Long-term, Non-interventional Study of Recipients of Tecartus for Treatment of Adult Patients With Relapsed or Refractory (R/R) Mantle Cell Lymphoma (MCL) or Adult Patients With R/R B-Cell Precursor Acute Lymphoblastic Leukemia (ALL)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• 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 and CIBMTR data

Study drug and medical condition

• Medicinal product name:
  TECARTUS
• Study drug International non-proprietary name (INN) or common name:
  BREXUCABTAGENE AUTOLEUCEL
• Anatomical Therapeutic Chemical (ATC) code:
  (L01X) OTHER ANTINEOPLASTIC AGENTS

  OTHER ANTINEOPLASTIC AGENTS
• Medical condition to be studied:
  Mantle cell lymphoma

  Acute lymphocytic leukaemia

Population studied

• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  1600

Study design details

• Main study objective:
  To evaluate the effectiveness of Tecartus by indication in terms of ORR (complete response [CR] + partial response [PR]) for MCL and OCR,CR + complete remission with incomplete hematologic recovery [CRi]) for ALL.
• 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, including secondary malignancies, Cytokine Release Syndrome (CRS), neurologic events, serious infections, prolonged cytopenias, non-relapse mortality (NRM) and hypogammaglobulinemia 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, CIBMTR, 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. Poisson regression will be used to determine follow-up adjusted incidence rate. ; Kaplan-Meier (KM) curves will be used to illustrate all time-to-event data without competing risks. For endpoints with competing risks, cumulative incidence will be provided based on competing risks methods.;