UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002441 |
|---|---|
| Receipt number | R000002986 |
| Scientific Title | Tacrolimus (graceptor (R)) for GVHD prophylaxis after allogeneic stem cell transplantation |
| Date of disclosure of the study information | 2009/10/01 |
| Last modified on | 2015/05/08 18:33:03 |
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Basic information
Public title
Tacrolimus (graceptor (R)) for GVHD prophylaxis after allogeneic stem cell transplantation
Acronym
Tacrolimus for GVHD prophylaxis
Scientific Title
Tacrolimus (graceptor (R)) for GVHD prophylaxis after allogeneic stem cell transplantation
Scientific Title:Acronym
Tacrolimus for GVHD prophylaxis
Region
| Japan |
Condition
Condition
acute myeloid leukemia, acute lymphoblastic leukemia, chronic myeloid leukemia, myelodysplastic syndrome, malignant lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Pharmacokinetics of oral tacrolims
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pharmacokinetics of oral tacrolims
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
tacrolimus
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who have indication of allogeneic stem cell transplantation with tacrolimus for GVHD prophylaxis
Key exclusion criteria
Patients who have internal organs dysfunction
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shingo Yano |
Organization
Jikei university school of medicine
Division name
Clinical Oncology and Hematology
Zip code
Address
3-25-8 Nishi Shinbashi Minato-ku, Tokyo, Japan
TEL
03-3433-1111
yano@jikei.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shingo Yano |
Organization
Jikei university school of medicine
Division name
Clinical Oncology and Hematology
Zip code
Address
3-25-8 Nishi-Shinbashi Minato-ku Tokyo Japan
TEL
03-3433-1111
Homepage URL
yano@jikei.ac.jp
Sponsor or person
Institute
Jikei university school of medicine
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center Hospital
Organization
Division
Category of Funding Organization
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
| 2009 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2009 | Year | 08 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 09 | Month | 03 | Day |
Last modified on
| 2015 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002986
