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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032426
Receipt No. R000036977
Scientific Title Phase II study of narrow band ultraviolet therapy for treatment-refractory skin graft versus host disease complicated with allogeneic hematopoietic stem cell transplantation
Date of disclosure of the study information 2018/09/01
Last modified on 2019/05/02

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Basic information
Public title Phase II study of narrow band ultraviolet therapy for treatment-refractory skin graft versus host disease complicated with allogeneic hematopoietic stem cell transplantation
Acronym Phase II study of NBUV for skin GVHD
Scientific Title Phase II study of narrow band ultraviolet therapy for treatment-refractory skin graft versus host disease complicated with allogeneic hematopoietic stem cell transplantation
Scientific Title:Acronym Phase II study of NBUV for skin GVHD
Region
Japan

Condition
Condition skin GVHD
Classification by specialty
Hematology and clinical oncology Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigation of the effect and safety of the narrow band ultraviolet B (NBUVB) for treatment-resistant acute and/or chronic GVHD
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Overall response rate
Key secondary outcomes 1. Rates for complete response, partial response, stable disease, and progressive disease
2. Duration of response
3. Sparing effect on calcineurin inhibitor and corticosteroid
4. Adverse event(s)
5. Profile of immune cells

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Narrow band ultraviolet B 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
16 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria 1. Patient who receives treatment between April 1st 2018 and March 31st 2023
2. post-allogeneic hematopoietic stem cell transplantation patient with acute or chronic skin GVHD which is refractory to calcineurin inhibitor and/or corticosteroid treatment (not excluding patient who has GVHD in other tissues in addition to skin)
3. Patient who is able to have written informed consent for the study enrollment
4. Age between 16 to 70 at the informed consent
5. No restriction for gender
6. Performance status 0-2 defined by Eastern Cooperative Oncology Group criteria
Key exclusion criteria 1. Pregnant female patient
2. Poor control diabetes mellitus
3. Any severe infection
4. Treatment-difficult skin disease other than GVHD
5. Patients whom an attending physician consider not appropriate for study enrollment
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name JUNYA KURODA
Organization Kyoto Prefectural University of Medicine
Division name Division of Hematology and Oncology
Zip code
Address 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, JAPAN
TEL 0752515740
Email junkuro@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name JUNYA KURODA
Organization Kyoto Prefectural University of Medicine
Division name Division of Hematology and Oncology
Zip code
Address 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, JAPAN
TEL 0752515740
Homepage URL
Email junkuro@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization JAPAN

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

Other administrative information
Date of disclosure of the study information
2018 Year 09 Month 01 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 Open public recruiting
Date of protocol fixation
2018 Year 04 Month 30 Day
Date of IRB
2018 Year 09 Month 18 Day
Anticipated trial start date
2018 Year 12 Month 18 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 04 Month 30 Day
Last modified on
2019 Year 05 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036977

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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