Long-term follow-up registry for Kymriah (tisagenlecleucel) in South Korea
A Registry to Assess Long-Term Safety of Patients With B-Lymphocyte Malignancies Treated With Tisagenlecleucel in South Korea
This project will follow people in Korea with B-cell leukemias or lymphomas who received Kymriah to see if the treatment stays safe and continues to work well over many years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 0 Years to 100 Years |
| Sex | All |
| Sponsor | Novartis Industry-sponsored |
| Locations | 16 sites (Bundang Gu, Gyeonggi-do and 15 other locations) |
| Trial ID | NCT06785818 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients in South Korea with B-ALL, DLBCL, or follicular lymphoma who have received commercial tisagenlecleucel (Kymriah) and consent to long-term data collection.
Not a fit: Patients who have not received commercial tisagenlecleucel, those enrolled in the Novartis long-term follow-up protocol CCTL019A2205B, or those who do not consent to data collection would not be included and therefore would not receive benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could clarify long-term safety and secondary malignancy risk and help clinicians and patients make better-informed decisions about Kymriah use in Korea.
How similar studies have performed: Other long-term postmarketing registries and follow-up programs for CAR‑T therapies have produced useful safety and durability data, so the approach is established though some long-term risks remain under study.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bundang Gu, Gyeonggi-do and 15 other locations
- 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)
- Novartis Investigative Site — Seoul, Seoul, South Korea (Recruiting)
- Novartis Investigative Site — Seoul, Seoul, South Korea (Recruiting)
- Novartis Investigative Site — Seoul, Seoul, South Korea (Recruiting)
- Novartis Investigative Site — Busan, South Korea (Recruiting)
- Novartis Investigative Site — Jeollanam, South Korea (Recruiting)
- Novartis Investigative Site — Seoul, South Korea (Recruiting)
- Novartis Investigative Site — Seoul, South Korea (Recruiting)
- Novartis Investigative Site — Seoul, South Korea (Recruiting)
- Novartis Investigative Site — Seoul, South Korea (Recruiting)
- Novartis Investigative Site — Ulsan, South Korea (Recruiting)
Study contacts
- Study coordinator: Novartis Pharmaceuticals
- Email: novartis.email@novartis.com
- Phone: +41613241111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.