UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000359 |
|---|---|
| Receipt number | 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 14:15:05 |
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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
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
Sponsor or person
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
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000457
