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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: jinzhengming519519@163.com
• Phone: 67781856

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.