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

Study Overview
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Brief Summary
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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
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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

Official Title
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CREEK is a Multicenter Retrospective Study to Understand the Clinical Characteristics, Treatment Pathway and Resource Utilization for Patients With Chronic Lymphocytic Leukemia in International Region.

Conditions
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Chronic Lymphocytic Leukemia

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe the clinical characteristics for with chronic lymphocytic leukemia (CLL) patients | To describe the clinical characteristics for with chronic lymphocytic leukemia (CLL) patients, recording the patient characteristic: - Demographics: (Age, gender, race, nationality, Performance status, Tobacco use, Family history of malignancies) | 5 year | 
| Calculation of Epidemiological Measure(s) of Interest | Calculation of Epidemiological Measure(s) of Interest e.g., descriptive statistics, hazard ratios, incidence rates, test/retest reliability) | 5 years | 
| To describe the clinical characteristics for with chronic lymphocytic leukemia (CLL) patients | To describe the clinical characteristics for with chronic lymphocytic leukemia (CLL) patients, recording the patient characteristic: Laboratory Status: CBC: Hemoglobin, Total leucocytic count, neutrophils, lymphocytes, and platelets Renal functions: serum creatinine, Urea, eGFR Hepatic function: ALT and AST Concomitant medications: Antagonists of vitamin K Oral Anticoagulants: rivaroxaban, apixaban, dabigatran Proton pump inhibitors (PPIs) H2 Antagonists Antacids Others | 5 Years | 
| To describe the clinical characteristics for with chronic lymphocytic leukemia (CLL) patients | To describe the clinical characteristics for with chronic lymphocytic leukemia (CLL) patients, recording the patient characteristic: Comorbidities. Risk stratification | 5 Years | 
| To describe disease Characteristics | To describe Staging of disease, Prognosis, Cytogenetics abnormalities and Immunogenetic analysis Date of diagnosis Staging of disease | 5 Years | 
| To describe disease Characteristics | To describe Staging of disease, Prognosis, Cytogenetics abnormalities and Immunogenetic analysis Prognosis made by fluorescence in situ hybridization (FISH) Immunogenetic analysis | 5 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recording the treatment patterns | Percentage of patients who received immediate therapy and median time of observation, Number of prior lines of treatment received. | 5 years | 
| Calculation of Epidemiological Measure(s) of Interest | First Treatment received: Number of prior lines of treatment received | 5 Years | 
| Subsequent lines of therapies | 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 | 5 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic lymphocytic leukemia, CLL