Last Update: Jul 30, 2026 A Registry to Assess Long-Term Safety of Patients With B-Lymphocyte Malignancies Treated With Tisagenlecleucel in South Korea ClinicalTrials.gov Identifier: [NCT06785818](https://clinicaltrials.gov/ct2/show/NCT06785818) Novartis Reference Number:CCTL019CKR02 [See if you Pre-qualify](#trial-eligibility "See if you Pre-qualify") All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. ## Study Description 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. This study will inform on long-term real-world safety and effectiveness of tisagenlecleucel. The primary objective is to evaluate the long-term safety and the risk of secondary malignancies in patients with B lymphocyte malignancies treated with tisagenlecleucel in a real-world setting. The main secondary objective is to evaluate the longterm effectiveness of tisagenlecleucel. All participants enrolled in this study will be followed up for 15 years from the time of Kymriah® infusion. Condition B-Cell Acute Lymphoblastic Leukemia, Diffuse Large B-Cell Lymphoma, Follicular Lymphoma Overall Status Recruiting Number of Participants500 Start Date Mar 12, 2025 Gender All Age(s) 0 Years - 100 Years (Child, Adult, Older Adult) ## Interventions Other ### Tisagenlecleucel This is an observational study. There is no treatment allocation. The decision to initiate tisagenlecleucel will be based solely on clinical judgement. ## 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. South Korea #### Novartis Investigative Site Recruiting Seoul,Korea,08308,South Korea #### Novartis Investigative Site Recruiting Seoul,Yangcheon gu,07985,South Korea #### Novartis Investigative Site Recruiting Seoul,Korea,03312,South Korea #### Novartis Investigative Site Recruiting Seoul,Seoul,03080,South Korea #### Novartis Investigative Site Recruiting Ulsan,44033,South Korea #### Novartis Investigative Site Recruiting Jeollanam,519763,South Korea #### Novartis Investigative Site Recruiting Seoul,Seoul,150-713,South Korea #### Novartis Investigative Site Recruiting Seoul,03722,South Korea #### Novartis Investigative Site Recruiting Seoul,Seoul,06351,South Korea #### Novartis Investigative Site Recruiting Bundang Gu,Gyeonggi-do,13620,South Korea #### Novartis Investigative Site Recruiting Seoul,Korea,02841,South Korea #### Novartis Investigative Site Recruiting Incheon,Korea,405 760,South Korea #### Novartis Investigative Site Recruiting Gyeonggi-do,Korea,10408,South Korea #### Novartis Investigative Site Recruiting Seongnam-si,Gyeonggi-do,463-712,South Korea #### Novartis Investigative Site Recruiting Seoul,06591,South Korea #### Novartis Investigative Site Recruiting Seoul,05505,South Korea #### Novartis Investigative Site Recruiting Seoul,04401,South Korea #### Novartis Investigative Site Recruiting Busan,49201,South Korea ## Worldwide Contacts If the location of your choosing does not feature any contact detail, please reach out using the information below. #### Novartis Pharmaceuticals Phone: [ +41613241111](tel:+41613241111) Email: