UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032426 |
|---|---|
| Receipt number | 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 | 2023/11/03 12:54:20 |
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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 | JUNYA |
| Middle name | |
| Last name | KURODA |
Organization
Kyoto Prefectural University of Medicine
Division name
Division of Hematology and Oncology
Zip code
602-8566
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, JAPAN
TEL
0752515740
junkuro@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | JUNYA |
| Middle name | |
| Last name | KURODA |
Organization
Kyoto Prefectural University of Medicine
Division name
Division of Hematology and Oncology
Zip code
602-8566
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, JAPAN
TEL
0752515740
Homepage URL
junkuro@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
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
Kyoto Prefectural University of Medicine, Clinical Research Review Board
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, JAPAN
Tel
075-251-5337
rinri@koto.kpu-m.ac.jp
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
Enrolling by invitation
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
| 2027 | 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
| 2023 | Year | 11 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036977
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