UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005529 |
|---|---|
| Receipt number | R000006558 |
| Scientific Title | Multi-centre Prospective Randomized Trial Intravenous Itraconazole versus Liposomal Amphotericin B For Empirical Antifungal Therapy In Patients With Persistent fever And Neutropenia (ILEAN study) |
| Date of disclosure of the study information | 2011/04/29 |
| Last modified on | 2017/05/22 19:06:02 |
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Basic information
Public title
Multi-centre Prospective Randomized Trial Intravenous Itraconazole versus Liposomal Amphotericin B For Empirical Antifungal Therapy In Patients With Persistent fever And Neutropenia (ILEAN study)
Acronym
Intravenous Itraconazole versus Liposomal Amphotericin B For Empirical Antifungal Therapy
Scientific Title
Multi-centre Prospective Randomized Trial Intravenous Itraconazole versus Liposomal Amphotericin B For Empirical Antifungal Therapy In Patients With Persistent fever And Neutropenia (ILEAN study)
Scientific Title:Acronym
Intravenous Itraconazole versus Liposomal Amphotericin B For Empirical Antifungal Therapy
Region
| Japan |
Condition
Condition
Patients With Persistent fever And Neutropenia
Classification by specialty
| Medicine in general | Hematology and clinical oncology | Infectious disease |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In hematological malignancy patients with persistent fever and neutropenia, we are conducting a prospective randomized, muliti-centre trial comparing intravenous Itraconazole with liposomal amphotericin B as empirical antifungal therapy. This study aims to demonstrate noninferiority of intravenous Itraconazole compared with liposomal amphotericin B in overall favorable response.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
Overall favorable response
( No.1, 2, 3, 4, and 5 key secondary outcomes all succeed)
Key secondary outcomes
1. Response of patients with base-line fungal infections by completion of trial therapy
2. No breakthrough fungal infection
3. No discontinuation due to toxicity before recovery from neutropenia
4. Resolution of fever during neutropenia
5. Survival 7 days after completion of trial therapy
6. Adverse events
7. Probable invasive fungal disease by completion of trial therapy
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
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Liposomal amphotericin B is initiated and continued at 3mg per kilogram intravenously per day.
Interventions/Control_2
Itraconazole is initiated at 200mg intravenously every12hours for 5 times followed by 200mg intravenously every 24hours.
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
| 15 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. ECOG Performance Status of 0 to 3 at initial administration of the study drug.
2. Patients who have been with chemotherapy for less than 30 days for hematological malignancy.
3. Neutropenia (an absolute neutrophil count below 500 cells per cubic millimeter ) persisted for 96 hours.
4. Patients had received more than 96 hours of systemic anti-bacterial therapy while continuing to have fever. After 96 hours, axillary temperature was above 37.5 C at least one time.
5. No prophylactic antifungal therapy without Amphotericin B syrup, micafungin, caspofungin, miconazole oral gel,and antifungal skin cream.
(Patients who not received fluconazole within 4 weeks before the initial administration of the study drug)
6. Patients with adequately maintained organ functions (e.g., bone marrow, liver, heart, and kidney funtions).
Platelets counts: >5,000 per cubic millimeter
ALP: <3.0 times the upper limit of the institutional normal range
Total bilirubin: < 3.0 times the upper limit of the institutional normal range
AST (GOT): < 5.0 times the upper limit of the institutional normal range
ALT (GPT): < 5.0 times the upper limit of the institutional normal range
Left ventricular ejection fraction:> 50%
Creatinine clearance: >30mL / min
7. Patients capable of personally giving voluntary informed consent in writing to participate in the study.
Key exclusion criteria
1. Patients have been proved invasive fungal disease at initial administration of the study drug
2. Patients have been diagnosed as definite virus or bacterial infection at initial administration of the study drug
3. Patients with prior severe allergies to intravenous itraconazole and liposomal amphotericin B
4. Patients with liver cirrhosis
5. Patients with serious, active heart disease
6. Patients with, or confirmed in the past to have had, angina pectoris, cardiac infarction, congestive heart failure
7. Patients with serious psychological disease
8. Patients who are pregnant or lactating
9. Patients who received pimozide, blonanserin, triazolam, quinidine sulfate, bepridil hydrochloride hydrate, azelnidipine, nisoldipine, simvastatin, ergotamine tartrate, dihydroergotamine mesilate, vardenafil hydrochloride hydrate, sildenafil citrate, eplerenone, aliskiren fumarate, tadalafil, or rivaroxaban
10. Patients who receive donor leukocyte infusion
11. Patients otherwise judged by investigator or sub investigator to be unsuitable
12. Patients who received other investigational products or unapproved medication or Japan clinical oncology group protocol study
13. Patients who are currently receiving or going to receive Vincristine
14. Patients who have proved invasive fungal disease in the past
Target sample size
850
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Isao Yoshida |
Organization
National Hospital Organization, Shikoku Cancer Center
Division name
Hematologic oncology
Zip code
Address
160 Kou, Minamiumemotocho, Matsuyama, Ehime, Japan
TEL
+81-89-999-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Isao Yoshida |
Organization
National Hospital Organization, Shikoku Cancer Center
Division name
Hematologic oncology
Zip code
Address
160 Kou, Minamiumemotocho, Matsuyama, Ehime, Japan
TEL
+81-89-999-1111
Homepage URL
https://center6.umin.ac.jp/islet/ilean/
iyoshida@shikoku-cc.go.jp
Sponsor or person
Institute
National Hospital Organization
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
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
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
国立病院機構 北海道がんセンター（北海道）、国立病院機構 仙台医療センター（宮城県）、国立病院機構 水戸医療センター（茨城県）、国立病院機構 西群馬病院（群馬県）、国立病院機構 東京医療センター（東京都）、国立病院機構 災害医療センター（東京都）、国立病院機構 まつもと医療センター（長野県）、国立病院機構 名古屋医療センター(愛知県)、国立病院機構 金沢医療センター（石川県）、国立病院機構 福井病院（福井県）、国立病院機構 あわら病院（福井県）、国立病院機構 京都医療センター（京都府）、国立病院機構 大阪医療センター（大阪府）、国立病院機構大阪南医療センター（大阪府）、国立病院機構 姫路医療センター（兵庫県）、国立病院機構 米子医療センター（鳥取県）、国立病院機構 岡山医療センター（岡山県）、国立病院機構 南岡山医療センター（岡山県）、国立病院機構 呉医療センター（広島県）、国立病院機構 広島西医療センター（広島県）、国立病院機構 四国がんセンター（愛媛県）、国立病院機構 九州医療センター（福岡県）、国立病院機構 九州がんセンター（福岡県）、国立病院機構 長崎医療センター（長崎県）、国立病院機構 熊本医療センター（熊本県）、国立病院機構 鹿児島医療センター（鹿児島県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 04 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://learningcenter.ehaweb.org/eha/2016/21st/133365/isao.yoshida.multicenter.prospective.randomize
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
Main results already published
Date of protocol fixation
| 2011 | Year | 01 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 07 | Month | 14 | Day |
Date trial data considered complete
| 2015 | Year | 07 | Month | 14 | Day |
Date analysis concluded
| 2015 | Year | 07 | Month | 14 | Day |
Other
Other related information
21th Congress of European Hematology Association
Management information
Registered date
| 2011 | Year | 04 | Month | 29 | Day |
Last modified on
| 2017 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006558
