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.
Study Type
OBSERVATIONAL
Enrollment
500
This is an observational study. There is no treatment allocation. The decision to initiate tisagenlecleucel will be based solely on clinical judgement.
Novartis Investigative Site
Bundang Gu, Gyeonggi-do, South Korea
RECRUITINGThe 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)
Time frame: 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.)
Time frame: 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.
Time frame: Up to 15 years post-infusion
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.
Time frame: 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.
Novartis Pharmaceuticals
CONTACT
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Novartis Investigative Site
Seongnam-si, Gyeonggi-do, South Korea
Novartis Investigative Site
Gyeonggi-do, Korea, South Korea
RECRUITINGNovartis Investigative Site
Incheon, Korea, South Korea
RECRUITINGNovartis Investigative Site
Seoul, Korea, South Korea
RECRUITINGNovartis Investigative Site
Seoul, Korea, South Korea
RECRUITINGNovartis Investigative Site
Seoul, Korea, South Korea
RECRUITINGNovartis Investigative Site
Seoul, Seoul, South Korea
RECRUITINGNovartis Investigative Site
Seoul, Seoul, South Korea
RECRUITINGNovartis Investigative Site
Seoul, Seoul, South Korea
RECRUITING...and 8 more locations
Time frame: 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.
Time frame: 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: * Death from any cause after remission * Relapse * Treatment failure (failure to achieve remission, including death without remission)
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
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.
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 15 years post-infusion
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
Time frame: Up to 15 years post-infusion