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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000019939
Receipt No. R000022927
Scientific Title Antitumor immune responses induced by anthracyclin in malignant lymphoma
Date of disclosure of the study information 2015/11/26
Last modified on 2017/09/07

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Basic information
Public title Antitumor immune responses induced by anthracyclin in malignant lymphoma
Acronym Antitumor immune responses in malignant lymphoma
Scientific Title Antitumor immune responses induced by anthracyclin in malignant lymphoma
Scientific Title:Acronym Antitumor immune responses in malignant lymphoma
Region
Japan

Condition
Condition malignant lymphoma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To examine whether anthracyclin agents or other anticancer drugs augments antitumor immune responses of tumor-infiltrating CD8+ T lymphocytes (TILs) derived from malignant lymphoma patients.
Basic objectives2 Others
Basic objectives -Others # To examine TCR clonality of above CD8+ TILs and whether genetically modified T cells to express engineered TCR from above CD8+TILs show antitumor effects.
# To identify tumor-specific antigens which are targeted by above TCR using exome sequencing analysis data for genome DNA in lymphoma cells
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes The absolute number and ratio of IFNg-producing CD8+ TILs after treatment by anthracyclin agents or other anticancer drugs.
Key secondary outcomes The ratio and absolute number of CD8+ TILs expressing PD-1 or CD137, the ratio and count of Treg to CD4+T cells.
Clinical findings (age, sex, prognosis), Blood count and biochemistry analysis.
TCR clonality of above CD8+ TILs and antitumor effects of genetically modified T cells to express engineered TCR.
Tumor-specific antigens obtained by exome sequencing analysis data.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 1) Adult patients who receive lymphoma tissue biopsy as daily medical practice
2) Patients who understand well and can agree with this study plan by himself
Key exclusion criteria 1) Patients diagnosed as double cancer
2) Patients whom researchers judged inappropriate as a subject
Target sample size 10

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Yasushi Takamatsu
Organization School of Medicine, Fukuoka University
Division name Division of Medical Oncology, Hematology and Infectious Diseases
Zip code
Address 7-45-1 Nanakuma, Jonan-ku, Fukuoka 814-0180, JAPAN
TEL 092-801-1011
Email yasushi@fukuoka-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Mutsunori Murahashi
Organization Kyushu University Hospital
Division name Department of Advanced Cell and Molecular Therapy
Zip code
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka-shi, Fukuoka 812-8582
TEL 092-642-5996
Homepage URL
Email murahashi.mutsunori.791@m.kyushu-u.ac.jp

Sponsor
Institute Department of Advanced Cell and Molecular Therapy
Kyushu University Hospital
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Laboratory of DNA Information Analysis, Human Genome Center, The Institute of Medical Science, The University of Tokyo
Project Division of ALA Advanced Medical Research, The Institute of Medical Science, The University of Tokyo
Department of Immunology, Graduate School of Medicine and Pharmaceutical Sciences, University of Toyama
Department of Cancer Therapy and Research, Graduate School of Medical Sciences, Kyushu University
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
2015 Year 11 Month 26 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 Enrolling by invitation
Date of protocol fixation
2014 Year 11 Month 26 Day
Date of IRB
Anticipated trial start date
2015 Year 01 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The results were partially reported in annual meeting of Japanese Society of Medical Oncology, July 18, 2015.

Management information
Registered date
2015 Year 11 Month 26 Day
Last modified on
2017 Year 09 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022927

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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