Study to Understand Clinical Characteristics, Treatment Pathway in Chronic Lymphocytic Leukemia

Completed

• Conditions: Chronic Lymphocytic Leukemia

• Registration Number: NCT04964908
• Lead Sponsor: AstraZeneca

Brief Summary

A Multicenter Retrospective Study to understand the clinical characteristics, treatment pathway and resource utilization for patients with chronic lymphocytic leukemia A retrospective, multi-centre, observational study to describe disease characteristics, treatment patterns, treatment-related outcomes, and resource utilization for Chronic Lymphocytic Leukemia (CLL) patients in multiple international regions

Detailed Description

CREEK is a retrospective, observational, registry-based study including patients with an incidental diagnosis of CLL and started treatment (1st line, 2nd line, or Subsequent lines of treatment) within the period between 01 June 2016 and 12 months before data collection as identified from the patient records (from participating hospitals across the GCC States and the International region countries) with at least 12 months of follow-up, after starting on treatment.

Moreover, the study will include a pilot cohort in the GCC as an exploratory objective to describe the clinical and patient characteristics for the treatment-naive CLL patient

Study Timeline

• Study First Submitted: 2021-07-08
• Study First Submitted QC: 2021-07-08
• Study First Posted: 2021-07-16
• Study Start: 2021-12-03
• Primary Completion: 2023-08-31
• Study Completion: 2023-08-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-16
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1088

Inclusion Criteria

• Primary diagnosis of Chronic Lymphocytic Leukemia (CLL)

• Initiated CLL treatment (including 1st line, 2nd line, or Subsequent lines of treatment) within the period between 01 June 2016, and 12 months before data collection

  • For GCC pilot cohort patients: treatment-naive CLL patients diagnosed between 01 June 2016, and 12 months before data collection.

• Available medical records at the participating site reflecting at least 12 months of follow-up after starting on treatment (except in the case of the participant death within one year following treatment initiation).

• Provision of informed consent by the patient or next of kin/legal representative (for deceased patients at study entry, unless a waiver was granted), according to local regulations.

• Adult male or female ≥18 years old at the time of diagnosis or according to the age of majority as defined by local regulations).

Exclusion Criteria

• Failure to meet one or more of the inclusion criteria.
• Any diagnosis of B-cell malignancies other than CLL.
• Current or prior use of "acalabrutinib" treatment.
• Currently/previously receiving treatment in an interventional clinical trial at the time of entry into this study for indications CLL.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To describe the clinical characteristics for with chronic lymphocytic leukemia (CLL) patients	5 Years	To describe the clinical characteristics for with chronic lymphocytic leukemia (CLL) patients, recording the patient characteristic: * Comorbidities.; * Risk stratification
To describe disease Characteristics	5 Years	To describe Staging of disease, Prognosis, Cytogenetics abnormalities and Immunogenetic analysis; * Prognosis made by fluorescence in situ hybridization (FISH); * Immunogenetic analysis
Calculation of Epidemiological Measure(s) of Interest	5 years	Calculation of Epidemiological Measure(s) of Interest e.g., descriptive statistics, hazard ratios, incidence rates, test/retest reliability)

Secondary Outcome Measures

Name	Time	Method
Calculation of Epidemiological Measure(s) of Interest	5 Years	* First Treatment received: * Number of prior lines of treatment received
Recording the treatment patterns	5 years	Percentage of patients who received immediate therapy and median time of observation, Number of prior lines of treatment received.
Subsequent lines of therapies	5 Years	Type of regimen (CIT or targeted therapies) and specific regimens or drugs; * Number of cycles; * Duration of treatment; * Pattern of response at the end of the treatment

Trial Locations

Locations (1)

Research Site; 🇦🇪 Abu Dhabi, United Arab Emirates