UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048958 |
|---|---|
| Receipt number | R000055782 |
| Scientific Title | Real world data of lisocabtagene maraleucel in Japanese patients with relapsed or refractory large B-cell lymphoma |
| Date of disclosure of the study information | 2023/01/01 |
| Last modified on | 2022/09/18 09:51:33 |
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Basic information
Public title
Real world data of lisocabtagene maraleucel in Japanese patients with relapsed or refractory large B-cell lymphoma
Acronym
JSCT CART23
Scientific Title
Real world data of lisocabtagene maraleucel in Japanese patients with relapsed or refractory large B-cell lymphoma
Scientific Title:Acronym
JSCT CART23
Region
| Japan |
Condition
Condition
B-cell lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To observe the efficacy and safety of Lisocabtagene maraleucel treatment (Liso-cel treatment) used in clinical practice in Japan.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival after CAR T cell infusion
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients who underwent Liso-cel treatment
2.Patients undergoing Liso-cel treatment
3. Aged 18 or older at the time of obtaining consent
4. Consent to participate in this study has been obtained from the principal investigator of the patient referral institution
Key exclusion criteria
If the doctor in charge determines that it is inappropriate to participate in this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | koji |
| Middle name | |
| Last name | kato |
Organization
Kyushu University
Division name
Department of Medicine and Biosystemic Science
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi Ward, Fukuoka City
TEL
092-642-5230
jsct-office@umin.ac.jp
Public contact
Name of contact person
| 1st name | toyohiro |
| Middle name | |
| Last name | kawano |
Organization
JSCT
Division name
office
Zip code
186-0004
Address
1-8-33 Kunitachi Naka
TEL
042-505-4251
Homepage URL
jsct-office@umin.ac.jp
Sponsor or person
Institute
JSCT
Institute
Department
Personal name
Funding Source
Organization
Bristol Myers Squibb
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Observational Research Ethics Review Committee, Department of Medical Sciences, Kyushu University
Address
3-1-1 Maidashi, Higashi Ward, Fukuoka City
Tel
092-642-6254
jsct-office@umin.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2022 | Year | 09 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Lisocabtagene maraleucel therapy (Liso-cel therapy) is a second-generation CAR T therapy that introduces CAR genes for each subset of CD4 and CD8 T cells. At present, there is no report on the actual treatment status of Liso-cel treatment in Japan, so we conducted an observational study to collect data on the safety and efficacy of Liso-cel treatment in Japanese patients, Promptly publish.
Management information
Registered date
| 2022 | Year | 09 | Month | 18 | Day |
Last modified on
| 2022 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055782
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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