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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015034
Receipt No. 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

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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)
Email 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
Email nuchida@toranomon.gr.jp

Sponsor
Institute Department of Hematology, Toranomon Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017490

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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