UMIN-CTR Clinical Trial

Basic information
Public title	Clinical phase II study of double-unit cord blood transplantation for hematological malignancies.(C-SHOT 0507)
Acronym	Double-unit cord blood transplantation(C-SHOT 0507)
Scientific Title	Clinical phase II study of double-unit cord blood transplantation for hematological malignancies.(C-SHOT 0507)
Scientific Title:Acronym	Double-unit cord blood transplantation(C-SHOT 0507)
Region	Japan

Condition
Condition	Hematological malignancies
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To study feasibility and effectiveness of double-unit cord blood transplantation
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Event-free survival at one year after double-unit cord blood transplantation
Key secondary outcomes	Time of hematopoietic engraftment, treatment-related toxicity, incidence and severity of acute and chronic graft versus host disease, disease-free survival and overall survival at 1-year

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	To study feasibility and effectiveness of double-unit cord blood (CB) transplantation in patients with hematological malignancies requiring hematopoietic stem cell transplantation without any available single-unit CB.
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	Not applicable
Age-upper limit	55 years-old >
Gender	Male and Female
Key inclusion criteria	1) Patient with poor risk hematologic malignancies 2) Patient who receives double-unit CBT as first stem cell transplantation 3) Age: less than 55 years old 4) Patient without active infection at starting conditioning chemoradiatherapy 5) HIV-antibody negative patient 6) Patient who has no HLA-matched or one antigen-mismatched relatives 7) Patient who has no HLA-matched unrelated donor, or who requires urgent transplant even if he/she has HLA-matched unrelated donor 8) Patient who has no single CB unit with cell dose of more than 2.5x107/kg and 2 or more HLA antigen mismatches
Key exclusion criteria	1) ECOG's performance status; 2 or more 2) Ejection fraction(EF); less than 50% 3) SaO2; more than 93% in room air 4) Serum creatinine; 1.3mg/dl or greater 5) Total bilirubin; 1.6mg/dl or greater, or GOT; 2 x normal value or greater 6) Down's syndrome 7) Fanconi's anemia
Target sample size	70

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shun-ichi Kato, Shunro Kai
Organization	1) Tokai University, School of Medicine 2) Hyogo College of Medicine
Division name	1) Research Center for regenerative medicine 2) The Department of Transfusion Medicine
Zip code
Address	1) Boseidai, Isehara-city, Kanagawa 2) 1-1,Mukogawa-cho,Nishinomiya,Hyogo
TEL	0463-93-1121
Email

Public contact
Name of contact person	1st name Middle name Last name Shiro Yoshiba
Organization	Registry office of double-unit cord blood transplantation
Division name	Research Center for regenerative medicine
Zip code
Address	Boseidai, Isehara-city, Kanagawa
TEL	0463-93-1121
Homepage URL
Email

Sponsor
Institute	A Research Grant on Human Genome, Tissue Engineering from the Japanese Ministry of Health, Labor & Welfare: Research on advancement and safety security of HSCT using umbilical cord blood.
Institute
Department

Funding Source
Organization	A Research Grant on Human Genome, Tissue Engineering from the Japanese Ministry of Health, Labor & Welfare: Research on advancement and safety security of HSCT using umbilical cord blood.
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

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	2006 Year 03 Month 15 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	2006 Year 03 Month 02 Day
Date of IRB
Anticipated trial start date	2006 Year 03 Month 01 Day
Last follow-up date	2010 Year 03 Month 01 Day
Date of closure to data entry	2010 Year 09 Month 01 Day
Date trial data considered complete	2011 Year 03 Month 01 Day
Date analysis concluded	2011 Year 07 Month 01 Day

Other
Other related information

Management information
Registered date	2006 Year 03 Month 15 Day
Last modified on	2013 Year 04 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000457

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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