Prospective non-interventional post authorization safety study (PASS) of idelalisib in Germany

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/44651
• EU PAS number:
  EUPAS9564
• Study ID:
  44651
• Official title and acronym:
  Prospective non-interventional post authorization safety study (PASS) of idelalisib in Germany
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  GS-DE-312-1750: This was a multicenter, non-interventional, two cohort (CLL and FL), prospective post authorization safety study (PASS) to evaluate the clinical effectiveness and safety of idelalisib for treatment of patients with Chronic Lymphocytic Leukemia (CLL) or Follicular Lymphoma (FL). This design was chosen to assess the effectiveness and safety of therapy with idelalisib up to 3 years per patient in clinical routine. The study enrolled adult patients with either CLL or FL with initiation of treatment with idelalisib alone or in combination with other antineoplastic agents and/or monoclonal antibodies in accordance with the approved label for Zydelig in the European Union (EU) and the current Zydelig EU SmPC. Participating study sites (hospitals and private practitioners) were specialized on treating oncology patients. All study sites were located in Germany. 87 medical centers distributed over all states of Germany participated in the study. The study included 179 adult patients with CLL or FL.
• Study status:
  Finalised

Research institution and networks

Institutions

Gilead Sciences

Multiple centres: 30 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 07/05/2015

Actual: 07/05/2015

Study start date

Planned: 30/09/2015

Actual: 30/09/2015

Data analysis start date

Planned: 31/12/2020

Date of interim report, if expected

Actual: 06/09/2017

Date of final study report

Planned: 31/12/2021

Actual: 10/09/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Gilead Sciences

Study protocol

Initial protocol

amd-4-prot-GS-DE-312-1750

Updated protocol

protocol-GS-DE-312-1750-FINAL-COMPLETE

Regulatory

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