UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000359
Receipt No. R000000457
Scientific Title Clinical phase II study of double-unit cord blood transplantation for hematological malignancies.(C-SHOT 0507)
Date of disclosure of the study information 2006/03/15
Last modified on 2013/04/17

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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


Contact us.