Prospective observational study to assess the long term safety profile of venetoclax in a Swedish cohort of Chronic Lymphocytic Leukaemia (CLL) patients

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/49279
• EU PAS number:
  EUPAS19010
• Study ID:
  49279
• Official title and acronym:
  Prospective observational study to assess the long term safety profile of venetoclax in a Swedish cohort of Chronic Lymphocytic Leukaemia (CLL) patients
• DARWIN EU® study:
  No
• Study countries:
  Sweden
• Study description:
  A large national cohort of CLL patients will be identified based on data from the national health registers (National Patient Register, Swedish Cancer Registry, Swedish Prescribed Drug Register and Cause of Death Register), which will allow for capturing adverse events, co-morbidities, prescribed medication, surgical and other procedures (including whole body skin scans, when performed), outcomes/progression (including adverse events and new malignancies) and mortality data. ; Research question and objectives: ; • To characterize long term safety of venetoclax, including determining the incidence of selected adverse events in CLL patients exposed to venetoclax (Primary objective) ; • To further characterize long term safety of venetoclax, by describing the treated patient population and factors associated with events of interest (Secondary objective a) ; • To compare safety profile of venetoclax against alternative treatment modalities (Secondary objective b) ; • To describe clinical characteristics of CLL patients at diagnosis such as age, gender, staging, comorbidities and prognostic factors (e.g. cytogenetic factors, renal and hepatic function) (Secondary objective c) ; • To describe treatment regimens and sequence of therapy based on patient characteristics and risk factors (Exploratory objective) ; • To assess any clinical outcome as a result of contraindicated medications use in patients who have received venetoclax in a real world setting.
• Study status:
  Ongoing

Research institutions and networks

Institutions

IQVIA

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 07/07/2017

Actual: 18/01/2018

Study start date

Planned: 30/11/2018

Actual: 02/01/2019

Data analysis start date

Planned: 01/01/2019

Actual: 26/09/2019

Date of interim report, if expected

Planned: 31/12/2019

Actual: 10/12/2020

Date of final study report

Planned: 31/03/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AbbVie

Study protocol

Initial protocol

p16-562-protocol-pmos-v3_redacted

Updated protocol

p16562-protocol-pmos-v6_Redacted.pdf

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)