跳至主要内容
临床试验/NCT04354402
NCT04354402已完成不适用

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)

SymBio Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2020年3月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
1
主要终点
Overall Survival (OS)

研究概览

简要总结

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:

  3. 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

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Subjects whose death was confirmed during the outcome investigation period in Study 2017002

结局指标

主要结局

Overall Survival (OS)

时间窗: 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.

次要结局

  • Progression-free Survival (PFS)(Up to 8 months)
  • Duration of Response (DOR)(Up to 8 months)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

终止
2 期
Three-year Follow-up of Participants After Administration of Boceprevir or Narlaprevir for the Treatment of Chronic Hepatitis C (P05063)Hepatitis C, ChronicHepacivirus
NCT00689390Merck Sharp & Dohme LLC1,954
已完成
2 期
BAY-43-9006 in Advanced, Metastatic Soft Tissue SarcomasSarcoma, Soft Tissue
NCT00406601Istituto Clinico Humanitas69
进行中(未招募)
不适用
A phase III long-term follow-up study to assess the immune responses following vaccination at 36-46 months of age with a booster dose of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine (10Pn-PD-DiT) and to evaluate the immunogenicity and safety of a 2-dose catch-up immunization course with the 10Pn-PD-DiT vaccine in the fourth year of life. - 10PN-PD-DIT-046 EXT:002 Y2A booster vaccination study against Streptococcus pneumoniae in subjects aged 36-46 months and a two-dose vaccination against Streptococcus pneumoniae of age-matched unprimed children.
EUCTR2008-003950-14-SEGlaxoSmithKline Biologicals210
进行中(未招募)
1 期
A phase III long-term follow-up study to assess the immune responses following vaccination at 36-46 months of age with a booster dose of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine (10Pn-PD-DiT) and to evaluate the immunogenicity and safety of a 2-dose catch-up immunization course with the 10Pn-PD-DiT vaccine in the fourth year of life. - 10PN-PD-DIT-046 EXT:002 Y2A booster vaccination study against Streptococcus pneumoniae in subjects aged 36-46 months and a two-dose vaccination against Streptococcus pneumoniae of age-matched unprimed children.
EUCTR2008-003950-14-SKGlaxoSmithKline Biologicals210
已完成
3 期
Combined Study - Phase 3b MenB Long Term Persistence in AdolescentsInfections, Meningococcal
NCT02446743GlaxoSmithKline531