The safety and clinical effectiveness of rapid infusion with CT-P10 in patients with non-Hodgkin’s lymphoma or chronic lymphocytic leukaemia: a retrospective non-interventional post-authorisation safety study in Europe (CT-P10 rapid infusion)

Study identification

• EU PAS number:
  EUPAS25213
• Study ID:
  29185
• Official title and acronym:
  The safety and clinical effectiveness of rapid infusion with CT-P10 in patients with non-Hodgkin’s lymphoma or chronic lymphocytic leukaemia: a retrospective non-interventional post-authorisation safety study in Europe (CT-P10 rapid infusion)
• DARWIN EU® study:
  No
• Study countries:
  France

  Italy

  Spain

  United Kingdom
• Study description:
  In February 2017, CT-P10 became the first biosimilar version of rituximab to be approved by the European Medicines Agency (EMA) for the treatment of rheumatic diseases and specific blood cancers including non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukaemia (CLL). The safety profile of rituximab has been documented in numerous clinical trials, with infusion-related reactions (IRRs), thought to be related to the release of cytokines, being the most commonly reported adverse reaction. To minimise the risk of IRRs, the standard administration protocol for rituximab, specified in the summary of product characteristics, takes approximately three to four hours for the first infusion and two to three hours for subsequent infusions for oncology treatment. This standard infusion protocol places a significant burden on the healthcare system and patients and, consequently, many healthcare professionals now administer rituximab as a rapid infusion (over a period of 90 minutes or less) for second or subsequent infusions in patients who did not experience serious complications with their initial infusion(s). A number of studies have been conducted to evaluate the safety of rapid infusion of rituximab in patients with haematological malignancies and have generally shown rapid administration to be safe and well-tolerated, with low incidences of IRRs. However, there are very limited data available on the safety of rapid infusion of CT-P10. These data are important to inform future decisions by physicians and healthcare providers regarding the most appropriate and cost-effective treatment strategy. This study will address this evidence gap by collecting real world data on the safety and effectiveness of rapidly infused CT-P10 in patients with NHL and CLL in Europe.
• Study status:
  Planned

Research institutions and networks

Institutions

Celltrion

Study timelines

Date when funding contract was signed

Planned:01/04/2018

Study start date

Planned:01/05/2018

Date of final study report

Planned:31/12/2020

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