Venetoclax (ABT-199) in Patients with Chronic Lymphocytic Leukemia: Experience through the Pre-Approval Access Program in European Countries: A Medical ChartReview (ExPloReR)

Study identification

• EU PAS number:
  EUPAS32308
• Study ID:
  37622
• Official title and acronym:
  Venetoclax (ABT-199) in Patients with Chronic Lymphocytic Leukemia: Experience through the Pre-Approval Access Program in European Countries: A Medical ChartReview (ExPloReR)
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  United Kingdom
• Study description:
  This study aims to collect real-world evidence of the effectiveness, safety and tolerability of Venetoclax treatment for Chronic Lymphocytic Leukemia (CLL) from medical charts of participants who received Venetoclax as part of Pre-Approval Access (PAA) cohort programs in Europe.
• Study status:
  Finalised

Research institutions and networks

Institutions

Multiple centres: 26 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual:11/12/2017

Study start date

Actual:01/04/2018

Date of final study report

Actual:30/01/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AbbVie

Regulatory

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

Other study registration identification numbers and links

H17-215