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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04354402
Recruitment Status : Completed
First Posted : April 21, 2020
Last Update Posted : April 18, 2023
Sponsor:
Information provided by (Responsible Party):
SymBio Pharmaceuticals

Study Description
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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


Condition or disease Intervention/treatment
Diffuse Large B Cell Lymphoma Other: No intervention

Study Design
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Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Retrospective
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)
Actual Study Start Date : March 26, 2020
Actual Primary Completion Date : November 11, 2020
Actual Study Completion Date : November 11, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Groups and Cohorts
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Intervention Details:
  • Other: No intervention
    No intervention

Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: 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 Outcome Measures :
  1. Progression-free Survival (PFS) [ Time Frame: 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.

  2. Duration of Response (DOR) [ Time Frame: 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04354402


Locations
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Japan
Research Site
Nagoya, Aichi, Japan
Research Site
Matsuyama, Ehime, Japan
Research Site
Ota, Gunma, Japan
Research Site
Fukuyama, Hiroshima, Japan
Research Site
Sapporo, Hokkaido, Japan
Research Site
Osakasayama, 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
Sponsors and Collaborators
SymBio Pharmaceuticals
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: SymBio Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04354402    
Other Study ID Numbers: 2019001
First Posted: April 21, 2020    Key Record Dates
Last Update Posted: April 18, 2023
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by SymBio Pharmaceuticals:
Diffuse Large B Cell Lymphoma
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin