ReCORD-FL

• Research type

  Research Study

• Full title

  A Retrospective Cohort Study of Treatment Outcomes Among Adult Patients with Refractory or Relapsed Follicular Lymphoma

• IRAS ID

  271895

• Contact name

  Piers Patten

• Contact email

  piers.patten1@nhs.net

• Sponsor organisation

  Novartis Pharmaceuticals Corporation

• Duration of Study in the UK

  0 years, 11 months, 31 days

• Research summary

  This study is a retrospective medical record review in a cohort of patients from multiple oncology centers in the US, United Kingdom (UK), France, Germany, Spain, Canada, and Japan. To obtain an adequate sample size and to include patients treated with different regimens reflecting evolving management strategies over the years (e.g., different eras have brought different agents, including chemoimmunotherapy and PI3K inhibitors into clinical practice), data will be collected from patients with Relapsed/Refractory (R/R) Follicular Lymphoma (FL) treated between 1998 and 2019. The study index date will be defined as the end date of the first qualifying salvage treatment.

  Data will be abstracted by designated site physicians or delegated clinical staff from participating study sites that currently treat patients with r/r FL. Medical records will be evaluated for study inclusion and exclusion.

  There are three general study periods or time points at which study variables will be collected or derived:
  1. From initial diagnosis of FL (earliest 1998) through the study index date;
  2. At the time of the study index date (between January 1, 2000 and July 31, 2017); and
  3. From the study index date until the earliest of the following: death, last available medical record/follow-up, or August 1, 2019

• REC name

  London - Camden & Kings Cross Research Ethics Committee

• REC reference

  20/LO/0073

• Date of REC Opinion

  31 Jan 2020

• REC opinion

  Favourable Opinion