UMIN-CTR Clinical Trial

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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