UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059113 |
|---|---|
| Receipt number | R000067621 |
| Scientific Title | Prospective Observational Study on Individualized Treatment with IsaVuconazole in Eastern Japan: KSGCT multicenter study |
| Date of disclosure of the study information | 2025/09/17 |
| Last modified on | 2025/09/17 16:41:38 |
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Basic information
Public title
Prospective Observational Study on Individualized Treatment with IsaVuconazole in Eastern Japan:KSGCT multicenter study
Acronym
POSITIVE-J study
Scientific Title
Prospective Observational Study on Individualized Treatment with IsaVuconazole in Eastern Japan: KSGCT multicenter study
Scientific Title:Acronym
POSITIVE-J study
Region
| Japan |
Condition
Condition
blood disorders
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This observational study will clarify the real-world use of isavuconazonium sulfate (ISAV) in patients with hematologic diseases by assessing treatment indications, administration route and duration, organ function, adverse events, drug levels, and reasons for discontinuation. The efficacy of ISAV in patients with proven or probable invasive mold infections will also be evaluated. Exploratory analyses will examine blood concentrations of calcineurin inhibitors (cyclosporine, tacrolimus) before ISAV initiation, QTcF changes when ISAV is combined with FLT3 inhibitors, and, when clinically required, drug monitoring of ISAV, venetoclax, quizartinib, and gilteritinib.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Survey on Real-World Use of ISAV
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients who have provided informed consent to participate in this study
2.Patients aged 18 years or older with hematologic diseases
3.Patients for whom the investigator has decided to initiate ISAV treatment, or who are within 14 days of ISAV initiation
Key exclusion criteria
1.Patients with contraindications to ISAV
2.Female patients who are pregnant or breastfeeding
3.Patients with a prior history of ISAV treatment who were intolerant to the drug or for whom it was proven ineffective against the current invasive fungal infection
4.Patients deemed unsuitable for study participation by the investigator
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Yoshinobu |
| Middle name | |
| Last name | Kanda |
Organization
Kanto Study Group for Cell Therapy
Division name
office
Zip code
1860004
Address
2F North, Ogasawara Building, 1-8-33 Naka, Kunitachi-shi, Tokyo 186-0004, Japan
TEL
042-505-4691
ksgctdc@ksgct.net
Public contact
Name of contact person
| 1st name | Toyohiro |
| Middle name | |
| Last name | Kawano |
Organization
Kanto Study Group for Cell Therapy
Division name
office
Zip code
1860004
Address
2F North, Ogasawara Building, 1-8-33 Naka, Kunitachi-shi, Tokyo 186-0004, Japan
TEL
042-505-4251
Homepage URL
ksgctdc@ksgct.net
Sponsor or person
Institute
Other
Institute
Department
Personal name
Funding Source
Organization
Asahi Kasei Pharma Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee for Clinical Research, Jichi Medical University Saitama Medical Center
Address
1-847 Amanuma-cho, Omiya-ku, Saitama City, Saitama, Japan
Tel
048-647-2111
ksgctdc@ksgct.net
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
| 2025 | Year | 09 | Month | 17 | 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
| 2025 | Year | 07 | Month | 02 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 16 | Day |
Last follow-up date
| 2028 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
With the increasing availability of antifungal agents, establishing appropriate criteria for drug selection has become essential. This study aims to clarify the current real-world usage of ISAV in Japan, including the patient background, underlying disease, and concomitant therapies influencing its selection. In addition, information on adverse events and therapeutic efficacy will be collected, and the impact of ISAV on the blood concentrations of calcineurin inhibitors will be evaluated. This is expected to provide important clinical information for considering the selection of ISAV, as well as data necessary for dose adjustment. These findings are anticipated to be valuable for the proper management of invasive fungal diseases (IFD), which are significant complications in acute myeloid leukemia (AML) and hematopoietic stem cell transplantation.
Management information
Registered date
| 2025 | Year | 09 | Month | 17 | Day |
Last modified on
| 2025 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067621
