Long-term, Non-interventional Study of Recipients of Tecartus for Treatment of Adult Patients With Relapsed or Refractory Mantle Cell Lymphoma (MCL)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Secondary use of EBMT data

Study drug and medical condition

• Name of medicine:
  TECARTUS
• Medical condition to be studied:
  Mantle cell 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:
  350

Study design details

• Main study objective:
  The primary objective is to evaluate effectiveness of Tecartus in terms of overall response rate.
• Outcomes:
  Overall response rate, Overall survival, complete remission, duration of response, time to next treatment, relapse or progression of the primary disease, safety & effectiveness profile by gender, age, and in special populations. Incidence rates & severity of adverse drug reactions, causes of death, risk of tumor lysis syndrome & aggravated Graft Versus Host Disease, and detection of replication-competent retrovirus.
• Data analysis plan:
  Analysis of all endpoints will include all eligible patients who are documented within the EBMT Registry and are treated with Tecartus. Categorical variables will be summarized descriptively by number and percentage of patients in each categorical definition with 95% confidence intervals. Continuous variables will be summarized descriptively by mean, standard deviation, median, lower quartile, upper quartile, minimum and maximum. Patient incidence of endpoint events will be provided. Multivariate Poisson regression analyses will be used to estimate cumulative incidence rates adjusted for the follow-up period and predefined characteristics, to estimate their prognostic effect on the outcome. Kaplan-Meier (KM) curves will be used to illustrate all time-to-event data. The analysis of the effectiveness endpoints will be conducted when effectiveness data from approximately 200 eligible patients has been documented. Time-to-event endpoints will be analyzed using the KM method.