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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN C000000349
Receipt No. R000000447
Scientific Title Induction of tumor-specific CTL after mini-transplantation for advanced pancreatic cancer
Date of disclosure of the study information 2006/03/10
Last modified on 2007/09/13

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Basic information
Public title Induction of tumor-specific CTL after mini-transplantation for advanced pancreatic cancer
Acronym Allogeneic immunotherapy against pancreatic cancer
Scientific Title Induction of tumor-specific CTL after mini-transplantation for advanced pancreatic cancer
Scientific Title:Acronym Allogeneic immunotherapy against pancreatic cancer
Region
Japan

Condition
Condition pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic medicine Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To enhance tumor-specific immune reaction by peptide vaccination following mini-transplantation for pancreatic cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Adverse events associated with peptide vaccination
Key secondary outcomes Induction of CTL
Tumor response

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Vaccine
Interventions/Control_1 Peptide vaccination after mini-transplantation.
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
65 years-old >
Gender Male and Female
Key inclusion criteria Pancreatic cancer not amenable to curative resection.
Patients must have an HLA-matched or one-locus-mismatched related donor.
HLA-A2402 positive.
Serum CEA above upper normal limit.
Key exclusion criteria ECOG PS 2-4
Target sample size 9

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshinobu Kanda
Organization University of Tokyo Hospital
Division name Department of Hematology & Oncology
Zip code
Address 7-3-1 Hongo, Bunkyo, Tokyo, Japan
TEL 03-3815-5411
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoshinobu Kanda
Organization University of Tokyo Hospital
Division name Department of Hematology & Oncology
Zip code
Address 7-3-1 Hongo, Bunkyo, Tokyo, Japan
TEL 03-3815-5411
Homepage URL http://www.h.u-tokyo.ac.jp/mukin/index.htm
Email ycanda-tky@umin.ac.jp

Sponsor
Institute Department of Hematology & Oncology
University of Tokyo Hospital
Institute
Department

Funding Source
Organization Ministry of Health, Labor and Welfare of Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Department of Gastroenterology
University of Tokyo Hospital
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
2006 Year 03 Month 10 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
2004 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2004 Year 04 Month 01 Day
Last follow-up date
2007 Year 03 Month 01 Day
Date of closure to data entry
2007 Year 03 Month 01 Day
Date trial data considered complete
2007 Year 12 Month 01 Day
Date analysis concluded
2007 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 03 Month 06 Day
Last modified on
2007 Year 09 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000447

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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