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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031940
Receipt No. R000036479
Scientific Title Phase 2 trial of autologous hematopoietic stem cell transplantation for severe systemic sclerosis
Date of disclosure of the study information 2018/03/28
Last modified on 2018/03/28

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Basic information
Public title Phase 2 trial of autologous hematopoietic stem cell transplantation for severe systemic sclerosis
Acronym Autologous hematopoietic stem cell transplantation for severe systemic sclerosis
Scientific Title Phase 2 trial of autologous hematopoietic stem cell transplantation for severe systemic sclerosis
Scientific Title:Acronym Autologous hematopoietic stem cell transplantation for severe systemic sclerosis
Region
Japan

Condition
Condition Systemic sclerosis
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 systemic sclerosis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Event-free survival at 2 years after transplantation
Key secondary outcomes Event-free survival at 1, 3 and 5 years after transplantation
Improvement of modified Rodnan total skin thickness score at 1, 3 and 5 years after transplantation
Improvement of %VC at 1, 3 and 5 years after transplantation
Safety, Progression-free survival, 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 systemic sclerosis with performance status (ECOG) 0 to 2.
a) Within 4 years after onset and modified Rodnan total skin thickness score (mRSS) is 15 or more, and applicable to one of the following organ complication
1) Pulmonary complications: interstitial pneumonia diagnosed by chest X-ray examination or chest CT, and %FVC or %DLCO is less than 80%.
2) Renal complications: systolic blood pressure is 160 mmHg or more or diastolic blood pressure is 110 mmHg or more, urinalysis abnormality (urine protein, urine occult blood, urinary sediment), microangiopathic hemolytic anemia, or elevated serum creatinine
3) cardiac complications: reversible heart failure, or arrhythmia (supraventricular, ventricular, AV block), or pericardial effusion
b) 1) Involvement of sclerosis to the trunk within 2 years after onset, mRSS is 20 or more, and
2) ESR is 25 mm/1h or more and/or Hb is 11 g/dL or less.
c) Progressive interstitial pneumonia during the course even though more than 4 years after onset or lower than 15 mRSS.
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 24

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
Email 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
Email mitoma@intmed1.med.kyushu-u.ac.jp

Sponsor
Institute Kyushu University
Institute
Department

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
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 03 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
2010 Year 09 Month 06 Day
Date of IRB
Anticipated trial start date
2010 Year 09 Month 07 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 28 Day
Last modified on
2018 Year 03 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036479

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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