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Recruiting
NCT06785818
Long-term Follow up Local Registry Study of Kymriah in South Korea
Conditions: B-Cell Acute Lymphoblastic Leukemia, Diffuse Large B-Cell Lymphoma, Follicular Lymphoma
Sex: All
Ages: 0 Years – 100 Years
Healthy volunteers: No
Enrollment: 500
Sponsor: Novartis Pharmaceuticals
Location: Novartis Investigative Site Bundang Gu Gyeonggi-do
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 Criteria
Inclusion Criteria:
1. 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).
2. Consented to data collection.
Exclusion Criteria:
1\. Patients who are enrolled or will be enrolled in the Novartis long term follow-up protocol CCTL019A2205B.
Source: ClinicalTrials.gov (NCT06785818). StuddyBuddy aggregates publicly available trial information.
