PENCIL-A

• Research type

  Research Study

• Full title

  Prospective evaluation of the safety and efficacy of CAR-T therapy in Non-Hodgkin Lymphoma - Axicabtagene ciloleucel

• IRAS ID

  287991

• Contact name

  Andrea Kuhnl

• Contact email

  andrea.kuhnl@nhs.net

• Sponsor organisation

  King’s College Hospital NHS Foundation Trust

• Duration of Study in the UK

  3 years, 0 months, 1 days

• Research summary

  This is a multi-centre observational cohort study. The study will include patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL; including transformed lymphomas) or primary mediastinal B-cell lymphoma (PMBL) treated with axicabtagene ciloleucel (axi-cel) CD19 chimeric antigen receptor T (CAR-T) cells in daily practice. The objectives of the study are to describe safety and clinical outcomes of axi-cel administered for the treatment of high-grade Non-Hodgkin lymphoma (NHL) in clinical practice and to assess exploratory biomarkers of response. Data will be collected from the date of enrolment until 24 months after CAR-T infusion or end of study, whichever comes first. The study will close when the last living patient has completed 12 months follow-up.

• REC name

  Wales REC 3

• REC reference

  22/WA/0125

• Date of REC Opinion

  31 May 2022

• REC opinion

  Further Information Favourable Opinion