UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058492 |
|---|---|
| Receipt number | R000066877 |
| Scientific Title | Treatment efficacy and safety of CAR-T cell therapy evaluated by the assessment of patients' immune cells. |
| Date of disclosure of the study information | 2025/07/16 |
| Last modified on | 2025/07/16 18:24:34 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Assessment of patients' immune cells and efficacy of CAR-T cell therapy.
Acronym
Analyses of patients' samples and CAR-T cell therapy.
Scientific Title
Treatment efficacy and safety of CAR-T cell therapy evaluated by the assessment of patients' immune cells.
Scientific Title:Acronym
Treatment efficacy and safety of CAR-T cell therapy evaluated by the assessment of patients' immune cells.
Region
| Japan |
Condition
Condition
Hematological malignancies
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To elucidate the factors associated with treatment efficacy and safety of CAR-T cell therapy through the anaylses using patients' samples obtained before/after CAR-T cell therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survivals for 3 years after CAR-T cell therapy.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
To adjust the dose and duration of therapeutic drugs for adverse events based on patients' immune cells after CAR-T cell therapy.
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with hematological malignancies treated with CAR-T cell therapy.
Key exclusion criteria
Patients with hematological malignancies who are not treated with CAR-T cell therapy.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Toshiki |
| Middle name | |
| Last name | Ochi |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Hematology, Clinical Immunology and Infectious Diseases
Zip code
791-0295
Address
454, Shitsukawa, Toon, Ehime
TEL
089-960-5296
ochi.toshiki.eg@ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshiki |
| Middle name | |
| Last name | Ochi |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Hematology, Clinical Immunology and Infectious Diseases
Zip code
791-0295
Address
454, Shitsukawa, Toon, Ehime
TEL
089-960-5296
Homepage URL
ochi.toshiki.eg@ehime-u.ac.jp
Sponsor or person
Institute
Ehime University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology (MEXT)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Therapeutic Trial Center, Ehime University Hospital
Address
454, Shitsukawa, Toon, Ehime
Tel
089-960-5914
cttc@m.ehime-u.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 | 07 | Month | 16 | 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
| 2025 | Year | 02 | Month | 25 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 25 | Day |
Last follow-up date
| 2033 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 07 | Month | 16 | Day |
Last modified on
| 2025 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066877
