Long-term, Non-interventional Study of Recipients of Yescarta® for Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma, Primary Mediastinal Large B-Cell Lymphoma, and Follicular Lymphoma

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/47191
• EU PAS number:
  EUPAS32539
• Study ID:
  47191
• Official title and acronym:
  Long-term, Non-interventional Study of Recipients of Yescarta® for Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma, Primary Mediastinal Large B-Cell Lymphoma, and Follicular Lymphoma
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  Canada

  Czechia

  France

  Germany

  Italy

  Netherlands

  Poland

  Portugal

  Spain

  Switzerland

  United Kingdom

  United States
• Study description:
  KT-EU-471-0117: This is a long-term, non-interventional study of patients with relapsed/refractory (r/r) diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL) or with relapsed/refractory follicular lymphoma (FL), who have been treated with YESCARTA. Data for this study will be retrieved from ongoing Registry holders EBMT and CIBMTR.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Gilead Sciences

Kite

Study timelines

Date when funding contract was signed

Planned: 31/03/2020

Actual: 23/05/2020

Study start date

Planned: 30/06/2020

Actual: 21/08/2020

Date of final study report

Planned: 30/06/2039

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Kite, A Gilead Company

Study protocol

Initial protocol

KT-EU-471-0117-appendix-16.1.1-protocol amendment 3_f-redact_reducedsize

Updated protocol

KT-EU-471-0117-appendix-16.1.1-protocol amendment 5_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)