Study type

Study type

Non-interventional study

Scope of the study

Safety study (incl. comparative)
Non-interventional study

Non-interventional study design

Other

Non-interventional study design, other

Secondary use of EBMT and CIBMTR data
Study drug and medical condition

Name of medicine

YESCARTA

Medical condition to be studied

Diffuse large B-cell lymphoma
Primary mediastinal large B-cell lymphoma
Follicular lymphoma
Population studied

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

2550
Study design details

Main study objective

The primary objective is to evaluate the incidence rate and severity of adverse drug reactions (ADRs) in patients treated with YESCARTA (pooled and by indication), including secondary malignancies, cytokine release
syndrome (CRS), neurologic events, serious infections, prolonged cytopenias, hypogammaglobulinemia, and
pregnancy outcomes in female patients of childbearing potential or partners of male patients.

Outcomes

Incidence rates of secondary malignancies, CRS, neurologic events, prolonged cytopenias, serious infections, hypogammaglobulinemia and pregnancies, and as applicable severity, time to onset, type and location, management and resolution of these events. Use of replacement immunoglobulin therapy and pregnancy outcome among females with childbearing potential. Overall survival, time to next treatment, relapse or progression of the primary disease, primary and secondary endpoints on subgroups by gender, age, and in special populations. Incidence rates, resolution and time to onset of TLS (also severity) and aggravation of GvHD (chronic and acute, for acute also severity and relationship to cell therapy), frequency of detection of RCR.

Data analysis plan

Analysis of endpoints for this study will include all eligible Yescarta patients within the EBMT Registry and CIBMTR Registry. The following will be summarized descriptively: Categorical variables by number and percentage of patients, including 95% confidence intervals, Continuous variables by mean, standard deviation, median, lower quartile, upper quartile, minimum and maximum. The following analyses will be provided: patient incidence of endpoint events, Multivariate Poisson regression analyses for cumulative incidence rates adjusted for follow-up period, specified subgroups and other potential confounders (demographics and baseline characteristics), Kaplan-Meier curves for all time-to-event data, Competing risk analysis method for time to onset and duration of endpoint events, time to relapse or progression, time to next treatment, and cumulative incidence at specified time points, Cox-proportional Hazard models for multivariate time-to-event data adjusted for subgroups and other potential confounders.