UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001151 |
|---|---|
| Receipt number | R000001367 |
| Scientific Title | Randomized controlled trial to compare cyclosporine and tacrolimus for GVHD prophylaxis after unrelated bone marrow transplantation |
| Date of disclosure of the study information | 2008/05/12 |
| Last modified on | 2014/05/12 09:12:28 |
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Basic information
Public title
Randomized controlled trial to compare cyclosporine and tacrolimus for GVHD prophylaxis after unrelated bone marrow transplantation
Acronym
RCT to compare CsA and FK506 for GVHD prophylaxis after unrelated BMT
Scientific Title
Randomized controlled trial to compare cyclosporine and tacrolimus for GVHD prophylaxis after unrelated bone marrow transplantation
Scientific Title:Acronym
RCT to compare CsA and FK506 for GVHD prophylaxis after unrelated BMT
Region
| Japan |
Condition
Condition
acute leukemia or myelodysplastic syndrome
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and toxicity of CsA and FK506 administered at appropriate blood concentration after unrelated BMT.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Success difined as 1) alive at day 100, 2) absence of grade II-IV acute GVHD, 3) discontinuation of assigned immunosuppressant, and 4) use of steroid.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
cyclosporine
Interventions/Control_2
tacrolimus
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
| 55 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients aged between 16 and 55 years old with acute leukemia or myelodysplastic syndrome who undergo unrelated BMT
Key exclusion criteria
Uncontrolled DM, HTN, and so on.
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichiro Okamoto |
Organization
KSGCT
Division name
Chairman
Zip code
Address
Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
KSGCT
Division name
Trial office
Zip code
Address
TEL
Homepage URL
ycanda-tky@umin.ac.jp
Sponsor or person
Institute
KSGCT
Institute
Department
Personal name
Funding Source
Organization
KSGCT
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
| 2008 | Year | 05 | Month | 12 | 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
| 2007 | Year | 09 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 05 | Month | 12 | Day |
Last modified on
| 2014 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001367
