RecruitingNCT06785818

Long-term Follow up Local Registry Study of Kymriah in South Korea

A Registry to Assess Long-Term Safety of Patients With B-Lymphocyte Malignancies Treated With Tisagenlecleucel in South Korea

Sponsor

Novartis Pharmaceuticals

Enrollment

500 participants

Start Date

Mar 12, 2025

Study Type

OBSERVATIONAL

Conditions

B-Cell Acute Lymphoblastic Leukemia, Diffuse Large B-Cell Lymphoma, Follicular Lymphoma

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

Min Age: 0 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This is a long-term follow-up registry study for patients in South Korea who have received Kymriah (tisagenlecleucel) — a CAR-T cell therapy approved for certain blood cancers like leukemia and lymphoma. Researchers are tracking patient outcomes over time to monitor for long-term safety and effectiveness. **You may be eligible if...** - You have received Kymriah (tisagenlecleucel) as a commercial treatment or through a special access program in South Korea - You have given consent for your data to be collected **You may NOT be eligible if...** - You are already enrolled in the Novartis-sponsored long-term follow-up study (CCTL019A2205B) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERTisagenlecleucel

This is an observational study. There is no treatment allocation. The decision to initiate tisagenlecleucel will be based solely on clinical judgement.

Locations(16)

Novartis Investigative Site

Bundang Gu, Gyeonggi-do, South Korea

Novartis Investigative Site

Seongnam-si, Gyeonggi-do, South Korea

Novartis Investigative Site

Gyeonggi-do, Korea, South Korea

Novartis Investigative Site

Incheon, Korea, South Korea

Novartis Investigative Site

Seoul, Korea, South Korea

Novartis Investigative Site

Seoul, Korea, South Korea

Novartis Investigative Site

Seoul, Korea, South Korea

Novartis Investigative Site

Seoul, Seoul, South Korea

Novartis Investigative Site

Seoul, Seoul, South Korea

Novartis Investigative Site

Busan, South Korea

Novartis Investigative Site

Jeollanam, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Ulsan, South Korea

View Full Details on ClinicalTrials.gov

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NCT06785818