NIPH Clinical Trials Search

Phase II Trial of Reduced-Dose PV-R-CHP Therapy for Elderly Patients

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	diffuse large B-cell lymphoma
Date of first enrollment	25/07/2025
Target sample size	75
Countries of recruitment
Study type	Interventional
Intervention(s)	For elderly patients aged 65 years or older with newly diagnosed DLBCL, written informed consent will be obtained from the patient. During the screening period, an evaluation using sGA will be performed to classify patients into one of the following categories: Fit, unFit, or Frail. Fit patients will be deemed ineligible for the study, while unFit patients will receive PV-R-mediumCHP, and Frail patients will receive PV-R-miniCHP.

Outcome(s)

Primary Outcome	Progression-free survival
Secondary Outcome	Secondary Endpoints Overall survival (OS) Time to next treatment (TTNT) Number of treatment courses Volume of red blood cell and platelet transfusions Safety Endpoints Incidence of adverse events (CTCAE v5.0 Grade >=3) Incidence of febrile neutropenia (FN) Incidence of peripheral sensory peripheral motor neuropathy

Key inclusion & exclusion criteria

Age minimum	>= 65age old
Age maximum	Not applicable
Gender	Both
Include criteria	1) Disease (Cancer Type) Patients who meet any of the following criteria: Newly diagnosed DLBCL T-cell rich B-cell lymphoma ALK-positive Large B-cell lymphoma Large B-cell lymphoma with IRF4 rearrangement EBV-positive DLBCL DLBCL with chronic inflammation Transformed DLBCL (WHO 5th edition) 2) Extent of Disease Newly diagnosed DLBCL at Ann Arbor stage 1 or higher, deemed unsuitable for R-CHOP+RT by the attending physician. Staging with contrast-enhanced CT is recommended, but plain CT or PET/CT is acceptable based on circumstances. 3) CD20 Antigen Expression Confirmed CD20 antigen expression by immunohistochemistry or flow cytometry. 4) Age 65 years or older. 5) Fitness Classification Patients classified as "unFit" or "Frail" according to sGA . 6) Performance Status (PS) ECOG performance status score of 2 or lower. (Patients with PS3 due to tumor-related deterioration are eligible.) 7) Measurability Presence of measurable lesions. (Lesions must be at least 1.5 cm in maximum diameter and measurable in two perpendicular dimensions by CT.) 8) Prior Treatment No prior chemotherapy or radiotherapy for any cancer type. (The use of steroids for symptom relief is permitted.) 9) Prior or Concomitant Treatment Restrictions No history of chemotherapy, radiotherapy, interferon, or antibody therapy for DLBCL. (The use of steroids for symptom relief is permitted.) 10) Laboratory Tests (Organ Function) T-Bil <= 2.0 mg/dL AST <= 150 U/L ALT <= 150 U/L Serum creatinine <= 2.0 mg/dL SpO2 >= 93% (on room air) No ischemic heart disease, atrial fibrillation, or treatment-requiring ventricular tachycardia on a resting 12-lead ECG within 28 days before enrollment. Left ventricular ejection fraction (EF) >= 50% on echocardiography within 56 days before enrollment. Neutrophil count >= 750/uL Platelet count >= 50,000/uL (If bone marrow infiltration is judged to be causing cytopenia, neutrophil count >= 500/uL and platelet count >= 30,000/uL are acceptable.) 11) Written Informed Consent Written informed consent has been obtained from the patient.
Exclude criteria	Exclusion Criteria 1) Presence of active synchronous malignancies. 2) Presence of an infection requiring systemic treatment. 3) Males whose partners wish to become pregnant. 4) Presence of a psychiatric disorder or symptoms that significantly interfere with daily life, making trial participation difficult. 5) Continuous systemic administration (oral or intravenous) of steroids or other immunosuppressants. (Steroid use for lymphoma symptom relief is excluded.) 6) Presence of uncontrolled diabetes mellitus. 7) Presence of uncontrolled hypertension. 8) Presence of unstable angina (angina that has developed or worsened within the last 3 weeks) or a history of myocardial infarction within 6 months prior to obtaining consent. 9) Presence of dilated cardiomyopathy or hypertrophic cardiomyopathy. 10) HIV antibody positivity. (Patients who have not been tested for HIV antibodies may still be enrolled.) 11) Presence of interstitial pneumonia, pulmonary fibrosis, or severe emphysema diagnosed by chest X-ray. 12) Clinically suspected central nervous system lesions. (CSF examination or brain MRI is not mandatory.) 13) HBs antigen positivity. 14) Allergy to polatuzumab vedotin, rituximab, doxorubicin, cyclophosphamide, or prednisolone.