Clinical Trial 23963

• Overview

  Study Title:

  A 12-Month, Prospective, Phase IV Study of the Disease Characteristics, Treatment Patterns, Efficacy, Adverse Event Safety Management and Patient-Reported Outcomes of Patients with Relapsed or Refractory Large B-cell Lymphoma Who Have Received Yescarta (axicabtagene ciloleucel) After One Line of Prior Therapy - The RESOLVE Study

  Summary:

  This is a real-world study, meaning we are looking at how treatments for LBCL work in everyday life. In this study, data about the participant and disease characteristics, treatment patterns, safety, and effectiveness of Yescarta, will be collected.

  Objective:

  Primary: To estimate incidence rate and severity of CRS and ICANS To describe and characterize acute AE management practices that include time to onset and duration of CRS and ICANS, duration of hospitalization, incidence and duration of cytopenias and infection Secondary: To assess the clinical effectiveness (i.e., objective response rate, complete response rate, and progression-free survival) To describe patient-reported and caregiver-reported outcomes To describe the patient journey at authorized treatment centers that administer CAR T therapy

• Treatments

  Therapies:

  CD19-directed genetically modified autologous T cell immunotherapy; Cell Therapy

  Medications:

  Axicabtagene Ciloleucel (Yescarta)

• Inclusion Criteria

  Key Inclusion Criteria:
  • Age ≥18 years at time of providing informed consent.
  • Eligible for, and planning to take Yescarta treatment for second line LBCL according to the labelled indication per the investigator discretion.
  • Capable of providing informed consent and agree to collection of PROs.

• Exclusion Criteria

  Key Exclusion Criteria:
  • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the US Prescribing Information or to gentamicin (a possible trace residue).
  • Current participation in any interventional clinical trial at time of screening, or planned participation prior to Yescarta infusion.
  • Prior treatment with CAR T therapy.

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