UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032036 |
|---|---|
| Receipt number | R000036552 |
| Scientific Title | Prospective observational study of cord blood transplantation in NJHSG |
| Date of disclosure of the study information | 2018/05/07 |
| Last modified on | 2019/10/01 09:09:37 |
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Basic information
Public title
Prospective observational study of cord blood transplantation in NJHSG
Acronym
NJHSG-CBT18
Scientific Title
Prospective observational study of cord blood transplantation in NJHSG
Scientific Title:Acronym
NJHSG-CBT18
Region
| Japan |
Condition
Condition
Acute leukemia, Myelodysplastic syndrome, Malignant lymphoma
Classification by specialty
| Hematology and clinical oncology | Blood transfusion |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the clinical course and outcome of standard CBT in NJHSG, focusing on GVHD prophylaxis and its incidence.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The incidence of grade III-IV acute GVHD at 100 days
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Patients who have hematologic malignancies as defined at least one of the following:
a) Acute Leukemia
b) MDS/MPD
c) Lymphoma, CR or chemosensitive PR
2.Age: over 20 years old.
3.Patients who have cord blood with following criteria
a) Disclosed in Cord Blood Banks in Japan
b) HLA, more than 4/6 matched
c) NCC, more than 2.0X107/kg
d) no DSA.
4.Patients who give written informed consent to participate in the study.
Key exclusion criteria
Patients who are not eligible for this study at the discretion of the investigator.
Target sample size
65
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Souichi Shiratori |
Organization
Hokkaido university hospital
Division name
Department of hematology
Zip code
Address
Kita-15 Nishi-7, Kita-ku, Sapporo, Hokkaido 060-8638, Japan
TEL
011-706-7214
s.shiratori@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Souichi Shiratori |
Organization
Hokkaido university hospital
Division name
Department of hematology
Zip code
Address
Kita-15 Nishi-7, Kita-ku, Sapporo, Hokkaido 060-8638, Japan
TEL
011-706-7214
Homepage URL
s.shiratori@med.hokudai.ac.jp
Sponsor or person
Institute
NJHSG
Institute
Department
Personal name
Funding Source
Organization
NJHSG
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 07 | 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 | 07 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. Transplantation-day100
1)Conditioning regimen
2)GVHD prophylaxis
3)Day of transplantation
4)NCC, CD34+ cell number
5)Engraftment
6)PIR,ES
7)HHV-6 encephalitis
8)Blood stream infection
9)oral mucositis
10)GVHD
11)Treatment for GVHD
12)Relapse
13)adverse events
14)Outcome
2. 1 year post CBT
1)cGVHD
2)Immunosuppressant
3)Relapse
4)Outcome
3. 2 year post CBT
1)cGVHD
2)Immunosuppressant
3)Relapse
4)Outcome
Management information
Registered date
| 2018 | Year | 03 | Month | 31 | Day |
Last modified on
| 2019 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036552
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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