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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tisagenlecleucel | Patients who have been treated with tisagenlecleucel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tisagenlecleucel | Other | This is an observational study. There is no treatment allocation. The decision to initiate tisagenlecleucel will be based solely on clinical judgement. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
1. Patients who are enrolled or will be enrolled in the Novartis long term follow-up protocol CCTL019A2205B.
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Patients with B-Lymphocyte Malignancies Treated with Tisagenlecleucel in South Korea
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novartis Pharmaceuticals | Contact | +41613241111 | novartis.email@novartis.com | |
| Novartis Pharmaceuticals | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Recruiting | Bundang Gu | Gyeonggi-do | 13620 | South Korea | |
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|
| Up to 15 years post-infusion |
| 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. | Up to 15 years post-infusion |
| 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. | Up to 15 years post-infusion |
| 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:
| 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 | 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) | 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 | 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 | 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) | 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) | 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 | 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) | 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 | 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 | 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 | 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) | 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 | pregnancy outcomes:
| Up to 15 years post-infusion |
| Novartis Investigative Site |
| Recruiting |
| Seongnam-si |
| Gyeonggi-do |
| 463-712 |
| South Korea |
| Novartis Investigative Site | Recruiting | Gyeonggi-do | Korea | 10408 | South Korea |
| Novartis Investigative Site | Recruiting | Incheon | Korea | 405 760 | South Korea |
| Novartis Investigative Site | Recruiting | Seoul | Korea | 02841 | South Korea |
| Novartis Investigative Site | Recruiting | Seoul | Korea | 08308 | South Korea |
| Novartis Investigative Site | Recruiting | Seoul | Seoul | 03080 | South Korea |
| Novartis Investigative Site | Recruiting | Seoul | Seoul | 06351 | South Korea |
| Novartis Investigative Site | Recruiting | Seoul | Seoul | 150-713 | South Korea |
| Novartis Investigative Site | Recruiting | Busan | 49201 | South Korea |
| Novartis Investigative Site | Recruiting | Jeollanam | 519763 | South Korea |
| Novartis Investigative Site | Recruiting | Seoul | 03722 | South Korea |
| Novartis Investigative Site | Recruiting | Seoul | 04401 | South Korea |
| Novartis Investigative Site | Recruiting | Seoul | 05505 | South Korea |
| Novartis Investigative Site | Recruiting | Seoul | 06591 | South Korea |
| Novartis Investigative Site | Recruiting | Ulsan | 44033 | South Korea |
| ID | Term |
|---|---|
| D002051 | Burkitt Lymphoma |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000626284 | tisagenlecleucel |
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