UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000015647
Receipt No. R000018190
Scientific Title 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
Date of disclosure of the study information 2014/11/10
Last modified on 2018/11/15

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title 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
Acronym Efficacy of conditioning regimen with FLU/BU(QD) or BU(QD)/CY for HSCT in AML/MDS
Scientific Title 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
Scientific Title:Acronym 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
Last name of lead principal investigator
1st name
Middle name
Last name Toshiro Ito
Organization Shinshu University of School of Medicine
Division name Second Department of Internal Medicine
Zip code
Address 3-1-1 Asahi, Matsumoto, Nagano, Japan
TEL 0263-357-2634
Email itot@shinshu-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Toshiro Ito
Organization Shinshu University of School of Medicine
Division name Second Department of Internal Medicine
Zip code
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)

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

Other administrative information
Date of disclosure of the study information
2014 Year 11 Month 10 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 Open public recruiting
Date of protocol fixation
2014 Year 03 Month 04 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000018190

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.