UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057306 |
|---|---|
| Receipt number | R000065509 |
| Scientific Title | Prognosis of relapsed cases after CAR-T therapy for relapsed and refractory follicular lymphoma (FL) and functional analysis of CAR-T cells |
| Date of disclosure of the study information | 2025/03/17 |
| Last modified on | 2025/03/17 09:25:04 |
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Basic information
Public title
Prognosis of relapsed cases after CAR-T therapy for relapsed and refractory follicular lymphoma (FL) and functional analysis of CAR-T cells(JSCT CART24 Follow-up)
Acronym
JSCT CART24 Follow-up
Scientific Title
Prognosis of relapsed cases after CAR-T therapy for relapsed and refractory follicular lymphoma (FL) and functional analysis of CAR-T cells
Scientific Title:Acronym
JSCT CART24 Follow-up
Region
| Japan |
Condition
Condition
follicular lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To fundamentally verify the clinical efficacy of tazemetostat versus non-tazemetostat in patients with recurrent follicular lymphoma (FL) after CAR-T therapy, and the changes in CAR-T cell function before and after treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Of the 20 cases of FL that were determined to be recurrent or refractory after undergoing CAR-T therapy, two cases in the tazemetostat group and two cases in the non-tazemetostat group will have peripheral blood samples taken before and after the start of the next treatment (just before the start of the next treatment after determining that the patient is recurrent or refractory, one month after administration, and three to six months after administration) to perform single cell RNA analysis and ATAC-seq.
Key secondary outcomes
1. Exploratory efficacy evaluation
Complete response rate (CR rate)
Overall response rate (ORR)
Duration of response rate (DOR rate)
Progression-free survival rate (PFS rate)
Overall survival rate (OS rate)
2 Safety evaluation
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 with follicular lymphoma (FL) who have undergone CAR-T therapy and are scheduled to receive anticancer drugs as a next treatment due to recurrence or incurable disease.
2. Patients aged 18 years or older at the time of obtaining consent.
3. Patients who have been informed of the contents of this study and have given written consent.
Key exclusion criteria
If the doctor in charge judges you to be inappropriate to participate in this study
Target sample size
20
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
Eisai Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
| 2025 | Year | 03 | Month | 17 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Our previous studies and recent reports have shown that CAR-T (chimeric antigen receptor T-cell) therapy with memory stem T cell (Tscm) phenotype is expected to have a sustained and strong antitumor effect through EZH2 inhibition. In this research project, we will investigate the clinical efficacy of tazemetostat, an EZH2 inhibitor, after CAR-T therapy in patients with relapsed or refractory follicular lymphoma (FL), and the relationship with the functional enhancement of CAR-T cells exposed to tazemetostat from both basic and clinical aspects. As a result, we hope to clarify a new aspect of tazemetostat as an immunotherapeutic drug and link it to the development of a new cell therapy through epigenetic regulation.
Management information
Registered date
| 2025 | Year | 03 | Month | 17 | Day |
Last modified on
| 2025 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065509
