UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031931 |
|---|---|
| Receipt number | R000036413 |
| Scientific Title | Phase 2 trial of autologous hematopoietic stem cell transplantation for severe dermatomyositis |
| Date of disclosure of the study information | 2018/03/27 |
| Last modified on | 2018/03/27 21:46:11 |
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Basic information
Public title
Phase 2 trial of autologous hematopoietic stem cell transplantation for severe dermatomyositis
Acronym
Autologous hematopoietic stem cell transplantation for severe dermatomyositis
Scientific Title
Phase 2 trial of autologous hematopoietic stem cell transplantation for severe dermatomyositis
Scientific Title:Acronym
Autologous hematopoietic stem cell transplantation for severe dermatomyositis
Region
| Japan |
Condition
Condition
Dermatomyositis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analysis of efficacy of autologous hematopoietic stem cell transplantation for severe dermatomyositis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Event-free survival at 1 year after transplantation
Key secondary outcomes
Event-free survival at 1, 3 and 5 years after transplantation
%VC at 1, 3 and 5 years after transplantation
%DLCO at 1, 3 and 5 years after transplantation
Myogenic enzymes at 1, 3 and 5 years after transplantation
Number and size of skin ulcers at 1, 3 and 5 years after transplantation
Safety, overall survival
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Cyclophosphamide 2g/m2, 2 days
Harvest of autologous hematopoietic stem cells
Cyclophosphamide 50mg/kg, 4 days
Transplantation of autologous hematopoietic stem cells
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
A patient diagnosed as dermatomyositis with Performance status (ECOG) 0 to 2,
a) Progressive interstitial pneumonia diagnosed by chest X-ray examination or chest CT, %FVC is less than 80% or %DLCO is less than 70%, resistant to treatment with corticosteroids, cyclosporine, cyclophosphamide.
b) skin ulcer resistant to treatment with corticosteroids, cyclosporine, cyclophosphamide.
Key exclusion criteria
A patient with one of the following severe organ complication,
a) Heart: uncontrollable arrhythmia, uncontrollable heart failure, LVEF is less than 50% in cardiac ultrasound examination, moderate or more pulmonary hypertension (mean pulmonary artery pressure is 40 mmHg or more)
b) Lung: PaO2 is less than 60 mmHg at room air, %VC is less than 50%. %DLCO is less than 20%.
c) Kidney: renal glomerular filtration rate is less than 40 ml/min, serum creatinine is 2 mg/dl or more.
d) Uncontrolled malignant neoplasm
e) Uncontrollable infection.
f) Cyclophosphamide is used more than 10 g in total.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Akashi |
Organization
Kyushu University Hospital
Division name
Department of Hematology, Oncology & Cardiovascular medicine, Department of Clinical Immunology and Rheumatology / Infectious Disease
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
TEL
092-641-1151
akashi@med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroki Mitoma |
Organization
Kyushu University Hospital
Division name
Department of Clinical Immunology and Rheumatology / Infectious Disease
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
TEL
092-641-1151
Homepage URL
mitoma@intmed1.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
九州大学病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 27 | 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
| 2010 | Year | 11 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 27 | Day |
Last modified on
| 2018 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036413
