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

Official title

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

Overview

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).

Detailed description

The study will start with an initial 21-days of induction therapy with Pro regimen (Pomalidomide, rituximab and orelabrutinib)，following imaging examinations to evaluate response rates. Patients with a lesion reduction of ≥25% received Pro-pola(Pro regimen plus polatuzumab vedotin), in a 21-day cycle for 6 cycles.

Interventions

• Drug Induction 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
• Drug Consolidation 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

Primary outcome measures

• Complete response rate(CRR) [Time frame: At the end of 6 cycles of Pro-pola regimen (each cycle is 21 days)]

Secondary outcome measures (4)

• Objective response rate(ORR) [Time frame: At the end of 6 cycles of Pro-pola regimen (each cycle is 21 days)]
• 2-year progression-free survival(PFS) [Time frame: From the enrollment to 2-year after the treatment of last patient]
• 2-year overall survival(OS) [Time frame: From the enrollment to 2-year after the treatment of last patient]
• Main adverse reactions [Time frame: From the enrollment to 1 months after 6 cycles of Pro-pola regimen of the last patient (each cycle is 21 days)]

Eligibility criteria

Inclusion criteria

• 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 criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• The First Affiliated Hospital of Soochow University — Suzhou

Identifiers

NCT: NCT07072208 · 2024471

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗