Clinical trial NCT06785818: Long-term Follow up Local Registry Study of Kymriah in South Korea
Official title: A Registry to Assess Long-Term Safety of Patients With B-Lymphocyte Malignancies Treated With Tisagenlecleucel in South Korea
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: B-Cell Acute Lymphoblastic Leukemia, Diffuse Large B-Cell Lymphoma, Follicular Lymphoma
Keywords: B-Lymphocyte Malignancies
B-ALL
DLBCL
FL
Tisagenlecleucel
South Korea
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2025-01-21
Enrollment: 500
Sex: ALL
Minimum age (years): 0
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with B-Lymphocyte Malignancies Treated with Tisagenlecleucel in South Korea

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The type and frequency of AEs, ADRs, SAEs, SADRs, UAEs, UADRs, USAEs, USADRs, AESI
timeFrame: Up to 15 years post-infusion
measure: Identify participants for chimeric antigen receptor (CAR) transgene detection and/or CAR surface expression (if applicable).
timeFrame: Up to 15 years post-infusion
measure: Identify presence of replication competent lentivirus (RCL) in blood or tissues
timeFrame: Up to 15 years post-infusion
Secondary outcomes:
measure: B-Cell Acute Lymphoblastic Leukemia - Overall response rate (ORR)
timeFrame: Up to 15 years post-infusion
measure: B-Cell Acute Lymphoblastic Leukemia - Duration of response (DOR)
timeFrame: Up to 15 years post-infusion
measure: B-Cell Acute Lymphoblastic Leukemia - Relapse-free survival (RFS)
timeFrame: Up to 15 years post-infusion
measure: B-Cell Acute Lymphoblastic Leukemia - Event-free survival (EFS)
timeFrame: Up to 15 years post-infusion
measure: 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
timeFrame: Up to 15 years post-infusion
measure: Diffuse Large B-Cell Lymphoma - Overall response rate (ORR)
timeFrame: Up to 15 years post-infusion
measure: Diffuse Large B-Cell Lymphoma - DOR
timeFrame: Up to 15 years post-infusion
measure: Diffuse Large B-Cell Lymphoma - RFS
timeFrame: Up to 15 years post-infusion
measure: Diffuse Large B-Cell Lymphoma - Progression-free survival (PFS)
timeFrame: Up to 15 years post-infusion
measure: Diffuse Large B-Cell Lymphoma - Overall survival (OS)
timeFrame: Up to 15 years post-infusion
measure: Follicular Lymphoma - ORR
timeFrame: Up to 15 years post-infusion
measure: Follicular Lymphoma -Complete response rate (CRR)
timeFrame: Up to 15 years post-infusion
measure: Follicular Lymphoma - DOR
timeFrame: Up to 15 years post-infusion
measure: Follicular Lymphoma - RFS
timeFrame: Up to 15 years post-infusion
measure: Follicular Lymphoma - PFS
timeFrame: Up to 15 years post-infusion
measure: Follicular Lymphoma - Overall survival (OS)
timeFrame: Up to 15 years post-infusion
measure: Frequency and rate of pregnancy outcomes
timeFrame: Up to 15 years post-infusion
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: