Tokyo, Dec. 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059928) titled 'TECENTRIQ Drug Use Surveillance (ENKL)' on Dec. 1.
Study Type:
Observational
Primary Sponsor:
Institute - Chugai Pharmaceutical Co. Ltd
Condition:
Condition - ENKL
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - The following items should be confirmed under the actual conditions of the use of Tecentriq intravenous infusion (hereinafter referred to as this drug) for patients with relapsed or refractory extranodal NK/T-cell lymphoma and nasal type (ENKL) aged 12 to 18 years (hereinafter referred to as children)
Primary objective: Calculation of response rate based on the judgment of the attending physician
Secondary objective: Calculation of the rate of side effects
Basic objectives2 - Safety
Eligibility:
Age-lower limit - 12
years-old
Gender - Male and Female
Key inclusion criteria - Enrolled Cases: All pediatric patients with relapsed or refractory ENKL who plan to use this drug from the date of addition of indication to relapsed or refractory ENKL (September 19, 2025) to the end of the enrollment period
Key exclusion criteria - None
Target Size - 10
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2025 Year 11 Month 26 Day
Date of IRB - 2025 Year 09 Month 04 Day
Anticipated trial start date - 2025 Year 12 Month 01 Day
Last follow-up date - 2028 Year 11 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068532
Disclaimer: Curated by HT Syndication.
