Follow-up Study of SyB L-0501 in Combination With Rituximab to Treat DLBCL
Follow-Up Study of Phase III Study of SyB L-0501 in Combination With Rituximab to Treat Recurrent/Relapsed Diffuse Large B-Cell Lymphoma (Protocol Number: 2017002)
1 other identifier
observational
25
1 country
17
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:
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2020
Shorter than P25 for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 26, 2020
CompletedFirst Submitted
Initial submission to the registry
April 16, 2020
CompletedFirst Posted
Study publicly available on registry
April 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 11, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 11, 2020
CompletedApril 18, 2023
June 1, 2022
8 months
April 16, 2020
April 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS)
The length of time from the date of case registration in Study 2017002 to the date of death from any cause.
Up to 8 months
Secondary Outcomes (2)
Progression-free Survival (PFS)
Up to 8 months
Duration of Response (DOR)
Up to 8 months
Interventions
No intervention
Eligibility Criteria
The study population includes 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) and who (or their legal representatives) give informed consent.
You may qualify if:
- Subjects who received the investigational product at least once in Study 2017002
- Subjects who or whose legal representatives gave written informed consent to provision of data pertaining to this study
You may not qualify if:
- \. Subjects whose death was confirmed during the outcome investigation period in Study 2017002
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Research Site
Nagoya, Aichi-ken, Japan
Research Site
Matsuyama, Ehime, Japan
Research Site
Ōta, Gunma, Japan
Research Site
Fukuyama, Hiroshima, Japan
Research Site
Sapporo, Hokkaido, Japan
Research Site
Sayama, Osaka, Japan
Research Site
Izumo, Shimane, Japan
Research Site
Chuo-ku, Tokyo, Japan
Research Site
Koto, Tokyo, Japan
Research Site
Shinagawa-ku, Tokyo, Japan
Research Site
Akita, Japan
Research Site
Fukuoka, Japan
Research Site
Ibaraki, Japan
Research Site
Kyoto, Japan
Research Site
Nagasaki, Japan
Research Site
Osaka, Japan
Research Site
Yamagata, Japan
Related Publications (1)
Murayama K, Kiguchi T, Izutsu K, Kameoka Y, Hidaka M, Kato H, Rai S, Kuroda J, Ishizawa K, Ichikawa S, Ando K, Ogura M, Fukushima K, Terui Y. Bendamustine plus rituximab in Japanese patients with relapsed or refractory diffuse large B-cell lymphoma. Ann Hematol. 2022 May;101(5):979-989. doi: 10.1007/s00277-022-04801-2. Epub 2022 Mar 4.
PMID: 35244756DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2020
First Posted
April 21, 2020
Study Start
March 26, 2020
Primary Completion
November 11, 2020
Study Completion
November 11, 2020
Last Updated
April 18, 2023
Record last verified: 2022-06