Long-term Follow up Local Registry Study of Kymriah in South Korea
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tisagenlecleucel.
- Who it may be relevant to
- Registry conditions: B-Cell Acute Lymphoblastic Leukemia, Diffuse Large B-Cell Lymphoma, Follicular Lymphoma. Basic parameters: 0 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Registry to Assess Long-Term Safety of Patients With B-Lymphocyte Malignancies Treated With Tisagenlecleucel in South Korea
Overview
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
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.
Interventions
- Other Tisagenlecleucel
This is an observational study. There is no treatment allocation. The decision to initiate tisagenlecleucel will be based solely on clinical judgement.
Primary outcome measures
- The type and frequency of AEs, ADRs, SAEs, SADRs, UAEs, UADRs, USAEs, USADRs, AESI [Time frame: Up to 15 years post-infusion]
- Identify participants for chimeric antigen receptor (CAR) transgene detection and/or CAR surface expression (if applicable). [Time frame: Up to 15 years post-infusion]
- Identify presence of replication competent lentivirus (RCL) in blood or tissues [Time frame: Up to 15 years post-infusion]
Secondary outcome measures (12)
- B-Cell Acute Lymphoblastic Leukemia - Overall response rate (ORR) [Time frame: Up to 15 years post-infusion]
- B-Cell Acute Lymphoblastic Leukemia - Duration of response (DOR) [Time frame: Up to 15 years post-infusion]
- B-Cell Acute Lymphoblastic Leukemia - Relapse-free survival (RFS) [Time frame: Up to 15 years post-infusion]
- B-Cell Acute Lymphoblastic Leukemia - Event-free survival (EFS) [Time frame: 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 [Time frame: Up to 15 years post-infusion]
- Diffuse Large B-Cell Lymphoma - Overall response rate (ORR) [Time frame: Up to 15 years post-infusion]
- Diffuse Large B-Cell Lymphoma - DOR [Time frame: Up to 15 years post-infusion]
- Diffuse Large B-Cell Lymphoma - RFS [Time frame: Up to 15 years post-infusion]
- Diffuse Large B-Cell Lymphoma - Progression-free survival (PFS) [Time frame: Up to 15 years post-infusion]
- Diffuse Large B-Cell Lymphoma - Overall survival (OS) [Time frame: Up to 15 years post-infusion]
- Follicular Lymphoma - ORR [Time frame: Up to 15 years post-infusion]
- Follicular Lymphoma -Complete response rate (CRR) [Time frame: Up to 15 years post-infusion]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
1\. Patients who are enrolled or will be enrolled in the Novartis long term follow-up protocol CCTL019A2205B.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 18 centers
- Novartis Investigative Site — Bundang Gu
- Novartis Investigative Site — Seongnam-si
- Novartis Investigative Site — Gyeonggi-do
- Novartis Investigative Site — Incheon
- Novartis Investigative Site — Seoul
- Novartis Investigative Site — Seoul
- Novartis Investigative Site — Seoul
- Novartis Investigative Site — Seoul
- … and 10 more centers
Identifiers
NCT: NCT06785818 · CCTL019CKR02