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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002817
Receipt No. 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

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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
Email

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
Email hyamazaki@med3.m.kanazawa-u.ac.jp

Sponsor
Institute Cellular Transplantation Biology, Kanazawa University Graduate School of Medical Science
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003430

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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