UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030308 |
|---|---|
| Receipt number | R000034613 |
| Scientific Title | A prospective feasibility study of cord blood transplant using once daily intravenous busulfan and fludarabine plus melphalan as conditioning regimen |
| Date of disclosure of the study information | 2017/12/09 |
| Last modified on | 2019/09/17 14:12:56 |
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Basic information
Public title
A prospective feasibility study of cord blood transplant using once daily intravenous busulfan and fludarabine plus melphalan as conditioning regimen
Acronym
FluBuOnceDaily plus Mel for CBT
Scientific Title
A prospective feasibility study of cord blood transplant using once daily intravenous busulfan and fludarabine plus melphalan as conditioning regimen
Scientific Title:Acronym
FluBuOnceDaily plus Mel for CBT
Region
| Japan |
Condition
Condition
Hematological malignancy
Classification by specialty
| Hematology and clinical oncology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the safety of once daily intravenous busulfan in combination with melphalan in the setting of CBT
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Engraftment rate
Key secondary outcomes
(1) non-relapse mortality rate at 100 days after CBT
(2) SOS rate at 100 days after CBT
(3) 1-year overall survival and relapse rates
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
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
once daily intravenous busulfan in combination with melphalan in the setting of CBT
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) Age 18 years or older
less than 70 years
(2) patients with a hematological malignancy
who are eligible for CBT
(3) patients who will receive CBT
(4) ECOG PS 0 or 1
(5) patients with consent to this study
Key exclusion criteria
(1) patients with organ dysfunction
(lung, renal, liver, heart)
(2) patients who are expected not to survive 100 days or longer
(3) patients with another active cancer
(4) pregnant or breast-feeding
(5) patients with mental disorder
(6) the physician consider inappropriate for this study
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
06-6945-1181
fujishige1231@gmail.com
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
06-6945-1181
Homepage URL
fujishige1231@gmail.com
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
Other
Nationality of Funding Organization
Japan
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
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 | 12 | Month | 09 | 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 schedule of treatment in this study was approved by the government, we decided to stop this trial.
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 | 12 | Month | 08 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 08 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 08 | 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 | 12 | Month | 08 | 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=R000034613
