RecruitingNot ApplicableNCT07072208

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

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

Sponsor

The First Affiliated Hospital of Soochow University

Enrollment

43 participants

Start Date

Nov 1, 2024

Study Type

INTERVENTIONAL

Conditions

Diffuse Large B Cell Lymphoma

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

Min Age: 70 Years

Inclusion Criteria9

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 Criteria9

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.

Interventions

DRUGInduction therapy-Pro regimen

Pro regimen induction(21days per cycle\*1 cycle) * Pomalidomide 4mg per tablet 4mg orally from Days 1 to 7 of each cycle * Rituximab 100mg per vial 375mg/m2, intravenous drip, Day 1 of each cycle * Orelabrutinib 50mg per tablet 150mg orally per day from Days 1 to 21 of each cycle

DRUGConsolidation therapy-Pro-pola regimen

Pro-pola regimen consolidation(21days per cycle\*6 cycle) -Pomalidomide 4mg per tablet 4mg orally from Days 1 to 7 of each cycle -Rituximab 100mg per vial 375mg/m2, intravenous drip, Day 1 of each cycle -Orelabrutinib 50mg per tablet 150mg orally per day from Days 1 to 21 of each cycle -Polatuzumab vedotin 30mg per vial 1.8 mg/kg, intravenous drip, Day 1 of each cycle