Polatuzumab vedotin plus R-CHP therapy in patients with previously untreated diffuse large B-cell lymphoma
Not Applicable
Recruiting
- Conditions
- Diffuse large B-cell lymphomDLBCLDLBC
- Registration Number
- JPRN-jRCT1071220082
- Lead Sponsor
- Kato Koji
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 500
Inclusion Criteria
1. Patients with previously untreated diffuse large B-cell lymphoma
2. Patients who are scheduled to undergo polatuzumab vedotin (Pola) plus R-CHP therapy as medical practice based on the latest package insert of Pola
3. Patients who have received a sufficient explanation about the content of this study, have provided voluntary written informed consent from themselves, and are able to comply with the requirements of the study protocol
4. Patients aged 18 years or older at the time of obtaining informed consent
Exclusion Criteria
Patients judged inappropriate for participation in this study by the site-investigator or sub-investigator
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival (OS)
- Secondary Outcome Measures
Name Time Method 1)Progression free survival (PFS)<br>2)Two years progression free survival (PFS24)<br>3)Central nervous system (CNS) recurrence rate<br>4)Time to CNS recurrence<br>5)Best overall response (BOR)<br>6)Complete response rate at the end of treatment (EOT-CRR)<br>7)Overall response rate at the end of treatment (EOT-ORR)<br>8)Duration of response (DOR)<br>9)Safety<br>10)Relationship between patient background/ baseline characteristics and efficacy/safety<br>11)Relationship between geriatric assessment (G8) and efficacy/safety<br>12)Correlation between relative dose intensity and efficacy/safety