Overview
The proposed study is a prospective, single-center and open-ended study in patients over the age of 70 with treatment-naive diffuse large B-cell lymphoma (DLBCL). This study intends to explore a new treatment pattern using Pro-miniCHOP-like regimen and simultaneously evaluate its safety and efficacy for future clinical practice.
Description
The study will start with an initial 21-days of induction therapy with combination of orelabrutinib, pomalidomide and rituximab(Pro regimen) in eligible patients, following contrast computed temography(CT) to guide the next treatment. Patients whose lesions have 25% or more reduction will next receive Pro-miniCHOP-like regimen for 6 cycles. Patients with reduction less than 25% will receive R-miniCHOP-like regimen also for 6 cycles. After that, maintenance therapy with pomalidomide for two years will be given to patients undergoing Pro-miniCHOP-like regimen.
Eligibility
Inclusion Criteria:
- Histopathologically or Cytologically confirmed newly diagnosed untreated DLBCL;
- There is at least one radiographically measurable lesion (i.e., ≥ 15mm in diameter);
- Age ≥ 70 years;
- Life expectancy >3 months;
- 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).
- Written informed consent obtained from the subject.
Exclusion Criteria:
- Patients with severe liver and kidney dysfunction (alanine aminotransferase, bilirubin, creatinine > 3 times the upper limit of normal);
- Patients with organic heart disease with clinical symptoms or cardiac dysfunction (NYHA grade ≥2);
- Uncontrolled active infection;
- Patients with central nervous system DLBCL;
- A history of vascular embolism;
- Co-existence of other tumors;
- Systemic corticosteroid therapy is needed;
- Any other psychological conditions that prevent patients from participating in the study or signing the informed consent form.