UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006128 |
|---|---|
| Receipt number | R000007250 |
| Scientific Title | Adoptive immunotherapy using zoledronate-expanded autologous gamma/delta T cells for patients with non-small cell lung cancer refractory to standard treatment. |
| Date of disclosure of the study information | 2011/08/08 |
| Last modified on | 2019/08/14 13:00:50 |
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Basic information
Public title
Adoptive immunotherapy using zoledronate-expanded autologous gamma/delta T cells for patients with non-small cell lung cancer refractory to standard treatment.
Acronym
Zoledronate-expanded autologous gamma/delta T cell therapy for NSCLC
Scientific Title
Adoptive immunotherapy using zoledronate-expanded autologous gamma/delta T cells for patients with non-small cell lung cancer refractory to standard treatment.
Scientific Title:Acronym
Zoledronate-expanded autologous gamma/delta T cell therapy for NSCLC
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate efficacy and safety of autologous gamma/delta T cell transfer therapy for patients with non-small cell lung cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Progression-free survival
Key secondary outcomes
Safety
Efficacy:
- Antitumor effect;
- Overall survival;
- Improvement of tumor-related markers;
- QOL score.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Autologous gamma/delta T cells are injected on day0, day14, day28, day42, day56, day70.
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
Non-small cell lung cancer patients who meet the following criteria:
- Refractory to standard treatment;
- Life-expectancy more than 6 months;
- 20 years or more;
- Performance status 0-1;
- No serious abnormality in bone marrow, liver and/or renal functions.
Key exclusion criteria
Patients who have:
- Uncontrolled infections;
- Active autoimmune diseases;
- Serious cardiac disease;
- Other cancers;
- Received continuous systemic steroids;
- Pregnant, to be pregnant, or nursing mothers;
- Principle investigator or co-investigator judged to be inappropriate to participate in this study.
Target sample size
85
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jun Nakajima |
Organization
The University of Tokyo Hospital
Division name
Department of Cardiothoracic surgery
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL
03-3815-5411
immunotherapy-admin@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Kakimi |
Organization
The University of Tokyo Hospital
Division name
Department of Immunotherapeutics
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL
03-5805-3163
Homepage URL
immunotherapy-admin@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
Address
Tel
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
東京大学医学部附属病院（東京都）、慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 08 | Month | 08 | 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
| 2011 | Year | 07 | Month | 28 | Day |
Date of IRB
| 2011 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 08 | Month | 08 | Day |
Last modified on
| 2019 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007250
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
