Orelabrutinib Combined With Pola-R-CHP as First-Line Treatment for Patients With Intermediate- to High-Risk DLBCL

August 20, 2026 updated by: Bing, Xu, The First Affiliated Hospital of Xiamen University

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Fujian
      • Xiamen, Fujian, China
        • Recruiting
        • The First Affiliated Hospital of Xiamen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged ≥ 18 years;
  2. 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;
  3. No prior receipt of other anti-tumor treatments;
  4. ECOG performance status 0-2;
  5. IPI score 2-5, and patients with stage III-IV disease;
  6. Life expectancy ≥ 6 months;
  7. Voluntarily sign a written informed consent form.

Exclusion Criteria:

  1. Lymphoma involving the central nervous system or leptomeningeal metastasis;
  2. 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;
  3. Primary mediastinal large B-cell lymphoma;
  4. Burkitt lymphoma;
  5. Left ventricular ejection fraction < 50%;

  6. Laboratory test values at screening: (unless caused by lymphoma);

    1. Neutrophils < 1.5×10⁹/L;
    2. Platelets < 75×10⁹/L;
    3. 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;
    4. Creatinine level higher than 1.5 times the upper limit of normal;
  7. Patients with psychiatric disorders or other patients who are known or suspected to be unable to fully comply with the study protocol;
  8. Pregnant or lactating women;
  9. 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;
  10. Need for continuous treatment with strong or moderate CYP3A inhibitors or CYP3A inducers;
  11. 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;
  12. Other concurrent and uncontrolled medical conditions that the investigator deems will affect the patient's participation in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Orelabrutinib Plus Pola-R-CHP Regimen
Orelabrutinib in combination with polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP)
Drug: Orelabrutinib Combined with Pola-R-CHP Regimen
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.
Other Names:
  • Orelabrutinib in combination with polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Response Rate (CRR)
Time Frame: up to 12 months
The proportion of patients who achieve Complete Response.
up to 12 months
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).
up to 12 months
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).
up to 24 months
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.
up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Xiamen University

Investigators

  • Principal Investigator: Bing Xu, PhD，MD, The First Affiliated Hospital of Xiamen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 30, 2026

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

July 21, 2026

First Submitted That Met QC Criteria

August 20, 2026

First Posted (Actual)

August 21, 2026

Study Record Updates

Last Update Posted (Actual)

August 21, 2026

Last Update Submitted That Met QC Criteria

August 20, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XMDYYYXYK-18

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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