Long-term Follow up Local Registry Study of Kymriah in South Korea
Recruiting
Observational Study
B-Cell Acute Lymphoblastic Leukemia, Diffuse Large B-Cell Lymphoma, Follicular Lymphoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
0 – 100
Sex
Any
Study type
Observational
Participants needed
500 (estimated)
Sponsor
Novartis Pharmaceuticals · Industry
Who this trial is looking for
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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.
Trial Locations
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Status
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.
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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.
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