Combining orelabrutinib with R-CHOP for treating newly diagnosed double expression DLBCL
A Phase II, Prospective ,Multicenter Study Evaluating the Efficacy and Safety of Orelabrutinib Plus R-CHOP in Treatment-naïve Patients With Double Expression Diffuse Large B-cell Lymphoma
PHASE2 · Shandong Cancer Hospital and Institute · NCT05933967
This study is testing if adding orelabrutinib to the standard R-CHOP treatment can help people newly diagnosed with a specific aggressive type of lymphoma feel better.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 31 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Shandong Cancer Hospital and Institute (other) |
| Drugs / interventions | orelabrutinib |
| Locations | 2 sites (Nanchang, Jiangxi and 1 other locations) |
| Trial ID | NCT05933967 on ClinicalTrials.gov |
What this trial studies
This multicenter, prospective, single-arm phase II study aims to evaluate the safety and efficacy of orelabrutinib in combination with the R-CHOP regimen for treatment-naïve patients diagnosed with double expression diffuse large B-cell lymphoma (DLBCL). Patients will receive 6 to 8 cycles of treatment, with each cycle lasting 21 days. The primary objective is to assess the complete response rate at the end of the induction therapy. This study seeks to provide a new treatment option for patients with this aggressive form of lymphoma.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with newly diagnosed double expression DLBCL and an ECOG performance status of 0-2.
Not a fit: Patients with systemic lymphoma involving the CNS or uncontrolled infections, cardiovascular diseases, or those preparing for transplantation may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve response rates and outcomes for patients with double expression DLBCL.
How similar studies have performed: While this approach is novel in the context of double expression DLBCL, similar combinations have shown promise in other lymphoma studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Newly diagnosed Double Expression Diffuse Large B-cell Lymphoma * Age 18-70 years * ECOG performance status 0-2 * Ann Arbor stage II-IV * 8.Subjects who in line with the testing standard of the clinical trial laboratory * Life expectancy ≥ 3months Exclusion Criteria: * • systemic lymphoma involved CNS. * Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulopathy, connective tissue diseases. * uncontrolled infections (including HBV, HCV, HIV/AIDS) * Subjects who prepared for transplantation * Pregnancy or active lactation
Where this trial is running
Nanchang, Jiangxi and 1 other locations
- The First Ailliated Hospital of Nanchang University — Nanchang, Jiangxi, China (RECRUITING)
- Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences — Jinan, Shandong, China (RECRUITING)
Study contacts
- Study coordinator: zengjun Li
- Email: zengjunli@163.com
- Phone: 13642138692
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.
Conditions: The First Affiliated Hospital of Nanchang University