UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015034 |
|---|---|
| Receipt number | R000017490 |
| Scientific Title | Development of analysing blood concentration of iv busulfan in patients by dried blood spot method |
| Date of disclosure of the study information | 2014/09/02 |
| Last modified on | 2014/10/10 22:54:20 |
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Basic information
Public title
Development of analysing blood concentration of iv busulfan in patients by dried blood spot method
Acronym
Analysis of blood concentration of busulfan by DBS method (DBS13)
Scientific Title
Development of analysing blood concentration of iv busulfan in patients by dried blood spot method
Scientific Title:Acronym
Analysis of blood concentration of busulfan by DBS method (DBS13)
Region
| Japan |
Condition
Condition
Acute myeloid leukemia, Chronic myeloid leukemia, Myelodysplastic syndrome, Acute lymphoblastic leukemia, Chronic lymphocytic leukemia, Malignant lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To develop the analytical method (dried blood spot method) for measuring blood concentration of iv busulfan (BU) using small volume of blood without plasma separation
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparative analysis of pharmacokinetics of BU by HPLC and DBS methods
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
*Diagnosis of either Acute myeloid leukemia, Chronic myeloid leukemia, Myelodysplastic syndrome, Acute lymphoblastic leukemia, Chronic lymphocytic leukemia, Malignant lymphoma
*Performance status (ECOG) ranging from 0 to 2
*Without severe comorbidity
*T.Bil=<2.0 mg/dL, AST･ALT=<3xULN, CCr>=30 mL/min, Cardiac output>=50%, SpO2>=95%
*At least 3 months lifespan is expected.
*Hematopoietic stem cell transplantation recipients with regimen including 3.2 mg/kg-12.8 mg/kg of BU (0.8 mg/kg/dose)
*Written informed consent for participation is obtained
Key exclusion criteria
*History of drug hypersensitivity to the drugs used in the treatment
*Dose of single injection is not 0.8 mg/kg for 2 hour infusion
*Patients who is not appropriate for entering the study by attending physician
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoyuki Uchida |
Organization
Toranomon Hospital
Division name
Department of Hematology
Zip code
Address
2-2-2 Toranomon, Minato-ku, Tokyo 105-8470, Japan
TEL
03-3588-1111(+81-3-3588-1111)
nuchida@toranomon.gr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoyuki Uchida |
Organization
Toranomon Hospital
Division name
Department of Hematology
Zip code
Address
2-2-2 Toranomon, Minato-ku, Tokyo 105-8470, Japan
TEL
03-3588-1111(+81-3-3588-1111)
Homepage URL
nuchida@toranomon.gr.jp
Sponsor or person
Institute
Department of Hematology, Toranomon Hospital
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Department of Clinical Pharmaceutics, Doshisha Women's College of Liberal Arts
Toray Research Center, Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
273-TADD-13004
Org. issuing International ID_1
Otsuka Pharmaceutical Co., Ltd.
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
虎の門病院(東京都)/Toranomon Hospital (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | Month | 02 | 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
| 2014 | Year | 02 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 21 | Day |
Last follow-up date
| 2014 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2014 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2014 | Year | 10 | Month | 09 | Day |
Date analysis concluded
| 2014 | Year | 10 | Month | 09 | Day |
Other
Other related information
The results obtained from HPLC and DBS methods will be compared. The equivalency is confirmed when the degree of dissociation of at least 2/3 of the samples are within +/-20%.
Management information
Registered date
| 2014 | Year | 09 | Month | 02 | Day |
Last modified on
| 2014 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017490
