UMIN-CTR Clinical Trial

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

malignant lymphoma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES

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

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.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Department of Advanced Cell and Molecular Therapy
Kyushu University Hospital

Institute

Department

Personal name

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

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)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

11

Month

26

Day

URL releasing protocol

Publication of results

Partially published

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

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 related information

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

Registered date

2015

Year

11

Month

26

Day

Last modified on

2017

Year

09

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022927