NCT07072208 Pomalidomide, Rituximab and Orelabrutinib Combined With Polatuzumab Vedotin in the Treatment of Newly Diagnosed Elderly Patients With DLBCL
| NCT ID | NCT07072208 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The First Affiliated Hospital of Soochow University |
| Condition | Diffuse Large B-Cell Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 43 participants |
| Start Date | 2024-11-01 |
| Primary Completion | 2027-05-01 |
Trial Parameters
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Brief Summary
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).
Eligibility Criteria
Inclusion Criteria: 1. Age ≥70 years unfit or frail 2. There is at least one image-measurable lesion with a measurable lesion of at least 15 mm. 3. Histologically confirmed treatment-naive DLBCL. 4. Life expectancy is\>3 months. 5. 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 6. 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. 7. Patients have the ability to understand and are willing to provide written informed consent. 8. Subjects with childbearing or childbearing potential must be willing to practice birth control from the date of registration in this s