Dose Optimization Study of Idelalisib in Follicular Lymphoma

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/33743
• EU PAS number:
  EUPAS15094
• Study ID:
  33743
• Official title and acronym:
  Dose Optimization Study of Idelalisib in Follicular Lymphoma
• DARWIN EU® study:
  No
• Study countries:
  Australia

  Canada

  Czechia

  France

  Israel

  Italy

  Poland

  Romania

  Spain

  United Kingdom
• Study description:
  GS-US-313-1580: The study was terminated early due to enrollment challenges (after enrollment of 96 participants), therefore, the primary objective of the study to establish a safe and effective dosing regimen of idelalisib (IDL) in participants with relapsed or refractory follicular lymphoma (FL) who have no other therapeutic options could not be determined.
• Study status:
  Finalised

Research institution and networks

Institutions

Gilead Sciences

Multiple centres: 44 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 01/09/2015

Actual: 12/06/2015

Study start date

Planned: 14/01/2016

Actual: 14/01/2016

Date of interim report, if expected

Planned: 26/12/2017

Actual: 07/12/2017

Date of final study report

Planned: 31/12/2026

Actual: 25/03/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Gilead Sciences

Study protocol

Initial protocol

amd-2-prot GS-US-313-1580-synopsis only

Updated protocol

GS-US-313-1580-appendix-16.1.1-protocol Amendment 6_f-redact

Regulatory

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