Tokyo, Sept. 18 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059113) titled 'Prospective Observational Study on Individualized Treatment with IsaVuconazole in Eastern Japan:KSGCT multicenter study' on Sept. 17.
Study Type:
Observational
Primary Sponsor:
Institute - Other
Condition:
Condition - blood disorders
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
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
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 Size - 70
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067621
Disclaimer: Curated by HT Syndication.
