UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety and efficacy of conditioning regimen with once-daily intravenous busulfan and fludarabine or cyclophosphamide for allogeneic hematopoietic stem cell transplantation in acute myelogenous leukemia or myelodysplastic syndrome
Title of the study (Brief title)	Efficacy of conditioning regimen with FLU/BU(QD) or BU(QD)/CY for HSCT in AML/MDS
Region	Japan

Condition
Condition	acute myelogenous leukemia, myelodysplastic syndrome
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	This study evaluate safety and efficacy of conditioning regimen with FLU/BU(QD) or BU(QD)/CY for allogeneic stem cell transplantation in AML/MDS patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	event-free survival at day 100 from transplantation
Key secondary outcomes

Base
Study type

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	once-daily 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	PS (ECOG) is 0 to 2 no sever organ dysfunction (T.Bil<2.0 mg/dL, AST/ALT =>3XUNL, CCr<2.0mg/dl, EF>50%, SpO2>95%) patients will survive more than three months AML(without FAB M3) or MDS patients transplant from following donors: HLA (A, B, DR) 6/6 allele matched related or unrelated donor HLA (A, B, DR) 5/6 allele matched related or unrelated donor less than 2 HLA (A, B, DR) antigens mismatched cord blood with =>2X10E7/kg nuclear cells patients obtained informed consent
Key exclusion criteria	patients with antibody of HIV patients has other malignancies patients has uncontrollable psychiatric disorders patients has active infections patients has history of hematopoietic stem cell transplantation patients has allergy of the drugs that use in protocol pregnant woman
Target sample size	30

Research contact person
Name of lead principal investigator	Toshiro Ito
Organization	Shinshu University of School of Medicine
Division name	Second Department of Internal Medicine
Address	3-1-1 Asahi, Matsumoto, Nagano, Japan
TEL	0263-357-2634
Email	itot@shinshu-u.ac.jp

Public contact
Name of contact person	Toshiro Ito
Organization	Shinshu University of School of Medicine
Division name	Second Department of Internal Medicine
Address	3-1-1 Asahi, Matsumoto, Nagano, Japan
TEL	0263-37-2634
Homepage URL
Email	itot@shinshu-u.ac.jp

Sponsor
Institute	Second Department of Internal Medicine, Shinshu University of School of Medicine
Institute
Department

Funding Source
Organization	Second Department of Internal Medicine, Shinshu University of School of Medicine
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	2014 Year 11 Month 10 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2014 Year 03 Month 04 Day
Anticipated trial start date	2014 Year 03 Month 04 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry	2016 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2014 Year 11 Month 10 Day
Last modified on	2018 Year 11 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018190