This is a prospective, single-arm, multicenter, phase II clinical trial to evaluate the efficacy and safety of orelabrutinib combined with the R-CHOP (rituximab, cyclophosphamide, vincristine, doxorubicin, and prednisone) regimen as first-line treatment in CD5-positive diffuse large B-cell lymphoma (DLBCL) patients.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Key Inclusion Criteria:
1. Subjects fully understand and voluntarily participate in this study and sign informed consent.
2. Aged ≥18 years, both male and female.
3. Pathologically confirmed CD5-positive DLBCL
4. There must be at least one measurable or evaluable lesion that meets the evaluation criteria for Lugano 2014 lymphoma.
5. Eastern Cooperative Oncology Group(ECOG) performance status score of 0-2.
6. Expected survival ≥3 months.
7. Sufficient bone marrow, liver, and kidney function.
Key Exclusion Criteria:
1. DLBCL combined with other types of lymphoma. Transformed DLBCL.
2. DLBCL with central nervous system invasion.
3. The patients had previously received BTK inhibitors.
4. The patients have contraindications to any drug in the combined treatment.
5. Patients with the infection of human immunodeficiency virus (HIV) and/or acquired immunodeficiency syndrome.
6. Inability to swallow tablets, presence of malabsorption syndrome, or any other gastrointestinal disease or dysfunction that may affect the absorption of the study drug.
7. Pregnant and lactating women, and subjects of childbearing age who do not want to use contraception.
8. Mentally ill persons or persons unable to obtain informed consent.
9. The investigators think that the patient is not suitable for the study.
Primary outcome measure(s)
2-year event-free survival (EFS) rate — Defined as the proportion of patients without disease progression, treatment discontinuation, or death for any reason within 24 months of enrollment To investigate the preliminary anti-tumor efficacy
Trial sites (11)
Facility
City
Region
Status
Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University,
Guangzhou
China
Recruiting
Gansu Cancer Hospital
Lanzhou
Gansu
Recruiting
Dongguan People's Hospital
Dongguan
Guangdong
Recruiting
Fifth Affiliated Hospital of Guangzhou Medical University
Guangzhou
Guangdong
Recruiting
First People's Hospital of Guangzhou
Guangzhou
Guangdong
Recruiting
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou
Guangdong
Recruiting
Second Affiliated Hospital of Guangzhou Medical University
Guangzhou
Guangdong
Recruiting
First Affiliated Hospital of Shantou University Medical College.
Shantou
Guangdong
Recruiting
Shenzhen People's Hospital
Shenzhen
Guangdong
Recruiting
Zhaoqing First People's Hospital
Zhaoqing
Guangdong
Recruiting
Fifth Affiliated Hospital of Sun Yat-sen University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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