Follow-up Study of SyB L-0501 in Combination With Rituximab to Treat DLBCL

Diffuse Large B Cell Lymphoma Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04354402
• Other study ID #: 2019001
• Status: Completed
• Start date: March 26, 2020
• Est. completion date: November 11, 2020

Study information

• Verified date: June 2022
• Source: SymBio Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: November 11, 2020
• Est. primary completion date: November 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diffuse Large B Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Japan	Research Site	Akita
Japan	Research Site	Chuo-ku	Tokyo
Japan	Research Site	Fukuoka
Japan	Research Site	Fukuyama	Hiroshima
Japan	Research Site	Ibaraki
Japan	Research Site	Izumo	Shimane
Japan	Research Site	Koto	Tokyo
Japan	Research Site	Kyoto
Japan	Research Site	Matsuyama	Ehime
Japan	Research Site	Nagasaki
Japan	Research Site	Nagoya	Aichi
Japan	Research Site	Osaka
Japan	Research Site	Osakasayama	Osaka
Japan	Research Site	Ota	Gunma
Japan	Research Site	Sapporo	Hokkaido
Japan	Research Site	Shinagawa-ku	Tokyo
Japan	Research Site	Yamagata

Sponsors (1)

Lead Sponsor	Collaborator
SymBio Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Progression-free Survival (PFS)	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.	Up to 8 months
Secondary	Duration of Response (DOR)	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.	Up to 8 months