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

NCT07078500 | Recruiting Phase 2

• 1 other identifier: 2025-0086
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diffuse Large B-Cell Lymphoma (DLBCL)

Outcome Measures

Primary Outcomes (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

  up to 2 years

Secondary Outcomes (3)

• Overall Response Rate (ORR)

  up to 8 months

• Complete Response Rate (CR)

  up to 8 months

• overall survival (OS)

  up to 3 years

Study Arms (1)

orelabrutinib combined with the Pola-R-CHP regimen

EXPERIMENTAL

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.

Drug: orelabrutinib combined with the Pola-R-CHP regimen

Interventions

orelabrutinib combined with the Pola-R-CHP regimen DRUG

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.

orelabrutinib combined with the Pola-R-CHP regimen

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.
• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• The Second Affiliated Hospital of Jiaxing University: collaborator
• Taizhou First People's Hospital: collaborator
• Huzhou Central Hospital: collaborator
• Zhejiang Cancer Hospital: collaborator
• Dongyang People's Hospital: collaborator
• Yuyao People's Hospital: collaborator
• Taizhou Hospital: collaborator
• Shaoxing Central Hospital: collaborator
• Affiliated Hospital of Jiaxing University: collaborator
• Shaoxing People's Hospital: collaborator
• The Central Hospital of Lishui City: collaborator
• Second Affiliated Hospital of Wenzhou Medical University: collaborator
• Ningbo People's Hospital: collaborator
• The People's Hospital of Quzhou: collaborator
• Zhuji People's hospital: collaborator
• Affiliated Hangzhou First People's Hospital: collaborator

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

hui Liu

CONTACT

+86 13819198629; sylen@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2025
• First Posted: July 22, 2025
• Study Start: May 5, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 19, 2025

Record last verified: 2025-02

Locations

CN (1)