Combining pomalidomide, rituximab, orelabrutinib and polatuzumab vedotin for elderly diffuse large B‑cell lymphoma

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

This tests whether adding polatuzumab vedotin to a pomalidomide, rituximab and orelabrutinib regimen helps patients aged 70 and older with newly diagnosed diffuse large B‑cell lymphoma.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 43 (estimated)
• Ages: 70 Years and up
• Sex: All
• Sponsor: The First Affiliated Hospital of Soochow University (Academic / other)
• Drugs / interventions: rituximab, polatuzumab, orelabrutinib
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT07072208 on ClinicalTrials.gov

What this trial studies

Patients begin with a 21‑day induction of pomalidomide, rituximab and orelabrutinib (Pro regimen), followed by imaging to measure tumor response. Those with at least a 25% reduction in measurable lesions move on to six 21‑day cycles that add polatuzumab vedotin (Pro‑pola regimen). The study will track tumor response rates and safety/tolerability in this elderly, unfit or frail population. Routine lab tests and imaging will be used to monitor organ function, blood counts, and treatment effects throughout.

Who should consider this trial

Good fit: Ideal candidates are treatment‑naive DLBCL patients aged 70 or older who are judged unfit or frail and who meet the required organ function and blood count criteria.

Not a fit: Patients under 70, those with prior DLBCL treatment, or those with severe cardiac, liver, renal, pulmonary dysfunction or inadequate blood counts are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this combo could offer an effective, potentially better‑tolerated frontline option for patients aged 70+ who are unfit for standard intensive chemotherapy.

How similar studies have performed: Polatuzumab vedotin has shown benefit in combinations for relapsed/refractory DLBCL, but using it with pomalidomide and orelabrutinib as frontline therapy in elderly patients is a novel approach with limited prior data.

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 study to the follow-up period of the study.

Exclusion Criteria:

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

Suzhou, Jiangsu

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

Study contacts

• Principal investigator: Nana Ping — The First Affiliated Hospital of Soochow University
• Study coordinator: Zhengming Jin

Conditions Diffuse Large B-Cell Lymphoma; Polatuzumab vedotin; pomalidomide; rituximab; elderly patients; orelabrutinib