Unique ID issued by UMIN | UMIN000006323 |
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Receipt number | 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 09:55:57 |
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
VRCZ vs ITCZ for fungal prophylaxis in GVHD patients
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
VRCZ vs ITCZ for fungal prophylaxis in GVHD patients
Japan |
Hematologic malignancy
Hematology and clinical oncology | Infectious disease |
Malignancy
NO
To compare efficacy and safety of VRCZ versus ITCZ for fungal prophylaxis in allogeneic HSCT patients with GVHD
Safety,Efficacy
Exploratory
Pragmatic
Phase II
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)
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
Central registration
2
Treatment
Medicine |
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.
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.
16 | years-old | <= |
Not applicable |
Male and Female
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.
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.
66
1st name | |
Middle name | |
Last name | Takahiro Fukuda |
National Cancer Center Hospital
Division of Hematopoietic Stem Cell Transplantation
5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045
03-3542-2511
tafukuda@ncc.go.jp
1st name | |
Middle name | |
Last name | Takahiro Fukuda |
National Cancer Center Hospital
Division of Hematopoietic Stem Cell Transplantation
5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045
03-3542-2511
tafukuda@ncc.go.jp
Grants from the Japanese Ministry of Health, Labor and Welfare
Grants from the Japanese Ministry of Health, Labor and Welfare
Japan
NO
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)
2011 | Year | 09 | Month | 12 | Day |
Unpublished
Completed
2008 | Year | 02 | Month | 07 | Day |
2009 | Year | 03 | Month | 01 | Day |
2013 | Year | 06 | Month | 01 | Day |
2011 | Year | 09 | Month | 10 | Day |
2013 | Year | 09 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007496
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