Study identification

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
First published:
22/04/2024
Institution Non-Pharmaceutical company ENCePP partner

Contact details

Hansson Lotta

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of interim report, if expected

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

AbbVie
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)