NCT07072208Recruiting
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
Source: ClinicalTrials.gov · Last updated 18 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 43 (estimated)
- First submitted
- 9 Jul 2025
- Start date
- Nov 2024
- Primary completion date
- May 2027
- Lead sponsor
- The First Affiliated Hospital of Soochow University
- Diseases
- Diffuse large B-cell lymphoma
- NCT number
- NCT07072208
What you commit to
- Study type: Interventional
- Planned participants: 43
- From Nov 2024 to the primary completion date, May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current or expected need for systemic corticosteroid treatment;
- Previous or current history of vascular embolism;
Other illness
- 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.
Lab values
- Severe abnormal liver and kidney function (alanine aminotransferase, bilirubin, creatinine\>3 times the upper limit of normal);
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 70 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.