UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Takuya Yamashita
Organization	National Cancer Center Hospital
Division name	Hematopoietic Stem Cell Transplantation Division
Address	5-1-1, Tsukiji, Chuo, Tokyo
TEL	+81-3-3542-2511
Email	tayamash@ncc.go.jp

Public contact
Name of contact person	Takuya Yamashita
Organization	National Cancer Center Hospital
Division name	Hematopoietic Stem Cell Transplantation Division
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 11 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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