Combining orelabrutinib with R-CHOP for treating CD5-positive DLBCL
Orelabrutinib in Combination with R-CHOP for CD5-positive DLBCL Patients: a Single-arm, Multicenter, Phase II Clinical Trial（Rocket Trial）
This study is testing if adding a new drug called orelabrutinib to the standard R-CHOP treatment can help people with untreated CD5-positive diffuse large B-cell lymphoma live longer without their cancer coming back.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 39 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | rituximab, orelabrutinib, cyclophosphamide, doxorubicin, prednisone |
| Locations | 11 sites (Guangzhou, China and 10 other locations) |
| Trial ID | NCT06647940 on ClinicalTrials.gov |
What this trial studies
This phase II clinical trial evaluates the efficacy and safety of orelabrutinib in combination with the R-CHOP regimen for patients with untreated CD5-positive diffuse large B-cell lymphoma (DLBCL). Participants will undergo 6 cycles of treatment with orelabrutinib added from the second cycle, followed by 2 additional cycles of rituximab and orelabrutinib. The primary endpoint of the trial is the 2-year event-free survival rate. This multicenter study aims to provide insights into a potentially effective first-line treatment for this specific patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with pathologically confirmed CD5-positive DLBCL and measurable lesions.
Not a fit: Patients with DLBCL combined with other types of lymphoma or those who have previously received BTK inhibitors may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve survival rates and outcomes for patients with CD5-positive DLBCL.
How similar studies have performed: While this approach is novel for CD5-positive DLBCL, similar combinations of targeted therapies and chemotherapy have shown promise in other lymphoma studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Guangzhou, China and 10 other locations
- Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University, — Guangzhou, China, China (Recruiting)
- Gansu Cancer Hospital — Lanzhou, Gansu, China (Recruiting)
- Dongguan People's Hospital — Dongguan, Guangdong, China (Recruiting)
- Fifth Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (Recruiting)
- First People's Hospital of Guangzhou — Guangzhou, Guangdong, China (Recruiting)
- Guangdong Provincial Hospital of Traditional Chinese Medicine — Guangzhou, Guangdong, China (Recruiting)
- Second Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (Recruiting)
- First Affiliated Hospital of Shantou University Medical College. — Shantou, Guangdong, China (Recruiting)
- Shenzhen People's Hospital — Shenzhen, Guangdong, China (Recruiting)
- Zhaoqing First People's Hospital — Zhaoqing, Guangdong, China (Recruiting)
- Fifth Affiliated Hospital of Sun Yat-sen University — Zhuhai, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Qingqing Cai, MD. PhD.
- Email: caiqq@sysucc.org.cn
- Phone: 02087342823
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.