UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011482 |
|---|---|
| Receipt number | R000013438 |
| Scientific Title | KIR ligand mismatched allogeneic cord blood transplantation for Leukemia in children |
| Date of disclosure of the study information | 2013/09/01 |
| Last modified on | 2014/02/14 14:50:26 |
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Basic information
Public title
KIR ligand mismatched allogeneic cord blood transplantation for Leukemia in children
Acronym
KIR ligand mismatched allogeneic cord blood transplantation for Leukemia in children
Scientific Title
KIR ligand mismatched allogeneic cord blood transplantation for Leukemia in children
Scientific Title:Acronym
KIR ligand mismatched allogeneic cord blood transplantation for Leukemia in children
Region
| Japan |
Condition
Condition
Acute Leukemia
Classification by specialty
| Hematology and clinical oncology | Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm the KIR ligand mismatched allogeneic cord blood transplantation for Leukemia in children
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Three year disease free survival after transplantation
Key secondary outcomes
Base
Study type
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
| Other |
Interventions/Control_1
KIR ligand mismatched allogeneic cord blood transplantation
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
| 0 | years-old | <= |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)children with Acute leukemia
(2)Written informed consent was obtained from patients or their guardians
(3)Performance status(ECOG) is 0 or 1
(4)Cord blood meeting the acceptability criterion is available
Key exclusion criteria
(1) the patients with active infection
(2) the patients with active mental illness
(3) the patients who have allergy for drugs of preconditioning or GVHD prophylaxis
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seiji Kojima |
Organization
Nagoya University Graduate School of Medicine, Nagoya, Japan
Division name
Department of Pediatrics
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi
TEL
052-744-2294
kojimas@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiyuki Takahashi |
Organization
Nagoya University Graduate School of Medicine, Nagoya, Japan
Division name
Department of Pediatrics
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi
TEL
052-744-2294
Homepage URL
ytakaha@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine, Nagoya, Japan
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
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
| 2013 | Year | 09 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2013 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 13 | Day |
Last modified on
| 2014 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013438
