UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006339 |
|---|---|
| Receipt number | R000007518 |
| Scientific Title | Cord blood transplantation using tacrolimus and MMF as GVHD prophylaxis |
| Date of disclosure of the study information | 2011/09/13 |
| Last modified on | 2015/10/21 11:06:42 |
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Basic information
Public title
Cord blood transplantation using tacrolimus and MMF as GVHD prophylaxis
Acronym
FBMTG-CBT2011
Scientific Title
Cord blood transplantation using tacrolimus and MMF as GVHD prophylaxis
Scientific Title:Acronym
FBMTG-CBT2011
Region
| Japan |
Condition
Condition
AML, ALL, CML, MDS, ML, ATLL
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Safety and efficacy of CBT for hematological malignancy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse effects more than grade3 within 100 days after CBT
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
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
| 16 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. available for suitable cord blood stem cells
2. performance status 0-2
3. preserved organ function
Key exclusion criteria
1.not sensitive to chemotherapy
2.complicated infection
3.positive for HBV,HCV,HIV
4.double cancer
Target sample size
23
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshihiro Miyamoto |
Organization
Kyushu University Hospital
Division name
Hematology & Oncology
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshihiro Miyamoto |
Organization
Kyushu University Hospital
Division name
Hematology & Oncology
Zip code
Address
TEL
Homepage URL
toshmiya@intmed1.med.kyushu-u.ac.jp
Sponsor or person
Institute
Fukuoka BMT group
Institute
Department
Personal name
Funding Source
Organization
Fukuoka BMT group
Organization
Division
Category of Funding Organization
Other
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
| 2011 | Year | 09 | Month | 13 | 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
Completed
Date of protocol fixation
| 2011 | Year | 07 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 09 | Month | 13 | Day |
Last modified on
| 2015 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007518
