that MCD subtype, N1 subtypes and BN2 subtype can significantly benefit from BTK inhibitors. In addition, given that the proportion of MCD subtypes is high in most extranodal DLBCL patients and secondary CNS involvement is prone to occur, BTK inhibitors can effectively penetrate the blood-brain barrier (BBB) and have both preventive and therapeutic effects on CNS lesions. Therefore, exploring the application of BTK inhibitor zanubrutinib combined with R-CHOP or Pola-R-CHP regimens in high-risk DLBCL patients with specific risk factors (or zanubrutinib combined with rituximab and high-dose MTX in primary central nervous system DLBCL) has good application prospects. It is conducive to further improving the prognosis of such high-risk patients. Therefore, this study aimed to explore the efficacy and safety of the BTK inhibitor zanubrutinib combined with Pola-R-CHP regimen (or zanubrutinib combined with rituximab and high-dose MTX in primary central nervous system DLBCL, etc.) in patients of DLBCL with specific risk factors (IPI score two points or more, ABC subtypes, double expressor lymphoma, double hit lymphoma, CD5 positive DLBCL, MCD subtypes, N1 subtypes, A53 subtypes, extranodal lesions of 2 or more, special locations involved, such as the central nervous system (CNS, breast, testes).
Read the detailed description
This study aimed to explore the efficacy and safety of the BTK inhibitor zanubrutinib combined with Pola-R-CHP regimen (or zanubrutinib combined with rituximab and high-dose MTX in primary central nervous system DLBCL, etc.) in patients of DLBCL with specific risk factors (IPI score two points or more, ABC subtypes, double expressor lymphoma, double hit lymphoma, CD5 positive DLBCL, MCD subtypes, N1 subtypes, A53 subtypes, extranodal lesions of 2 or more, special locations involved, such as the central nervous system (CNS, breast, testes).
- Conditions
- Diffuse Large B Cell Lymphoma (DLBCL)
- Being tested
- Zanubrutinib+Pola-R-CHP
- Keywords
- diffuse large b cell lymphoma (DLBCL), BTK inhibitors, zanubrutinib, high-risk factors
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zanubrutinib+Pola-R-CHPDrug
zanubrutinib combined with Pola-R-CHP regimen: zanubrutinib 160mg bid d1-d21/C1-C6; polatuzumab 1.8mg/kg d1/C1-C6; rituximab 375mg/㎡, iv, d1/C1-C6; cyclophosphamide 750mg/㎡, iv, d1/C1-C6; doxorubicin 50mg/㎡, iv, d1/C1-C6; predinisone 60mg/㎡ d1-5/C1-C6.
| Study group | Role | What they receive |
|---|---|---|
| treatment arm (for DLBCL patients witout central nervous system lesions) | Experimental | zanubrutinib combined with Pola-R-CHP regimen: zanubrutinib 160mg bid d1-d21/C1-C6; polatuzumab 1.8mg/kg d1/C1-C6; rituximab 375mg/㎡, iv, d1/C1-C6; cyclophosphamide 750mg/㎡, iv, d1/C1-C6; doxorubicin 50mg/㎡, iv, d1/C1-C6; predinisone 60mg/㎡ d1-5/C1-C6. Receives: Drug: Zanubrutinib+Pola-R-CHP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best complete remission rate (CRR)
Response assessment was done after every two cycles of treatment. Best CRR was defined as the CRR during all the six cycles of treatment.
Measured: From the start of the first cycle of treatment up to 24 weeks (when all six cycles of treatment was completed)
Secondary outcomes (3)
best overall response rate (ORR)
Response assessment was done after every two cycles of treatment. Best ORR was defined as the ORR during all the six cycles of treatment.
Measured: From the start of the first cycle of treatment up to 24 weeks (when all six cycles of treatment was completed).
Two-year progression free survival (PFS) rate
PFS was caculated from the date of start of treatment to date of disease progression, death of any cause, or last follow-up, whichever came first.
Measured: From the start of the first cycle of treatment up to 24 months after initiation of treatment for the last enrolled patient.
Two-year overall survival (OS) rate
OS was caculated from the date of start of treatment to date of death of any cause, or last follow-up, whichever came first.
Measured: From the start of the first cycle of treatment up to 24 months after initiation of treatment for the last enrolled patient.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start20 Nov 2025
- Primary completion29 Feb 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B Cell Lymphoma (DLBCL)Studies of the same condition, open and under way.
- More trials run by Beijing Tongren 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LIANG WANG, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07371923
- Sponsor's protocol ID
- TRhos-DLBCL-01
- Status last verified
- Jan 2026
- First submitted
- 18 Nov 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Zanubrutinib-based Combination Regimens in the Treatment of Newly-diagnosed Diffuse Large B-cell Lymphoma: A Phase II, Prospective, Single-center, Single-arm Clinical Study
- ClinicalTrials.gov ID
- NCT07371923
- Acronym / sponsor ID
- TRhos-DLBCL-01
- Conditions
- Diffuse Large B Cell Lymphoma (DLBCL)
- Keywords
- diffuse large b cell lymphoma (DLBCL), BTK inhibitors, zanubrutinib, high-risk factors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- 29 Feb 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 28 Jan 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.
Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin's lymphoma. Currently, the first-line treatment regimen based on R-CHOP can only achieve clinical cure for 50% to 60% of patients. Previous studies have shown that patients with high-risk factors have a poor response to R-CHOP treatment and need further improvement. These high-risk factors include: IPI score ≥2 points, ABC subtype, double-expressing lymphoma, double-hit lymphoma, CD5-positive DLBCL, MCD subtype, N1 subtype, A53 subtype, extranodal lesions ≥2, special site involvement, such as central nervous system CNS, breast, testis, ovary, uterus, bone marrow, vitreoretinal, paraspinal, paranasal sinuses and intravascular, etc. Patients with DLBCL accompanied by high-risk factors also have a significantly increased risk of secondary CNS infiltration during recurrence. In previous RCHOP+X research strategies, only the combination of polatuzumab achieved significant 2-year PFS benefits in the overall population. None of the other studies achieved significant PFS benefits in the overall population. Therefore, the latest version of the CSCO guidelines recommends the Pola-R-CHP regimen as the first-line treatment for primary DLBCL. However, there is still considerable room for improvement in the survival of DLBCL patients with high-risk factors in clinical practice. Therefore, the strategy of the Pola-R-CHP-based combined with X regimen in high-risk DLBCL patients with specific risk factors can be explored subsequently.
The Phoenix study for young double expression of lymphoma patients, R - CHOP combined with BTK inhibitors can significantly improve the patient's survival, the subsequent omics data analysis indicates that MCD subtype, N1 subtypes and BN2 subtype can significantly benefit from BTK inhibitors. In addition, given that the proportion of MCD subtypes is high in most extranodal DLBCL patients and secondary CNS involvement is prone to occur, BTK inhibitors can effectively penetrate the blood-brain barrier (BBB) and have both preventive and therapeutic effects on CNS lesions. Therefore, exploring the application of BTK inhibitor zanubrutinib combined with R-CHOP or Pola-R-CHP regimens in high-risk DLBCL patients with specific risk factors (or zanubrutinib combined with rituximab and high-dose MTX in primary central nervous system DLBCL) has good application prospects. It is conducive to further improving the prognosis of such high-risk patients. Therefore, this study aimed to explore the efficacy and safety of the BTK inhibitor zanubrutinib combined with Pola-R-CHP regimen (or zanubrutinib combined with rituximab and high-dose MTX in primary central nervous system DLBCL, etc.) in patients of DLBCL with specific risk factors (IPI score two points or more, ABC subtypes, double expressor lymphoma, double hit lymphoma, CD5 positive DLBCL, MCD subtypes, N1 subtypes, A53 subtypes, extranodal lesions of 2 or more, special locations involved, such as the central nervous system (CNS, breast, testes).
Detailed description
This study aimed to explore the efficacy and safety of the BTK inhibitor zanubrutinib combined with Pola-R-CHP regimen (or zanubrutinib combined with rituximab and high-dose MTX in primary central nervous system DLBCL, etc.) in patients of DLBCL with specific risk factors (IPI score two points or more, ABC subtypes, double expressor lymphoma, double hit lymphoma, CD5 positive DLBCL, MCD subtypes, N1 subtypes, A53 subtypes, extranodal lesions of 2 or more, special locations involved, such as the central nervous system (CNS, breast, testes).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment arm (for DLBCL patients witout central nervous system lesions) | Experimental | Drug: Zanubrutinib+Pola-R-CHPzanubrutinib combined with Pola-R-CHP regimen: zanubrutinib 160mg bid d1-d21/C1-C6; polatuzumab 1.8mg/kg d1/C1-C6; rituximab 375mg/㎡, iv, d1/C1-C6; cyclophosphamide 750mg/㎡, iv, d1/C1-C6; doxorubicin 50mg/㎡, iv, d1/C1-C6; predinisone 60mg/㎡ d1-5/C1-C6. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Pathologically confirmed diffuse large B-cell lymphoma (DLBCL);
- Have a "measurable lesions" ;
- Have at least one of the following risk factors, including: IPI score ≥2 points, ABC subtype, double-expressor lymphoma, double-hit lymphoma, CD5-positive DLBCL, MCD subtype, N1 subtype, A53 subtype, extranodal lesions ≥2, special site involvement, such as central nervous system CNS, breast, testis, ovary, uterus, bone marrow, vitreoretinal, paraspinal, paranasal sinuses and intravascular, etc.
- ECOG score 0-3;
- Expected survival time for 3 months or more;
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Zanubrutinib+Pola-R-CHPzanubrutinib combined with Pola-R-CHP regimen: zanubrutinib 160mg bid d1-d21/C1-C6; polatuzumab 1.8mg/kg d1/C1-C6; rituximab 375mg/㎡, iv, d1/C1-C6; cyclophosphamide 750mg/㎡, iv, d1/C1-C6; doxorubicin 50mg/㎡, iv, d1/C1-C6; predinisone 60mg/㎡ d1-5/C1-C6. | Drug | treatment arm (for DLBCL patients witout central nervous system lesions) |
Primary outcome
Best complete remission rate (CRR)
Time frame: From the start of the first cycle of treatment up to 24 weeks (when all six cycles of treatment was completed)
Response assessment was done after every two cycles of treatment. Best CRR was defined as the CRR during all the six cycles of treatment.
3 secondary outcomes
best overall response rate (ORR)
Time frame: From the start of the first cycle of treatment up to 24 weeks (when all six cycles of treatment was completed).
Two-year progression free survival (PFS) rate
Time frame: From the start of the first cycle of treatment up to 24 months after initiation of treatment for the last enrolled patient.
Two-year overall survival (OS) rate
Time frame: From the start of the first cycle of treatment up to 24 months after initiation of treatment for the last enrolled patient.
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 28 Jan 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 Zanubrutinib+Pola-R-CHP in people with Diffuse Large B Cell Lymphoma (DLBCL), run by Beijing Tongren 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 13 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 28 Jan 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 Liang Wang, M.D. (+861058266633, wangliangtrhos@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best complete remission rate (CRR) (time frame: From the start of the first cycle of treatment up to 24 weeks (when all six cycles of treatment was completed)). 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 28 Jan 2026.