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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012283
Receipt No. R000014364
Scientific Title Clinical and immunological analysis on the effect of LEM in the adoptive immunotherapy using autologous activated lymphocytes in patients with incurable cancer
Date of disclosure of the study information 2013/12/01
Last modified on 2018/01/25

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Basic information
Public title Clinical and immunological analysis on the effect of LEM in the adoptive immunotherapy using autologous activated lymphocytes in patients with incurable cancer
Acronym LEM on AIT for Cancer
Scientific Title Clinical and immunological analysis on the effect of LEM in the adoptive immunotherapy using autologous activated lymphocytes in patients with incurable cancer
Scientific Title:Acronym LEM on AIT for Cancer
Region
Japan

Condition
Condition Incurable cancer
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Clinical and immunological analysis on the effect of LEM in the adoptive immunotherapy using autologous activated lymphocytes in patients with incurable cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Immunological activity
Key secondary outcomes QOL, safety

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
Food
Interventions/Control_1 LEM 1800mg/day, twice a day, orally, 4weeks
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) Histologically-defined panreatic cancer
2) Measurable lesion
3) on-going AIT
4) Age 20-80
5) PS 0-2
6) Estimated prognosis >= 3 months
7) Sufficient organ function
WBC>4,000/mm3, <12,000/mm3
NE>2,000/mm3
PLT>100.000/mm3
Hg>10.0g/dl
GOT/GPT<Normal range x 2
Bil<1.5mg/dl
Creat<1.5mg/dl
8) Written informed consent
9) No pregnancy
Key exclusion criteria 1) Autoimmune disease
2) Uncontrollable complications including
infection, diabetes, hypertension, ischemic heart disease, cerebral infarction, interstitial pneumonitis, cancer pain
3) Pregnancy
4) Allergy
5) General symptoms including dyspnea, jaundice, edema, effusions, clamp, paralysis, fracture, difficult for out-patient
6) Steroid or immunosuppressive agents
7) Other unacceptable reasons
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiyuki YAMAGUCHI
Organization Kawasaki Medical School
Division name Department of Clinical Oncology
Zip code
Address Matsushima 577, Kurashiki, Okayama 701-0192, Japan
TEL 086-462-1111
Email shogo@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiyuki YAMAGUCHI
Organization Kawasaki Medical School
Division name Department of Clinical Oncology
Zip code
Address Matsushima 577, Kurashiki, Okayama 701-0192, Japan
TEL 086-462-1111
Homepage URL
Email shogo@med.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki Medical School
Institute
Department

Funding Source
Organization Kawasaki Medical School
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

Other administrative information
Date of disclosure of the study information
2013 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Completed
Date of protocol fixation
2013 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 01 Day
Last follow-up date
2017 Year 08 Month 17 Day
Date of closure to data entry
2017 Year 09 Month 14 Day
Date trial data considered complete
2017 Year 10 Month 30 Day
Date analysis concluded
2018 Year 01 Month 15 Day

Other
Other related information

Management information
Registered date
2013 Year 11 Month 13 Day
Last modified on
2018 Year 01 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014364

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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