New treatment approach for elderly patients with untreated diffuse large B-cell lymphoma
Prospective Exploratory Clinical Study of Orelabrutinib, Pomalidomide, Rituximab Combined With miniCHOP-like Regimen in Treatment-naive Elderly Patients With DLBCL
This study is testing a new combination treatment for older patients with untreated diffuse large B-cell lymphoma to see if it helps them respond better to therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 70 Years and up |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Soochow University Academic / other |
| Drugs / interventions | rituximab, orelabrutinib |
| Locations | 1 site (Suzhou, Jiangsu) |
| Trial ID | NCT05809180 on ClinicalTrials.gov |
What this trial studies
This study is a prospective, single-center trial focusing on patients aged 70 and older who have been newly diagnosed with treatment-naive diffuse large B-cell lymphoma (DLBCL). It aims to evaluate the safety and efficacy of a Pro-miniCHOP-like regimen, which includes a combination of orelabrutinib, pomalidomide, and rituximab, followed by maintenance therapy. Patients will undergo an initial 21-day induction therapy, and their response will determine the subsequent treatment regimen. The study seeks to provide insights into a new treatment pattern for this patient population.
Who should consider this trial
Good fit: Ideal candidates are patients aged 70 and older with newly diagnosed untreated diffuse large B-cell lymphoma and at least one measurable lesion.
Not a fit: Patients with severe organ dysfunction, central nervous system DLBCL, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a more effective treatment option for elderly patients with diffuse large B-cell lymphoma.
How similar studies have performed: While this approach is novel, similar studies have shown promise in treating DLBCL with combination therapies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Histopathologically or Cytologically confirmed newly diagnosed untreated DLBCL; 2. There is at least one radiographically measurable lesion (i.e., ≥ 15mm in diameter); 3. Age ≥ 70 years; 4. Life expectancy \>3 months; 5. Patients with proper organic function (alanine aminotransferase, bilirubin, creatinine \< 3 times the upper limit of normal; cardiac ejection fraction ≥ 50%; SPO2\>90% under non-oxygenated conditions). 6. Written informed consent obtained from the subject. Exclusion Criteria: 1. Patients with severe liver and kidney dysfunction (alanine aminotransferase, bilirubin, creatinine \> 3 times the upper limit of normal); 2. Patients with organic heart disease with clinical symptoms or cardiac dysfunction (NYHA grade ≥2); 3. Uncontrolled active infection; 4. Patients with central nervous system DLBCL; 5. A history of vascular embolism; 6. Co-existence of other tumors; 7. Systemic corticosteroid therapy is needed; 8. Any other psychological conditions that prevent patients from participating in the study or signing the informed consent form.
Where this trial is running
Suzhou, Jiangsu
- the First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Zhengming Jin
- Email: jinzhengming519519@163.com
- Phone: 67781856
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.