UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012283
Receipt number 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 15:50:25

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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 or person

Institute

Kawasaki Medical School

Institute

Department

Personal name



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

Value
https://center6.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