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

AbbVie71 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Chronic Lymphocytic Leukemia (CLL)Cancer

Interventions

VenetoclaxDRUG

tablet;oral

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (20)

Oncology Dispensary #2 /ID# 215831

Sochi, Krasnodarskiy Kray, Russia

Outcomes

Primary Outcomes

Objective Response Rate (ORR) 12 Months after Treatment Initiation

ORR is defined as the percentage of participants who reach either complete remission (CR), CR with incomplete bone marrow recovery (CRi), nodular partial remission (nPR), or partial remission (PR) to treatment.

Time frame: Up to approximately 12 months after treatment initiation

Secondary Outcomes

Objective Response Rate (ORR) 24 Months after Treatment Initiation

Time frame: Up to approximately 24 months after treatment initiation

Time to First Response to Treatment

The time to response to treatment is defined by the time between the date of the first venetoclax intake and the date of the first assessment having documented a response (CR, CRi, nPR, and PR).

Time frame: Up to approximately 24 months

Time to Best Response to Treatment

The time to best response to treatment is defined by the time between the date of the first venetoclax intake and the date of the best response documented (CR, CRi, nPR, and PR).

Time frame: Up to approximately 24 months

Duration of Response (DoR)

DoR defined as the number of days from the date of first response (CR, CRi, nPR, or PR) to the date of disease progression or death from any cause, whichever comes first.

Time frame: Up to approximately 24 months

Time To Next Treatment

The time to next treatment is defined as the time between the date of the first venetoclax intake and the date of the first next treatment intake after venetoclax discontinuation.

Data from ClinicalTrials.gov

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