UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014634
Receipt number R000016971
Scientific Title Clinical Study of TC-V in Patients with Chronic GVHD
Date of disclosure of the study information 2014/07/28
Last modified on 2016/11/18 13:00:10

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Basic information

Public title

Clinical Study of TC-V in Patients with Chronic GVHD

Acronym

Clinical Study of TC-V in Patients with Chronic GVHD

Scientific Title

Clinical Study of TC-V in Patients with Chronic GVHD

Scientific Title:Acronym

Clinical Study of TC-V in Patients with Chronic GVHD

Region

Japan


Condition

Condition

Chronic GVHD after hematopoietic stem cell transplantation

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate efficacy and safety of conducting ECP therapy using TC-V in patients with chronic GVHD

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To evaluate based on the changes the organ score and the changes in steroid level at prior to ECP therapy and that at Week 24 of ECP therapy.

Key secondary outcomes



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

Device,equipment

Interventions/Control_1

ECP therapy

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patients who were diagnosed with chronic GVHD according to GVHD guideline after the transplantation of hematopoietic stem cell derived from related donor or unrelated donor.
2. Patients who are judged to be steroid-resistant, steroid-dependent, or steroid-intolerant.
3. Patients who received an explanation for clinical study and submitted a written informed consent.

Key exclusion criteria

1. Patients who are allergic or hypersensitive to methoxsalen.
2. Patients who cannot tolerate the changes in blood flow associated with ECP therapy.
3. Patients who are hypersensitive or allergic to both heparin and Acid Citrate Dextrose Solution (ACD) (Patients who are hypersensitive or allergic only one of them are not excluded).
4. Patients who are pregnant, patients who have possibility of being pregnant, or patients who are breastfeeding.
5. Patients who cannot use appropriate contraceptive method throughout the study period.
6. Patients who are infected with human immunodeficiency virus (HIV) or active hepatitis B.
7. Patients with diseases associated with aphakia or photosensitivity (such as systemic lupus erythematosus, porphyria, and albinism) (Non-sighted patients with aphakia are not excluded).
8. Patients who are enrolled in other clinical studies not including a treatment outcome study.
9. Patients with previous experience with ECP therapy.
10. Patients with infectious disease which requires treatment.
11. Patients in whom the blood vessel access is difficult.
12. Patients whose kidney function was worsened within past three months (showing serum creatinine concentration of over 3.0 mg/dL).
13. Patients with life expectancy of less than 6 months.
14. Patients in whom the white blood cell count and platelet count are significantly decreased (white blood cell count of less than 1000/micro L and platelet count of less than 25000/micro L).
15. Patients with Karnofsky Performance Scale of less than 30.
16. Patients with active bleeding in gastrointestinal tract (GI bleeding).
17. Patients who received new drug or increased dose of drug within 14 days for the therapy to treat GVHD.
18. Patients in whom the control of primary disease is difficult.
19. Other patients who are judged by physician as being unsuitable.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Okamoto, Shinichiro

Organization

Keio University Hospital

Division name

Hematology

Zip code


Address

35 Shinano-machi, Shinjuku-ku, Tokyo

TEL

03-3353-1211

Email

okamoto@a7.keio.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kohama, Ichiro

Organization

Vorpal Technologies K.K.

Division name

Regulatory Research Development & Quality Managemant

Zip code


Address

4-15-1 Akasaka, Minato-ku, Tokyo

TEL

03-5544-8340

Homepage URL


Email

kohama@vorpaltechnologies.com


Sponsor or person

Institute

Vorpal Technologies K.K.

Institute

Department

Personal name



Funding Source

Organization

Vorpal Technologies K.K.

Organization

Division

Category of Funding Organization

Profit organization

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

慶應義塾大学病院(東京都)/ Keio University Hospital (Tokyo)
名古屋第一赤十字病院(名古屋)/ Japanese Red Cross Nagoya Daiichi Hospital (Nagoya)
北海道大学病院(北海道)/ Hokkaido University Hospital (Hokkaido)


Other administrative information

Date of disclosure of the study information

2014 Year 07 Month 28 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

Completed

Date of protocol fixation

2013 Year 04 Month 07 Day

Date of IRB


Anticipated trial start date

2014 Year 07 Month 28 Day

Last follow-up date

2016 Year 06 Month 15 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 07 Month 24 Day

Last modified on

2016 Year 11 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016971


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name