Clinical effectiveness and safety of CT-P10 in patients with diffuse large B-cell lymphoma: an observational study in Europe

Study identification

• EU PAS number:
  EUPAS25317
• Study ID:
  29188
• Official title and acronym:
  Clinical effectiveness and safety of CT-P10 in patients with diffuse large B-cell lymphoma: an observational study in Europe
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Italy

  Spain

  United Kingdom
• Study description:
  Celltrion manufacture CT-P10, the first monoclonal antibody biosimilar version of rituximab to be approved by the European Medicines Agency (EMA) for the treatment of rheumatic diseases and specific blood cancers including NHL and CLL (4). In France, Germany, Italy, the Netherlands, Spain and the United Kingdom (UK) it is licensed as TruximaTM for intravenous use in adults with rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis, non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukaemia (CLL). Diffuse large B-cell lymphoma (DLBCL) represents 30 to 58% of NHL, with the crude incidence in Europe being 3.8 per 100,000 patient years (5). Patients with DLBCL are often treated with a combination of four chemotherapy drugs, plus rituximab immunotherapy, known by the acronym R-CHOP (6). Clinical similarity between CT-P10 and rituximab has been accepted by the EMA (7). It has been reported that the introduction of CT-P10 in Europe will be associated with significant budget savings, with the reallocation of such enabling more patients to access treatment (8). However, there are currently no studies investigating the effectiveness or safety of CT-P10 treatment in patients with DLBCL in the real world clinical setting. This study will therefore address this evidence gap by collecting real world data on the effectiveness and safety of CT-P10 treatment in patients with DLBCL in European countries.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Celltrion

Study timelines

Date when funding contract was signed

Planned: 01/12/2017

Actual: 06/02/2018

Study start date

Planned: 02/04/2018

Actual: 31/07/2018

Date of final study report

Planned: 01/02/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Celltrion Healthcare Hungary Kft.

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable