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Diffuse Large B-Cell Lymphoma (DLBCL)Phase 2NCT07078500

Orelabrutinib Combined With Pola-R-CHP Regimen for the Treatment of Untreated Non-GCB Diffuse Large B-Cell Lymphoma

A Phase 2 study testing orelabrutinib combined with the Pola-R-CHP regimen in people with Diffuse Large B-Cell Lymphoma (DLBCL), run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Assess the preliminary efficacy and safety of orelabrutinib in combination with the Pola-R-CHP regimen for the treatment of treatment-naive Non-GCB diffuse large B-cell lymphoma. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Diffuse Large B-Cell Lymphoma (DLBCL)
What is being tested?
orelabrutinib combined with the Pola-R-CHP regimen
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteChina
Study dates
5 May 2025to 31 Dec 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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 to 80 years old.
  • Diffuse large B-cell lymphoma (DLBCL) confirmed by tumor tissue pathology, with at least one measurable lesion.
  • Non-GCB.
  • No prior anti-tumor treatment.
  • ECOG score of 0-2.
  • Life expectancy of ≥6 months.
  • Voluntary written informed consent.

Who cannot join

  • Lymphoma involving the central nervous system or leptomeningeal metastasis.
  • Transformed lymphoma, that is, 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.
  • Laboratory values at screening (unless due to lymphoma):
  • Neutrophils <1.5×10⁹/L;
Show all 15Show fewer
  • Platelets <75×10⁹/L;
  • ALT or AST more than 2 times the upper limit of normal, ALP and bilirubin more than 1.5 times the upper limit of normal;
  • Creatinine level more than 1.5 times the upper limit of normal.
  • Patients with psychiatric disorders or other known or suspected inability to fully comply with the study protocol.
  • Pregnant or breastfeeding women.
  • Known human immunodeficiency virus (HIV) infection, or active hepatitis B or C virus infection (positive result by polymerase chain reaction [PCR]). If the patient tests positive for HbsAg, HBV DNA testing is required. If HBV DNA <10³ IU/ml, the patient may be enrolled. If the patient tests negative for HbsAg but positive for HBcAb (regardless of HBsAb status), HBV DNA testing is also required. If HBV DNA <10³ IU/ml, the patient may be enrolled. If the patient tests positive for HCV antibody, HCV RNA is detected by PCR. If positive, the patient meets the exclusion criteria.
  • Need for continuous treatment with strong or moderate CYP3A inhibitors or CYP3A inducers.
  • Inability to swallow capsules or significant gastrointestinal disorders, such as malabsorption syndrome, bariatric surgery, inflammatory bowel disease, or partial or complete intestinal obstruction.
  • Other concurrent and uncontrolled medical conditions that the investigator believes will 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.

hui Liu contact

+86 13819198629

sylen@zju.edu.cn

China1 site, 1 recruiting

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    Hangzhou, Zhejiang

    Hui Liu, +86 13819198629, sylen@zju.edu.cn

    Recruiting

Other trials in China

About this study

Official title: A Prospective, Single-Arm, Multicenter Clinical Study of Orelabrutinib Combined With Pola-R-CHP Regimen for the Treatment of Untreated Non-GCB Diffuse Large B-Cell Lymphoma

Assess the preliminary efficacy and safety of orelabrutinib in combination with the Pola-R-CHP regimen for the treatment of treatment-naive Non-GCB diffuse large B-cell lymphoma.

Read the detailed description

Currently, the R-CHOP regimen can cure approximately 60% of DLBCL patients. The Pola-R-CHP regimen has shown further improvement on this basis. However, from the POLARIX study, it was observed that patients under 60 years old, with an IPI score of 2, and those with large masses did not show further benefits from the Pola regimen. Meanwhile, for patients with poor prognosis such as non-GCB, there is still room for further improvement with the Pola-R-CHP regimen. BTK inhibitors have demonstrated ideal therapeutic effects for the aforementioned patient types, and currently, a large number of patients have been treated with this type of therapy in clinical practice. However, the vast majority have been combined with R-CHOP-like regimens. There are no data reported on the combination of BTK inhibitors with the Pola regimen. Therefore, this study plans to assess the preliminary efficacy and safety of orelabrutinib in combination with the Pola-R-CHP regimen for the treatment of treatment-naive non-GCB diffuse large B-cell lymphoma (DLBCL). Enrolled patients will receive six cycles of orelabrutinib in combination with the Pola-R-CHP regimen, with each 21-day period being one cycle. At the end of the six cycles, an interim efficacy evaluation will be conducted. Patients with a response of CR or PR will receive an additional two cycles of orelabrutinib in combination with rituximab and undergo a final efficacy evaluation. Patients with a response of CR/PR after eight cycles of induction therapy will receive maintenance treatment with orelabrutinib for up to two years.

Being tested
orelabrutinib combined with the Pola-R-CHP regimen
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.

  • orelabrutinib combined with the Pola-R-CHP regimenDrug

    Enrolled patients will receive six cycles of orelabrutinib in combination with the Pola-R-CHP regimen, with each 21-day period being one cycle. At the end of the six cycles, an interim efficacy evaluation will be conducted. Patients with a response of CR or PR will receive an additional two cycles of orelabrutinib in combination with rituximab and undergo a final efficacy evaluation. Patients with a response of CR/PR after eight cycles of induction therapy will receive maintenance treatment with orelabrutinib for up to two years.

Study groups in NCT07078500
Study groupRoleWhat they receive
orelabrutinib combined with the Pola-R-CHP regimenExperimentalEnrolled patients will receive six cycles of orelabrutinib in combination with the Pola-R-CHP regimen, with each 21-day period being one cycle. At the end of the six cycles, an interim efficacy evaluation will be conducted. Patients with a response of CR or PR will receive an additional two cycles of orelabrutinib in combination with rituximab and undergo a final efficacy evaluation. Patients with a response of CR/PR after eight cycles of induction therapy will receive maintenance treatment with orelabrutinib for up to two years.
Receives: Drug: orelabrutinib combined with the Pola-R-CHP regimen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 2 years Progression free survival (2Y-PFS)

    PFS is defined as the time from registration to the first occurrence of progression or relapse as assessed by the investigator, or death from any cause. PFS for patients without disease progression, relapse, or death will be censored at the time of the last tumor assessment

    Measured: up to 2 years

Secondary outcomes (3)

  1. Overall Response Rate (ORR)

    ORR is defined as the proportion of patients with a response of CR or PR

    Measured: up to 8 months

  2. Complete Response Rate (CR)

    The rate of patients who achieved complete response after treatment

    Measured: up to 8 months

  3. overall survival (OS)

    Overall survival is defined as the period from the induction registration to death from any cause. Patients who have not died until the time of the analysis will be censored at their last contact date.

    Measured: up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2025
  2. Study start5 May 2025
  3. Primary completion31 Oct 2026 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

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
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07078500
Sponsor's protocol ID
2025-0086
Status last verified
Feb 2025
First submitted
13 Jul 2025
Last updated
19 Aug 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing orelabrutinib combined with the Pola-R-CHP regimen in people with Diffuse Large B-Cell Lymphoma (DLBCL), run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 7 inclusion and 15 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 19 Aug 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 hui Liu (+86 13819198629, sylen@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

2 years Progression free survival (2Y-PFS) (time frame: up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07078500.

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 Aug 2025.

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