UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015166 |
|---|---|
| Receipt number | R000017639 |
| Scientific Title | Target dose adjustment of busulfan in pediatric patients undergoing hematopoietic stem cell transplantation |
| Date of disclosure of the study information | 2014/09/15 |
| Last modified on | 2024/04/02 20:13:36 |
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Basic information
Public title
Target dose adjustment of busulfan in pediatric patients undergoing hematopoietic stem cell transplantation
Acronym
Target dose adjustment of busulfan in pediatric patients undergoing hematopoietic stem cell transplantation
Scientific Title
Target dose adjustment of busulfan in pediatric patients undergoing hematopoietic stem cell transplantation
Scientific Title:Acronym
Target dose adjustment of busulfan in pediatric patients undergoing hematopoietic stem cell transplantation
Region
| Japan |
Condition
Condition
hematological malignat disease, solid tumor, benign disease
Classification by specialty
| Hematology and clinical oncology | Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To build the safe and effective way of the administration of BU
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1 year survival after transplantation
Key secondary outcomes
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 |
Interventions/Control_1
measurment of BU TDM
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
The patient who is planed stem cell transplantation with BU as pre-conditioning
Key exclusion criteria
1 uncontroled infection
2 uncontroled mental disease
3 pregnantor possible pregnant womanan
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seiji Kojima |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Pediatrics
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya
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
Division name
Department of Pediatrics
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2294
Homepage URL
ytakaha@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
KAKEN
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2014 | Year | 09 | 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
50
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
Terminated
Date of protocol fixation
| 2013 | Year | 05 | Month | 07 | Day |
Date of IRB
| 2013 | Year | 05 | Month | 07 | Day |
Anticipated trial start date
| 2013 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 15 | Day |
Last modified on
| 2024 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017639
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
