Long-term, Non-interventional Study of Recipients of Tecartus for Treatment of Adult Patients With Relapsed or Refractory Mantle Cell Lymphoma (MCL)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/50709
• EU PAS number:
  EUPAS45813
• Study ID:
  50709
• Official title and acronym:
  Long-term, Non-interventional Study of Recipients of Tecartus for Treatment of Adult Patients With Relapsed or Refractory Mantle Cell Lymphoma (MCL)
• DARWIN EU® study:
  No
• Study countries:
  Germany

  Spain

  Switzerland

  United Kingdom
• Study description:
  KT-EU-472-6036: This is a long-term, non-interventional study of adult patients with relapsed/refractory (r/r) mantle cell lymphoma (MCL), who have been treated with Tecartus® after 2 or more lines of systemic therapy including a Bruton’s tyrosine kinase inhibitor (BTK). The primary objective of this study is to evaluate effectiveness of Tecartus in terms of overall response rate.
• Study status:
  Planned

Research institution and networks

Institutions

Gilead Sciences

Kite

Study timelines

Date when funding contract was signed

Planned: 31/08/2022

Actual: 18/01/2023

Study start date

Planned: 28/04/2023

Date of final study report

Planned: 31/03/2043

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Kite, A Gilead Company

Study protocol

Initial protocol

KT-EU-472-6036-appendix-16.1.1-protocol version 1.2_f-redact_reducedsize

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)