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

April 29, 2026 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Novartis Pharmaceuticals

Study Locations

  • South Korea
      • Busan, South Korea, 49201
        • Recruiting
        • Novartis Investigative Site
      • Jeollanam, South Korea, 519763
        • Recruiting
        • Novartis Investigative Site
      • Seoul, South Korea, 05505
        • Recruiting
        • Novartis Investigative Site
      • Seoul, South Korea, 06591
        • Recruiting
        • Novartis Investigative Site
      • Seoul, South Korea, 03722
        • Recruiting
        • Novartis Investigative Site
      • Seoul, South Korea, 04401
        • Recruiting
        • Novartis Investigative Site
      • Ulsan, South Korea, 44033
        • Recruiting
        • Novartis Investigative Site
    • Gyeonggi-do
      • Bundang Gu, Gyeonggi-do, South Korea, 13620
        • Recruiting
        • Novartis Investigative Site
      • Seongnam-si, Gyeonggi-do, South Korea, 463-712
        • Recruiting
        • Novartis Investigative Site
    • Korea
      • Gyeonggi-do, Korea, South Korea, 10408
        • Recruiting
        • Novartis Investigative Site
      • Incheon, Korea, South Korea, 405 760
        • Recruiting
        • Novartis Investigative Site
      • Seoul, Korea, South Korea, 02841
        • Recruiting
        • Novartis Investigative Site
      • Seoul, Korea, South Korea, 08308
        • Recruiting
        • Novartis Investigative Site
    • Seoul
      • Seoul, Seoul, South Korea, 06351
        • Recruiting
        • Novartis Investigative Site
      • Seoul, Seoul, South Korea, 150-713
        • Recruiting
        • Novartis Investigative Site
      • Seoul, Seoul, South Korea, 03080
        • Recruiting
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with B-Lymphocyte Malignancies Treated with Tisagenlecleucel in South Korea

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Tisagenlecleucel
Patients who have been treated with tisagenlecleucel
Other: Tisagenlecleucel
This is an observational study. There is no treatment allocation. The decision to initiate tisagenlecleucel will be based solely on clinical judgement.
Other Names:
  • Kymriah®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The type and frequency of AEs, ADRs, SAEs, SADRs, UAEs, UADRs, USAEs, USADRs, AESI
Time Frame: Up to 15 years post-infusion
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).
Time Frame: Up to 15 years post-infusion
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
Time Frame: Up to 15 years post-infusion
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
B-Cell Acute Lymphoblastic Leukemia - Overall response rate (ORR)
Time Frame: Up to 15 years post-infusion
The overall response rate (ORR) is defined as the percentage of subjects with a best overall disease response of complete response (CR) or Complete remission with incomplete blood count recovery (CRi). For ALL (Acute Lymphoblastic Leukemia), complete remission is defined as: less than 5% blasts in marrow, less than 1% blasts in blood and no EM disease.
Up to 15 years post-infusion
B-Cell Acute Lymphoblastic Leukemia - Duration of response (DOR)
Time Frame: Up to 15 years post-infusion
Duration of Response (DoR) is defined as the time from first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever was first.
Up to 15 years post-infusion
B-Cell Acute Lymphoblastic Leukemia - Relapse-free survival (RFS)
Time Frame: Up to 15 years post-infusion
RFS is defined as the time from the date of first dose of the study treatment to the date of the first documented disease recurrence or death due to any cause whichever comes first.
Up to 15 years post-infusion
B-Cell Acute Lymphoblastic Leukemia - Event-free survival (EFS)
Time Frame: Up to 15 years post-infusion

Event free survival is the time from the date of start of treatment to the earliest of the following:

  • Death from any cause after remission
  • Relapse
  • Treatment failure (failure to achieve remission, including death without remission)
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
MRD is a term used to describe a very small number of cancer cells that remain in the body during or after treatment. MRD is defined as positive by immunophenotype if 1/1000 cells is positive.
Up to 15 years post-infusion
Diffuse Large B-Cell Lymphoma - Overall response rate (ORR)
Time Frame: Up to 15 years post-infusion
The overall response rate (ORR) is defined as the percentage of subjects with a best overall disease response of complete response (CR) or Partial response (PR)
Up to 15 years post-infusion
Diffuse Large B-Cell Lymphoma - DOR
Time Frame: Up to 15 years post-infusion
Duration of Response (DoR) is defined as the time from first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever was first.
Up to 15 years post-infusion
Diffuse Large B-Cell Lymphoma - RFS
Time Frame: Up to 15 years post-infusion
RFS is defined as the time from the date of first dose of the study treatment to the date of the first documented disease recurrence or death due to any cause whichever comes first.
Up to 15 years post-infusion
Diffuse Large B-Cell Lymphoma - Progression-free survival (PFS)
Time Frame: Up to 15 years post-infusion
Progression-free survival is defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause whichever comes first.
Up to 15 years post-infusion
Diffuse Large B-Cell Lymphoma - Overall survival (OS)
Time Frame: Up to 15 years post-infusion
Overall survival is the time from date of start of treatment to the date of death due to any reason.
Up to 15 years post-infusion
Follicular Lymphoma - ORR
Time Frame: Up to 15 years post-infusion
The overall response rate (ORR) is defined as the percentage of subjects with a best overall disease response of complete response (CR) or Partial response (PR)
Up to 15 years post-infusion
Follicular Lymphoma -Complete response rate (CRR)
Time Frame: Up to 15 years post-infusion
Complete response rate is the proportion of patients with a complete disease response, which is defined as the best disease response recorded from date of start of treatment until progressive disease or start of new anticancer therapy, whichever comes first.
Up to 15 years post-infusion
Follicular Lymphoma - DOR
Time Frame: Up to 15 years post-infusion
Duration of Response (DoR) is defined as the time from first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever was first.
Up to 15 years post-infusion
Follicular Lymphoma - RFS
Time Frame: Up to 15 years post-infusion
RFS is defined as the time from the date of first dose of the study treatment to the date of the first documented disease recurrence or death due to any cause whichever comes first.
Up to 15 years post-infusion
Follicular Lymphoma - PFS
Time Frame: Up to 15 years post-infusion
Progression-free survival is defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause whichever comes first.
Up to 15 years post-infusion
Follicular Lymphoma - Overall survival (OS)
Time Frame: Up to 15 years post-infusion
Overall survival is the time from date of start of treatment to the date of death due to any reason.
Up to 15 years post-infusion
Frequency and rate of pregnancy outcomes
Time Frame: Up to 15 years post-infusion

pregnancy outcomes:

  • Live birth, at term (presence or absence of congenital abnormality)
  • Live birth, premature (presence or absence of congenital abnormality)
  • Intrauterine fetal death
  • Spontaneous abortion
  • Elective abortion
  • Unknown
Up to 15 years post-infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2025

Primary Completion (Estimated)

December 30, 2039

Study Completion (Estimated)

December 30, 2039

Study Registration Dates

First Submitted

January 15, 2025

First Submitted That Met QC Criteria

January 15, 2025

First Posted (Actual)

January 21, 2025

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCTL019CKR02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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