Tests orelabrutinib with R-CHOP for CD5-positive large B-cell lymphoma
Tests orelabrutinib plus R-CHOP chemotherapy in adults with newly treated CD5-positive lymphoma.
Plain-language title generated from the registry record
Registry title: Orelabrutinib in Combination with R-CHOP for CD5-positive DLBCL Patients（Rocket Trial）
Key facts
- Where
- Dongguan, Guangzhou, Lanzhou, Shantou, Shenzhen, Zhaoqing, and Zhuhai, ChinaSee the 11 sites
- Phase
- Phase 2
Where in China
- Dongguan People's HospitalDongguan, ChinaTaking people
- Fifth Affiliated Hospital of Guangzhou Medical UniversityGuangzhou, ChinaTaking people
- First People's Hospital of GuangzhouGuangzhou, ChinaTaking people
- Guangdong Provincial Hospital of Traditional Chinese MedicineGuangzhou, ChinaTaking people
- Second Affiliated Hospital of Guangzhou Medical UniversityGuangzhou, ChinaTaking people
- Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University,Guangzhou, ChinaTaking people
- Gansu Cancer HospitalLanzhou, ChinaTaking people
- First Affiliated Hospital of Shantou University Medical College.Shantou, ChinaTaking people
- Shenzhen People's HospitalShenzhen, ChinaTaking people
- Zhaoqing First People's HospitalZhaoqing, ChinaTaking people
- Fifth Affiliated Hospital of Sun Yat-sen UniversityZhuhai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sun Yat-sen University
- Trial code
- NCT06647940
- Record updated
- 22 October 2024
- Original description
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.Read full original descriptionShow less
Orelabrutinib in Combination with R-CHOP for CD5-positive DLBCL Patients: a Single-arm, Multicenter, Phase II Clinical Trial（Rocket Trial）
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.
Inclusion: Subjects fully understand and voluntarily participate in this study and sign informed consent; Aged ≥18 years, both male and female; Pathologically confirmed CD5-positive DLBCL; There must be at least one measurable or evaluable lesion that meets the evaluation criteria for Lugano 2014 lymphoma; Eastern Cooperative Oncology Group(ECOG) performance status score of 0-2; Expected survival ≥3 months; Sufficient bone marrow, liver, and kidney function.
Exclusion: The patients had previously received BTK inhibitors; The patients have contraindications to any drug in the combined treatment; Patients with the infection of human immunodeficiency virus (HIV) and/or acquired immunodeficiency syndrome; Inability to swallow tablets, presence of malabsorption syndrome, or any other gastrointestinal disease or dysfunction that may affect the absorption of the study drug; Pregnant and lactating women, and subjects of childbearing age who do not want to use contraception; DLBCL combined with other types of lymphoma. Transformed DLBCL; DLBCL with central nervous system invasion; Mentally ill persons or persons unable to obtain informed consent; The investigators think that the patient is not suitable for the study.