UMIN-CTR Clinical Trial

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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