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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032147
Receipt No. 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 2018/09/05

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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
Middle name
Last name Akihide Kondo
Organization Juntendo University Hospital
Division name Neurosurgery
Zip code
Address 3-1-3, Hongo, Bunkyo-ku, Tokyo, 113-8431, Japan
TEL 03-3813-3111
Email knd-aki@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akihide Kondo
Organization Juntendo University Hospital
Division name Neurosurgery
Zip code
Address 3-1-3, Hongo, Bunkyo-ku, Tokyo, 113-8431, Japan
TEL 03-3813-3111
Homepage URL
Email knd-aki@juntendo.ac.jp

Sponsor
Institute Juntendo University Faculty of Medicine
Institute
Department

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
Address
Tel
Email

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 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 Enrolling by invitation
Date of protocol fixation
2018 Year 03 Month 14 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 04 Month 07 Day
Last modified on
2018 Year 09 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036671

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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