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NCT Number: NCT04964908

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

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

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Key information

Conditions

Chronic Lymphocytic Leukemia Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Buenos Aires, Argentina

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. To describe the clinical characteristics for with chronic lymphocytic leukemia (CLL) patients

    Time frame: 5 year

    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)

  2. Calculation of Epidemiological Measure(s) of Interest

    Time frame: 5 years

    Calculation of Epidemiological Measure(s) of Interest e.g., descriptive statistics, hazard ratios, incidence rates, test/retest reliability)

  3. To describe the clinical characteristics for with chronic lymphocytic leukemia (CLL) patients

    Time frame: 5 Years

    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

  4. To describe the clinical characteristics for with chronic lymphocytic leukemia (CLL) patients

    Time frame: 5 Years

    To describe the clinical characteristics for with chronic lymphocytic leukemia (CLL) patients, recording the patient characteristic:

    • Comorbidities.
    • Risk stratification

  5. To describe disease Characteristics

    Time frame: 5 Years

    To describe Staging of disease, Prognosis, Cytogenetics abnormalities and Immunogenetic analysis

    • Date of diagnosis
    • Staging of disease

  6. To describe disease Characteristics

    Time frame: 5 Years

    To describe Staging of disease, Prognosis, Cytogenetics abnormalities and Immunogenetic analysis

    • Prognosis made by fluorescence in situ hybridization (FISH)
    • Immunogenetic analysis

Secondary outcomes

  1. Recording the treatment patterns

    Time frame: 5 years

    Percentage of patients who received immediate therapy and median time of observation, Number of prior lines of treatment received.

  2. Calculation of Epidemiological Measure(s) of Interest

    Time frame: 5 Years

    • First Treatment received:
    • Number of prior lines of treatment received

  3. Subsequent lines of therapies

    Time frame: 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

Other outcomes

  1. Recording the treatment-related outcomes

    Time frame: 5 years

    Assessment of best response followed the IWCLL 2018 guidelines based on clinical description and biochemistry,

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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.

Acronym: CREEK

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 16, 2021
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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