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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006323
Receipt No. R000007496
Scientific Title Voriconazole (VRCZ) versus Itraconazole (ITCZ) for fungal prophylaxis in allogeneic hematopoietic stem cell transplantation (HSCT) patients with graft-versus-host disease (GVHD): A multicenter randomized trial
Date of disclosure of the study information 2011/09/12
Last modified on 2013/09/10

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Basic information
Public title Voriconazole (VRCZ) versus Itraconazole (ITCZ) for fungal prophylaxis in allogeneic hematopoietic stem cell transplantation (HSCT) patients with graft-versus-host disease (GVHD): A multicenter randomized trial
Acronym VRCZ vs ITCZ for fungal prophylaxis in GVHD patients
Scientific Title Voriconazole (VRCZ) versus Itraconazole (ITCZ) for fungal prophylaxis in allogeneic hematopoietic stem cell transplantation (HSCT) patients with graft-versus-host disease (GVHD): A multicenter randomized trial
Scientific Title:Acronym VRCZ vs ITCZ for fungal prophylaxis in GVHD patients
Region
Japan

Condition
Condition Hematologic malignancy
Classification by specialty
Hematology and clinical oncology Infectious disease
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare efficacy and safety of VRCZ versus ITCZ for fungal prophylaxis in allogeneic HSCT patients with GVHD
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes The primary endpoint was the treatment success defined by the following criteria during the period from randomization to day 60:
1) alive
2) free from proven or probable invasive fungal infection defined by the revised EORTC criteria
3) able to continue the assigned drug for more than 80% of the study period (48 days or longer)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 VRCZ arm (for 60 days)
VRCZ tablet:
200 mg twice daily between meals for patients 40 kg or more,
100 mg twice daily between meals for patients less than 40 kg.

If oral drug administration is not possible, intraveneous formulation (4 mg/kg, q12h) can be used.
Interventions/Control_2 ITCZ arm (for 60 days)
ITCZ oral solution:
2.5 mg/kg twice daily before meals.

If oral drug administration is not possible, intraveneous formulation (200 mg, q24h) can be used.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients who undergo allogeneic HSCT. All disease types, donors, graft types, conditioning regimens were eligible.
2) Patients who developed one of the following GVHD: (A)grade II-IV acute GVHD, or (B)chronic GVHD that required 0.3 mg/kg/d or more prednisone (or equivalent steroid dose).
3) Patients who did not have proven or probable invasive fungal infection defined by the revised EORTC criteria at registration. Chest CT scan, galactomannan, and beta-D-glucan tests were required within 7 days before registration.
4) Absolute neutrophil count of 500/micro-L or more
5) Adequate hepatic function indicated by ALT level less than 5 times the upper limit of the normal range and total bilirubin level less than 2.5 mg/dL.
6) Adequate renal function indicated by creatinine clearance level 30 mL/min or more using Cockcroft&Gault formula.
7) Written informed consent obtained.
Key exclusion criteria 1) Patients who had hypersensitivity against the study drugs.
2) Patients who received VRCZ or ITCZ within 7 days before registration. Patients who received antifungal drugs other than the study drugs (such as fluconazole and micafungin) can be registered if they discontinue the antifungal drugs before before registration.
3) Patients who had recurrent malignancies during the period from HSCT to registration.
4) Patients with chronic GVHD whose steroid dose was planed rapidly decreased within 3 weeks.
5) Patients who required medications that are contraindicated for the concurrent use of azoles.
Target sample size 66

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takahiro Fukuda
Organization National Cancer Center Hospital
Division name Division of Hematopoietic Stem Cell Transplantation
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045
TEL 03-3542-2511
Email tafukuda@ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takahiro Fukuda
Organization National Cancer Center Hospital
Division name Division of Hematopoietic Stem Cell Transplantation
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045
TEL 03-3542-2511
Homepage URL
Email tafukuda@ncc.go.jp

Sponsor
Institute Grants from the Japanese Ministry of Health, Labor and Welfare
Institute
Department

Funding Source
Organization Grants from the Japanese Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 国立がん研究センター中央病院(東京都)
松下記念病院(大阪府)
神奈川県立がんセンター(神奈川県)
国立病院機構熊本医療センター(熊本県)
大阪市立大学医学部附属病院(大阪府)
がん・感染症センター 東京都立駒込病院(東京都)
島根県立中央病院(島根県)
佐世保市立総合病院(長崎県)
名鉄病院(愛知県)
北海道大学病院(北海道)
信州大学医学部附属病院(長野県)
東京慈恵会医科大学附属病院(東京都)
金沢大学附属病院(石川県)
自治医科大学附属さいたま医療センター(埼玉県)
日本赤十字社 和歌山医療センター(和歌山県)
和歌山県立医科大学(和歌山県)
愛知県厚生農業協同組合連合会 江南厚生病院(愛知県)
国家公務員共済組合連合会 浜の町病院(福岡県)
札幌北楡病院(北海道)
浜松医科大学(静岡県)

Other administrative information
Date of disclosure of the study information
2011 Year 09 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
2008 Year 02 Month 07 Day
Date of IRB
Anticipated trial start date
2009 Year 03 Month 01 Day
Last follow-up date
2013 Year 06 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
2011 Year 09 Month 10 Day
Last modified on
2013 Year 09 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007496

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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