UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015647 |
|---|---|
| Receipt number | 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 15:36:50 |
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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
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
itot@shinshu-u.ac.jp
Public contact
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
itot@shinshu-u.ac.jp
Sponsor or person
Institute
Second Department of Internal Medicine, Shinshu University of School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018190
