Real-World retrospective study on R/R DLBCL patients

• Research type

  Research Study

• Full title

  A NON-INTERVENTIONAL, RETROSPECTIVE, MULTI-CENTER STUDY TO GENERATE REAL-WORLD EVIDENCE OF TREATMENT OUTCOMES IN SUBJECTS WITH RELAPSED/REFRACTORY AGGRESSIVE B-CELL NON-HODGKIN LYMPHOMA

• IRAS ID

  254220

• Contact name

  Christopher Fox

• Contact email

  Christopher.fox@nhs.net

• Sponsor organisation

  Celgene

• Duration of Study in the UK

  0 years, 5 months, 30 days

• Research summary

  Diffuse large B-cell lymphoma (DLBCL) is an aggressive lymphoma. It is the most common type of lymphoma, accounting for approximately 31% of all non-Hodgkin Lymphomas (NHLs) and 37% of B-cell lymphomas worldwide.

  First line therapy for DLBCL generally consists of immunochemotherapy with R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone). However, more than 30% of DLBCL patients do not achieve durable remission and will ultimately relapse. Of these patients, only 30-40% will respond to the standard second-line treatment of salvage chemotherapy and may subsequently undergo consolidation with autologous stem cell transplantation.
  For patients in third and later treatment lines (second or later disease relapse), there is no standard of care and response rates to available therapies are limited.
  Thus, there is an urgent and unmet need for effective treatments for patients with relapsed/refractory (R/R) DLBCL who do not respond to subsequent salvage regimens.

  This global, non-interventional, retrospective, multi-center study aims to describe the clinical outcomes of subjects with R/R DLBCL in real-world settings - as opposed to clinical trial settings - and to understand the current standard of care for patients having received 2 lines of therapy or more. Data collected in this non-interventional cohort study may be compared with data generated in single-arm interventional studies. The study seeks 1,000+ patient observations from multiple sites across the US, Japan, and the EU, recruiting from around three sites within the UK.

  Data will be collected from a combination of known lymphoma databases and electronic case report form (eCRF) questionnaire where the physician or member of the research team will collect data from medical records (see paragraph A13 for more information on data collection methods).

• REC name

  North East - Newcastle & North Tyneside 1 Research Ethics Committee

• REC reference

  19/NE/0021

• Date of REC Opinion

  7 Jan 2019

• REC opinion

  Favourable Opinion