UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032147 |
|---|---|
| Receipt number | R000036671 |
| Scientific Title | A clinical study on the safety of immune-cell therapy combined with standard therapy for high-grade glioma |
| Date of disclosure of the study information | 2018/04/09 |
| Last modified on | 2020/03/28 11:51:57 |
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Basic information
Public title
A clinical study on the safety of immune-cell therapy combined with standard therapy for high-grade glioma
Acronym
A clinical study on the safety of immune-cell therapy combined with standard therapy for high-grade glioma
Scientific Title
A clinical study on the safety of immune-cell therapy combined with standard therapy for high-grade glioma
Scientific Title:Acronym
A clinical study on the safety of immune-cell therapy combined with standard therapy for high-grade glioma
Region
| Japan |
Condition
Condition
glioma
Classification by specialty
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purposes of this study is to evaluate the efficacy of combination with immune-cell therapy (alpha betaT-cell therapy) and maintenance chemotherapy (Temozolomide) for patients with IDH-unmutated high-grade glioma that is amenable to surgery, radiotherapy, and Temozolomide, and the safety and immunological responses.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Efficacy
Key secondary outcomes
The quality of life for patients
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
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
alpha beta T cell therapy
Temozolomide
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Diagnosed with IDH-unmutated high-grade glioma
2) Receive Temozolomide maintenance therapy after standard therapy including surgery, radiotherapy, and chemotherapy with Temozolomide
3) Be at score 70 or over of Karnofsky Performance Status (KPS)
4) Be expected to survive for 2months or longer after initiation of the study therapy
5) Be at age 20 or older
6) Visit outpatient department
7) Have an adequate function of liver, kidney, and bone marrow when eligibility is confirmed
8) Provide written consent to participate this study
Key exclusion criteria
1) Be apparent from the clinical manifestation of pulmonary fibrosis or interstitial pneumonia
2) Have a history of a serious drug allergy
3) Have a positive result of HIV or HTLV-1 antibody test
4) Have a serious cardiac disorder
5) Have an active autoimmune disorder
6) Have a cancer other than glioma
7) Have an infectious disorder that is difficult to control
8) Be a female who is pregnant
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Akihide |
| Middle name | |
| Last name | Kondo |
Organization
Juntendo University Hospital
Division name
Neurosurgery
Zip code
113-8431
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo, 113-8431, Japan
TEL
03-3813-3111
knd-aki@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Akihide |
| Middle name | |
| Last name | Kondo |
Organization
Juntendo University Hospital
Division name
Neurosurgery
Zip code
113-8431
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo, 113-8431, Japan
TEL
03-3813-3111
Homepage URL
knd-aki@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board of Juntendo University Faculty of Medicine
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo
Tel
03-3813-3176
rinri@juntendo.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
jRCTc030190246
Org. issuing International ID_1
jRCT (Japan Registry Clinical Trials)
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
順天堂大学医学部付属順天堂医院（東京都）
Juntendo University Hospital (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 09 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 03 | Month | 14 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 12 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 09 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Transition to jRCT (Japan Registry Clinical Trials).
Management information
Registered date
| 2018 | Year | 04 | Month | 07 | Day |
Last modified on
| 2020 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036671
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