Clinical trial NCT04354402: Follow-up Study of SyB L-0501 in Combination With Rituximab to Treat DLBCL
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diffuse Large B Cell Lymphoma
Keywords: Diffuse Large B Cell Lymphoma
Lead sponsor: SymBio Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2020-04-21
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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


Eligibility criteria: 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

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to 8 months
Secondary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: Up to 8 months
measure: Duration of Response (DOR)
timeFrame: Up to 8 months
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Research Site
state: Aichi
city: Matsuyama
country: Japan
facility: Research Site
state: Ehime
city: Ota
country: Japan
facility: Research Site
state: Gunma
city: Fukuyama
country: Japan
facility: Research Site
state: Hiroshima
city: Sapporo
country: Japan
facility: Research Site
state: Hokkaido
city: Osakasayama
country: Japan
facility: Research Site
state: Osaka
city: Izumo
country: Japan
facility: Research Site
state: Shimane
city: Chuo-ku
country: Japan
facility: Research Site
state: Tokyo
city: Koto
country: Japan
facility: Research Site
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Research Site
state: Tokyo
city: Akita
country: Japan
facility: Research Site
city: Fukuoka
country: Japan
facility: Research Site
city: Ibaraki
country: Japan
facility: Research Site
city: Kyoto
country: Japan
facility: Research Site
city: Nagasaki
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Yamagata
country: Japan
facility: Research Site
Study officials:
References:
citation: 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.