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B-Cell Acute Lymphoblastic Leukemia, Diffuse Large B-Cell Lymphoma, Follicular LymphomaNCT06785818

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

An observational study of B-Cell Acute Lymphoblastic Leukemia, Diffuse Large B-Cell Lymphoma, Follicular Lymphoma, run by Novartis Pharmaceuticals at 18 sites in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 0 to 100 years
What is being tested?
Tisagenlecleucel
How many people
500 participants
Where
18 sitesSouth Korea
Study dates
12 Mar 2025to 30 Dec 2039
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 to 100 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients with B-Lymphocyte Malignancies Treated with Tisagenlecleucel in South Korea

Who may be able to join

  • 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.

Who cannot join

  • 1. Patients who are enrolled or will be enrolled in the Novartis long term follow-up protocol CCTL019A2205B.

Trial locations and contacts

18 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Novartis Pharmaceuticals contact

+41613241111

novartis.email@novartis.com

Novartis Pharmaceuticals contact

18 sites in 1 country

South Korea18 sites, 18 recruiting

  • Novartis Investigative Site

    Bundang Gu, Gyeonggi-do, 13620

    Recruiting

  • Novartis Investigative Site

    Busan, 49201

    Recruiting

  • Novartis Investigative Site

    Gyeonggi-do, Korea, 10408

    Recruiting

  • Novartis Investigative Site

    Incheon, Korea, 405 760

    Recruiting

  • Novartis Investigative Site

    Jeollanam, 519763

    Recruiting

  • Novartis Investigative Site

    Seongnam-si, Gyeonggi-do, 463-712

    Recruiting

  • Novartis Investigative Site

    Seoul, Korea, 02841

    Recruiting

  • Novartis Investigative Site

    Seoul, Korea, 03312

    Recruiting

  • Novartis Investigative Site

    Seoul, Korea, 08308

    Recruiting

  • Novartis Investigative Site

    Seoul, Seoul, 03080

    Recruiting

  • Novartis Investigative Site

    Seoul, Seoul, 06351

    Recruiting

  • Novartis Investigative Site

    Seoul, Seoul, 150-713

    Recruiting

  • Novartis Investigative Site

    Seoul, Yangcheon gu, 07985

    Recruiting

  • Novartis Investigative Site

    Seoul, 03722

    Recruiting

  • Novartis Investigative Site

    Seoul, 04401

    Recruiting

  • Novartis Investigative Site

    Seoul, 05505

    Recruiting

  • Novartis Investigative Site

    Seoul, 06591

    Recruiting

  • Novartis Investigative Site

    Ulsan, 44033

    Recruiting

Other trials in South Korea

About this study

Official title: 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.

Read the 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.

Being tested
Tisagenlecleucel
Keywords
B-Lymphocyte Malignancies, B-ALL, DLBCL, FL, Tisagenlecleucel, South Korea
Medical subject headings
Burkitt Lymphoma, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TisagenlecleucelOther

    Also called Kymriah®

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

Study groups in NCT06785818
Study groupRoleWhat they receive
TisagenlecleucelPatients who have been treated with tisagenlecleucel
Receives: Other: Tisagenlecleucel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Up to 15 years post-infusion

  2. 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.)

    Measured: Up to 15 years post-infusion

  3. 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.

    Measured: Up to 15 years post-infusion

Secondary outcomes (17)

  1. B-Cell Acute Lymphoblastic Leukemia - Overall response rate (ORR)

    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.

    Measured: Up to 15 years post-infusion

  2. B-Cell Acute Lymphoblastic Leukemia - Duration of response (DOR)

    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.

    Measured: Up to 15 years post-infusion

  3. B-Cell Acute Lymphoblastic Leukemia - Relapse-free survival (RFS)

    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.

    Measured: Up to 15 years post-infusion

  4. B-Cell Acute Lymphoblastic Leukemia - Event-free survival (EFS)

    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)

    Measured: Up to 15 years post-infusion

  5. 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

    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.

    Measured: Up to 15 years post-infusion

  6. Diffuse Large B-Cell Lymphoma - Overall response rate (ORR)

    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)

    Measured: Up to 15 years post-infusion

  7. Diffuse Large B-Cell Lymphoma - DOR

    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.

    Measured: Up to 15 years post-infusion

  8. Diffuse Large B-Cell Lymphoma - RFS

    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.

    Measured: Up to 15 years post-infusion

  9. Diffuse Large B-Cell Lymphoma - Progression-free survival (PFS)

    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.

    Measured: Up to 15 years post-infusion

  10. Diffuse Large B-Cell Lymphoma - Overall survival (OS)

    Overall survival is the time from date of start of treatment to the date of death due to any reason.

    Measured: Up to 15 years post-infusion

  11. Follicular Lymphoma - ORR

    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)

    Measured: Up to 15 years post-infusion

  12. Follicular Lymphoma -Complete response rate (CRR)

    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.

    Measured: Up to 15 years post-infusion

  13. Follicular Lymphoma - DOR

    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.

    Measured: Up to 15 years post-infusion

  14. Follicular Lymphoma - RFS

    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.

    Measured: Up to 15 years post-infusion

  15. Follicular Lymphoma - PFS

    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.

    Measured: Up to 15 years post-infusion

  16. Follicular Lymphoma - Overall survival (OS)

    Overall survival is the time from date of start of treatment to the date of death due to any reason.

    Measured: Up to 15 years post-infusion

  17. Frequency and rate of pregnancy outcomes

    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

    Measured: Up to 15 years post-infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jan 2025
  2. Study start12 Mar 2025
  3. Primary completion30 Dec 2039 (estimated)
  4. Study completion30 Dec 2039 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06785818
Sponsor's protocol ID
CCTL019CKR02
Status last verified
Jul 2026
First submitted
15 Jan 2025
Last updated
30 Jul 2026
Results posted
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of B-Cell Acute Lymphoblastic Leukemia, Diffuse Large B-Cell Lymphoma, Follicular Lymphoma, run by Novartis Pharmaceuticals at 18 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Novartis Pharmaceuticals (+41613241111, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The type and frequency of AEs, ADRs, SAEs, SADRs, UAEs, UADRs, USAEs, USADRs, AESI (time frame: Up to 15 years post-infusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06785818.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.

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