UMIN-CTR Clinical Trial

Public title

Clinical study of the efficacy of cell-based immunotherapy for malignant tumors (Observational study)

Acronym

Observational study of the efficacy of cell-based cancer immunotherapy.

Scientific Title

Clinical study of the efficacy of cell-based immunotherapy for malignant tumors (Observational study)

Scientific Title:Acronym

Observational study of the efficacy of cell-based cancer immunotherapy.

Region

Japan

Condition

All classes of malignant tumors, for which cell-based immunotherapy was performed in the Center for Advanced Medical Innovation, Kyushu University.

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Efficacy of cell-based immunotherapy for malignant tumors

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

Overall survival period (OS) for each class of malignant tumors

Key secondary outcomes

Progression-free survival period (PFS),
Disease-free survival period (DFS), response rate, efficience rate, disease control rate, side effetcs etc for each class of malignant tumors

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

Patients with malignant tumors, for whom cell-based immunotherapy has been performed in our center, and who would agree with entering into this observational study.

Key exclusion criteria

Patients to be excluded would satisfy any of the following conditions:
(1) patients for whom the standard therapies have not been finished.
(2) age under 20 years old
(3) T cell- or NK cell-originated leukemia/lymphoma
(4) serum positive for HTLV-1 and/or HIV antibody for lymphokine-activated killer cell therapy, or serum positive for HIV antibody for dendritic cell-based vaccine therapy
(5) patients of whom prognosis to be estimated at less than three months.
(6) Inward patients
(7) Patients to be or wishing for pregnancy, or breast-feeding
(8) Patients who are regarded as inadequate for study enrollment by the investigator

Target sample size

50

Name of lead principal investigator

1st name
Middle name
Last name	Koichi Akashi

Organization

Department of Medicine and Biosystemic Science, Graduate School of Medical Sciences, Kyushu University and Project Division, Center for Advanced Medical Innovation, Kyushu University

Division name

Professor, Dupty Director

Zip code

Address

3-1-1, Maidashi, Higashi-ku, Fukuoka city, Fukuoka prefecture, Japan

TEL

092-642-5228

Email

akashi@med.kyushu-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Shigeo Takaishi

Organization

Center for Advanced Medical Innovation, Kyushu University

Division name

Division of Advanced Cell Therapy

Zip code

Address

3-1-1, Maidashi, Higashi-ku, Fukuoka city, Fukuoka prefecture, Japan

TEL

092-642-4538

Homepage URL

Email

takaishi@kuhp.kyoto-u.ac.jp

Institute

Center for Advanced Medical Innovation, Kyushu University

Institute

Department

Personal name

Organization

Center for Advanced Medical Innovation, Kyushu University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Co-sponsor

MEDINET Co,. Ltd.

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

YES

Study ID_1

11-E02

Org. issuing International ID_1

Clinical Research Network Fukuoka

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

九州大学先端医療イノベーションセンター（福岡県）、
Center for Advanced Medical Innovation, Kyushu University(Fukuoka pref.)

Date of disclosure of the study information

2015

Year

10

Month

16

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

The subject entry has been closed at November 5th 2012. Total 44 subjects were registered, and five subjects among them were confirmed to be alive at September 24th 2015.

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

Completed

Date of protocol fixation

2011

Year

09

Month

09

Day

Date of IRB

Anticipated trial start date

2011

Year

09

Month

09

Day

Last follow-up date

2016

Year

03

Month

31

Day

Date of closure to data entry

2016

Year

03

Month

31

Day

Date trial data considered complete

2016

Year

03

Month

31

Day

Date analysis concluded

2017

Year

03

Month

31

Day

Other related information

Study design: Observational cohort study.
Subject recruitment method: Among all patients being treated in our center during 2011/10/01 - 2012/11/11, those who satisfied with the selection criteria for this study.
Items to be recorded: Clinical information (age, sexuality, the class of malignant tumors, treatment method, etc) & Examination results (blood test, medical body imaging, immunological data, etc)

Registered date

2015

Year

10

Month

15

Day

Last modified on

2017

Year

06

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022391