UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002817 |
|---|---|
| Receipt number | R000003430 |
| Scientific Title | Prophylaxis of acute GVHD after bone marrow transplantation from unrelated donors with C3 monitoring of cyclosporine: a multicenter prospective study. |
| Date of disclosure of the study information | 2009/12/01 |
| Last modified on | 2009/12/01 02:31:54 |
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Basic information
Public title
Prophylaxis of acute GVHD after bone marrow transplantation from unrelated donors with C3 monitoring of cyclosporine: a multicenter prospective study.
Acronym
Prophylaxis of acute GVHD with C3 monitoring of cyclosporine.
Scientific Title
Prophylaxis of acute GVHD after bone marrow transplantation from unrelated donors with C3 monitoring of cyclosporine: a multicenter prospective study.
Scientific Title:Acronym
Prophylaxis of acute GVHD with C3 monitoring of cyclosporine.
Region
| Japan |
Condition
Condition
Hematological malignancy
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the efficacy of keeping an intravenous cyclosporine drip infusion for 3 hours and its blood level monitoring at the end of the infusion in the prophylaxis of acute GVHD after bone marrow transplantation from unrelated donors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of grade II-IV and grade III-IV acute GVHD within 100 days after bone marrow transplantation.
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
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Dose adjustment of cyclosporine by monitoring of its blood levels
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
| 55 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients with hematological malignancies who undergo bone marrow transplantation from unrelated donors.
2) Donors need to be HLA-A, B, C, DRB1 genotypically matched, HLA-A, B, C genotypically matched and DRB1 single allele mismatched or HLA-A, B, DRB1 genotypically matched and HLA-C single allele mismatched and KIR matched.
3) Patients who can give written informed consent to the enrollment into this trial.
Key exclusion criteria
1) Non-myeloablative allogeneic transplantation
2) Past transplantation history
3) T-cell depleted transplantation
4) Use of ATG or ALG as preparative regimens
5) Serum creatinine level >= 2.0 mg/dL or >= 1.5 times the upper limit of the normal range, Ccr < 50 mL/min
6) Serum total bilirubin level >= 2.0 mg/dL, serum AST/ALT level >= 2 times the upper limit of the normal range
7) Uncontrolled hypertension
8) Uncontrolled diabetes mellitus on insulin therapy
9) Uncontrolled active infections
10) History of epilepsy
11) Other severe complications
12) Pregnant female
13) Allergic to cyclosporine
14) Any patients who are judged unsuitable for the enrollment by the attending physician
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinji Nakao |
Organization
Kanazawa University Graduate School of Medical Science
Division name
Cellular Transplantation Biology
Zip code
Address
13-1 Takaramachi, Kanazawa, Ishikawa 920-8641, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirohito Yamazaki |
Organization
Kanazawa University Graduate School of Medical Science
Division name
Cellular Transplantation Biology
Zip code
Address
13-1 Takaramachi, Kanazawa, Ishikawa 920-8641, Japan
TEL
076-265-2275
Homepage URL
hyamazaki@med3.m.kanazawa-u.ac.jp
Sponsor or person
Institute
Cellular Transplantation Biology, Kanazawa University Graduate School of Medical Science
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2009 | Year | 12 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2009 | Year | 10 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | 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 | 12 | Month | 01 | Day |
Last modified on
| 2009 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003430
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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