DLBCL - Diffuse Large B Cell LymphomaNCT07778212
Orelabrutinib Combined With Pola-R-CHP as First-Line Treatment for Patients With Intermediate- to High-Risk DLBCL
A study testing Orelabrutinib Combined with Pola-R-CHP Regimen in people with DLBCL - Diffuse Large B Cell Lymphoma and Intermediate-High Risk, run by The First Affiliated Hospital of Xiamen University at 2 sites in China.
Trial summary
To evaluate orelabrutinib in combination with polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP) as first-line treatment for patients with intermediate- to high-risk diffuse large B-cell lymphoma (DLBCL). 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, Intermediate-High Risk, First-Line
- What is being tested?
- Orelabrutinib Combined with Pola-R-CHP Regimen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesChina
- Study dates
- 30 Aug 2026to 31 Dec 2028
- Phase
- Interventional
- 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
- Aged ≥ 18 years;
- Pathologically confirmed diffuse large B-cell lymphoma (DLBCL) by tumor tissue, with at least one measurable lesion, including DLBCL, not otherwise specified (GCB and non-GCB subtypes), DLBCL with MYC and BCL-2 rearrangements, and high-grade B-cell lymphoma;
- No prior receipt of other anti-tumor treatments;
- ECOG performance status 0-2;
- IPI score 2-5, and patients with stage III-IV disease;
- Life expectancy ≥ 6 months;
- Voluntarily sign a written informed consent form.
Who cannot join
- Lymphoma involving the central nervous system or leptomeningeal metastasis;
- Transformed lymphoma, i.e., transformed from other types of lymphoma, such as follicular lymphoma, marginal zone lymphoma, chronic lymphocytic leukemia, or small B-cell lymphoma;
- Primary mediastinal large B-cell lymphoma;
- Burkitt lymphoma;
- Left ventricular ejection fraction < 50%;
- Laboratory test values at screening: (unless caused by lymphoma);
Show all 16Show fewer
- Neutrophils < 1.5×10⁹/L;
- Platelets < 75×10⁹/L;
- ALT or AST higher than 2 times the upper limit of normal, AKP and bilirubin higher than 1.5 times the upper limit of normal;
- Creatinine level higher than 1.5 times the upper limit of normal;
- Patients with psychiatric disorders or other patients who are known or suspected to be unable to fully comply with the study protocol;
- Pregnant or lactating women;
- Known infection with human immunodeficiency virus (HIV), or active hepatitis B or C virus infection (positive result by polymerase chain reaction [PCR]). If a patient has a positive HBsAg test result, HBV DNA testing is required. If HBV DNA < 10³ IU/ml, the patient can be enrolled. If the HBsAg test result is negative, but the HBcAb test is positive (regardless of HBsAb status), HBV DNA testing is also required. If HBV DNA < 10³ IU/ml, the patient can be enrolled. If a patient is HCV antibody positive, HCV RNA is detected by PCR technology, and a positive result meets the exclusion criterion;
- Need for continuous treatment with strong or moderate CYP3A inhibitors or CYP3A inducers;
- nability to swallow capsules or presence of diseases that significantly affect gastrointestinal function, such as malabsorption syndrome, bariatric surgery, inflammatory bowel disease, or partial or complete intestinal obstruction;
- Other concurrent and uncontrolled medical conditions that the investigator deems will affect the patient's participation in the study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
the First Affiliated Hospital of Xiamen University
Xiamen, Fujian
Bing Xu, Dr, 18750918842, xubingzhangjian@126.com
- Recruiting
the First Affiliated Hospital of Xiamen University
Xiamen, Fujian
Bing Xu, 18750918842, xubingzhangjian@126.com
About this study
Official title: A Translational Study of Orelabrutinib Combined With Polatuzumab Vedotin, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (Pola-R-CHP) as First-Line Treatment for Patients With Intermediate- to High-Risk Diffuse Large B-Cell Lymphoma (DLBCL)
To evaluate orelabrutinib in combination with polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP) as first-line treatment for patients with intermediate- to high-risk diffuse large B-cell lymphoma (DLBCL).
Read the detailed description
This study is designed to evaluate the efficacy and safety of orelabrutinib in combination with polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP) as first-line treatment for patients with intermediate- to high-risk Diffuse large B-cell lymphoma (DLBCL).
Participants will receive orelabrutinib 150 mg orally once daily on Days 1-21 of each 21-day cycle. Polatuzumab vedotin will be administered intravenously at 1.8 mg/kg once every 21 days in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for 6 cycles. During Cycles 7 and 8, participants will receive rituximab in combination with orelabrutinib. Thereafter, orelabrutinib maintenance therapy will be continued for up to 1 year.
- Being tested
- Orelabrutinib Combined with Pola-R-CHP Regimen
- 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.
Orelabrutinib Combined with Pola-R-CHP RegimenDrug
Also called Orelabrutinib in combination with polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP)
Participants will receive orelabrutinib 150 mg orally once daily on Days 1-21 of each 21-day cycle. Polatuzumab vedotin will be administered intravenously at 1.8 mg/kg once every 21 days in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for 6 cycles. During Cycles 7 and 8, participants will receive rituximab in combination with orelabrutinib. Thereafter, orelabrutinib maintenance therapy will be continued for up to 1 year.
| Study group | Role | What they receive |
|---|---|---|
| Orelabrutinib Plus Pola-R-CHP Regimen | Experimental | Orelabrutinib in combination with polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP) Receives: Drug: Orelabrutinib Combined with Pola-R-CHP Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response Rate (CRR)
The proportion of patients who achieve Complete Response.
Measured: up to 12 months
Objective Response Rate (ORR):
The proportion of patients who achieve either a complete response (CR) or a partial response (PR, partial reduction of tumor lesions).
Measured: up to 12 months
Progression-Free Survival (PFS)
The length of time during which a patient's disease does not progress (i.e., no new tumor growth or spread of existing tumors).
Measured: up to 24 months
Overall Survival (OS)
The length of time from the start of treatment until a patient's death from any cause.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start30 Aug 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 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.
- More trials run by The First Affiliated Hospital of Xiamen UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bing, Xu, The First Affiliated Hospital of Xiamen University
- Investigators
- Bing Xu, PhD，MD, Principal investigator, The First Affiliated Hospital of Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07778212
- Sponsor's protocol ID
- XMDYYYXYK-18
- Status last verified
- Aug 2026
- First submitted
- 21 Jul 2026
- Last updated
- 21 Aug 2026
- 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 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Translational Study of Orelabrutinib Combined With Polatuzumab Vedotin, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (Pola-R-CHP) as First-Line Treatment for Patients With Intermediate- to High-Risk Diffuse Large B-Cell Lymphoma (DLBCL)
- ClinicalTrials.gov ID
- NCT07778212
- Acronym / sponsor ID
- XMDYYYXYK-18
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Study start
- 30 Aug 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 21 Aug 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.
To evaluate orelabrutinib in combination with polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP) as first-line treatment for patients with intermediate- to high-risk diffuse large B-cell lymphoma (DLBCL).
Detailed description
This study is designed to evaluate the efficacy and safety of orelabrutinib in combination with polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP) as first-line treatment for patients with intermediate- to high-risk Diffuse large B-cell lymphoma (DLBCL).
Participants will receive orelabrutinib 150 mg orally once daily on Days 1-21 of each 21-day cycle. Polatuzumab vedotin will be administered intravenously at 1.8 mg/kg once every 21 days in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for 6 cycles. During Cycles 7 and 8, participants will receive rituximab in combination with orelabrutinib. Thereafter, orelabrutinib maintenance therapy will be continued for up to 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orelabrutinib Plus Pola-R-CHP Regimen | Experimental | Drug: Orelabrutinib Combined with Pola-R-CHP RegimenOrelabrutinib in combination with polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged ≥ 18 years;
- Pathologically confirmed diffuse large B-cell lymphoma (DLBCL) by tumor tissue, with at least one measurable lesion, including DLBCL, not otherwise specified (GCB and non-GCB subtypes), DLBCL with MYC and BCL-2 rearrangements, and high-grade B-cell lymphoma;
- No prior receipt of other anti-tumor treatments;
- ECOG performance status 0-2;
- IPI score 2-5, and patients with stage III-IV disease;
Key exclusion criteria (16 listed)
- Lymphoma involving the central nervous system or leptomeningeal metastasis;
- Transformed lymphoma, i.e., transformed from other types of lymphoma, such as follicular lymphoma, marginal zone lymphoma, chronic lymphocytic leukemia, or small B-cell lymphoma;
- Primary mediastinal large B-cell lymphoma;
- Burkitt lymphoma;
- Left ventricular ejection fraction < 50%;
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 |
|---|---|---|
| Orelabrutinib Combined with Pola-R-CHP RegimenAlso: Orelabrutinib in combination with polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP)Participants will receive orelabrutinib 150 mg orally once daily on Days 1-21 of each 21-day cycle. Polatuzumab vedotin will be administered intravenously at 1.8 mg/kg once every 21 days in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for 6 cycles. During Cycles 7 and 8, participants will receive rituximab in combination with orelabrutinib. Thereafter, orelabrutinib maintenance therapy will be continued for up to 1 year. | Drug | Orelabrutinib Plus Pola-R-CHP Regimen |
Primary outcome
Complete Response Rate (CRR)
Time frame: up to 12 months
The proportion of patients who achieve Complete Response.
Objective Response Rate (ORR):
Time frame: up to 12 months
The proportion of patients who achieve either a complete response (CR) or a partial response (PR, partial reduction of tumor lesions).
Progression-Free Survival (PFS)
Time frame: up to 24 months
The length of time during which a patient's disease does not progress (i.e., no new tumor growth or spread of existing tumors).
Overall Survival (OS)
Time frame: up to 24 months
The length of time from the start of treatment until a patient's death from any cause.
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 Aug 2026.
Related trials for DLBCL - Diffuse Large B Cell Lymphoma
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
Not yet recruitingPhase 2
The CARDIOPROTECT Trial
Diffuse Large B-cell Lymphoma (DLBCL), Cardiotoxicity
RecruitingPhase 2
Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/or Refractory Aggressive B-cell Lymphoma
High Grade B-Cell Lymphoma With MYC and BCL6 Rearrangements, Recurrent Diffuse Large B-Cell Lymphoma
Not yet recruitingPhase 2
MRD-Adapted Low-Dose Radiation Therapy During Frontline Chemoimmunotherapy for Diffuse Large B-Cell Lymphoma
Diffuse Large B-Cell Lymphoma
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.
Bing Xu, PhD，MD principal investigator
The First Affiliated Hospital of Xiamen University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orelabrutinib Combined with Pola-R-CHP Regimen in people with DLBCL - Diffuse Large B Cell Lymphoma and Intermediate-High Risk, run by The First Affiliated Hospital of Xiamen University at 2 sites 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 7 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: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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 Bing Xu, PhD，MD (18750918842, xubingzhangjian@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response Rate (CRR) (time frame: up to 12 months). The study lists 4 primary outcomes in all. 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 Aug 2026.