Non-interventional study to assess the safety profile of idelalisib in patients with refractory follicular lymphoma (FL)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/49406
• EU PAS number:
  EUPAS19618
• Study ID:
  49406
• Official title and acronym:
  Non-interventional study to assess the safety profile of idelalisib in patients with refractory follicular lymphoma (FL)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  France

  Germany

  Greece

  Ireland

  Italy

  Portugal

  Spain

  Sweden

  United Kingdom
• Study description:
  GS-EU-313-4172: The objective of this study was to assess the overall safety profile of idelalisib monotherapy in patients with refractory FL.
• Study status:
  Finalised

Research institution and networks

Institutions

Gilead Sciences

Multiple centres: 83 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 18/08/2016

Actual: 18/08/2016

Study start date

Planned: 02/04/2018

Actual: 25/05/2018

Data analysis start date

Planned: 31/05/2022

Date of interim report, if expected

Planned: 29/03/2019

Actual: 24/06/2019

Date of final study report

Planned: 30/03/2023

Actual: 17/08/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Gilead Sciences

Study protocol

Initial protocol

GS-EU-313-4172 Protocol Final V1.1 13Jun2017

Updated protocol

GS-EU-313-4172-16.1.1-appendix-protocol Amendment 4.1_f-redact

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)