UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029115 |
|---|---|
| Receipt number | R000033295 |
| Scientific Title | A prospective feasibility study of allogeneic hematopoietic stem cell transplantation using once daily intravenous busulfan and fludarabine as conditioning regimen |
| Date of disclosure of the study information | 2017/09/12 |
| Last modified on | 2019/09/17 14:05:58 |
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Basic information
Public title
A prospective feasibility study of allogeneic hematopoietic stem cell transplantation using once daily intravenous busulfan and fludarabine as conditioning regimen
Acronym
Flu plus Bu Once Daily
Scientific Title
A prospective feasibility study of allogeneic hematopoietic stem cell transplantation using once daily intravenous busulfan and fludarabine as conditioning regimen
Scientific Title:Acronym
Flu plus Bu Once Daily
Region
| Japan |
Condition
Condition
hematological malignancy
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the feasibility of once daily busulfan in allogeneic hematopoietic stem cell transplantation in patients with hematological malignancy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Engraftment rate
Key secondary outcomes
(1) 100 day non-relapse mortality rate
(2) 100 day SOS rate
(3) 1 year overall survival, relapse rate
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Once daily intravenous busulfan as conditioning regimen for allogeneic hematopoietic stem cell transplantation
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
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) 18 years or older, and younger than 70 years
(2) patient with hematological malignancy with an indication of allogeneic HSCT
(3) Allogeneic BMT or PBSCT from an HLA-matched or 1-locus mismatched donor determined by 8 loci including HLA-A, B, C, DRB1 loci
(4) ECOG PS 0 or 1
(5) Informed consent
Key exclusion criteria
No exclusion criteria
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Shigeo |
| Middle name | |
| Last name | Fuji |
Organization
Osaka International Cancer Institute
Division name
Department of Hematology
Zip code
5418567
Address
3-1-69, Otemae, Chuo-ku, Osaka-city, Osaka
TEL
+81-6-6945-1181
fuji-si@mc.pref.osaka.jp
Public contact
Name of contact person
| 1st name | Shigeo |
| Middle name | |
| Last name | Fuji |
Organization
Osaka International Cancer Institute
Division name
Department of Hematology
Zip code
5418567
Address
3-1-69, Otemae, Chuo-ku, Osaka-city, Osaka
TEL
+81-6-6945-1181
Homepage URL
fuji-si@mc.pref.osaka.jp
Sponsor or person
Institute
Osaka International Cancer Institute
Institute
Department
Personal name
Funding Source
Organization
Osaka International Cancer Institute
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka International Cancer Institute, Clinical Research Center
Address
3-1-69, Otemae, Chuo-ku, Osaka, Japan
Tel
06-6945-1181
rinri01@opho.jp
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
大阪国際がんセンター
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | Month | 12 | Day |
Related information
URL releasing protocol
NA
Publication of results
Unpublished
Result
URL related to results and publications
NA
Number of participants that the trial has enrolled
0
Results
Because the new treatment schedule was approved by the government, we stopped the study which assessed the feasibility of the same schedule of administration.
Results date posted
| 2019 | Year | 09 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
NA
Participant flow
NA
Adverse events
NA
Outcome measures
NA
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2017 | Year | 09 | Month | 07 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 07 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 12 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 12 | Day |
Last modified on
| 2019 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033295
