Study of the Use of Venetoclax in Participants With Chronic Lymphocytic Leukemia (CLL) Under Real-Life Setting

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAbbVie

About this trial

An observational study to assess the effectiveness, health economic-relevant costs and participant reported outcomes in participants with Chronic lymphocytic leukemia (CLL) receiving venetoclax as a monotherapy or in combination with rituximab, obinutuzumab, ibrutinib, or acalabrutinib as prescribed at the discretion of the physician and in accordance with local clinical practice and label.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

Participants with chronic lymphocytic leukemia (CLL) administering venetoclax per the local label.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

500 Participants
are grouped into 5 trial groups
Group A: Participants Receiving Venetoclax
Group B: Participants Receiving Venetoclax + Rituximab
Group C: Participants Receiving Venetoclax + Obinutuzumab
Group D: Participants Receiving Venetoclax + Ibrutinib
Group E: Participants Receiving Venetoclax + Acalabrutinib

Trial outcomes

Primary outcomes

1

Percentage of Participants Achieving Best Overall Response Rate (ORR)

ORR is defined as the percentage of participants achieving partial response (PR) and complete response with incomplete regeneration of bone marrow (CRi) and complete response (CR) according to physician's assessment to therapy with venetoclax.

Time frame
Up to 12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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