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

NCT ID: NCT06785818

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

179 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-12

Study Completion Date

2039-12-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Keywords

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B-Lymphocyte Malignancies B-ALL DLBCL FL Tisagenlecleucel South Korea

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Tisagenlecleucel

Patients who have been treated with tisagenlecleucel

Tisagenlecleucel

Intervention Type OTHER

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

Interventions

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Tisagenlecleucel

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

Intervention Type OTHER

Other Intervention Names

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Kymriah®

Eligibility Criteria

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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.
Minimum Eligible Age

0 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Bundang Gu, Gyeonggi-do, South Korea

Site Status RECRUITING

Novartis Investigative Site

Seongnam-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Novartis Investigative Site

Gyeonggi-do, Korea, South Korea

Site Status RECRUITING

Novartis Investigative Site

Incheon, Korea, South Korea

Site Status RECRUITING

Novartis Investigative Site

Seoul, Korea, South Korea

Site Status RECRUITING

Novartis Investigative Site

Seoul, Korea, South Korea

Site Status RECRUITING

Novartis Investigative Site

Seoul, Korea, South Korea

Site Status RECRUITING

Novartis Investigative Site

Seoul, Seoul, South Korea

Site Status RECRUITING

Novartis Investigative Site

Busan, , South Korea

Site Status RECRUITING

Novartis Investigative Site

Seoul, , South Korea

Site Status RECRUITING

Novartis Investigative Site

Seoul, , South Korea

Site Status RECRUITING

Novartis Investigative Site

Seoul, , South Korea

Site Status RECRUITING

Novartis Investigative Site

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Novartis Pharmaceuticals

Role: CONTACT

Phone: +41613241111

Email: [email protected]

Novartis Pharmaceuticals

Role: CONTACT

Other Identifiers

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CCTL019CKR02

Identifier Type: -

Identifier Source: org_study_id