A Study to Assess Effectiveness of Venclexta (Venetoclax) in Patients With Relapse or Refractory Chronic Lymphocytic Leukemia in Routine Clinical Practice in Russian Federation (FORTE)

AbbVie

Status: Completed

Conditions: Cancer; Chronic Lymphocytic Leukemia (CLL)

Treatments: Drug: Venetoclax

Study type: Observational

Funder types: Industry

Identifiers

NCT03873857

P19-569

Details and patient eligibility

About

This study seeks to assess the effectiveness and safety of venetoclax in patients with relapsed and refractory chronic lymphocytic leukemia (CLL) in a real-world setting across clinical practice in the Russian Federation.

Enrollment: 71 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has a confirmed diagnosis of relapsed or refractory CLL.
• Patient for whom the physician has decided to initiate CLL treatment with venetoclax (mono and combo therapy), or up to 4 weeks after venetoclax treatment initiation
• Patient voluntarily agrees to participate in this study and signs informed consent form

Exclusion criteria

• Has contraindications to venetoclax as listed on the approved local label in Russian Federation.
• Has Richter syndrome
• Participated in a clinical trial with an investigative drug for CLL within 30 days prior to treatment initiation

Trial design

71 participants in 1 patient group

Venetoclax

Description:

Participants in this observational study will receive treatment with venetoclax for up to 24 months for treatment of relapsed or refractory CLL. The prescription of a treatment regimen is at the discretion of the physician in accordance with local clinical practice and label, is made independently from this observational study and precedes the decision to offer the patient the opportunity to participate in this study.

Treatment:

Drug: Venetoclax