UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006323
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

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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 or person

Institute

Grants from the Japanese Ministry of Health, Labor and Welfare

Institute

Department

Personal name



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

Value
https://center6.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