diffuse large B-cell lymphoma
Conditions
Interventions
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 perfor
Sponsors
Hosoi Hiroki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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 lymphoma. (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 = 93% (on room air) No arrhythmias that would be considered problematic for initiating chemotherapy are observed within 28 days prior to registration (the same wee kday four weeks before the registration date is acce ptable). 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.
Exclusion criteria
Exclusion 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 intra venous) of steroids. (Steroid use for lymphoma symptom relief is excluded.) 6) Presence of uncontrolled diabetes mellitus. 7) Presence of uncontrolled hypertension. 8) Classified as NYHA grade 3 or 4. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactYoshikazu Hori
Wakayama Medical University Hospital
Outcome results
None listed