UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of efficacy of dose-adjusted intravenous busulfan in allogeneic hematopoietic stem cell transplantaion
Title of the study (Brief title)	Evaluation of efficacy of dose-adjusted intravenous busulfan
Region	Japan

Condition
Condition	Hematologic disease
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. 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
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	Yasunori Ueda
Organization	Kurashiki Central Hospital
Division name	Department of Hematology / Oncology
Address	1-1-1 Miwa, Kurasiki, Okayama
TEL	086-422-0210
Email	ueda-y@kchnet.or.jp

Public contact
Name of contact person	Aki Sato
Organization	Kurashiki Central Hospital
Division name	Department of Hematology / Oncology
Address	1-1-1 Miwa, Kurasiki, Okayama
TEL	086-422-0210
Homepage URL
Email	as14404@kchnet.or.jp

Sponsor
Institute	Kurashiki Central Hospital
Institute
Department

Funding Source
Organization	Kurashiki Central Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2016 Year 09 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 06 Month 17 Day
Anticipated trial start date	2016 Year 09 Month 01 Day
Last follow-up date	2017 Year 11 Month 14 Day
Date of closure to data entry	2017 Year 11 Month 14 Day
Date trial data considered complete	2017 Year 11 Month 14 Day
Date analysis concluded	2017 Year 11 Month 14 Day

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Publication of results	Unpublished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

Management information
Registered date	2016 Year 08 Month 09 Day
Last modified on	2017 Year 11 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027145