Diffuse Large B Cell Lymphoma
Conditions
Keywords
Diffuse Large B Cell Lymphoma
Brief summary
This study is a follow-up study to update the survival time data (overall survival, progression-free survival, and duration of response) of the subjects who received SyB L-0501 at least once in Phase III Study of SyB L-0501 in combination with rituximab to treat recurrent/relapsed diffuse large B-cell lymphoma study (2017002) by reviewing their follow-up information following the study completion of Study 2017002. In this study, the follow-up information gathered until the end of the investigation period is reviewed after obtaining informed consent from the subjects or their legal representatives. Accordingly, no intervention, such as administration of the investigational product or examination, will be performed. Investigative methods 1. The investigator or subinvestigator gives an explanation to a subject or his/her legal representative to obtain written informed consent to provision of information pertaining to this study. 2. After obtaining informed consent, the investigator or subinvestigator reviews the follow-up information following the completion of Study 2017002 in source documents regarding the following items: 1\. Survival status 2. Aggravation (progression or recurrence) 3. Drugs or procedures used for treatment of DLBCL or prophylaxis against its progression or recurrence 4. Occurrence of other malignant tumors
Interventions
OTHERNo intervention
No intervention
Sponsors
SymBio Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects who received the investigational product at least once in Study 2017002 2. Subjects who or whose legal representatives gave written informed consent to provision of data pertaining to this study
Exclusion criteria
1\. Subjects whose death was confirmed during the outcome investigation period in Study 2017002
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Up to 8 months | The length of time from the date of case registration in Study 2017002 to the date of death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (PFS) | Up to 8 months | The length of time from the date of treatment initiation (Day 1) in the first cycle in Study 2017002 to the date of progression (including recurrence/relapse), death from any cause, or censoring. |
| Duration of Response (DOR) | Up to 8 months | The length of time from the date when complete response (CR) or partial response (PR) was achieved in Study 2017002 to the date of progression (including recurrence/relapse), death from any cause, or censoring. |
Countries
Japan
Outcome results
None listed