UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019501 |
|---|---|
| Receipt number | R000022547 |
| Scientific Title | Evaluation of efficacy of dose-adjusted intravenous busulfan in allogeneic hematopoietic stem cell transplantation by analyzing busulfan concentration in dried blood spot method. |
| Date of disclosure of the study information | 2015/11/01 |
| Last modified on | 2015/10/26 13:48:09 |
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Basic information
Public title
Evaluation of efficacy of dose-adjusted intravenous busulfan in allogeneic hematopoietic stem cell transplantation by analyzing busulfan concentration in dried blood spot method.
Acronym
Evaluation of efficacy of dose-adjusted intravenous busulfan by DBS method.
Scientific Title
Evaluation of efficacy of dose-adjusted intravenous busulfan in allogeneic hematopoietic stem cell transplantation by analyzing busulfan concentration in dried blood spot method.
Scientific Title:Acronym
Evaluation of efficacy of dose-adjusted intravenous busulfan by DBS method.
Region
| Japan |
Condition
Condition
Hematological malignancy
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of safety and efficacy of dose-adjusted intravenous busulfan by analyzing busulfan concentration under the conditioning regimen.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The proportion of patients with event-free survival in 100 days 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
Dose-adjusted intravenous busulfan
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
| 16 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Hematological malignancy for AML, MDS, CML, ALL, ML and MM
2. Performance status(PS, ECOG) of 0-2
3. Patients without major organ dysfunction
4. T.Bil less than 2.0 mg/dL
5. AST and ALT less than 3 upper limit of the normal range
6. SCr less than 2.0mg/dl
7. Heart ejection fraction more than 40%
8. SpO2 more than 93%
9. Patients requird to have an appropriate donor identified before enrollment.
(1) HLA-matched related or unrelated donor
(2) 1 HLA-mismatched related or unrelated donor
(3) Cord blood with nucleated cell counts more than 1.5 107/kg and mismatched HLA less than 2
10. Ability to provide informed consent.
Key exclusion criteria
1. positive for anti-HIV antibody
2. positive for Hbs antigen
3. active another malignancy
4. uncontrollable psychological disorders
5. uncontrollable active infection
6. known hypersensitivity to busulfan
7. pregnant women
8. Patients judged as inappropriate for this study by physicians
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasunori Ueda |
Organization
Kurashiki Central Hospital
Division name
Department of Hematology / Oncology
Zip code
Address
1-1-1 Miwa, Kurasiki, Okayama
TEL
086-422-0210
ueda-y@kchnet.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Aki Sato |
Organization
Kurashiki Central Hospital
Division name
Department of Hematology / Oncology
Zip code
Address
1-1-1 Miwa, Kurasiki, Okayama
TEL
086-422-0210
Homepage URL
as14404@kchnet.or.jp
Sponsor or person
Institute
Kurashiki Central Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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
| 2015 | Year | 11 | 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
| 2015 | Year | 03 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | 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
| 2015 | Year | 10 | Month | 26 | Day |
Last modified on
| 2015 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022547
| 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 |
