Diffuse large B-cell lymphoma
Conditions
Interventions
Polatuzumab vedotin plus R-CHP (Pola-R-CHP) will be administered every 3 weeks for a total of 6 cycles. If the scheduled date for the subsequent cycle falls on a weekend or national holiday, the timin
Sponsors
Clinical Research Unit, Tokyo Metropolitan Komagome Hospital, Tokyo Metropolitan Hospital Organization
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Study Population Patients diagnosed with diffuse large B-cell lymphoma (DLBCL) who are either hospitalized or receiving outpatient care at the Department of Oncology, Tokyo Metropolitan Komagome Hospital, will be considered eligible for enrollment. (2) Inclusion Criteria Patients must meet all of the following criteria to be eligible for study participation: - Age >= 70 years at the time of informed consent. - Histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) according to the 2017 WHO Classification of Tumours of Haematopoietic and Lymphoid Tissues (4th revised edition), including cases of histologic transformation and high-grade B-cell lymphoma with MYC and BCL2 rearrangements, as well as follicular lymphoma grade 3B. - CD20 expression on tumor cells confirmed by immunohistochemistry or flow cytometry using biopsy or surgically resected specimens. - Presence of at least one measurable lesion as determined by imaging studies. - WHO performance status of 0 to 3. - Written informed consent voluntarily provided by the patient after receiving a full explanation of the study and demonstrating adequate understanding of its nature and purpose.
Exclusion criteria
Exclusion criteria: Patients meeting any of the following criteria will be excluded from the study: - Primary central nervous system lymphoma (including intraocular lymphoma), or evidence of central nervous system involvement at diagnosis based on cerebrospinal fluid analysis or neuroimaging. - Hepatic dysfunction defined as total serum bilirubin >= 3.0 mg/dL and/or AST >= 3 times the institutional upper limit of normal. - Renal impairment defined as serum creatinine >= 2.0 mg/dL. - Hematologic abnormalities: absolute neutrophil count <= 1000/uL or platelet count <= 75000/uL, unless cytopenia is attributable to bone marrow infiltration by lymphoma. - Positive test for human immunodeficiency virus (HIV) antibodies. - Presence of active, serious infections requiring systemic treatment. - History of psychiatric disorders or psychiatric symptoms deemed by the investigator to interfere with the patient's ability to participate in the study. - Any other condition that, in the judgment of the investigator, would make the patient unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The 2-year overall survival rate (2-year OS) will be estimated as a secondary endpoint. Overall survival is defined as the time from the date of enrollment to death from any cause. Patients who are lost to follow-up will be censored at the date of last confirmed survival. Overall survival will be analyzed in the full analysis set. Annual survival rates will be estimated using the Kaplan-Meier method. The 95% confidence interval (CI) for the median overall survival will be calculated using the method of Brookmeyer and Crowley, while the 95% CI for annual survival rates will be derived using Greenwood s formula. | — |
Countries
Japan
Contacts
Public ContactYu Yagi
Medical Oncology. Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital Medical Oncology
Outcome results
None listed