RecruitingNCT06785818
Long-term Follow up Local Registry Study of Kymriah in South Korea
A Registry to Assess Long-Term Safety of Patients With B-Lymphocyte Malignancies Treated With Tisagenlecleucel in South Korea
Sponsor
Novartis Pharmaceuticals
Enrollment
500 participants
Start Date
Mar 12, 2025
Study Type
OBSERVATIONAL
Conditions
Summary
This study is multicenter, primary data collection, non-interventional registry study to assess long-term safety, secondary malignancy risk, and effectiveness of tisagenlecleucel in patients with B-cell malignancies in a routine clinical practice setting in Korea.
Eligibility
Min Age: 0 YearsMax Age: 100 Years
Inclusion Criteria2
- Patients who receive tisagenlecleucel infusion in the commercial setting, treated under a managed access program or other pathway, e.g., when product was manufactured for the commercial setting but turned out to be out of specification (OOS).
- Consented to data collection.
Exclusion Criteria1
- \. Patients who are enrolled or will be enrolled in the Novartis long term follow-up protocol CCTL019A2205B.
Interventions
OTHERTisagenlecleucel
This is an observational study. There is no treatment allocation. The decision to initiate tisagenlecleucel will be based solely on clinical judgement.
Locations(16)
View Full Details on ClinicalTrials.gov
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NCT06785818