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Recruiting NCT07908888

Efficacy and Safety of Polatuzumab Vedotin, Rituximab Combined With Reduced-dose Cyclophosphamide, Doxorubicin and Prednisone Regimen in the Treatment of Elderly Patients With Diffuse Large B-cell Lymphoma: A Multicenter, Single-arm, Prospective Study

Conditions: Diffuse Large B-Cell Lymphoma

Sex: All
Ages: 65 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 26
Sponsor: The First Hospital of Jilin University

Location: The First Hospital of Jilin University Changchun Jilin

Summary

This is a multicenter, single-arm, prospective study evaluating the efficacy and safety of polatuzumab vedotin and rituximab combined with a reduced-dose regimen of cyclophosphamide, doxorubicin and prednisone (Pola-R-miniCHP) as first-line treatment in elderly, frail patients with diffuse large B-cell lymphoma (DLBCL). The primary objective is to assess the 2-year progression-free survival (PFS) rate. Eligible participants are elderly patients with previously untreated DLBCL who are assessed as frail or with poor tolerance by comprehensive geriatric assessment.

Eligibility Criteria

Inclusion Criteria: 1. Histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL). 2. Age \>= 75 years; or age \>= 65 years with a G8 screening score \= 1.0 x 10\^9/L, platelets (PLT) \>= 75 x 10\^9/L; (b) Hepatic: AST and ALT \= 50%. 6. Expected survival \>= 3 months. 7. The patient or their legal representative voluntarily participates in the study and signs the written informed consent form. Exclusion Criteria: 1. Prior anti-tumor therapy directed at DLBCL. 2. Bone marrow involvement or involvement of immune-privileged sites. 3. Concurrent other active malignancy, or a prior malignancy that in the investigator's judgment may affect the efficacy and safety evaluation of this study. 4. Currently participating in another interventional clinical study, or receiving other anti-tumor drug therapy that may affect the efficacy assessment of this study. 5. Uncontrolled active infection. 6. Severe cardiac, pulmonary, hepatic, renal or other major organ dysfunction that in the investigator's judgment precludes tolerance of the study treatment. 7. Other conditions considered unsuitable for enrollment by the investigator. 8. Patients eligible for transplantation.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07908888). StuddyBuddy aggregates publicly available trial information.