NCT06647940RecruitingPhase 2
Orelabrutinib in Combination with R-CHOP for CD5-positive DLBCL Patients(Rocket Trial)
Orelabrutinib in Combination with R-CHOP for CD5-positive DLBCL Patients: a Single-arm, Multicenter, Phase II Clinical Trial(Rocket Trial)
Source: ClinicalTrials.gov · Last updated 22 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 39 (estimated)
- First submitted
- 16 Oct 2024
- Start date
- 1 Nov 2024
- Primary completion date
- 1 Nov 2026
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Diffuse large B-cell lymphoma
- NCT number
- NCT06647940
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 39
- From 1 Nov 2024 to the primary completion date, 1 Nov 2026
- 11 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- The patients had previously received BTK inhibitors.
- The patients have contraindications to any drug in the combined treatment.
Other illness
- 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.
Age
- Pregnant and lactating women, and subjects of childbearing age who do not want to use contraception.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dongguan People's Hospital Coordinator of this site? Confirm its status | Dongguan | China | Recruiting |
| Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University, Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Second Affiliated Hospital of Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Guangdong Provincial Hospital of Traditional Chinese Medicine Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| First People's Hospital of Guangzhou Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Fifth Affiliated Hospital of Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Gansu Cancer Hospital Coordinator of this site? Confirm its status | Lanzhou | China | Recruiting |
| First Affiliated Hospital of Shantou University Medical College. Coordinator of this site? Confirm its status | Shantou | China | Recruiting |
| Shenzhen People's Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Recruiting |
| Zhaoqing First People's Hospital Coordinator of this site? Confirm its status | Zhaoqing | China | Recruiting |
| Fifth Affiliated Hospital of Sun Yat-sen University Coordinator of this site? Confirm its status | Zhuhai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.