Pro-miniCHOP-like Regimen for Treatment-naive Elderly Patients

Prospective Exploratory Clinical Study of Orelabrutinib, Pomalidomide, Rituximab Combined With miniCHOP-like Regimen in Treatment-naive Elderly Patients With DLBCL

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.

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.

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.