Non-interventional retrospective study evaluating the real-life idelalisib use in the population enrolled in the French cohort Temporary Authorization for Use (ATUc) in Chronic Lymphocytic Leukemia (CLL) and indolent Non-Hodgkin Lymphoma (iNHL) (REALIST)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/30894
• EU PAS number:
  EUPAS19711
• Study ID:
  30894
• Official title and acronym:
  Non-interventional retrospective study evaluating the real-life idelalisib use in the population enrolled in the French cohort Temporary Authorization for Use (ATUc) in Chronic Lymphocytic Leukemia (CLL) and indolent Non-Hodgkin Lymphoma (iNHL) (REALIST)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  GS-FR-312-2033: This real-life retrospective study will collect and describe effectiveness and safety data of idelalisib in monotherapy or in combination with rituximab in adult patients who were previously enrolled in the cohort Authorization for Temporary Use (ATUc) program.
• Study status:
  Finalised

Research institutions and networks

Institutions

Gilead Sciences

Multiple centres: 40 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 18/04/2016

Actual: 15/08/2016

Study start date

Planned: 28/07/2017

Actual: 11/09/2017

Data analysis start date

Planned: 27/11/2017

Actual: 14/06/2018

Date of final study report

Planned: 31/05/2019

Actual: 21/06/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Gilead Sciences SAS

Study protocol

Initial protocol

Realist study_GS-FR-312-2033_V2 12oct2016_signed with noEU PASS register

Regulatory

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