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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009769
Receipt No. R000011445
Scientific Title Pharmacokinetic study of busulfan in allogeneic hematopoietic stem cell transplantation for patients with myeloid malignancies using once daily intravenous busulfan and fludarabine as conditioning regimen
Date of disclosure of the study information 2013/01/21
Last modified on 2018/10/31

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Basic information
Public title Pharmacokinetic study of busulfan in allogeneic hematopoietic stem cell transplantation for patients with myeloid malignancies using once daily intravenous busulfan and fludarabine as conditioning regimen
Acronym IVBU1002(FB4)-PK: Pharmacokinetic study of busulfan in once daily intravenous busulfan and fludarabine phosphate
Scientific Title Pharmacokinetic study of busulfan in allogeneic hematopoietic stem cell transplantation for patients with myeloid malignancies using once daily intravenous busulfan and fludarabine as conditioning regimen
Scientific Title:Acronym IVBU1002(FB4)-PK: Pharmacokinetic study of busulfan in once daily intravenous busulfan and fludarabine phosphate
Region
Japan

Condition
Condition acute myeloid leukemia(AML)
myelodysplastic syndrome(MDS)
chronic myelogenous leukemia(CML)
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate pharmakokinetics of
busulfan in allogeneic hematopoietic
stem cell transplantation using once
daily intravenous busulfan(ivBu) and
fludarabine phosphate(Flu) as conditioning regimen for patients with AML, MDS and CML, as the ancillary study of phase II study of allogeneic hematopoietic stem cell
transplantation for patients with myeloid malignancies using once daily intravenous busulfan and fludarabine phosphate as conditioning regimen (IVBU1002(FB4): main study)
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Proportion of patients who reach the
targeted AUC range of busulfan after
first and fourth dose
Key secondary outcomes Relationship between pharmacokinetics of busulfan and adverse events

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
16 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria (1) Patients who are eligible for the main study and registered to it
(2) Patients who give written informed consent following sufficient explanation. Patients who are under 20 years old are required to give informed consent from both persons with parental authority
Key exclusion criteria (1) Patients who withdraw the consent to participate in this study
(2) Patients who are considered as inappropriate to register by attending
physicians
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takuya Yamashita
Organization National Cancer Center Hospital
Division name Hematopoietic Stem Cell Transplantation Division
Zip code
Address 5-1-1, Tsukiji, Chuo, Tokyo
TEL +81-3-3542-2511
Email tayamash@ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takuya Yamashita
Organization National Cancer Center Hospital
Division name Hematopoietic Stem Cell Transplantation Division
Zip code
Address 5-1-1, Tsukiji, Chuo, Tokyo
TEL +81-3-3542-2511
Homepage URL
Email tayamash@ncc.go.jp

Sponsor
Institute Hematopoietic Stem Cell Transplantation Division, National Cancer Center Hospital
Institute
Department

Funding Source
Organization The Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 国立がん研究センター中央病院(東京都)

Other administrative information
Date of disclosure of the study information
2013 Year 01 Month 21 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
2012 Year 11 Month 28 Day
Date of IRB
Anticipated trial start date
2013 Year 01 Month 21 Day
Last follow-up date
2015 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Blood sampling is performed at 3, 5, 8 and 24 hours after first dose of ivBu, and at just before and 3 hours after fourth dose. Blood concentration of Bu is measured by gas
chromatograohy and mass spectrometry. AUC is caluculated according to a established method

Management information
Registered date
2013 Year 01 Month 13 Day
Last modified on
2018 Year 10 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011445

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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