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
1 other identifier
observational
500
1 country
16
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2025
Longer than P75 for all trials
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 15, 2025
CompletedFirst Posted
Study publicly available on registry
January 21, 2025
CompletedStudy Start
First participant enrolled
March 12, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2039
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2039
May 5, 2026
April 1, 2026
14.8 years
January 15, 2025
April 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
The type and frequency of AEs, ADRs, SAEs, SADRs, UAEs, UADRs, USAEs, USADRs, AESI
The type and frequency of adverse event (AE)/adverse drug reaction (ADR)/ serious adverse event (SAE)/serious adverse drug reaction (SADR)/ unexpected adverse event (UAE)/unexpected adverse drug reaction (UADR)/ unexpected serious adverse event (USAE)/unexpected serious adverse drug reaction (USADR)/ adverse event of special interest (AESI)
Up to 15 years post-infusion
Identify participants for chimeric antigen receptor (CAR) transgene detection and/or CAR surface expression (if applicable).
When applicable, identify patients for CAR transgene detection and/or CAR surface expression by quantitative polymerase chain reaction (q-PCR), in-situ hybridization, flow cytometry and/or immunohistochemistry (IHC), whichever testing is appropriate, in relevant samples (blood, bone marrow, etc.)
Up to 15 years post-infusion
Identify presence of replication competent lentivirus (RCL) in blood or tissues
Replication competent lentiviruses (RCL) are virus particles capable of infecting cells and replicating to produce additional infectious particles.
Up to 15 years post-infusion
Secondary Outcomes (17)
B-Cell Acute Lymphoblastic Leukemia - Overall response rate (ORR)
Up to 15 years post-infusion
B-Cell Acute Lymphoblastic Leukemia - Duration of response (DOR)
Up to 15 years post-infusion
B-Cell Acute Lymphoblastic Leukemia - Relapse-free survival (RFS)
Up to 15 years post-infusion
B-Cell Acute Lymphoblastic Leukemia - Event-free survival (EFS)
Up to 15 years post-infusion
B-Cell Acute Lymphoblastic Leukemia - Proportion of patients with minimal residual disease (MRD) negative status in bone marrow who achieve a best overall response (BOR) of CR or CRi
Up to 15 years post-infusion
- +12 more secondary outcomes
Study Arms (1)
Tisagenlecleucel
Patients who have been treated with tisagenlecleucel
Interventions
This is an observational study. There is no treatment allocation. The decision to initiate tisagenlecleucel will be based solely on clinical judgement.
Eligibility Criteria
Patients with B-Lymphocyte Malignancies Treated with Tisagenlecleucel in South Korea
You may qualify if:
- 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).
- Consented to data collection.
You may not qualify if:
- \. Patients who are enrolled or will be enrolled in the Novartis long term follow-up protocol CCTL019A2205B.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Novartis Investigative Site
Bundang Gu, Gyeonggi-do, 13620, South Korea
Novartis Investigative Site
Seongnam-si, Gyeonggi-do, 463-712, South Korea
Novartis Investigative Site
Gyeonggi-do, Korea, 10408, South Korea
Novartis Investigative Site
Incheon, Korea, 405 760, South Korea
Novartis Investigative Site
Seoul, Korea, 02841, South Korea
Novartis Investigative Site
Seoul, Korea, 08308, South Korea
Novartis Investigative Site
Seoul, Seoul, 03080, South Korea
Novartis Investigative Site
Seoul, Seoul, 06351, South Korea
Novartis Investigative Site
Seoul, Seoul, 150-713, South Korea
Novartis Investigative Site
Busan, 49201, South Korea
Novartis Investigative Site
Jeollanam, 519763, South Korea
Novartis Investigative Site
Seoul, 03722, South Korea
Novartis Investigative Site
Seoul, 04401, South Korea
Novartis Investigative Site
Seoul, 05505, South Korea
Novartis Investigative Site
Seoul, 06591, South Korea
Novartis Investigative Site
Ulsan, 44033, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Central Study Contacts
Novartis Pharmaceuticals
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 15, 2025
First Posted
January 21, 2025
Study Start
March 12, 2025
Primary Completion (Estimated)
December 30, 2039
Study Completion (Estimated)
December 30, 2039
Last Updated
May 5, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share