Tests a combination of drugs in older adults with newly diagnosed large B-cell lymphoma
Tests a drug combination for lymphoma in people aged 70 and older newly diagnosed.
Plain-language title generated from the registry record
Registry title: Pomalidomide, Rituximab and Orelabrutinib Combined With Polatuzumab Vedotin in the Treatment of Newly Diagnosed Elderly Patients With DLBCL
Key facts
- Where
- Suzhou, ChinaSee the site
Where in China
- The First Affiliated Hospital of Soochow UniversitySuzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The First Affiliated Hospital of Soochow University
- Trial code
- NCT07072208
- Record updated
- 18 July 2025
- Original description
To evaluate the efficacy and safety of the Pro-Pola （Pomalidomide, rituximab, orelabrutinib and polatuzumab vedotin) regimen in elderly patients (aged ≥70 years) with newly diagnosed diffuse large B-cell lymphoma (DLBCL).Read full original descriptionShow less
A Prospective and Exploratory Clinical Study of Pomalidomide, Rituximab and Orelabrutinib Combined With Polatuzumab Vedotin in the Treatment of Newly Diagnosed Elderly Patients With DLBCL
To evaluate the efficacy and safety of the Pro-Pola （Pomalidomide, rituximab, orelabrutinib and polatuzumab vedotin) regimen in elderly patients (aged ≥70 years) with newly diagnosed diffuse large B-cell lymphoma (DLBCL).
Inclusion: Age ≥70 years unfit or frail; There is at least one image-measurable lesion with a measurable lesion of at least 15 mm; Histologically confirmed treatment-naive DLBCL; Life expectancy is>3 months; appropriate organ function: Cardiac function: Cardiac ejection fraction ≥50%; Liver function: alanine aminotransferase and aspartate aminotransferase ≤3 times the upper limit of normal; Renal function: Serum creatinine clearance ≥30mL/min; Lung function: SPO2 >90% without oxygen inhalation; Adequate bone marrow reserve is defined as:; Hemoglobin ≥8g/dL, platelet count ≥75×10\^9/L, Absolute neutrophil value ≥1.0×10\^9/L, If accompanied by bone marrow invasion, platelet count ≥50×10\^9/L, absolute neutrophil count ≥0.75×10\^9/L; Patients have the ability to understand and are willing to provide written informed consent; Subjects with childbearing or childbearing potential must be willing to practice birth control from the date of registration in this study to the follow-up period of the study.
Exclusion: Current or expected need for systemic corticosteroid treatment; Previous or current history of vascular embolism; Presence of organic heart disease or severe arrhythmia leading to clinical symptoms or abnormal cardiac function (NYHA Functional Class Grade ≥2); Uncontrolled active infection; Other psychological conditions that prevent the patient from participating in the study or signing informed consent; Severe abnormal liver and kidney function (alanine aminotransferase, bilirubin, creatinine>3 times the upper limit of normal); Co-existence of other tumors requiring treatment or intervention; DLBCL involving central nervous system; In the investigator's judgment, it is unlikely that the subject will complete all protocol-required study visits or procedures, including follow-up visits, or will not meet the requirements for participation in the study.