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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032036
Receipt No. 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

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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
Email 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
Email s.shiratori@med.hokudai.ac.jp

Sponsor
Institute NJHSG
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036552

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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