Long-term follow-up registry for Kymriah (tisagenlecleucel) in South Korea

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, non-interventional registry will collect primary data on patients in South Korea who received commercial tisagenlecleucel (Kymriah) for B-cell malignancies. Participants will be followed for 15 years after infusion to record long-term safety events, the incidence of secondary malignancies, and measures of real-world effectiveness. The registry enrolls patients treated in routine clinical practice or under managed access pathways and excludes those already in the Novartis long-term follow-up protocol CCTL019A2205B. Data collection is observational and based on medical records and scheduled follow-up visits without additional experimental interventions.

Why it matters

Who can join: the full rules

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.

Where it's running

• Novartis Investigative Site
  Bundang Gu, Gyeonggi-do, South Korea Recruiting
• Novartis Investigative Site
  Seongnam-si, Gyeonggi-do, South Korea Recruiting
• Novartis Investigative Site
  Gyeonggi-do, Korea, South Korea Recruiting
• Novartis Investigative Site
  Incheon, Korea, South Korea Recruiting
• Novartis Investigative Site
  Seoul, Korea, South Korea Recruiting
• Novartis Investigative Site
  Seoul, Korea, South Korea Recruiting

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: +41613241111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.