NCT07072208 Pomalidomide, Rituximab and Orelabrutinib Combined With Polatuzumab Vedotin in the Treatment of Newly Diagnosed Elderly Patients With DLBCL
| NCT ID | NCT07072208 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The First Affiliated Hospital of Soochow University |
| Condition | Diffuse Large B-Cell Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 43 participants |
| Start Date | 2024-11-01 |
| Primary Completion | 2027-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 43 participants in total. It began in 2024-11-01 with a primary completion date of 2027-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Zhengming Jin
STUDY CHAIR
The First Affiliated Hospital of Soochow University
Frequently Asked Questions
Who can join the NCT07072208 clinical trial?
This trial is open to participants of all sexes, aged 70 Years or older, studying Diffuse Large B-Cell Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07072208 currently recruiting?
Yes, NCT07072208 is actively recruiting participants. Contact the research team at jinzhengming519519@163.com for enrollment information.
Where is the NCT07072208 trial being conducted?
This trial is being conducted at Suzhou, China.
Who is sponsoring the NCT07072208 clinical trial?
NCT07072208 is sponsored by The First Affiliated Hospital of Soochow University. The principal investigator is Zhengming Jin at The First Affiliated Hospital of Soochow University. The trial plans to enroll 43 participants.