Pomalidomide, Rituximab and Orelabrutinib Combined With Polatuzumab Vedotin in the Treatment of Newly Diagnosed Elderly Patients With DLBCL

Recruiting now · Not applicable

Conditions studied: Diffuse Large B-Cell Lymphoma

In brief

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).

Key facts

Study ID

NCT07072208

Run by

The First Affiliated Hospital of Soochow University

People needed

43

Starts

2024-11-01

Expected to finish

2027-05-01

Last updated by the study team

2025-07-18

Who can join

Age: 70 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Severe abnormal liver and kidney function (alanine aminotransferase, bilirubin, creatinine>3 times the upper limit of normal);
• Presence of organic heart disease or severe arrhythmia leading to clinical symptoms or abnormal cardiac function (NYHA Functional Class Grade ≥2);
• Uncontrolled active infection;
• Co-existence of other tumors requiring treatment or intervention;
• DLBCL involving central nervous system;
• Current or expected need for systemic corticosteroid treatment;
• Previous or current history of vascular embolism;
• Other psychological conditions that prevent the patient from participating in the study or signing informed consent.
• 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.

Where it is running

• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (enrolling)

Full record on ClinicalTrials.gov

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